This is an observational pilot study to assess the feasibility of remote functional assessments of gait, balance, and functional mobility via a telemedicine platform enabled via the Abbott Infinity devices. The clinical care of the participant will not be changed based on the remote functional assessments.
This is a single-center, non-randomized pilot observational study to explore the feasibility and tolerability of remotely assessing gait speed, functional mobility and balance measures in patients with Parkinson's disease experiencing medication-refractory tremor, motor complications and/or dyskinesias undergoing initiation of deep brain stimulation therapy. This study explores the feasibility of remotely performing and collecting functional assessments of gait, balance and mobility in the setting of programming deep brain stimulation (DBS). Ten participants who are deemed surgical candidates for receiving DBS for Parkinson's disease under standard of clinical care processes (neuropsychological testing, neurology consultation and neurosurgery consultation) and have opted for the Abbott DBS system will be enrolled in the study and undergo the pre-surgical and post-surgical visits. A pre-operative in-clinic visit will take place approximately 28 days (day -42) prior to surgical DBS electrode lead implantation. An at-home assessment will take place within 14 days (day -28) of this baseline visit, still prior to surgical DBS electrode lead implantation. Participants will receive care as usual including their first post-operative clinic visit for initial programming (day 28), just like standard of care for DBS patients.
Study Type
OBSERVATIONAL
Feasibility of remotely assessing gait speed during DBS therapy initiation
A telemedicine platform enabled via the Abbott Infinity device will be used to remotely assess gait speed.
Time frame: 20 weeks
Feasibility of remotely assessing functional mobility during DBS therapy initiation
A telemedicine platform enabled via the Abbott Infinity device will be used to remotely assess functional mobility.
Time frame: 20 weeks
Feasibility of remotely assessing balance during DBS therapy initiation
A telemedicine platform enabled via the Abbott Infinity device will be used to remotely assess balance.
Time frame: 20 weeks
Mobility assessment: 4 meter walk
Gait speed as performed during the 4-meter walk: Measured as time taken to walk 4 meters in seconds.
Time frame: days -42, -28, 21, 28, 42, 56, 70, and 84
Mobility assessment: Timed up and go (TUG)
The TUG assesses mobility, balance, walking ability and fall risk in older adults and has been validated showing good agreement between in-person and telehealth and raters. On the command, "go" the patient rises from the chair, walks 3 meters at a comfortable safe pace, turns and walks back to the chair and sits down. Measured as time taken to complete task in seconds.
Time frame: days -42, -28, 21, 28, 42, 56, 70, and 84
Mobility assessment: 5 times sit to stand
This is a timed task that requires the participant to stand from a seated position five times in a row. Measured as time taken to complete task in seconds.
Time frame: days -42, -28, 21, 28, 42, 56, 70, and 84
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Mobility assessment: 360 degree turns
The 360 degree turn test is a measure of dynamic balance in which the participant turns in a complete circle. Measured as time taken to complete task in seconds.
Time frame: days -42, -28, 21, 28, 42, 56, 70, and 84
Mobility assessment: Activity-specific balance confidence (ABC) scale
Self-reported confidence in performing 16 activities without losing balance. Participants rate using an 11-point likert-type scale, from 0% (no confidence) to 100% (completely confident) with 10% increments. A total score will be calculated as the mean of the items.
Time frame: days -42, -28, 21, 28, 42, 56, 70, and 84
Mobility assessment: Single-leg stance
Amount of time participant is able to stand on one leg (performed for each leg), measured in seconds.
Time frame: Day -28, 21, 42, 56, 70
Movement disorders
The Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Parts I-IV The Movement Disorder Society's Unified Parkinson's Disease Rating Scales (MDS-UPDRS) consists of 65 items across four domains: non-motor experiences, motor experiences, a motor examination, and motor complications, rated from 0 (normal) to 4 (severe). Subscales and a total score are calculated by adding items. A higher score is a worse outcome and indicates more severe symptoms of Parkinson's disease.
Time frame: day -42 and day 84
Quality of Life in PD
The Parkinson's Disease Questionnaire (PDQ-39) will be used to assess living difficulties across 8 dimensions of daily living including mobility subscores. The PDQ-39 assesses life concerns of individuals with PD. It is composed of a summary index and eight domain scores-mobility, activities of daily living, emotional well-being, stigma, social support, cognitions, communication, and bodily discomfort. Each item is rated on a 0 (never) to 4 (always) scale. A higher score indicates a higher self-perceived frequency of quality of life and health problems in the past month that are due to the disease, with each domain normed to a scale on which 0 indicating never a problem and 100 always a problem. The summary index is the average of the normed domain scores. A higher score is a worse outcome for quality of life.
Time frame: day -42 and day 84
Change in 3-day step count before DBS
Step count will be measured continuously by a StepWatch4 over a 3 day period.
Time frame: day -42, day 84
Change in amount of time spent with tremor and dyskinesia
The amount of time spent with tremor and dyskinesia will be measured with the Apple watch.
Time frame: baseline, day 84
Patient global impression of change
The Patient Global Impression - Improvement scale (CGI-I) is a 7 point scale, from 1 (normal) through to 7 (amongst the most severely ill), that requires the patient to assess how much their illness has improved or worsened relative to a baseline state at the beginning of the study. Higher scores reflect more severe illness.
Time frame: baseline, day 28, 42, 56, 70 and 84
Clinician global impression of change
The Clinical Global Impression - Improvement scale (CGI-I) is a 7 point scale, from 1 (normal) through to 7 (amongst the most severely ill), that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the study. Higher scores reflect more severe illness.
Time frame: baseline, day 28, 42, 56, 70 and 84