Mobility Rehab, a Therapist-assisted System for Gait Rehabilitation

NCT ID: NCT03869879

Last Updated: 2020-05-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-24

Study Completion Date

2021-05-30

Brief Summary

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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

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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.

Conditions

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Parkinson Disease Stroke Multiple Sclerosis Gait Disorders, Neurologic Gait Disorder, Sensorimotor Gait, Unsteady Gait Ataxia Gait, Stumbling Gait, Shuffling

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
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).

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Feedback-assisted physical therapy

Intervention Type OTHER

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

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.

Group Type PLACEBO_COMPARATOR

Traditional physical therapy

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Traditional physical therapy

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* unable to follow instructions (up to the practitioner's judgement)
Minimum Eligible Age

60 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NorthWest Rehabilitations Associates

UNKNOWN

Sponsor Role collaborator

APDM

UNKNOWN

Sponsor Role collaborator

Oregon Health and Science University

OTHER

Sponsor Role lead

Responsible Party

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Martina Mancini

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Martina Mancini, PhD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

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Northwest Rehabilitation Associate

Salem, Oregon, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Martina Mancini, PhD

Role: CONTACT

503-418-2602

Fay Horak, PhD

Role: CONTACT

503-418-2602

Facility Contacts

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Mike Studer

Role: primary

References

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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.

Reference Type DERIVED
PMID: 37875971 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34552549 (View on PubMed)

Other Identifiers

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eIRB 16282

Identifier Type: -

Identifier Source: org_study_id

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