Parkinson's disease (PD) affects over 10 million worldwide, causing unstable gait and falls in 70% of patients despite medication. This leads to confidence loss, isolation, fractures, and hospitalizations. Treadmill training, augmented by mechanical/virtual-reality triggers, has proven effective in enhancing gait and reducing falls. However, underlying treadmill training mechanisms are unclear. To personalize training, we'll explore how PD patients benefit and transfer effects to daily life. This trial is part of three parallel randomized controlled trials within the Steps Against the Burden of Parkinson's Disease (CT-IDs: 6ef2e427b002, 6ef2e427b003, 6ef2e427b004) project, which will perform a pooled analysis across all sites in addition to individual RCT analyses. Each trial adheres to a shared core protocol while allowing for adaptations in the perturbation protocol, ensuring that data can be combined. Importantly, mechanistic findings and outcomes from this specific RCT will be reported independently, but also as part of a pooled analysis. In this trials, PD patients will undergo treadmill training with and without adaptaions (perturbations). 12 sessions of treadmill training will be provided, with pre/post assessments and a follow-up with pre/post assessments and a follow-up at 8 to 12 weeks after the post assessment. For post treadmill training a phone app will be offered as a home-based speed dependent walk training intervention. This intervention is an App based training for gait adaptability and allows users to set their own training time and pace. It delivers a rhythmic metronomic beat for three different walking speeds, designed to trigger movement and encourage better walking patterns.. Gait improvements are expected, driven by sensorimotor integration improving balance control. Biomechanical data analysis will reveal enhanced foot placement control. Neurophysiological changes will be studied through EEG and EMG, aiming to find improved gait stability with reduced EEG beta power and increased EEG-EMG coherence. Gait improvement in the lab might not correlate with daily-life results. Gait self-efficacy could influence transfer, prompting investigation into mechanistic associations with mobility outcomes. Remote digital tools will assess week-long mobility outcomes, employing machine learning to comprehend why some improve both in lab and life, while others don't. This will uncover mechanisms translating treatment effects into real-world outcomes, aiding personalized intervention development.
i. Rationale The rationale of this trial is that speed dependent treadmill training (SDTT) improves gait through improved sensorimotor integration, with changes in cortical activity as neural correlates. Additional benefits of treadmill training can be seen if perturbation or adaptations are added. This is based on the idea, that in addition to the sensorimotor integration the reactive balance in trained as well18. Furthermore, it hypothesizes that treadmill training and its effects on gait quality will improve gait self-efficacy, which mediates and/or modifies transfer of training effects to improved daily-life gait. ii. Objectives Thus, the objectives of our StepuP project are: 1. To understand the kinematic and neural mechanisms that underlie improvements in gait due to treadmill training with and without mechanically and VR-triggered gait adaptations in people with PD; 2. To assess to what extent improvements in gait due to treadmill training, as measured in the lab, transfer to improvements in daily life mobility; 3. To understand the mechanisms that underpin transfer from improvements in gait to improvements of mobility in daily life in people with PD; 4. To understand for whom treadmill training improves lab-based gait characteristics and for whom it does not, and understand for whom treadmill training improves mobility in daily life and for whom it does not. Attaining these objectives will provide a better understanding of the successes and failures of treadmill training to improve gait stability and prevent falls in people with PD at an individual level, which in the medium term will allow targeted delivery of such interventions and in the long term will allow personalization of such interventions to improve outcomes for all. iii. Endpoints Concerning the endpoints, this trial examines the effect of treadmill training with and without perturbations on gait performance, and neural correlates in people with PD. The primary endpoint is (change in) gait speed, secondary endpoints are divided into three groups (clinical, kinematic and neurophysiological). Clinical measures are used to assess the effect of training on disease symptoms. Kinematic measures are changes from baseline to follow-up, all under controlled conditions (treadmill), and provide insight into gait performance and quality. Neurophysiological measures aim to understand the neural control mechanisms underlying the training effects. On an exploratory level, the study aims to assess the training effects on daily-life gait by using wearable devices and assess gait self-efficacy using previously validated questionnaires.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
42
The SDTT+ VR triggered adaptations program will trigger reactive gait adaptations by presenting obstacles in VR.
