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CompletedNCT03005457Updated Dec 29, 2016

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

An interventional study of Hemiparesis Therapy with VR in Stroke, Hemiparesis and Upper Extremity Dysfunction, sponsored by Ohio State University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-12-29.

Sponsored by Ohio State University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Stroke
  • Hemiparesis
  • Upper Extremity Dysfunction

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In context

Paresis

519 studies on the registry are indexed under Paresis; 111 are open to participants now.

This study's enrollment of 32 is below the median of 36 across 448 interventional studies indexed under Paresis.

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Lead sponsor

Ohio State University is the lead sponsor of 640 studies on the registry; 144 are open to participants now.

Of its 60 completed or terminated interventional studies of FDA-regulated products, 45 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    Stroke

    Behavioral: Hemiparesis Therapy with VR

  • Experimental
    Hemiparesis other

    Behavioral: Hemiparesis Therapy with VR

Interventions

  • BehavioralHemiparesis 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

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What researchers measure

Primary outcomes

  1. Change in Motor Activity Log

    Self-report measure of arm use for daily activities

    Time frame: Week 0 and Week 3

  2. Change in Wolf Motor Function Test

    Objective measure of motor function in a laboratory setting

    Time frame: Week 0 and Week 3

Secondary outcomes

  1. Kinematic Data

    Kinematic data recorded during game play

    Time frame: Week 0 and Week 3

  2. Brief Kinesthesia test

    Clinical Assessment of sensation

    Time frame: Week 0 and Week 3

  3. Patient Health Questionnaire

    Measures Depression

    Time frame: Week 0 and Week 3

  4. Strok Specific Quality of Life Scale

    Quality of life measurement

    Time frame: Week 0 and Week 3

  5. Weschler Adult Intelligence Scale Symbol Seach

    Cognitive processing speed assessment

    Time frame: Week 0 and Week 3

  6. Montreal Cognitive Assessment

    Baseline cognitive screen

    Time frame: Week 0 and Week 3

  7. Survey

    Survey on satisfaction with the intervention

    Time frame: Week 0 and Week 3

  8. Mitt Compliance

    Hours of use

    Time frame: Week 0 and Week 3

  9. Total game-play time

    Time frame: Week 0 and Week 3

  10. Gestures

    Number of gestures of each type registered in game

    Time frame: Week 0 and Week 3

  11. Bilateral activity monitors

    Objective measure of arm use

    Time frame: Week 0 and Week 3

  12. Action Research Arm Test (ARAT)

    Asses Changes in Limb Function

    Time frame: Week 0 and Week 3

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Study locations

1 site
  • The Ohio State University, 2154 Dodd Hall
    Columbus, Ohio 43210, United States
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References and documents

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. PubMed 30246613 ↗

Individual participant data

Plan to share: Yes — Will be shared upon publication acceptance.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 29, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03005457
Lead sponsor
Ohio State University
Collaborators
Nationwide Children
Responsible party
Lynne Gauthier , PhD (Assistant Prof. PM&R, Ohio State University) — Principal investigator
First posted
Dec 29, 2016
Start date
Jul 2012
Primary completion
Dec 2014
Completion
Dec 2014
Last update
Dec 29, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.

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