Effect of Constraint-Induced Gaming Therapy in an Acute Care Setting

NCT03578536 | Completed Results

• 2 other identifiers: B2726-PRX-002726-01A1
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

Current protocols for therapy on a rehabilitation unit call for intensive rehabilitation composed of high intensity, long duration therapy. Evidence from brain healing and animal research, along with motor learning principles suggest that a treatment program composed of short duration therapy sessions distributed throughout the day may provide better rehabilitation outcomes for stroke patients. Such a program can be implemented using constraint-induced therapy in which the Veteran is provided with opportunities to use the affected limb while participating in a video game and completing complementary tasks in therapy. Additionally, rehabilitation outcomes may improve if Veterans are provided with regular opportunities to participate in gaming therapy at home after discharge from the hospital rather than having to travel to a clinic or receive limited or no follow-up in rural areas. This project will develop a therapeutic model that promotes use of the impaired arm and hand. Researchers often call this type of therapy "constraint induced therapy". In this study, participants focus on using the impaired limb rather than the unaffected limb. A small group of patients will participate in a question and answer session about preferences for activities which make up transfer tasks. Up to twenty-four (24) Veterans inpatient with hemiparesis due to stroke in the brain will be recruited from the Minneapolis VA Health Care System. Study participants will only be able to play the game using the impaired limb. Participants may also receive automated reminders to use the impaired arm throughout the day. Gaming will occur in patient room and during occupational therapy. Participants will have the option of being discharged with the gaming system for continued gameplay. Outcome measures will include motor function tests that evaluate upper extremity function.

Conditions

Stroke

Keywords

Stroke; Therapy, Occupational; Hemiplegia

Outcome Measures

Primary Outcomes (2)

• Action Research Arm Test (ARAT)

  The ARAT is a 19-item observational method used to assess upper extremity function on four subscales (grasp, pinch, gross movement, and grip). ARAT scores range from 0-57 points, with 57 points indicating no upper extremity impairment, and 0 points indicating no upper extremity movement.

  The ARAT was administered by OT at Day 0 (Enrollment), and discharge at 6 weeks post-enrollment for subject 1 and at 4 weeks post-enrollment for subject 2

• Motor Activity Log (MAL) Change (Discharge MAL - Enrollment MAL)

  The Motor Activity Log (MAL) is a motivational tool to assist stroke survivors in identifying goal movements and tracking progress. The Quality of Movement (QOM) subscale has participants rate themselves on how well they perform various activities of daily living with their more affected arm on a 0-5 scale. Scores are averaged across items and range from 0-5, with higher scores indicating the participant's ability to use their affected arm just as well as before their stroke.

  Performed at Day 0 (enrollment) and at discharge (at 6 weeks post-enrollment for subject 1 and 4 weeks post-enrollment for subject 2)

Secondary Outcomes (1)

• Wolf Motor Function Test (WMFT)

  The WMFT may be administered by OT at at Day 0 (Enrollment), discharge, and potentially at 3 months post-discharge.

Study Arms (1)

CIT with Recovery Rapids

EXPERIMENTAL

This project will develop a therapeutic model that promotes use of the impaired arm and hand. Researchers often call this type of therapy "constraint induced therapy". In this study, participants focus on using the impaired limb rather than the unaffected limb. Study participants will only be able to play the game using the impaired limb. A small group of patients will participate in a question and answer session about preferences for activities which make up transfer tasks. Patients will also receive automated reminders to use the impaired arm throughout the day. Twelve (12) Veterans will be recruited annually from the inpatient Stroke Specialty Program. Six (6) patients will be assigned to the Treatment group and receive the intervention. The remaining six (6) will receive the current standard of care. Outcome measures will include motor function tests that evaluate upper extremity function.

Device: Recovery Rapids

Interventions

Recovery Rapids DEVICE

This project utilizes a new gaming system technology called Recovery Rapids. The game is custom-made by Games That Move You, LLC and runs on an XBOX platform with motion input via a Kinect system.

CIT with Recovery Rapids

Eligibility Criteria

• Age: 18 Years - 88 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Veteran between 18 and 88 years of age
• Inpatient at the Minneapolis VAHCS
• Willing and able to give Informed Consent or meets criteria for surrogate consent
• Upper extremity hemiparesis resulting from stroke in the brain (including brainstem) or tumor resection at the discretion of the therapist
• Lives within vicinity of the Minneapolis VA

You may not qualify if:

• Complete loss of arm function
• No contact address or telephone
• Active substance use disorder or major uncontrolled psychiatric disorder

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, 55417, United States

Location

Related Publications (2)

• Morris DM, Uswatte G, Crago JE, Cook EW 3rd, Taub E. The reliability of the wolf motor function test for assessing upper extremity function after stroke. Arch Phys Med Rehabil. 2001 Jun;82(6):750-5. doi: 10.1053/apmr.2001.23183.

  PMID: 11387578 BACKGROUND

• Taub E, Wolf SL. Constraint Induced Movement Techniques To Facilitate Upper Extremity Use in Stroke Patients. Top Stroke Rehabil. 1997 Jan;3(4):38-61. doi: 10.1080/10749357.1997.11754128.

  PMID: 27620374 BACKGROUND

MeSH Terms

Conditions

Stroke; Hemiplegia

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

The majority of Veterans approached for our study had nearly full day-time schedules limiting recruitment. We also experienced major problems related to the COVID-19 pandemic.

Results Point of Contact

• Title: Andrew Hansen, PhD
• Organization: Minneapolis VA Health Care System

Andrew.Hansen2@va.gov

612-467-2910

Study Officials

• Andrew H Hansen, PhD

  Minneapolis VA Health Care System, Minneapolis, MN

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Single Group: Clinical trials with a single arm

Study Record Dates

• First Submitted: June 4, 2018
• First Posted: July 6, 2018
• Study Start: September 30, 2019
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: January 16, 2024
• Results First Posted: January 16, 2024

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)