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

NCT03005457 | Completed

• 1 other identifier: 60047824
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke; Hemiparesis; Upper Extremity Dysfunction

Outcome Measures

Primary Outcomes (2)

• Change in Motor Activity Log

  Self-report measure of arm use for daily activities

  Week 0 and Week 3

• Change in Wolf Motor Function Test

  Objective measure of motor function in a laboratory setting

  Week 0 and Week 3

Secondary Outcomes (12)

• Kinematic Data

  Week 0 and Week 3

• Brief Kinesthesia test

  Week 0 and Week 3

• Patient Health Questionnaire

  Week 0 and Week 3

• Strok Specific Quality of Life Scale

  Week 0 and Week 3

• Weschler Adult Intelligence Scale Symbol Seach

  Week 0 and Week 3

Study Arms (2)

Stroke

EXPERIMENTAL

Behavioral: Hemiparesis Therapy with VR

Hemiparesis other

EXPERIMENTAL

Behavioral: Hemiparesis Therapy with VR

Interventions

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

Hemiparesis other; Stroke

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Ohio State University: lead
• Nationwide Children: collaborator

Study Sites (1)

The Ohio State University, 2154 Dodd Hall

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

• 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.

  PMID: 30246613 DERIVED

MeSH Terms

Conditions

Stroke; Paresis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Prof. PM&R

Study Record Dates

• First Submitted: December 21, 2016
• First Posted: December 29, 2016
• Study Start: July 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 29, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will share

Locations

US (1)