Pilot Study to Assess the Feasibility and Initial Efficacy of Therapist-as-consultant, Game-based CI Therapy

Not Applicable

Completed

• Conditions: Upper Extremity Dysfunction; Stroke; Hemiparesis
• Interventions: Behavioral: Hemiparesis Therapy with VR

• Registration Number: NCT03005457
• Lead Sponsor: Ohio State University

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-07
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2016-12
• Study First Submitted: 2016-12-21
• Study First Submitted QC: 2016-12-25
• Last Update Submitted: 2016-12-25
• Study First Posted: 2016-12-29
• Last Update Posted: 2016-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hemiparesis other	Hemiparesis Therapy with VR	-
Stroke	Hemiparesis Therapy with VR	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Weschler Adult Intelligence Scale Symbol Seach	Week 0 and Week 3	Cognitive processing speed assessment
Action Research Arm Test (ARAT)	Week 0 and Week 3	Asses Changes in Limb Function
Montreal Cognitive Assessment	Week 0 and Week 3	Baseline cognitive screen
Bilateral activity monitors	Week 0 and Week 3	Objective measure of arm use
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
Kinematic Data	Week 0 and Week 3	Kinematic data recorded during game play
Survey	Week 0 and Week 3	Survey on satisfaction with the intervention
Mitt Compliance	Week 0 and Week 3	Hours of use
Brief Kinesthesia test	Week 0 and Week 3	Clinical Assessment of sensation
Total game-play time	Week 0 and Week 3
Gestures	Week 0 and Week 3	Number of gestures of each type registered in game

Trial Locations

Locations (1)

The Ohio State University, 2154 Dodd Hall; 🇺🇸 Columbus, Ohio, United States