Trial Outcomes & Findings for Effect of Constraint-Induced Gaming Therapy in an Acute Care Setting (NCT NCT03578536)

Last Updated: 2024-01-16

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

3 participants

Primary outcome 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

Results posted on

2024-01-16

Participant Flow

Participant milestones

Participant milestones
Measure	CIT With Recovery Rapids 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. Veterans will be recruited from the inpatient Stroke Specialty Program and be assigned to receive the intervention. Outcome measures will include motor function tests that evaluate upper extremity function. Recovery Rapids: 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.
Overall Study STARTED	3
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	CIT With Recovery Rapids 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. Veterans will be recruited from the inpatient Stroke Specialty Program and be assigned to receive the intervention. Outcome measures will include motor function tests that evaluate upper extremity function. Recovery Rapids: 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.
Overall Study Lost to Follow-up	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CIT With Recovery Rapids n=3 Participants 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. Veterans will be recruited from the inpatient Stroke Specialty Program and be assigned to receive the intervention. Outcome measures will include motor function tests that evaluate upper extremity function. Recovery Rapids: 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.
Age, Continuous	72 years STANDARD_DEVIATION 16 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Action Research Arm Test (ARAT)	36 units on a scale n=5 Participants

PRIMARY outcome

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

Population: Veterans with stroke and impaired upper extremity function

Outcome measures

Outcome measures
Measure	CIT With Recovery Rapids n=2 Participants 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. Veterans will be recruited from the inpatient Stroke Specialty Program and be assigned to receive the intervention. Outcome measures will include motor function tests that evaluate upper extremity function. Recovery Rapids: 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.
Action Research Arm Test (ARAT) Baseline ARAT	37.5 units on a scale Interval 37.0 to 38.0
Action Research Arm Test (ARAT) Discharge ARAT	47 units on a scale Interval 42.0 to 52.0

PRIMARY outcome

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)

Population: Veterans with stroke and impaired upper extremity function.

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.

Outcome measures

Outcome measures
Measure	CIT With Recovery Rapids n=2 Participants 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. Veterans will be recruited from the inpatient Stroke Specialty Program and be assigned to receive the intervention. Outcome measures will include motor function tests that evaluate upper extremity function. Recovery Rapids: 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.
Motor Activity Log (MAL) Change (Discharge MAL - Enrollment MAL)	2.7 units on a scale Interval 2.42 to 3.0

SECONDARY outcome

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

Population: Veterans with stroke and impaired upper extremity function. Participants were room bound due to COVID and there was not enough space in their rooms to perform the assessment.

The Wolf Motor Function Test (WMFT) is a time-limited method to evaluate upper extremity performance while providing insight into joint-specific and total limb movements.

Outcome measures

Outcome data not reported

Adverse Events

CIT With Recovery Rapids

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Andrew Hansen, PhD

Minneapolis VA Health Care System

Phone: 612-467-2910

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place