An Interactive Computer Game, Called Duck Duck Punch, for Stroke Rehabilitation at Home and in a Rehabilitation Clinic

Stroke Clinical Trial

— DDPHme/Hsp  

Official title:

A Virtual Environment for Post-Stroke Upper Extremity Rehabilitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02882997
• Other study ID #: Pro00029185
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 5, 2016
• Last updated: August 24, 2016
• Start date: November 2013
• Est. completion date: August 2016

Study information

• Verified date: August 2016
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This study will determine the feasibility of using an interactive computer game to elicit repetitive practice of paretic arm movements in the homes of community dwelling stroke survivors and during non-therapy hours at an inpatient stroke rehabilitation hospital.

Description:

More than 75% of the 800,000 people who annually suffer stroke exhibit persistent arm/hand hemiparesis restricting independence thus burdening caregivers. Arm motor skill can recover if the rehabilitation program provides an adequate "dose" of repetitive movement practice. However, the vast majority of stroke survivors lack the proper practice-dose because the duration of inpatient stroke rehabilitation is limited by cost, or residence in medically underserved rural settings. To meet the pressing need for innovative cost-effective rehabilitation options, the investigators developed, tested and licensed a prototype virtual environment (VE) for post-stroke arm rehabilitation. Its custom built design motivates extended practice of specific arm motor skills known to improve quality of life. Excitingly, practice sessions do not require direct therapist supervision. Published pilot data demonstrated improved real-world arm movement after VE training. These promising initial results led to software upgrades that will now enable installation and testing in the primary markets for this technology; stroke rehabilitation hospitals, and patients' homes. The overall goal for this small pilot study is to test the feasibility of self-directed VE practice in these settings measured by movement repetitions and motor skill improvement. To that end, this project will address the following Specific Aims (1) Determine the number of daily movement repetitions and treatment effect achieved by inpatients in a stroke rehabilitation hospital who self-direct VE practice sessions during non-therapy hours (evenings, weekends) compared to standard evening activities; and (2) Determine the number of daily movement repetitions and treatment effect achieved by in-home stroke survivors who self-direct daily VE practice sessions compared to a group of in-home survivors with a standard self-directed exercise program.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 90 Years

Eligibility

Inclusion Criteria:

• experienced uni-hemispheric ischemic or hemorrhagic stroke

• exhibit voluntarily shoulder flexion (affected UE) =20° with simultaneous elbow extension =10°. We reason that persons at this motor ability level have enough residual arm activation to engage in VE training

• passive range of motion in affected shoulder and elbow and within 20 degrees of normal values

Additional inclusion criteria for community dwelling stroke survivors

• live at home

• no current rehabilitation therapy

• live within a 60 minute drive of the university

Additional inclusion criteria for inpatient stroke patients

• medically stable

• expected to remain in the hospital for the next 7 days

• able to sit in a chair for 60 minutes without difficulty

Exclusion Criteria:

• lesion in brainstem or cerebellum

• presence of other neurological disease that may impair motor skills (e.g., Parkinson's Disease)

• pain in the paretic arm that would interfere with movement

• unable to understand and follow 3-step directions

• orthopedic condition or impaired corrected vision that would interfere with reaching.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• an interactive computer game
Duck Duck Punch is an interactive computer game designed to elicit repetitive practice of paretic arm movements in stroke patients.
• standard activities
For community dwelling stroke survivors this is a hard copy, written/illustrated home exercise program for the paretic arm. For inpatient stroke patients this is standard recreational activities organized by the facility during non therapy hours (evenings and weekends).

Locations

Country	Name	City	State
United States	The Medical University of South Carolina	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	University of Delaware

Country where clinical trial is conducted

United States, 

References & Publications (1)

Woodbury ML, Anderson K, Finetto C, Fortune A, Dellenbach B, Grattan E, Hutchison S. Matching Task Difficulty to Patient Ability During Task Practice Improves Upper Extremity Motor Skill After Stroke: A Proof-of-Concept Study. Arch Phys Med Rehabil. 2016 Apr 23. pii: S0003-9993(16)30073-9. doi: 10.1016/j.apmr.2016.03.022. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Paretic arm use	The amount of paretic arm use will be measured by wrist worn accelerometers. Subjects will be shown how to don/doff wristwatch sized triaxial Actigraph accelerometers (GT3X+ Activity Monitor; ActiGraph LLC) by securing a Velcro band on the dorsal aspect of each wrist proximal to the wrist joint. Subjects will be instructed to don the accelerometers each time they engaged in either the computer game or standard activity and wear them only for the duration of the activity. The accelerometers will be stored in a box during other times. Accelerometry data will be recorded in 1 minute epochs as the number of arm activity counts. At the final study evaluation session, data will be used to create a ratio of paretic to non-paretic arm activity counts. A value of 1 will indicate bilateral arm use, a value higher than 1 will indicate that the paretic arm was used more than the non-paretic arm, and a value less than 1 will indicate that the paretic arm was used less than the non-paretic arm.	1 year	No
Secondary	Fugl Meyer Upper Extremity Assessment	a 33-item measure of arm impairment testing the subject's ability to achieve various postures with the paretic arm and hand, scored on a 3 point ordinal rating scale with higher scores indicating less motor impairment.	up to 7 days	No
Secondary	Wolf Motor Function Test	A 15-item evaluation of paretic arm motor function, testing the amount of time required for a subject to use the paretic arm to accomplish various functional tasks.	up to 7 days	No
Secondary	Stroke Impact Scale - Hand subtest	A 5-item evaluation of patient self-reported level of difficulty using the paretic hand to perform various functional activities at home. Items are rated on a 4 point ordinal scale so that higher numbers indicate less difficulty.	up to 7 days	No

External Links

•   A paper presented at a conference on the initial development of the interactive computer game.