This training methodology focuses on adjusting the treadmill's speed according to the individual's walking pace, creating a more dynamic and adaptive exercise environment. SDTT is designed to mimic real-world walking conditions and challenges, promoting neuromuscular coordination, balance, and overall mobility. By tailoring the treadmill speed to match the user's gait, SDTT encourages the development of natural and efficient walking patterns. This training technique has shown promise in various clinical settings, aiding individuals with gait impairments caused by neurological conditions, musculoskeletal disorders, or post-injury rehabilitation. Its adaptability allows for progressive adjustments as a person's walking abilities improve, making it a versatile tool for optimizing gait mechanics and functional mobility. To ensure continued progress and integration into daily life, home-based walking training, supported by a phone application, will be included between T1 and T2.
Tel-Aviv Sourasky Medical Center
Tel Aviv, Israel
RECRUITINGIRCCS Istituto delle Scienze Neurologiche di Bologna
Bologna, Italy
RECRUITINGGait speed - T0
Comfortable walking speed overground
Time frame: Baseline
Gait speed - T1
Comfortable walking speed overground
Time frame: After Intervention (2-12 weeks)
Gait speed - T2
Comfortable walking speed overground
Time frame: After Follow-up 12±2 weeks following T1 (20-32 weeks)
Fall events (occurrence and frequency) and fall related injuries - T0
The number of falls and whether the falls were injurious will be recorded. Twelve-month retrospective.
Time frame: Baseline (T0)
Fracture history - T0
Number and type of fracture sustained will be recorded. Twelve-month retrospective.
Time frame: Baseline (T0)
Medication - T0
Current medication will be recorded at each visit.
Time frame: Baseline (T0)
Medication - T1
Current medication will be recorded at each visit.
Time frame: After Intervention (2-12 weeks)
Medication - T2
Current medication will be recorded at each visit.
Time frame: Follow-up 12±2 weeks following T1
Euro-Quality of life (EQ-5D) - T0
The first part is a descriptive system, assessing health in five dimensions.The second part of the questionnaire consists of a visual analog scale (VAS) on which patients mark their perceived level of health on a scale ranging from 0 (worst conceivable state of health) to 100 (best conceivable state of health).
Time frame: Baseline (T0)
Euro-Quality of life (EQ-5D) - T1
The first part is a descriptive system, assessing health in five dimensions.The second part of the questionnaire consists of a visual analog scale (VAS) on which patients mark their perceived level of health on a scale ranging from 0 (worst conceivable state of health) to 100 (best conceivable state of health).
Time frame: After Intervention (2-12 weeks)
Euro-Quality of life (EQ-5D) - T2
The first part is a descriptive system, assessing health in five dimensions.The second part of the questionnaire consists of a visual analog scale (VAS) on which patients mark their perceived level of health on a scale ranging from 0 (worst conceivable state of health) to 100 (best conceivable state of health).
Time frame: Follow-up 12±2 weeks following T1
Frailty Index (FI) - T0
Measures frailty based on five criteria: shrinking, low physical endurance/energy, low physical activity, weakness, and slow walking speed.
Time frame: Baseline (T0)
Frailty Index (FI) - T1
Measures frailty based on five criteria: shrinking, low physical endurance/energy, low physical activity, weakness, and slow walking speed. For the Frailty Index, higher scores mean a worse outcome (increased frailty).
Time frame: After Intervention (2-12 weeks)
Frailty Index (FI) - T2
Measures frailty based on five criteria: shrinking, low physical endurance/energy, low physical activity, weakness, and slow walking speed. For the Frailty Index, higher scores mean a worse outcome (increased frailty).
