Mobility Rehab, a Therapist-assisted System for Gait Rehabilitation

Oregon Health & Science University (OHSU)

Status: Unknown

Conditions: Gait, Unsteady; Stroke; Gait, Shuffling; Gait, Stumbling; Gait Disorders, Neurologic; Multiple Sclerosis; Gait Disorder, Sensorimotor; Parkinson Disease; Gait Ataxia

Treatments: Other: Traditional physical therapy; Other: Feedback-assisted physical therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03869879

eIRB 16282

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 60 to 89 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 2 patient groups, including a placebo group

Feedback-assisted physical therapy

Active Comparator group

Description:

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.

Treatment:

Other: Feedback-assisted physical therapy

Traditional physical therapy

Placebo Comparator group

Description:

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.

Treatment:

Other: Traditional physical therapy