Mobility Rehab, a Therapist-assisted System for Gait Rehabilitation

Not Applicable

• Conditions: Parkinson Disease; Stroke; Gait Disorders, Neurologic; Gait, Stumbling; Gait, Shuffling; Gait, Unsteady; Gait Ataxia; Multiple Sclerosis; Gait Disorder, Sensorimotor
• Interventions: Other: Feedback-assisted physical therapy; Other: Traditional physical therapy

• Registration Number: NCT03869879
• Lead Sponsor: Oregon Health and Science University

Brief Summary

Phase II of this study includes a pragmatic clinical trial which will take place at Northwest Rehabilitation Associates (NWRA) in Salem, OR to verify the efficacy of the system in a physical therapy clinic.

Detailed Description

This Phase II project is a collaboration among: 1) APDM, an innovative small business that has successfully commercialized several innovative products to quantify human movement; 2) the Balance Disorders Laboratory in the department of Neurology at Oregon Health \& Science University (OHSU); and 3) NorthWest Rehabilitation Associates (NWRA), a nationally-recognized outpatient rehabilitation center that will test the effectiveness of Mobility Rehab for adults with mobility disturbances.

The objective of this Phase II application is to prepare the Mobility Rehab system for commercialization and demonstrate its efficacy for mobility training. Our hypothesis is that feedback-based rehabilitation will be more effective than standard rehabilitation for gait in older adults with gait disturbances. In this Phase II, we will use a pragmatic clinical trial to evaluate the effectiveness of Mobility Rehab on 300 patients with various types of gait disturbances in a physical therapy clinic. In addition to visual feedback, the system will be optimized in Phase II to also provide verbal feedback commands for patients during training.

Study Timeline

• Study First Submitted: 2019-02-20
• Study First Submitted QC: 2019-03-07
• Study First Posted: 2019-03-11
• Study Start: 2019-07-24
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-08
• Last Update Posted: 2020-05-11
• Primary Completion: 2021-05-30
• Study Completion: 2021-05-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• 60-89 years old
• gait disturbances requiring physical therapy

Exclusion Criteria

• unable to follow instructions (up to the practitioner's judgement)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Feedback-assisted physical therapy	Feedback-assisted physical therapy	During a visual feedback session, therapists will spend 30min per session using the Mobility Rehab system for gait training with patients. Therapists may select modality, overground walking and/or treadmill, tasks (dual task, head turns, etc. as above) as appropriate for each patient. They will additionally spend 15min on endurance, strength, and static and dynamic balance in functional tasks.
Traditional physical therapy	Traditional physical therapy	During a regular session, patients with gait impairment will work on gait with the following tasks for 30min: weights on ankles, dual tasks, UE support, partial body weight support, speed challenges, obstacles, and head turning. Therapists may select modality, overground walking and/or treadmill, tasks (dual task, head turns, etc. as above) as appropriate for each patient. They will additionally spend 15min on endurance, strength, and static and dynamic balance in functional tasks.

Primary Outcome Measures

Name	Time	Method
Activities-Specific Balance Confidence (ABC) Scale	Collected at a participant's baseline visit and final study visit, after an average of one month	This questionnaire measures an individual's perception of their own balance. Individuals use a scale ranging from 0% to 100% in rating the amount of confidence they have in their balance during 16 hypothetical daily-life activities. A score of 100% would represent one being fully confident in their balance during a specific task, while a score of 0% would represent one having no confidence at all in their balance. Total score ranges from 0 to 1600.

Secondary Outcome Measures

Name	Time	Method
Gait speed	Collected at a participant's baseline visit and final study visit, after an average of one month	Gait speed is measured through two instrumented, two-minute walks. The first walk is performed at the individual's casual walking pace and the second is performed at a pace the individual considers to be faster than their casual pace.

Trial Locations

Locations (1)

Northwest Rehabilitation Associate; 🇺🇸 Salem, Oregon, United States