Time frame: Follow-up 12±2 weeks following T1
Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue scale - T0
Measures fatigue during usual daily activities over the past week. The FACIT-F scale consists of 13 items, each scored from 0 (Not at all) to 4 (Very much). Some items are reverse-scored. The total score ranges from 0 to 52. For the FACIT-F scale, higher scores indicate less fatigue (a better outcome).
Time frame: Baseline (T0)
Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue scale - T1
Measures fatigue during usual daily activities over the past week. The FACIT-F scale consists of 13 items, each scored from 0 (Not at all) to 4 (Very much). Some items are reverse-scored. The total score ranges from 0 to 52. For the FACIT-F scale, higher scores indicate less fatigue (a better outcome).
Time frame: After Intervention (2-12 weeks)
Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue scale - T2
Measures fatigue during usual daily activities over the past week. The FACIT-F scale consists of 13 items, each scored from 0 (Not at all) to 4 (Very much). Some items are reverse-scored. The total score ranges from 0 to 52. For the FACIT-F scale, higher scores indicate less fatigue (a better outcome).
Time frame: Follow-up 12±2 weeks following T1
Kinematics: 3D motion capture data - T0
3D motion capture data.
Time frame: Baseline
Kinematics: 3D motion capture data - T1
3D motion capture data.
Time frame: After Intervention (2-12 weeks)
Kinematics: 3D motion capture data - T2
3D motion capture data.
Time frame: Follow-up 12±2 weeks following T1
Electroencephalography (EEG) - T0
EEG measures brain activity to assess cortical involvement and sensorimotor integration for foot placement control. We'll specifically analyze beta power and beta band corticomuscular coherence with the rectus femoris muscle. Before analysis, EEG data will be cleaned using filtering and ICA to remove artifacts like muscle and eye movements. Coherence will be computed across the gait cycle using time-normalized EEG and EMG cross-spectra, and beamforming will localize sources.
Time frame: Baseline
Electroencephalography (EEG) - T1
EEG measures brain activity to assess cortical involvement and sensorimotor integration for foot placement control. We'll specifically analyze beta power and beta band corticomuscular coherence with the rectus femoris muscle. Before analysis, EEG data will be cleaned using filtering and ICA to remove artifacts like muscle and eye movements. Coherence will be computed across the gait cycle using time-normalized EEG and EMG cross-spectra, and beamforming will localize sources.
Time frame: After Intervention (2-12 weeks)
Electroencephalography (EEG) - T2
EEG measures brain activity to assess cortical involvement and sensorimotor integration for foot placement control. We'll specifically analyze beta power and beta band corticomuscular coherence with the rectus femoris muscle. Before analysis, EEG data will be cleaned using filtering and ICA to remove artifacts like muscle and eye movements. Coherence will be computed across the gait cycle using time-normalized EEG and EMG cross-spectra, and beamforming will localize sources.
Time frame: Follow-up 12±2 weeks following T1
Electromyography (EMG) - T0
Surface EMG records electrical activity of superficial muscles to assess muscle function, fatigue, and activation patterns.
Time frame: Baseline
Electromyography (EMG) - T1
Surface EMG records electrical activity of superficial muscles to assess muscle function, fatigue, and activation patterns.
Time frame: After Intervention (2-12 weeks)
Electromyography (EMG) - T2
Surface EMG records electrical activity of superficial muscles to assess muscle function, fatigue, and activation patterns.
Time frame: Follow-up 12±2 weeks following T1
Gait speed (Preferred and maximal) - T0
Preferred gait speed and maximal gait speed using a 20-m walk test will be derived.
Time frame: Baseline
Gait speed (Preferred and maximal) - T1
Preferred gait speed and maximal gait speed using a 20-m walk test will be derived.
Time frame: After Intervention (2-12 weeks)
Gait speed (Preferred and maximal) - T2
Preferred gait speed and maximal gait speed using a 20-m walk test will be derived.
