Balance Tele-Rehab in Parkinson's Disease

Oregon Health and Science University80 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Parkinson Disease

Interventions

Balance Tele-Rehabilitation Agility Boot Camp (ABC)OTHER

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.

Eligibility

Sex: ALLMin age: 55 YearsMax age: 85 Years

Medical Language ↔ Plain English

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. 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.

Locations (1)

Oregon Health Science University

Portland, Oregon, United States

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: Pre and Post rehabilitation

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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

Time frame: 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.

Central Contacts

Laurie King, PhD

CONTACT

503-418-2602 kingla@ohsu.edu

Martina Mancini, PhD

CONTACT

503-418-2600 mancinim@ohsu.edu

Data from ClinicalTrials.gov

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