Gait Ataxia, Gait Disorder, Sensorimotor, Gait Disorders, Neurologic, Gait, Shuffling, Gait, Stumbling, Gait, Unsteady, Multiple Sclerosis, Parkinson Disease, Stroke
Conditions
Keywords
gait, balance, falls, mobility, feedback
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.
Interventions
OTHERFeedback-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.
OTHERTraditional physical therapy
Therapists will treat these patients with traditional therapeutic modalities and practices.
Sponsors
NorthWest Rehabilitations Associates
APDM
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes 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).
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.
Eligibility
Sex/Gender
ALL
Age
60 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* 60-89 years old * gait disturbances requiring physical therapy
Exclusion criteria
* unable to follow instructions (up to the practitioner's judgement)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Activities-Specific Balance Confidence (ABC) Scale | Collected at a participant's baseline visit and final study visit, after an average of one month | 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
| Measure | Time frame | Description |
|---|---|---|
| Gait speed | Collected at a participant's baseline visit and final study visit, after an average of one month | 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. |
Countries
United States
Contacts
Primary ContactMartina Mancini, PhD
Backup ContactFay Horak, PhD
Outcome results
None listed