Recruiting

Mobility Rehab

Sponsor:

Oregon Health and Science University

Code:

NCT03869879

Conditions

Parkinson Disease

Stroke

Multiple Sclerosis

Gait Disorders, Neurologic

Gait Disorder, Sensorimotor

Eligibility Criteria

Sex: All

Age: 60 - 70+

Healthy Volunteers: Not accepted

Interventions

Feedback-assisted physical therapy

Traditional physical therapy

Study Details

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.

Conditions

Parkinson Disease

Stroke

Multiple Sclerosis

Gait Disorders, Neurologic

Gait Disorder, Sensorimotor

Study ID

NCT03869879

Start date

Jul 24, 2019

Status verified date

May, 2020

Completion date

May 30, 2021

Anticipated

Primary completion date

May 30, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 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.

placebo comparator: 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.

Interventions

Feedback-assisted physical therapy

The system uses unobtrusive, wearable, inertial sensors with real-time algorithms to provide real-time feedback on: step time asymmetry, foot clearance, arm swing, trunk lateral range, and foot strike angle during gait.

Traditional physical therapy

Therapists will treat these patients with traditional therapeutic modalities and practices.

Primary outcome measure

  • Activities-Specific Balance Confidence (ABC) Scale [ Time Frame: Collected at a participant's baseline visit and final study visit, after an average of one month ]

Central Contacts and Locations

Central contacts

Martina Mancini, PhD

503-418-2602mancinim@ohsu.edu

Fay Horak, PhD

503-418-2602horakf@ohsu.edu

Locations

Northwest Rehabilitation Associate

Recruiting

Salem, Oregon, United States, 97302

More Information

Sponsor

Oregon Health and Science University

Last update posted

May 11, 2020

Last verified

May, 2020

Keywords

  • gait
  • balance
  • falls
  • mobility
  • feedback

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Oregon Health and Science University on 2020-05-11.