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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03005457
• Other study ID #: 60047824
• 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

Related Conditions & MeSH terms

• Hemiparesis
• Musculoskeletal Diseases
• Paresis
• Stroke
• Upper Extremity Dysfunction

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