Clinical trial NCT03869879: 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
Overall status: UNKNOWN
Phase: NA
Conditions: 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
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: NorthWest Rehabilitations Associates
name: APDM
First posted: 2019-03-11
Enrollment: 300
Sex: ALL
Minimum age (years): 60
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Activities-Specific Balance Confidence (ABC) Scale
timeFrame: Collected at a participant's baseline visit and final study visit, after an average of one month
Secondary outcomes:
measure: Gait speed
timeFrame: Collected at a participant's baseline visit and final study visit, after an average of one month
Other outcomes:
Locations:
city: Salem
country: United States
facility: Northwest Rehabilitation Associate
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Martina Mancini, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.