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Mobility Rehab, a Therapist-assisted System for Gait Rehabilitation

Primary Purpose

Parkinson Disease, Stroke, Multiple Sclerosis

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Feedback-assisted physical therapy
Traditional physical therapy
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring gait, balance, falls, mobility, feedback

Eligibility Criteria

60 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • Northwest Rehabilitation AssociateRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Feedback-assisted physical therapy

Traditional physical therapy

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
February 20, 2019
Last Updated
May 8, 2020
Sponsor
Oregon Health and Science University
Collaborators
NorthWest Rehabilitations Associates, APDM
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1. Study Identification

Unique Protocol Identification Number
NCT03869879
Brief Title
Mobility Rehab, a Therapist-assisted System for Gait Rehabilitation
Official Title
Mobility Rehab: A Feedback System for Mobility Rehabilitation for Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 24, 2019 (Actual)
Primary Completion Date
May 30, 2021 (Anticipated)
Study Completion Date
May 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
Collaborators
NorthWest Rehabilitations Associates, APDM

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Stroke, Multiple Sclerosis, Gait Disorders, Neurologic, Gait Disorder, Sensorimotor, Gait, Unsteady, Gait Ataxia, Gait, Stumbling, Gait, Shuffling
Keywords
gait, balance, falls, mobility, feedback

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Eligible participants are randomized into two groups. One group will receive standard physical therapy for their gait or balance issue while the other will receive visual feedback-aided physical therapy.
Masking
InvestigatorOutcomes Assessor
Masking Description
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).
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Feedback-assisted physical therapy
Arm Type
Active Comparator
Arm 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.
Arm Title
Traditional physical therapy
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Other
Intervention Name(s)
Feedback-assisted physical therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Traditional physical therapy
Intervention Description
Therapists will treat these patients with traditional therapeutic modalities and practices.
Primary Outcome Measure Information:
Title
Activities-Specific Balance Confidence (ABC) Scale
Description
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.
Time Frame
Collected at a participant's baseline visit and final study visit, after an average of one month
Secondary Outcome Measure Information:
Title
Gait speed
Description
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.
Time Frame
Collected at a participant's baseline visit and final study visit, after an average of one month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 60-89 years old gait disturbances requiring physical therapy Exclusion Criteria: unable to follow instructions (up to the practitioner's judgement)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Martina Mancini, PhD
Phone
503-418-2602
Email
mancinim@ohsu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Fay Horak, PhD
Phone
503-418-2602
Email
horakf@ohsu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martina Mancini, PhD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwest Rehabilitation Associate
City
Salem
State/Province
Oregon
ZIP/Postal Code
97302
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mike Studer

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
34552549
Citation
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.
Results Reference
derived

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Mobility Rehab, a Therapist-assisted System for Gait Rehabilitation

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