Clinical trial NCT03578536: Effect of Constraint-Induced Gaming Therapy in an Acute Care Setting
Official title: Effect of Constraint-Induced Gaming Therapy in an Acute Care Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke
Therapy, Occupational
Hemiplegia
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2018-07-06
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Group: Clinical trials with a single arm
Primary purpose: TREATMENT

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.

Detailed description: Research Question

The two questions to be answered by this study are: 1) To what extent does game-based CI therapy (with the Transfer Package) increase use of the more affected upper extremity from inpatient rehabilitation through subacute follow-up.

2) What is the clinical effectiveness of distributed gaming CI therapy for improving motor function of the more affected upper extremity at 3 months post-discharge.

Background

Constraint-Induced (CI) Movement therapy is arguably the best treatment paradigm to pilot throughout the continuum of care because it is established as the most empirically-supported intervention in subacute and chronic stroke and is more effective than standard care in acute stroke when lower duration/intensity protocols are utilized. CI therapy has strong evidence of increased effectiveness relative to standard care in the only positive definitively-powered upper extremity trial. A limitation of the acute CI therapy literature is that most studies omitted the most essential component of CI therapy: The Transfer Package of behavioral techniques that promotes carry-over of training to daily activities. In absence of the Transfer Package, everyday use of the weaker arm does not substantially improve and structural brain plasticity and quality of life gains are not realized. Early studies also show that any treatment advantage of CI therapy acutely is not maintained in follow-up, suggesting that maintenance therapy post-discharge is likely essential for altering the recovery trajectory.

Clinical Significance

This work will have a positive impact on the field of rehabilitation because it offers a solution to the main barriers of delivering distributed empirically-based treatment within an inpatient rehabilitation setting. By providing a paradigm for delivering distributed upper extremity practice, the product of this work has the potential to improve post-stroke health outcomes, lower-cost, and maintain the continuity of treatment from inpatient rehabilitation to community care.

Methods

The project will involve participatory action research methods to identify potential barriers to implementation of this new intervention within the VA and to refine the treatment approach to meet the needs of an inpatient population. A focus group will involve at least 3 patients who are currently on the inpatient rehabilitation unit (or recently discharged), their families, and occupational therapy/physical therapy (OT/PT)/recreational therapy staff. This meeting will serve to finalize the treatment protocol for this study. Areas that will be addressed will include the "dosing" schedule for the game-based intervention and needed adaptations to the CI therapy Transfer Package techniques (described below) to promote maximal carry-over from trained activities to everyday use of the weaker upper extremity. Any needed modifications to the technology platform (e.g. data storage) will also be made to comply with the VA's regulatory policies regarding adoption of new technology.

Up to 24 stroke survivors with upper extremity hemiparesis will be enrolled. Participants have the option of taking the gaming system home after discharge.

Gaming CI Therapy (Approximate Schedule)

1. 30 total inpatient hours OT/PT:

   * One 30-minute session to teach game play
   * 4.5 hours devoted to Transfer Package
   * Remainder time spent in usual care activities
2. 14 hours independent game play while inpatient
3. 18 hours independent game play following discharge (30 min, 3 times weekly) over and above standard care (will be documented as covariate)
4. Optional use of smart watch with biofeedback

This study will be conducted at the Minneapolis Veterans Affairs Medical Center (MVAMC). The MVAMC is home to the Stroke Specialty Program (SSP), a Commission on Accreditation of Rehabilitation Facilities (CARF) accredited program. The SSP tailors rehabilitation for survivors of any stroke mechanism (hemorrhagic, occlusive, etc.) affecting any part of the brain. Services can be adapted for survivors with cognitive challenges. The SSP has averaged 41 admissions in the past three years, though 2017 has projected admissions over 50. Retrospective chart review demonstrates the primary diagnosis resulting from stroke to be hemiplegia in approximately half of the admissions. Most patients (85%) are older than 60 years, predominantly Caucasian (85%) or African-American (10%) and male (98%).

Study participants will be patients enrolled in the MVAMC Stroke Specialty Program. Prospective participants will be screened by study staff. A retrospective chart review will be conducted to review outcomes of patients who underwent stroke rehabilitation at the Minneapolis VA but did not receive the study intervention. These subjects will serve as a retrospective control.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Action Research Arm Test (ARAT)
timeFrame: 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
measure: Motor Activity Log (MAL) Change (Discharge MAL - Enrollment MAL)
timeFrame: 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:
measure: Wolf Motor Function Test (WMFT)
timeFrame: The WMFT may be administered by OT at at Day 0 (Enrollment), discharge, and potentially at 3 months post-discharge.
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Minneapolis VA Health Care System, Minneapolis, MN
state: Minnesota
Study officials:
affiliation: Minneapolis VA Health Care System, Minneapolis, MN
name: Andrew H Hansen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.