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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03005457
Other study ID # 60047824
Secondary ID
Status Completed
Phase N/A
First received December 21, 2016
Last updated December 25, 2016
Start date July 2012
Est. completion date December 2014

Study information

Verified date December 2016
Source Ohio State University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Behavioral:
Hemiparesis 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

Locations

Country Name City State
United States The Ohio State University, 2154 Dodd Hall Columbus Ohio

Sponsors (2)

Lead Sponsor Collaborator
Ohio State University Nationwide Children

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Motor Activity Log Self-report measure of arm use for daily activities Week 0 and Week 3 No
Primary Change in Wolf Motor Function Test Objective measure of motor function in a laboratory setting Week 0 and Week 3 No
Secondary Kinematic Data Kinematic data recorded during game play Week 0 and Week 3 No
Secondary Brief Kinesthesia test Clinical Assessment of sensation Week 0 and Week 3 No
Secondary Patient Health Questionnaire Measures Depression Week 0 and Week 3 No
Secondary Strok Specific Quality of Life Scale Quality of life measurement Week 0 and Week 3 No
Secondary Weschler Adult Intelligence Scale Symbol Seach Cognitive processing speed assessment Week 0 and Week 3 No
Secondary Montreal Cognitive Assessment Baseline cognitive screen Week 0 and Week 3 No
Secondary Survey Survey on satisfaction with the intervention Week 0 and Week 3 No
Secondary Mitt Compliance Hours of use Week 0 and Week 3 No
Secondary Total game-play time Week 0 and Week 3 No
Secondary Gestures Number of gestures of each type registered in game Week 0 and Week 3 No
Secondary Bilateral activity monitors Objective measure of arm use Week 0 and Week 3 No
Secondary Action Research Arm Test (ARAT) Asses Changes in Limb Function Week 0 and Week 3 No
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