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

Completed · Not applicable

Conditions studied: Stroke, Hemiparesis, Upper Extremity Dysfunction

In brief

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.

Key facts

Study ID

NCT03005457

Run by

Ohio State University

People needed

32

Starts

2012-07-01

Expected to finish

2014-12-01

Last updated by the study team

2016-12-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• The Ohio State University, 2154 Dodd Hall — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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