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

NCT ID: NCT03005457

Last Updated: 2016-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2014-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke Hemiparesis Upper Extremity Dysfunction

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Stroke

Group Type EXPERIMENTAL

Hemiparesis Therapy with VR

Intervention Type 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

Hemiparesis other

Group Type EXPERIMENTAL

Hemiparesis Therapy with VR

Intervention Type 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

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nationwide Children

UNKNOWN

Sponsor Role collaborator

Ohio State University

OTHER

Sponsor Role lead

Responsible Party

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Lynne Gauthier , PhD

Assistant Prof. PM&R

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The Ohio State University, 2154 Dodd Hall

Columbus, Ohio, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 30246613 (View on PubMed)

Other Identifiers

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60047824

Identifier Type: -

Identifier Source: org_study_id