Mobility Rehab, a Therapist-assisted System for Gait Rehabilitation

Stroke Clinical Trial

Official title:

Mobility Rehab: A Feedback System for Mobility Rehabilitation for Older Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03869879
• Other study ID #: eIRB 16282
• Status: Recruiting
• Phase: N/A
• Start date: July 24, 2019
• Est. completion date: May 30, 2021

Study information

• Verified date: May 2020
• Source: Oregon Health and Science University
• Contact: Martina Mancini, PhD
• Phone: 503-418-2602
• Email: mancinim[@]ohsu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: May 30, 2021
• Est. primary completion date: May 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 89 Years

Eligibility

Inclusion Criteria:

• 60-89 years old

• gait disturbances requiring physical therapy

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Disease
• Gait Ataxia
• Gait Disorder, Sensorimotor
• Gait Disorders, Neurologic
• Gait, Shuffling
• Gait, Stumbling
• Gait, Unsteady
• Multiple Sclerosis
• Nervous System Diseases
• Parkinson Disease
• Stroke

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Northwest Rehabilitation Associate	Salem	Oregon

Sponsors (3)

Lead Sponsor	Collaborator
Oregon Health and Science University	APDM, NorthWest Rehabilitations Associates

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Activities-Specific Balance Confidence (ABC) Scale	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.	Collected at a participant's baseline visit and final study visit, after an average of one month
Secondary	Gait speed	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.	Collected at a participant's baseline visit and final study visit, after an average of one month