Skip to main content
OpenTrials
Completed

NCT Number: NCT03005457

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemiparesis Nervous System Diseases Neurologic Manifestations Paresis Pathological Conditions, Signs and Symptoms Signs and Symptoms Upper Extremity Dysfunction Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ohio State University, 2154 Dodd Hall

Columbus, Ohio, 43210, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hemiparesis Therapy with VR

Behavioral

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 outcomes

  1. Change in Motor Activity Log

    Time frame: Week 0 and Week 3

    Self-report measure of arm use for daily activities

  2. Change in Wolf Motor Function Test

    Time frame: Week 0 and Week 3

    Objective measure of motor function in a laboratory setting

Secondary outcomes

  1. Kinematic Data

    Time frame: Week 0 and Week 3

    Kinematic data recorded during game play

  2. Brief Kinesthesia test

    Time frame: Week 0 and Week 3

    Clinical Assessment of sensation

  3. Patient Health Questionnaire

    Time frame: Week 0 and Week 3

    Measures Depression

  4. Strok Specific Quality of Life Scale

    Time frame: Week 0 and Week 3

    Quality of life measurement

  5. Weschler Adult Intelligence Scale Symbol Seach

    Time frame: Week 0 and Week 3

    Cognitive processing speed assessment

  6. Montreal Cognitive Assessment

    Time frame: Week 0 and Week 3

    Baseline cognitive screen

  7. Survey

    Time frame: Week 0 and Week 3

    Survey on satisfaction with the intervention

  8. Mitt Compliance

    Time frame: Week 0 and Week 3

    Hours of use

  9. Total game-play time

    Time frame: Week 0 and Week 3

  10. Gestures

    Time frame: Week 0 and Week 3

    Number of gestures of each type registered in game

  11. Bilateral activity monitors

    Time frame: Week 0 and Week 3

    Objective measure of arm use

  12. Action Research Arm Test (ARAT)

    Time frame: Week 0 and Week 3

    Asses Changes in Limb Function

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Collaborators

  • Nationwide Children's Hospital

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Dec 29, 2016
Registry last updated
Dec 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.