Mobility Rehab, a Therapist-assisted System for Gait Rehabilitation
Mobility Rehab: A Feedback System for Mobility Rehabilitation for Older Adults
1 other identifier
interventional
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable parkinson-disease
Started Jul 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 20, 2019
CompletedFirst Posted
Study publicly available on registry
March 11, 2019
CompletedStudy Start
First participant enrolled
July 24, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2021
CompletedMay 11, 2020
May 1, 2020
1.9 years
February 20, 2019
May 8, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Gait speed
Collected at a participant's baseline visit and final study visit, after an average of one month
Study Arms (2)
Feedback-assisted physical therapy
ACTIVE COMPARATORDuring 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
PLACEBO COMPARATORDuring 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
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.
Therapists will treat these patients with traditional therapeutic modalities and practices.
Eligibility Criteria
You may qualify if:
- years old
- gait disturbances requiring physical therapy
You may not qualify if:
- unable to follow instructions (up to the practitioner's judgement)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oregon Health and Science Universitylead
- NorthWest Rehabilitations Associatescollaborator
- APDMcollaborator
Study Sites (1)
Northwest Rehabilitation Associate
Salem, Oregon, 97302, United States
Related Publications (2)
Silva-Batista C, Harker G, Vitorio R, Studer M, Whetten B, Lapidus J, Carlson-Kuhta P, Pearson S, VanDerwalker J, Horak FB, El-Gohary M, Mancini M. Mobility Rehab visual feedback system for gait rehabilitation in older adults. J Neuroeng Rehabil. 2023 Oct 24;20(1):144. doi: 10.1186/s12984-023-01260-2.
PMID: 37875971DERIVEDVitorio 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.
PMID: 34552549DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Martina Mancini, PhD
Oregon Health and Science University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Directing physical therapist will assess eligibility, and randomize participants. Physical therapy aide will conduct baseline measures (questionnaires, ABC scale, and 2min walk). The four treating physical therapists are split into two groups: two therapists will provide traditional physical therapy, while the two other therapists will provide visual feedback-aided therapy for their participants. A second, blinded physical therapy aide will complete a follow-up assessment (ABC scale, 2min walk).
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
February 20, 2019
First Posted
March 11, 2019
Study Start
July 24, 2019
Primary Completion
May 30, 2021
Study Completion
May 30, 2021
Last Updated
May 11, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- At the conclusion of the project.
- Access Criteria
- Email study PI for IPD access
At the conclusion of the study raw data of motor tasks will be available, within the bounds allowed by HIPAA and institutional privacy policies.