Time frame: Follow-up 12±2 weeks following T1
Use of mobility aids - T0
The use of commonly used walking aids (indoor and outdoor) will be recorded.
Time frame: Baseline
Use of mobility aids - T2
The use of commonly used walking aids (indoor and outdoor) will be recorded.
Time frame: Follow-up 12±2 weeks following T1
Timed Up and Go (TUG) - T0
A common clinical measure to assess mobility, balance, and walking ability in older adults.
Time frame: Baseline
Timed Up and Go (TUG) - T1
A common clinical measure to assess mobility, balance, and walking ability in older adults.
Time frame: After Intervention (2-12 weeks)
Timed Up and Go (TUG) - T2
A common clinical measure to assess mobility, balance, and walking ability in older adults.
Time frame: Follow-up 12±2 weeks following T1
Two-minute walking test (2MWT) - T0
Measures functional exercise capacity. Distance in meters covered in 6 minutes is recorded.
Time frame: Baseline
Two-minute walking test (2MWT) - T1
Measures functional exercise capacity. Distance in meters covered in 6 minutes is recorded.
Time frame: After Intervention (2-12 weeks)
Two-minute walking test (2MWT) - T2
Measures functional exercise capacity. Distance in meters covered in 6 minutes is recorded.
Time frame: Follow-up 12±2 weeks following T1
Mini-BESTest - T0
The Mini-BESTest (Mini-Balance Evaluation Systems Test) is a clinical balance assessment tool designed to evaluate various balance control systems. It assesses an individual's balance and stability on a series of functional tasks. The unabbreviated scale title is Mini-Balance Evaluation Systems Test (Mini-BESTest). It has a minimum value of 0 and a maximum value of 28. The Mini-BESTest is comprised of 14 items, each scored on a 3-point ordinal scale (0 = severe impairment, 1 = moderate impairment, 2 = no impairment). The scores from all items are summed to provide a total score. Higher scores on the Mini-BESTest indicate better balance and stability, representing a better outcome.
Time frame: Baseline
Mini-BESTest - T1
The Mini-BESTest (Mini-Balance Evaluation Systems Test) is a clinical balance assessment tool designed to evaluate various balance control systems. It assesses an individual's balance and stability on a series of functional tasks. The unabbreviated scale title is Mini-Balance Evaluation Systems Test (Mini-BESTest). It has a minimum value of 0 and a maximum value of 28. The Mini-BESTest is comprised of 14 items, each scored on a 3-point ordinal scale (0 = severe impairment, 1 = moderate impairment, 2 = no impairment). The scores from all items are summed to provide a total score. Higher scores on the Mini-BESTest indicate better balance and stability, representing a better outcome.
Time frame: After Intervention (2-12 weeks)
Mini-BESTest - T2
The Mini-BESTest (Mini-Balance Evaluation Systems Test) is a clinical balance assessment tool designed to evaluate various balance control systems. It assesses an individual's balance and stability on a series of functional tasks. The unabbreviated scale title is Mini-Balance Evaluation Systems Test (Mini-BESTest). It has a minimum value of 0 and a maximum value of 28. The Mini-BESTest is comprised of 14 items, each scored on a 3-point ordinal scale (0 = severe impairment, 1 = moderate impairment, 2 = no impairment). The scores from all items are summed to provide a total score. Higher scores on the Mini-BESTest indicate better balance and stability, representing a better outcome.
Time frame: Follow-up 12±2 weeks following T1
Modified Gait Efficacy Scale (mGES) - T0
The Modified Gait Efficacy Scale (mGES) assesses an individual's confidence in their walking ability across various challenging everyday circumstances. It is a self-report measure. The unabbreviated scale title is Modified Gait Efficacy Scale (mGES). It has a minimum value of 0 and a maximum value of 100. The mGES typically consists of several items where individuals rate their confidence on a scale (e.g., 0-10 or 0-100) for various walking situations. The total score is often calculated as an average or sum and then converted to a percentage. Higher scores on the Modified Gait Efficacy Scale indicate greater walking confidence, representing a better outcome.
