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

Oregon Health & Science University (OHSU)

Status: Enrolling

Conditions: Parkinson Disease

Treatments: Other: Balance Tele-Rehabilitation Agility Boot Camp (ABC)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05680597

1R01HD107074-01A1 (U.S. NIH Grant/Contract)

1R01HD107074-01

Details and patient eligibility

About

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

Full description

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 55 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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
2. responsive to levodopa (self-reported)
3. Hoehn & Yahr stages I-III;
4. ages 55-85 years old
5. ability to follow directions in order to participate in testing procedures and exercise classes
6. free of any medical conditions or medication that contraindicates participation in an exercise program
7. 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

1. 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.)
2. no medical condition that precludes exercise
3. 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
4. recurrent fallers, defined as those who fall more than 3 times a week (from patient and caregiver recollection)
5. excessive use of alcohol or recreational drugs
6. recent change in medication
7. inability to stand and walk for ISAW without an assistive device.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

80 participants in 2 patient groups

Supervised Tele-Rehabilitation Home Exercise

Experimental group

Description:

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.

Treatment:

Other: Balance Tele-Rehabilitation Agility Boot Camp (ABC)

Unsupervised Rehabilitation Home Exercise

Active Comparator group

Description:

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.

Treatment:

Other: Balance Tele-Rehabilitation Agility Boot Camp (ABC)