N/A
N=23
Efficacy Study of the LARA Wheelchair System for Subacute Stroke Patients
Cerebrovascular Accident
Bottom Line
View on ClinicalTrials.gov: NCT02830893 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Jul 2020
Primary outcome: Primary: Fugl-Meyer (FM) Motor Assessment of the Upper Extremity — 28.5; 27.4; 14.2; 7.9 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- LARA (Device); Standard (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, Irvine
- Primary completion
- Jan 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Fugl-Meyer (FM) Motor Assessment of the Upper Extremity |
28.5; 27.4; 14.2; 7.9; 18.8; 14.1 | — |
| SECONDARY Modified Ashworth Spasticity Scale |
0.64; 0.56; 0.47; 0.77; 0.61; 0.96 | — |
| SECONDARY Timed 10-meter Walk |
18.8; 23.4; 15.2; 14.4; 11.8; 11.8 | — |
| SECONDARY Box and Blocks Test |
8.5; 11.9; 23.5; 22.1; 53.4; 45.8 | — |
Summary
This study will test the effectiveness of a new lever drive wheelchair, LARA - Lever Actuated Resonance Assistance. LARA facilitates patients in performing a high amount of practice using their moderate to severely impaired upper extremity after stroke.
Investigators will recruit 44 subjects with subacute strokes to participate in the study through the acute rehabilitation unit of the UC Irvine Douglas Hospital. Study participants will be randomized into 2 groups: LARA therapy group or standard therapy group. The LARA therapy group will use LARA to propel themselves to therapy appointments in the unit and to play video games with the affected upper extremity for 30 mins / day. The standard therapy group will use a standard wheelchair to propel themselves using their unaffected upper and lower extremities. They will be asked to perform a matched duration of standard arm exercises for 30 mins/ day. This program of standard arm exercises was developed by an OT at the Rehabilitation Institute of Chicago which consists of graded-difficulty table-supported exercises.
This study will have 3 assessment visits: baseline, 3 weeks after therapy or upon discharge from the acute rehabilitation unit if sooner, and a 3-month follow up.
Eligibility Criteria
Inclusion Criteria
- Age ≥ 18 years at the time of enrollment
- Stroke onset 1-4 weeks prior to study enrollment
- Arm motor FM score of 80 years at the time of enrollment
- Severe tone in the affected upper extremities (Score ≥ 4 on the Modified Ashworth Spasticity Scale)
- Severe language problem that would prevent participants from properly understanding instructions
- Severe reduced level of consciousness
- Severe aphasia (score of 3 on the NIH stroke scale (question 9))
- Severe loss of sensation in stroke-affected upper extremities (Score < 1 on the Nottingham sensory assessment)
- Currently pregnant
- Difficulty in understanding or complying with the instructions given by the experimenter
- Inability to perform the experimental task that will be studied
Data sourced from ClinicalTrials.gov (NCT02830893). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.