Time frame: Baseline
Modified Gait Efficacy Scale (mGES) - T1
The Modified Gait Efficacy Scale (mGES) assesses an individual's confidence in their walking ability across various challenging everyday circumstances. It is a self-report measure. The unabbreviated scale title is Modified Gait Efficacy Scale (mGES). It has a minimum value of 0 and a maximum value of 100. The mGES typically consists of several items where individuals rate their confidence on a scale (e.g., 0-10 or 0-100) for various walking situations. The total score is often calculated as an average or sum and then converted to a percentage. Higher scores on the Modified Gait Efficacy Scale indicate greater walking confidence, representing a better outcome.
Time frame: After Intervention (2-12 weeks)
Modified Gait Efficacy Scale (mGES) - T2
The Modified Gait Efficacy Scale (mGES) assesses an individual's confidence in their walking ability across various challenging everyday circumstances. It is a self-report measure. The unabbreviated scale title is Modified Gait Efficacy Scale (mGES). It has a minimum value of 0 and a maximum value of 100. The mGES typically consists of several items where individuals rate their confidence on a scale (e.g., 0-10 or 0-100) for various walking situations. The total score is often calculated as an average or sum and then converted to a percentage. Higher scores on the Modified Gait Efficacy Scale indicate greater walking confidence, representing a better outcome.
Time frame: Follow-up 12±2 weeks following T1
Hand grip strength - T0
Hand grip strength.
Time frame: Baseline
Short Falls Efficacy Scale International (Short FES-i) - T0
The Short Falls Efficacy Scale International (Short FES-I) measures the level of concern about falling during social and physical activities, both inside and outside the home. It is a widely used self-report questionnaire. It has a minimum value of 7 and a maximum value of 28. The Short FES-I consists of 7 items. Each item is rated on a 4-point scale, from 1 (not concerned at all) to 4 (completely concerned). The scores for all 7 items are summed. Higher scores on the Short FES-I indicate a greater concern about falling, representing a worse outcome.
Time frame: Baseline
Short Falls Efficacy Scale International (Short FES-i) - T1
The Short Falls Efficacy Scale International (Short FES-I) measures the level of concern about falling during social and physical activities, both inside and outside the home. It is a widely used self-report questionnaire. It has a minimum value of 7 and a maximum value of 28. The Short FES-I consists of 7 items. Each item is rated on a 4-point scale, from 1 (not concerned at all) to 4 (completely concerned). The scores for all 7 items are summed. Higher scores on the Short FES-I indicate a greater concern about falling, representing a worse outcome.
Time frame: After Intervention (2-12 weeks)
Short Falls Efficacy Scale International (Short FES-i) - T2
The Short Falls Efficacy Scale International (Short FES-I) measures the level of concern about falling during social and physical activities, both inside and outside the home. It is a widely used self-report questionnaire. It has a minimum value of 7 and a maximum value of 28. The Short FES-I consists of 7 items. Each item is rated on a 4-point scale, from 1 (not concerned at all) to 4 (completely concerned). The scores for all 7 items are summed. Higher scores on the Short FES-I indicate a greater concern about falling, representing a worse outcome.
Time frame: Follow-up 12±2 weeks following T1
Montreal Cognitive Assessment (MoCA) - T0
The Montreal Cognitive Assessment (MoCA) is a quick screening tool designed to detect mild cognitive impairment, assessing a broad range of cognitive domains. It has a minimum value of 0 and a maximum value of 30. The MoCA assesses attention and concentration, executive functions, memory, language, visuospatial skills, conceptual thinking, calculations, and orientation. Each correct response contributes to the total score. A score of 26 or above is generally considered normal. Higher scores on the MoCA indicate better cognitive function, representing a better outcome.
