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

Sponsor

Oregon Health and Science University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05680597

Collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease	Other: Balance Tele-Rehabilitation Agility Boot Camp (ABC)	N/A

Detailed Description

This project consists of a virtual balance assessment which will use objective measures of balance and gait obtained with wearable sensors (instrumented socks on the feet, Opal on the waist, sternum and wrists). During a virtual assessment, the 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 tele-rehabilitation there will be 80 participants randomized into two groups: 1) unsupervised home Agility Boot Camp (ABC) exercises (standard of care), 2) balance (ABC) with therapist tele-rehabilitation, and mobility during daily-life to explore if improvements after tele-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 their safe independence during daily life.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention 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.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 (Outcomes Assessor)

Masking Description:

Clinical pre- and post-testing will be carried out by a researcher who is blinded to group assignment. Scientists analyzing daily life monitoring data will also be blinded to pre-post status.

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2027

Anticipated Study Completion Date :

Jun 1, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Supervised Tele-Rehabilitation Home Exercise 40 subjects will have tele-rehabilitation virtually with a physical therapist for 60 minutes, three times per week for four weeks of intervention. Subjects 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) The intervention is tele-rehabilitation conducted by a physical therapist virtually for 60 minutes three times a week for four weeks. Subjects will be assessed for seven days pre and post intervention using the Opal sensors (APDM wearable technologies) to monitor daily mobility. Other Names: Opal sensors; APDM Wearable Technologies
Active Comparator: Unsupervised Rehabilitation Home Exercise 40 subjects will complete their home exercise Agility Boot Camp (ABC) program for 60 minutes, three times per week for four weeks of intervention. Subjects 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) The intervention is tele-rehabilitation conducted by a physical therapist virtually for 60 minutes three times a week for four weeks. Subjects will be assessed for seven days pre and post intervention using the Opal sensors (APDM wearable technologies) to monitor daily mobility. Other Names: Opal sensors; APDM Wearable Technologies

Arm

Intervention/Treatment

Experimental: Supervised Tele-Rehabilitation Home Exercise

40 subjects will have tele-rehabilitation virtually with a physical therapist for 60 minutes, three times per week for four weeks of intervention. Subjects 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)

The intervention is tele-rehabilitation conducted by a physical therapist virtually for 60 minutes three times a week for four weeks. Subjects will be assessed for seven days pre and post intervention using the Opal sensors (APDM wearable technologies) to monitor daily mobility.

Other Names:

Opal sensors; APDM Wearable Technologies

Active Comparator: Unsupervised Rehabilitation Home Exercise

40 subjects will complete their home exercise Agility Boot Camp (ABC) program for 60 minutes, three times per week for four weeks of intervention. Subjects 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)

Other Names:

Opal sensors; APDM Wearable Technologies

Outcome Measures

Primary Outcome Measures

Change from Baseline in the Mini-BESTest, a 14-item test of 4 domains of balance at week 4 [Baseline and 4 weeks]
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.

Secondary Outcome Measures

Change from Baseline in the Modified Instrumented Stand and Walk Test (ISAW) at 4 weeks [Baseline and 4 weeks]
In this test, the participant will don 3 sensors and will 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.
Change from Baseline in the Patient Global Impression of Change (PGIC), a seven point scale depicting the patient's impression of improvement, at 4 weeks [4 weeks of intervention]
The PGIC is one question rated on a seven point Likert scale measuring impression of change after intervention.
Montreal Cognitive Assessment (MoCA) [10 minutes]
This test screens for thinking skills like memory and attention
Parkinson's Disease Questionaire-39 (PDQ-39) [10 minutes]
This is a questionnaire looking at how Parkinson's Disease affects your quality of life over the last month
MDS-United Parkinson's Disease Rating Scale (UPDRS) [10 minutes]
This is a clinical exam of Parkinson's Disease symptoms including stiffness, slowness and tremor
Freezing of Gait Questionnaire (FoGQ) [5 minutes]
This is a questionnaire asking about different situations that cause freezing of gait and how it may affect your balance (5 minutes). minutes to complete
International Physical Activity Questionnaire- Short Form (IPAQ) [5 minutes]
This questionnaire asks about intensity and type of physical activity performed in the last 7 days
Wearable Sensors to Measure Daily Life Mobility (steps per day) [8-10 hours per day for 7 days]
use instrumented socks and a sensor around the waist (APDM) to measure activity parameters such as steps per day
Wearable Sensors to Measure Daily Life Mobility [8-10 hours per day for 7 days]
use instrumented socks and a sensor around the waist (APDM) to measure quality measure such as turn angle
Wearable Sensors to Measure Daily Life Mobility (turn speed) [8-10 hours per day for 7 days]
use instrumented socks and a sensor around the waist (APDM) to measure quality measure such as turn speed over seven days of monitoring.

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 62 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 3x/week for 4 weeks while also refraining from other exercise programs or changes in medications 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
≤ 21 Montreal Cognitive Assessment (MoCA), or prior diagnosis of dementia, or inability to follow directions
recurrent fallers, defined as multiple falls each day (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.