Balance Tele-Rehab in Parkinson's Disease Parkinson's Disease

Study Overview
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Brief Summary
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This project will determine the feasibility and efficacy of remote assessment and treatment of balance disorders in people with Parkinson's disease.

Detailed Description
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This project consists of a virtual balance assessment which will use objective measures of balance and gait obtained with wearable sensors on the feet and waist. During a virtual assessment, the Modified Instrumented Stand and Walk Test (ISAW) will be conducted in 80 people with Parkinson's disease (PD) to predict a gold-standard, clinical in-person assessment of balance, the Mini-Balance Evaluation System Test (Mini-BESTest). For the balance rehabilitation there will be 80 participants randomized into two groups: 1) unsupervised home Agility Boot Camp (ABC) exercises (standard of care), 2) telerehabilitation with therapist conducting the ABC exercise program. Mobility during daily life will be measured using wearable sensors to explore if improvements after rehabilitation transfer to daily life mobility. The long-term goal of this project is to develop a more effective, home-based balance assessment and treatment that can be used in older adults with balance impairments to improve safe mobility during daily life.

Official Title
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Balance Tele-rehabilitation With Wearable Technology for Older Adults With Parkinson's Disease

Conditions
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Parkinson Disease

Intervention / Treatment
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* Other: Balance Tele-Rehabilitation Agility Boot Camp (ABC)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of idiopathic PD from movement disorders neurologist with the United Kingdom Brain Bank criteria of bradykinesia and one or more of the following - rest tremor, rigidity, and balance problems not from visual, vestibular, cerebellar or proprioceptive conditions responsive to levodopa (self-reported) Hoehn & Yahr stages I-III; ages 55-85 years old ability to follow directions in order to participate in testing procedures and exercise classes free of any medical conditions or medication that contraindicates participation in an exercise program willing and able to participate in rehabilitation intervention approximately 3x/week for 4 weeks while also refraining from making changes to medications (as reasonable) or to other exercise programs during the study period. Exclusion Criteria: Major musculoskeletal or neurological disorders, structural brain disease, epilepsy, acute illness or health history, other than PD, significantly affecting gait and balance (i.e., musculoskeletal disorder, vestibular problem, head injury, stroke, cardiac disease, etc.) no medical condition that precludes exercise cognitive inability to participate in an exercise program, such as MoCA score less than or equal to 19, prior diagnosis of dementia or inability to follow directions recurrent fallers, defined as those who fall more than 3 times a week (from patient and caregiver recollection) excessive use of alcohol or recreational drugs recent change in medication inability to stand and walk for ISAW without an assistive device.

