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

A Low-cost Virtual Reality Gaming Platform for Neurorehabilitation of Hemiparesis

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Upper Extremity Dysfunction; Hemiparesis
• Intervention / Treatment: Behavioral: Hemiparesis Therapy with VR

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University, 2154 Dodd Hall

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stroke	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
Experimental: Hemiparesis other	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Motor Activity Log	Self-report measure of arm use for daily activities	Week 0 and Week 3
Change in Wolf Motor Function Test	Objective measure of motor function in a laboratory setting	Week 0 and Week 3

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ohio State University
• Collaborators: Nationwide Children

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: December 21, 2016
• First Submitted That Met QC Criteria: December 25, 2016
• First Posted (Estimate): December 29, 2016

Study Record Updates

• Last Update Posted (Estimate): December 29, 2016
• Last Update Submitted That Met QC Criteria: December 25, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Paresis
• Other Study ID Numbers: 60047824

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Will be shared upon publication acceptance.