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

Primary Purpose

Stroke, Hemiparesis, Upper Extremity Dysfunction

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hemiparesis Therapy with VR
Sponsored by
Ohio State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Ohio State University, 2154 Dodd Hall

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Stroke

Hemiparesis other

Arm Description

Outcomes

Primary Outcome Measures

Change in Motor Activity Log
Self-report measure of arm use for daily activities
Change in Wolf Motor Function Test
Objective measure of motor function in a laboratory setting

Secondary Outcome Measures

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

Full Information

First Posted
December 21, 2016
Last Updated
December 25, 2016
Sponsor
Ohio State University
Collaborators
Nationwide Children
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1. Study Identification

Unique Protocol Identification Number
NCT03005457
Brief Title
Pilot Study to Assess the Feasibility and Initial Efficacy of Therapist-as-consultant, Game-based CI Therapy
Official Title
A Low-cost Virtual Reality Gaming Platform for Neurorehabilitation of Hemiparesis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University
Collaborators
Nationwide Children

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Hemiparesis, Upper Extremity Dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stroke
Arm Type
Experimental
Arm Title
Hemiparesis other
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Hemiparesis Therapy with VR
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in Motor Activity Log
Description
Self-report measure of arm use for daily activities
Time Frame
Week 0 and Week 3
Title
Change in Wolf Motor Function Test
Description
Objective measure of motor function in a laboratory setting
Time Frame
Week 0 and Week 3
Secondary Outcome Measure Information:
Title
Kinematic Data
Description
Kinematic data recorded during game play
Time Frame
Week 0 and Week 3
Title
Brief Kinesthesia test
Description
Clinical Assessment of sensation
Time Frame
Week 0 and Week 3
Title
Patient Health Questionnaire
Description
Measures Depression
Time Frame
Week 0 and Week 3
Title
Strok Specific Quality of Life Scale
Description
Quality of life measurement
Time Frame
Week 0 and Week 3
Title
Weschler Adult Intelligence Scale Symbol Seach
Description
Cognitive processing speed assessment
Time Frame
Week 0 and Week 3
Title
Montreal Cognitive Assessment
Description
Baseline cognitive screen
Time Frame
Week 0 and Week 3
Title
Survey
Description
Survey on satisfaction with the intervention
Time Frame
Week 0 and Week 3
Title
Mitt Compliance
Description
Hours of use
Time Frame
Week 0 and Week 3
Title
Total game-play time
Time Frame
Week 0 and Week 3
Title
Gestures
Description
Number of gestures of each type registered in game
Time Frame
Week 0 and Week 3
Title
Bilateral activity monitors
Description
Objective measure of arm use
Time Frame
Week 0 and Week 3
Title
Action Research Arm Test (ARAT)
Description
Asses Changes in Limb Function
Time Frame
Week 0 and Week 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
The Ohio State University, 2154 Dodd Hall
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Will be shared upon publication acceptance.
Citations:
PubMed Identifier
30246613
Citation
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.
Results Reference
derived

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

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