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

The Ohio State University

Status: Completed

Conditions: Stroke; Upper Extremity Dysfunction; Hemiparesis

Treatments: Behavioral: Hemiparesis Therapy with VR

Study type: Interventional

Funder types: Other

Identifiers

NCT03005457

60047824

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Stroke

Experimental group

Treatment:

Behavioral: Hemiparesis Therapy with VR

Hemiparesis other

Experimental group

Treatment:

Behavioral: Hemiparesis Therapy with VR