Clinical trial NCT03005457: Pilot Study to Assess the Feasibility and Initial Efficacy of Therapist-as-consultant, Game-based CI Therapy
Official title: A Low-cost Virtual Reality Gaming Platform for Neurorehabilitation of Hemiparesis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Hemiparesis
Upper Extremity Dysfunction
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Nationwide Children
First posted: 2016-12-29
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Motor Activity Log
timeFrame: Week 0 and Week 3
measure: Change in Wolf Motor Function Test
timeFrame: Week 0 and Week 3
Secondary outcomes:
measure: Kinematic Data
timeFrame: Week 0 and Week 3
measure: Brief Kinesthesia test
timeFrame: Week 0 and Week 3
measure: Patient Health Questionnaire
timeFrame: Week 0 and Week 3
measure: Strok Specific Quality of Life Scale
timeFrame: Week 0 and Week 3
measure: Weschler Adult Intelligence Scale Symbol Seach
timeFrame: Week 0 and Week 3
measure: Montreal Cognitive Assessment
timeFrame: Week 0 and Week 3
measure: Survey
timeFrame: Week 0 and Week 3
measure: Mitt Compliance
timeFrame: Week 0 and Week 3
measure: Total game-play time
timeFrame: Week 0 and Week 3
measure: Gestures
timeFrame: Week 0 and Week 3
measure: Bilateral activity monitors
timeFrame: Week 0 and Week 3
measure: Action Research Arm Test (ARAT)
timeFrame: Week 0 and Week 3
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University, 2154 Dodd Hall
state: Ohio
Study officials:
References:
citation: Kelly KM, Borstad AL, Kline D, Gauthier LV. Improved quality of life following constraint-induced movement therapy is associated with gains in arm use, but not motor improvement. Top Stroke Rehabil. 2018 Oct;25(7):467-474. doi: 10.1080/10749357.2018.1481605. Epub 2018 Sep 22.