Hemiparesis, Stroke, Upper Extremity Dysfunction
Conditions
Brief summary
Pilot study to assess the feasibility and initial efficacy of therapist-as-consultant, game-based CI therapy. Pre/post study design. Participant received a target of 30 hours game-based motor intervention, 100 hours constraint of the less affected upper extremity, and 5 hours therapist consultation (including completion of a behavioral contract at the first study visit). Duration of intervention was 10 consecutive weekdays, with pre-treatment and post-treatment testing performed within 1 week prior to and 1 week post-intervention by an independent tester.
Interventions
BEHAVIORALHemiparesis Therapy with VR
An in-home therapist-as-consultant model of CI therapy in which motor practice with shaping and the Motor Activity Log with problem solving were delivered via a custom avatar-based video game called Recovery Rapids
Sponsors
Nationwide Children
Ohio State University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Provide signed and dated informed consent form * Willing to comply with all study procedures and be available for the duration of the study * Male or female aged \> 17 * Preserved ability to comprehend English and participate in basic elements of the therapy * Community-dwelling * Experienced mild to moderate hemiparesis at least six months prior * Can independently operate the gaming system (those with severe cognitive impairments can usually achieve this) * Corrected vision of at least 20/70 as assessed by their ability to identify game objects on the monitor from 5 feet away
Exclusion criteria
* concurrent participation in other experimental upper extremity trials * concurrent participation in other outpatient rehabilitation for their upper extremity * Botox within the last 3 months (confound) * near-normal motor function (9-hole Peg Test score above the 10th percentile of a normative sample) * minimal nonuse (Motor Activity Log at baseline \>2.5, Accelerometry \> 60%) * major medical issues that would interfere with study treatments or make intensive rehabilitation difficult to tolerate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Motor Activity Log | Week 0 and Week 3 | Self-report measure of arm use for daily activities |
| Change in Wolf Motor Function Test | Week 0 and Week 3 | Objective measure of motor function in a laboratory setting |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire | Week 0 and Week 3 | Measures Depression |
| Strok Specific Quality of Life Scale | Week 0 and Week 3 | Quality of life measurement |
| Weschler Adult Intelligence Scale Symbol Seach | Week 0 and Week 3 | Cognitive processing speed assessment |
| Montreal Cognitive Assessment | Week 0 and Week 3 | Baseline cognitive screen |
| Survey | Week 0 and Week 3 | Survey on satisfaction with the intervention |
| Kinematic Data | Week 0 and Week 3 | Kinematic data recorded during game play |
| Total game-play time | Week 0 and Week 3 | — |
| Gestures | Week 0 and Week 3 | Number of gestures of each type registered in game |
| Bilateral activity monitors | Week 0 and Week 3 | Objective measure of arm use |
| Action Research Arm Test (ARAT) | Week 0 and Week 3 | Asses Changes in Limb Function |
| Mitt Compliance | Week 0 and Week 3 | Hours of use |
| Brief Kinesthesia test | Week 0 and Week 3 | Clinical Assessment of sensation |
Countries
United States
Outcome results
None listed