Time frame: Baseline
Montreal Cognitive Assessment (MoCA) - T2
The Montreal Cognitive Assessment (MoCA) is a quick screening tool designed to detect mild cognitive impairment, assessing a broad range of cognitive domains. It has a minimum value of 0 and a maximum value of 30. The MoCA assesses attention and concentration, executive functions, memory, language, visuospatial skills, conceptual thinking, calculations, and orientation. Each correct response contributes to the total score. A score of 26 or above is generally considered normal. Higher scores on the MoCA indicate better cognitive function, representing a better outcome.
Time frame: Follow-up 12±2 weeks following T1
Color Trail Test (CTT) - T0
The Color Trail Test (CTT) is a neuropsychological assessment with two parts (CTT-1, CTT-2) that evaluates cognitive flexibility, visual scanning, and executive function. Participants connect numbered circles, then alternate between numbers and letters. Key measures are completion time (min 0s, max typically 120-240s) and errors. Lower times and fewer errors indicate better attention, mental flexibility, and processing speed, signifying a better outcome.
Time frame: Baseline
Color Trail Test (CTT) - T2
The Color Trail Test (CTT) is a neuropsychological assessment with two parts (CTT-1, CTT-2) that evaluates cognitive flexibility, visual scanning, and executive function. Participants connect numbered circles, then alternate between numbers and letters. Key measures are completion time (min 0s, max typically 120-240s) and errors. Lower times and fewer errors indicate better attention, mental flexibility, and processing speed, signifying a better outcome.
Time frame: Follow-up 12±2 weeks following T1
Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) - T0
The Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is a comprehensive, clinician-rated scale used to assess the severity and progression of Parkinson's Disease. Part III specifically focuses on the Motor Examination. It has a minimum value of 0 and a maximum value of 132 (sum of all 33 items in Part III, each scored 0-4). Part III consists of 33 items (e.g., speech, facial expression, rigidity, tremor, bradykinesia, gait, postural stability), each scored from 0 (normal) to 4 (severe impairment). The scores for all items are summed. Higher scores on the MDS-UPDRS Part III indicate greater motor impairment and more severe Parkinson's disease symptoms, representing a worse outcome.
Time frame: Baseline
Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) - T1
The Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is a comprehensive, clinician-rated scale used to assess the severity and progression of Parkinson's Disease. Part III specifically focuses on the Motor Examination. It has a minimum value of 0 and a maximum value of 132 (sum of all 33 items in Part III, each scored 0-4). Part III consists of 33 items (e.g., speech, facial expression, rigidity, tremor, bradykinesia, gait, postural stability), each scored from 0 (normal) to 4 (severe impairment). The scores for all items are summed. Higher scores on the MDS-UPDRS Part III indicate greater motor impairment and more severe Parkinson's disease symptoms, representing a worse outcome.
Time frame: After Intervention (2-12 weeks)
Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) - T2
The Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) is a comprehensive, clinician-rated scale used to assess the severity and progression of Parkinson's Disease. Part III specifically focuses on the Motor Examination. It has a minimum value of 0 and a maximum value of 132 (sum of all 33 items in Part III, each scored 0-4). Part III consists of 33 items (e.g., speech, facial expression, rigidity, tremor, bradykinesia, gait, postural stability), each scored from 0 (normal) to 4 (severe impairment). The scores for all items are summed. Higher scores on the MDS-UPDRS Part III indicate greater motor impairment and more severe Parkinson's disease symptoms, representing a worse outcome.
Time frame: Follow-up 12±2 weeks following T1
New Freezing of Gait Questionnaire (NFOGQ) - T0
The New Freezing of Gait Questionnaire (NFOGQ) is a patient-reported outcome measure specifically designed to detect and evaluate the impact and severity of freezing of gait (FOG) in individuals with Parkinson's disease or other neurological conditions. It has a minimum value of 0 and a maximum value of 45. The NFOGQ consists of 9 items, with a total score calculated by summing the scores for all items. Each item is typically scored on a 5-point Likert scale. Higher scores on the NFOGQ indicate a greater severity, frequency, and impact of freezing of gait, representing a worse outcome.