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: We will randomize the 80 participants into two groups: 1) unsupervised home Agility Boot Camp (ABC) exercises (standard of care), 2) supervised balance (ABC) with therapist tele-rehabilitation.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supervised Tele-Rehabilitation Home Exercise<br>40 participants will have tele-rehabilitation virtually with a physical therapist for 60 minutes approximately three times per week for four weeks of intervention (12 visits). Participants will also be assessed for daily life mobility for seven days pre and post intervention with wearable sensors. | Other: Balance Tele-Rehabilitation Agility Boot Camp (ABC)<br>* The intervention is tele-rehabilitation conducted by a physical therapist virtually for 60 minutes approximately three times a week for four weeks (12 sessions). Participants will be assessed for seven days pre and post intervention using wearable sensors (APDM wearable technologies) to monitor daily mobility.<br>* Other names: Opal sensors; APDM Wearable Technologies;|
| Active Comparator: Unsupervised Rehabilitation Home Exercise<br>40 participants will complete their home exercise Agility Boot Camp (ABC) program for 60 minutes approximately three times per week for four weeks of intervention (12 sessions). Participants will also be assessed for daily life mobility for seven days pre and post intervention with wearable sensors. | Other: Balance Tele-Rehabilitation Agility Boot Camp (ABC)<br>* The intervention is tele-rehabilitation conducted by a physical therapist virtually for 60 minutes approximately three times a week for four weeks (12 sessions). Participants will be assessed for seven days pre and post intervention using wearable sensors (APDM wearable technologies) to monitor daily mobility.<br>* Other names: Opal sensors; APDM Wearable Technologies;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in the Mini-BESTest, a 14-item test of 4 domains of balance post-rehabilitation | The Mini-BESTest, a 14-item test of 4 domains of balance, that has been well studied and is related to fall risk in people with Parkinson's disease. | Pre and Post rehabilitation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in the modified and standard Instrumented Stand and Walk (Modified ISAW and ISAW, respectively) tests post-rehabilitation | For the ISAW, the participant will don 3 sensors and be instructed to stand for 30 seconds, walk 12 steps, turn around, and walk back. The ISAW has the ability to characterize multiple domains of balance, similar to the Mini-BESTest, including postural sway in standing with feet together with eyes open for 30 seconds prior to step initiation and gait with a 180-degree turn. During the Modified ISAW, the participant will don 3 sensors and be instructed to stand for 30 seconds, walk at least 10 steps, turn 90 degrees and complete an L-shaped path, then turn 180 degrees and retrace the L-shaped path. | Pre and Post rehabilitation | 
| Change from Baseline in the Patient Global Impression of Change (PGIC), a seven point scale depicting the patient's impression of improvement post-rehabilitation | The PGIC is one question rated on a seven point Likert scale measuring impression of change after intervention. | after rehabilitation | 
| Parkinson's Disease Questionaire-39 (PDQ-39) | This is a questionnaire looking at how Parkinson's Disease has affected quality of life over the last month | Pre and Post rehabilitation | 
| MDS-United Parkinson's Disease Rating Scale (UPDRS) I-IV | This is a questionnaire evaluating various aspects of Parkinson's disease, including motor and non-motor symptoms and activities of daily living. | Pre and Post rehabilitation | 
| Freezing of Gait Questionnaire (FoGQ) | This is a questionnaire asking about different situations that cause freezing of gait and how it may affect your balance. | Pre and Post rehabilitation | 
| International Physical Activity Questionnaire- Short Form (IPAQ) | This questionnaire asks about intensity and type of physical activity performed in the last 7 days | Pre and Post rehabilitation | 
| Wearable Sensors to Measure Daily Life Mobility | Use instrumented socks and a sensor (manufacturer: APDM) around the waist to measure gait quality, such as turn speed, over seven days of monitoring. | 8-10 hours per day for 7 days; Pre and Post rehabilitation | 
| Activities-Specific Balance Confidence | This is a questionnaire that measures confidence during ambulatory activities without falling or experiencing a sense of unsteadiness. It consists of 16 questions and is scored from 0-100 (0 is no confidence and 100 is full confidence). | Pre and Post rehabilitation | 
| Falls Efficacy Scale International | This is a test that measures level of concern about falling during social and physical activities inside and outside the home whether or not the person actually does the activity. It is a 16-item questionnaire, with a score ranging from minimum 16 (no concern about falling) to maximum 64 (severe concern about falling). | Pre and Post rehabilitation | 
| Self-Efficacy for Exercise Scale | This is a questionnaire looking at beliefs in ability to continue exercising on a three-time-a-week basis at moderate intensities. It consists of 8 questions and is scored 0-100% per question where 0 is not at all confident and 100 is highly confident. | Pre and Post rehabilitation | 
| Life Space Assessment Questionnaire | This is a questionnaire where you will report on the area in which you live. | Pre and Post rehabilitation | 
| Time Up and Go Test | This test measures the time taken to rise from a seated position, walk 3 meters at a comfortable pace, turn on the spot, return to the starting point, and sit back down. | Pre-rehabilitation and approximately seven days after the last rehabilitation session (+/- three days). | 
| TabCAT | Participants will use an iPad to complete tests looking at different aspects of cognitive function: 1) Benton Judgement of Line Orientation (JLO) will be used to assess visuospatial and executive function. 2) The Flanker test will be used to assess cognitive control and inhibition. 3) The Set Shifting test will be used to assess cognitive flexibility. These tests are components of the TabCAT test battery. | Pre-rehabilitation and approximately seven days after the last rehabilitation session (+/- three days). | 
| Floor Transfer Test | This timed test measures a participant's ability to sit down and rise from the floor. | Pre-rehabilitation and approximately seven days after the last rehabilitation session (+/- three days). | 
| 360 Degree Turn Test | This test measures the time taken to turn 360 degrees to the left and right. | Pre-rehabilitation and approximately seven days after the last rehabilitation session (+/- three days). | 
| Five-Time Sit-to-Stand Test | This test measures functional mobility and lower-body strength. Participants will be timed as they rise five times from sitting (standard chair height) to standing. | Pre-rehabilitation and approximately seven days after the last rehabilitation session (+/- three days). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tele-rehabilitation, Balance, Mobility, Tele-assessment, Wearable-sensors