The purpose of this research is to compare improvements between the rehab intervention with walking practice using the robotic exoskeleton versus walking practice that is vigorous enough to keep participants' heart rate over a certain target level during physical therapy sessions. Investigators want to compare improvements in your walking function and mental health that occur after 20 interventions. The study also aims to evaluate if participants' mental health, social support, and health literacy affect attendance at physical therapy sessions.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
3
1 session of Forward Walking with EksoGT per week 1 session of conventional neurorehabilitation intervention per week * Transfer training * Gait training * Balance (sitting/standing; static/dynamic) * Strength * Neuromuscular re-education * Orthotics * Positioning * Caregiver education * Assistive device * Wheelchair assessment and mobility * Endurance training
2 sessions of High-Intensity Gait Training at a target heart rate of 60-80% of the maximum heart rate or target RPE of 15-18 * Forward stepping practice * Backwards stepping practices * Sidestepping * Stairs * Balance and compliant surface training while walking * Propulsion * Lateral balance training * Stability training * Stance control training * Limb advancement
Good Shepherd Rehabilitation
Allentown, Pennsylvania, United States
Demographic Questionnaire
Questions include age, sex, date of birth, race/ethnicity, total income during T the past 12 months, main occupation and when was the last work, language at home, marital status, education level, and if they take any antidepressants.
Time frame: Pre-intervention
Newest Vital Sign (NVS)
The NVS is a 6-question screening tool that identifies participants' risk of low or limited health literacy (HL) based on interpreting an ice cream nutrition label.
Time frame: Pre-intervention
Multidimensional Scale of Perceived Social Support (MSPSS)
The Multidimensional Scale of Perceived Social Support is a 12-item self-administered scale that measures social support. The total score for the MSPSS ranges from 12 to 84, with higher scores indicating higher levels of perceived social support.
Time frame: Pre-intervention
Patient Health Questionnaire (PHQ-9)
The PHQ-9 is a self-administered depression screening tool with nine items. It has been reported that the PHQ-9 is the best-performing tool for screening for post-stroke depression.
Time frame: Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks)
3-Meter Backwards Walk Test (3MBWT)
The 3MBWT measures the time (in seconds) it takes for a participant to walk 3 meters backward, hence assessing a backward gait speed. Backward gait speed is used to evaluate neuromuscular control, proprioception, protective reflexes, fall risk, and balance. Use of assistive devices will be documented.
Time frame: Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks)
6-Minute Walk Test
The 6MWT assesses participants' aerobic capacity/endurance by recording the distance (in meters) that the participants walk in 6 minutes. Assistive devices may be used and will be documented.
Time frame: Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks)
10-meter Walk Test
The 10mWT assesses walking speed in meters/second (m/s) over a short distance (10m). Two trials are administered at the patient's comfortable walking speed, followed by 2 trials at their fast walking speed, per Physical Therapist's instruction. The 2 trials for each speed are then averaged and the 2 gait speeds (preferred and fast) are documented in m/s. Assistive devices may be used, and will be documented.
Time frame: Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks)
Muscle coactivation index
Muscle coactivation index will be calculated based on the EMG signals from 8 leg muscles (bilateral tibialis anterior, medial gastrocnemius, rectus femoris, medial hamstring). Surface electromyographic recordings will be conducted during forward and backward walking tests.
Time frame: Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks)
Berg Balance Scale (BBS)
The Berg Balance Scale is a 14-item clinician-rated measure that assesses static and balance in sitting and standing. It has a maximum score of 56 points. Each item is scored on a 5-point scale from 0 to 4, with 0 indicating the subject is unable to perform the task and 4 being the highest score.
Time frame: Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks)
Functional Gait Assessment (FGA)
The FGA is used to assess postural stability during walking and assesses an individual's ability to perform multiple motor tasks while walking. The Functional Gait Assessment (FGA) is scored on a 4-point ordinal scale ranging from 0-3, with 0 indicating severe impairment and 3 indicating normal ambulation. The total score is calculated by summing all the items and ranges from 0-30, with lower scores indicating greater impairment.
Time frame: Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks)
Borg rating scale of Perceived Exertion
The Borg Rating Scale of Perceived Exertion will be measured in all participants at the completion of 6 minute walk test. It measures exertion on a scale of 0 (no exertion or resting) to 10 (pushing oneself to the max).
Time frame: Pre-intervention, After 10 interventions (~5 weeks), After 20 interventions (~10 weeks)
Patient compliance
Patient attendance to physical therapy is tracked and will be measured as \>80% attendance to physical therapy.
Time frame: After 20 interventions (~10 weeks)
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