Time frame: Baseline
New Freezing of Gait Questionnaire (NFOGQ) - T1
The New Freezing of Gait Questionnaire (NFOGQ) is a patient-reported outcome measure specifically designed to detect and evaluate the impact and severity of freezing of gait (FOG) in individuals with Parkinson's disease or other neurological conditions. It has a minimum value of 0 and a maximum value of 45. The NFOGQ consists of 9 items, with a total score calculated by summing the scores for all items. Each item is typically scored on a 5-point Likert scale. Higher scores on the NFOGQ indicate a greater severity, frequency, and impact of freezing of gait, representing a worse outcome.
Time frame: After Intervention (2-12 weeks)
New Freezing of Gait Questionnaire (NFOGQ) - T2
The New Freezing of Gait Questionnaire (NFOGQ) is a patient-reported outcome measure specifically designed to detect and evaluate the impact and severity of freezing of gait (FOG) in individuals with Parkinson's disease or other neurological conditions. It has a minimum value of 0 and a maximum value of 45. The NFOGQ consists of 9 items, with a total score calculated by summing the scores for all items. Each item is typically scored on a 5-point Likert scale. Higher scores on the NFOGQ indicate a greater severity, frequency, and impact of freezing of gait, representing a worse outcome.
Time frame: Follow-up 12±2 weeks following T1
Home assessment: Steps per day - T0
The steps per day will be recorded.
Time frame: Baseline (T0)
Home assessment: Steps per day - T1
The steps per day will be recorded.
Time frame: After Intervention (2-12 weeks)
Home assessment: Steps per day - T2
The steps per day will be recorded.
Time frame: Follow-up 12±2 weeks following T1
Home assessment: Amount and length of uninterrupted walk durations - T0
The amount and length of uninterrupted walk durations will be determined.
Time frame: Baseline (T0)
Home assessment: Amount and length of uninterrupted walk durations - T1
The amount and length of uninterrupted walk durations will be determined.
Time frame: After Intervention (2-12 weeks)
Home assessment: Amount and length of uninterrupted walk durations - T2
The amount and length of uninterrupted walk durations will be determined.
Time frame: Follow-up 12±2 weeks following T1
Home assessment: Stride time variability - T0
The stride time variability will be derived.
Time frame: Baseline (T0)
Home assessment: Stride time variability - T1
The stride time variability will be derived.
Time frame: After Intervention (2-12 weeks)
Home assessment: Stride time variability - T2
The stride time variability will be derived.
Time frame: Follow-up 12±2 weeks following T1
Home assessment: Symmetry of gait - T0
Symmetry of gait will be determined.
Time frame: Baseline (T0)
Home assessment: Symmetry of gait - T1
Symmetry of gait will be determined.
Time frame: After Intervention (2-12 weeks)
Home assessment: Symmetry of gait - T2
Symmetry of gait will be determined.
Time frame: Follow-up 12±2 weeks following T1
Home assessment: FOG episodes, Medication, and Physical activity (self-reports) - T0
FOG episodes, Medication and Physical activity will be recorded by self-reports.
Time frame: Baseline (T0)
Home assessment: FOG episodes, Medication, and Physical activity (self-reports) - T1
FOG episodes, Medication and Physical activity will be recorded by self-reports.
Time frame: After Intervention (2-12 weeks)
Home assessment: Weekly Calendars for Physical activity, Falls and Injurious Falls - T0
Weekly Calendars will be used to assess Physical activity, Falls and Injurious Falls.
