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

• Sponsor: Ohio State University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03005457
• Collaborator: Nationwide Children (Other)
• Enrollment: 32
• Location: 1
• Arms: 2
• Duration (Months): 29
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke; Hemiparesis; Upper Extremity Dysfunction	Behavioral: Hemiparesis Therapy with VR	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 32 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Low-cost Virtual Reality Gaming Platform for Neurorehabilitation of Hemiparesis
• Study Start Date: Jul 1, 2012
• Actual Primary Completion Date: Dec 1, 2014
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change in Motor Activity Log [Week 0 and Week 3]

   Self-report measure of arm use for daily activities

2. Change in Wolf Motor Function Test [Week 0 and Week 3]

   Objective measure of motor function in a laboratory setting

Secondary Outcome Measures

1. Kinematic Data [Week 0 and Week 3]

   Kinematic data recorded during game play

2. Brief Kinesthesia test [Week 0 and Week 3]

   Clinical Assessment of sensation

3. Patient Health Questionnaire [Week 0 and Week 3]

   Measures Depression

4. Strok Specific Quality of Life Scale [Week 0 and Week 3]

   Quality of life measurement

5. Weschler Adult Intelligence Scale Symbol Seach [Week 0 and Week 3]

   Cognitive processing speed assessment

6. Montreal Cognitive Assessment [Week 0 and Week 3]

   Baseline cognitive screen

7. Survey [Week 0 and Week 3]

   Survey on satisfaction with the intervention

8. Mitt Compliance [Week 0 and Week 3]

   Hours of use

9. Total game-play time [Week 0 and Week 3]

10. Gestures [Week 0 and Week 3]

    Number of gestures of each type registered in game

11. Bilateral activity monitors [Week 0 and Week 3]

    Objective measure of arm use

12. Action Research Arm Test (ARAT) [Week 0 and Week 3]

    Asses Changes in Limb Function

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Ohio State University, 2154 Dodd Hall	Columbus	Ohio	United States	43210

Sponsors and Collaborators

• Ohio State University
• Nationwide Children

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lynne Gauthier , PhD, Assistant Prof. PM&R, Ohio State University
• ClinicalTrials.gov Identifier: NCT03005457
• Other Study ID Numbers: 60047824
• First Posted: Dec 29, 2016
• Last Update Posted: Dec 29, 2016
• Last Verified: Dec 1, 2016

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Additional relevant MeSH terms: Paresis

Study Results

No Results Posted as of Dec 29, 2016