Purpose

The current proposal aims to conduct a multi-site randomized controlled trial comparing virtual-reality gaming delivery of Constraint Induced Movement therapy (CI therapy) with (1) traditional clinic-based CI therapy of equal total active therapy duration and (2) a control group equating the dose of in-person therapy. Individuals with chronic stroke will be randomized to one of four different interventions: (1) traditional clinic-based CI therapy (35 therapist/client contact hours), (2) therapist-as-consultant virtual reality CI therapy (5 therapist/client contact hours in the clinic and 15 hours of independent game play at home), (3) therapist-as-consultant virtual reality CI therapy with additional therapist contact via telerehabilitation (5 therapist/client contact hours in the clinic, 4 therapist contact hours via teleconference, and 15 hours of independent game play in the home), and (4) 5 hours of standard occupational therapy. After 6-month follow-up, individuals assigned to standard OT/PT will cross over to a modified gaming therapy condition (a stand-alone application of the rehabilitation game without additional therapist contact).

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Males, females, or any gender identity 18 years of age or older - Experienced a stroke resulting in mild-to-moderate hemiparesis at least six months prior to enrollment (suggested ROM criteria includes: 45° shoulder abduction and flexion, 20° elbow extension, 20° wrist extension, and 10° extension of thumb and finger) - Have preserved ability to comprehend and participate in basic elements of the therapy

Exclusion Criteria

  • Concurrent participation in other experimental trials for motor dysfunction treatment - Receiving Botox therapy currently or in the past 3 months - Have medical conditions that would place volunteers at higher risk of adverse events (e.g., renal disease, frailty, pregnancy, dementia, severe pain, end-stage/degenerative diseases) - Have received intensive upper-extremity rehabilitation in the chronic phase post-stroke

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Traditional CI Therapy
Participants will receive a 35-hour "dose" of CI therapy. Treatment will consist of 35 therapist/client contact hours in the clinic, 10 weekdays, over 3 weeks. To promote carry-over of motor gains to daily activities, participants will complete: (1) a treatment contract, (2) daily self-report of arm use, and (3) problem-solving to overcome barriers to use of the more affected upper extremity. In addition, the client will agree to wear a padded restraint mitt on the less affected hand for the majority of waking hours to encourage use of the weaker hand for daily activities. Finally, the participant will agree to 30 minutes per day of individualized task-practice outside the clinic (in addition to training in the clinic) focused on functional activities catered towards accomplishing the person's therapeutic goals.
  • Behavioral: Traditional CI Therapy
    Intensive in-person therapy for upper extremity hemiparesis.
Active Comparator
Gaming CI Therapy
15 hours of progressive massed motor practice will occur through in-home video game play over 15 consecutive weekdays. Participants will play the game during times of their choosing. The participant will wear an activity monitor biofeedback device for the majority of waking hours. As with traditional CI therapy, the client will agree to an additional 30 minutes per day of individualized task-practice. Five therapist/client contact hours will occur in the clinic on approximate treatment days 1, 3, 6, and 11 and will focus on treatment elements that cannot be readily addressed through the game, such as problem-solving to help the participant carry over motor gains to daily life.
  • Behavioral: Gaming CI Therapy
    Intensive remote (via video game) therapy for upper extremity hemiparesis.
  • Behavioral: Gaming CI Therapy with Additional Contact via Video Conference
    Intensive remote (via video game) therapy for upper extremity hemiparesis with additional therapist contact via video conference.
Active Comparator
Gaming CI Therapy with Additional Contact via Video Conference
This group will receive treatment that is identical to Group 2, but will receive an additional 4 hours video conference consultation throughout the treatment period.
  • Behavioral: Gaming CI Therapy with Additional Contact via Video Conference
    Intensive remote (via video game) therapy for upper extremity hemiparesis with additional therapist contact via video conference.
Active Comparator
Traditional Occupational Therapy/Physical Therapy
Five therapist/client contact hours will occur on approximate treatment days 1, 3, 6, and 11 (same schedule as gaming CI therapy). 1 hour progressive resistance exercise to establish and progress an upper extremity home exercise program, 2 hours of neuromuscular reeducation, and 2 hours functional practice on ADLs with verbal encouragement to use the more affected upper extremity to the largest extent possible. Home practice consists of stretching exercises, designed to increase range of motion, prescribed twice daily. After completing their participation in the standard OT condition (6 months), participants will be crossed-over to a CI therapy gaming only condition. This condition will be identical to that described above, excluding therapist contact throughout the intervention. Rather, participants will receive a DVD explaining the intervention and guiding them through use of the system.
  • Behavioral: Traditional Occupational Therapy/Physical Therapy
    Traditional in-person therapy focusing on the rehabilitation of the upper extremity.

More Details

Status
Completed
Sponsor
Ohio State University

Study Contact

Detailed Description

Detailed study description in press with BMC Neurology (2017).

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.