Time frame: Baseline (T0)
Home assessment: Weekly Calendars for Physical activity, Falls and Injurious Falls - T1
Weekly Calendars will be used to assess Physical activity, Falls and Injurious Falls.
Time frame: After Intervention (2-12 weeks)
Home assessment: Weekly Calendars for Physical activity, Falls and Injurious Falls - T2
Weekly Calendars will be used to assess Physical activity, Falls and Injurious Falls.
Time frame: Follow-up 12±2 weeks following T1
Acceptability and satisfaction with the intervention (System Usability Scale and PACES) - T1
The Physical Activity Enjoyment Scale (PACES) is a self-report questionnaire designed to measure an individual's enjoyment of physical activity. It typically consists of 18 items where participants rate their feelings about physical activity on a 7-point bipolar scale. It has a minimum possible score of 18 (if each item is rated '1') and a maximum possible score of 126 (if each item is rated '7'). Scores from all 18 items are summed to create a total score. Higher scores on the PACES indicate greater enjoyment of physical activity, representing a better outcome. Additionally it includes questions developed specifically for the components of this study.
Time frame: After Intervention (2-12 weeks)
Acceptability and satisfaction with the intervention (System Usability Scale and PACES) - T2
The Physical Activity Enjoyment Scale (PACES) is a self-report questionnaire designed to measure an individual's enjoyment of physical activity. It typically consists of 18 items where participants rate their feelings about physical activity on a 7-point bipolar scale. It has a minimum possible score of 18 (if each item is rated '1') and a maximum possible score of 126 (if each item is rated '7'). Scores from all 18 items are summed to create a total score. Higher scores on the PACES indicate greater enjoyment of physical activity, representing a better outcome. Additionally it includes questions developed specifically for the components of this study.
Time frame: Follow-up 12±2 weeks following T1
Changes in attitudes towards physical activity (Exercise Self-Efficacy Scale) - T1
The Exercise Self-Efficacy Scale (ESES) is designed to assess an individual's confidence in their ability to engage in regular exercise, particularly in challenging situations. There are various versions of self-efficacy scales, but they generally follow a similar structure. It has a minimum possible score of 0 (or the lowest point on the chosen confidence scale) and a maximum possible score of 100 (or the highest point on the chosen confidence scale). Participants typically rate their confidence for various exercise-related scenarios on a percentage scale, for instance, 0% = not at all confident to 100% = completely confident. The scores are then averaged or summed. Higher scores on the Exercise Self-Efficacy Scale indicate greater confidence in one's ability to exercise, representing a better outcome.
Time frame: After Intervention (2-12 weeks)
Changes in attitudes towards physical activity (Exercise Self-Efficacy Scale) - T2
The Exercise Self-Efficacy Scale (ESES) is designed to assess an individual's confidence in their ability to engage in regular exercise, particularly in challenging situations. There are various versions of self-efficacy scales, but they generally follow a similar structure. It has a minimum possible score of 0 (or the lowest point on the chosen confidence scale) and a maximum possible score of 100 (or the highest point on the chosen confidence scale). Participants typically rate their confidence for various exercise-related scenarios on a percentage scale, for instance, 0% = not at all confident to 100% = completely confident. The scores are then averaged or summed. Higher scores on the Exercise Self-Efficacy Scale indicate greater confidence in one's ability to exercise, representing a better outcome.
Time frame: Follow-up 12±2 weeks following T1
Exit interviews (Barriers and enablers to long-term use) - T1
Exit interviews will be conducted to explore the barriers and enablers to long-term use and reasons for ceased involvement (if applicable) using pre-prepared, open-ended questions according to qualitative interview methods.
Time frame: After Intervention (2-12 weeks)
Exit interviews (Barriers and enablers to long-term use) - T2
Exit interviews will be conducted to explore the barriers and enablers to long-term use and reasons for ceased involvement (if applicable) using pre-prepared, open-ended questions according to qualitative interview methods.
Time frame: Follow-up 12±2 weeks following T1
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