Mobility Rehab, a Therapist-assisted System for Gait Rehabilitation

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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Martina Mancini, PhD; Phone Number: 503-418-2602; Email: mancinim@ohsu.edu
• Study Contact Backup: Name: Fay Horak, PhD; Phone Number: 503-418-2602; Email: horakf@ohsu.edu

Study Locations

• United States
  • Oregon
    • Salem, Oregon, United States, 97302
      • Recruiting
      • Northwest Rehabilitation Associate
      • Contact: Mike Studer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.	Other: Traditional physical therapy; Therapists will treat these patients with traditional therapeutic modalities and practices.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Collaborators: NorthWest Rehabilitations Associates; APDM
• Investigators: Principal Investigator: Martina Mancini, PhD, Oregon Health and Science University

Publications and helpful links

General Publications

• Vitorio R, El-Gohary M, Pearson S, Carlson-Kuhta P, Harker G, Horak FB, Lapidus J, Studer M, Mancini M. Effectiveness of the Mobility Rehab System for Mobility Training in Older Adults: A Pragmatic Clinical Trial. Front Neurol. 2021 Sep 6;12:680637. doi: 10.3389/fneur.2021.680637. eCollection 2021.

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2019
• Primary Completion (Anticipated): May 30, 2021
• Study Completion (Anticipated): May 30, 2021

Study Registration Dates

• First Submitted: February 20, 2019
• First Submitted That Met QC Criteria: March 7, 2019
• First Posted (Actual): March 11, 2019

Study Record Updates

• Last Update Posted (Actual): May 11, 2020
• Last Update Submitted That Met QC Criteria: May 8, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: gait; falls; feedback; mobility; balance
• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Neurologic Manifestations; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Dyskinesias; Ataxia; Multiple Sclerosis; Disease; Parkinson Disease; Nervous System Diseases; Gait Disorders, Neurologic; Gait Ataxia
• Other Study ID Numbers: eIRB 16282

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: At the conclusion of the study raw data of motor tasks will be available, within the bounds allowed by HIPAA and institutional privacy policies.
• IPD Sharing Time Frame: At the conclusion of the project.
• IPD Sharing Access Criteria: Email study PI for IPD access
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No