Biofeedback-enhanced Interactive Computer-play for Youth With Cerebral Palsy
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|ClinicalTrials.gov Identifier: NCT03677193|
Recruitment Status : Not yet recruiting
First Posted : September 19, 2018
Last Update Posted : September 19, 2018
The protocol aims to evaluate the feasibility and potential efficacy of an Interactive Computer Play (ICP) intervention. The ICP intervention is built to help youth with Cerebral palsy (CP) who have difficulty performing activities of daily living with their hand.
The ICP intervention is a video game controlled by performing gestures with the non-dominant hand. Using Low-cost commercial technology muscle activity and arm movement is used to recognize the gestures which control the game. Players will get feedback in the game about the quality of their movements through the built-in points and rewards system. This repetitive practice and feedback will help the participants build strength and control in their arm. To evaluate this ICP intervention, 10 participants, with hemiplegic CP and 8-18 years old, from Holland Bloorview will be recruited for a pilot feasibility study using a single-case experimental design (SCED). The design is as follows:
Phase 1. Participants will speak with therapists / researchers in an Initial Dialogue to:
- Introduce the study/game and what it offers types of daily activities
- Set Performance goal areas (Canadian Occupational Performance Measure (COPM)), and
- Develop an action plan to facilitate the successful achievement of their goals.
- Phase 2. Participants will perform baseline functional assessments including: active range of motion (AROM), Assisting Hand Assessment (AHA), Box and Blocks Test (B&B).
- Phase 3. During the 4-week intervention, participants will play the ICP game from their home according to the goals they define during the initial dialogue. This is expected to be 20-30 min * 5 days per week. Once per week, participants will play the ICP intervention with a researcher in clinic or at home who will also measure AROM while recording the play session.
- Phase 4. After the intervention, participants will complete clinical measures of functional performance (AROM, AHA, B&B) a final time and speak with therapist and researcher to re-evaluate goals (COPM).
By leveraging the motivational and immersive aspects of ICP and combining it with evidence-based movement feedback this protocol has the potential to improve home-based ICP therapies for persons with CP.
|Condition or disease||Intervention/treatment||Phase|
|Cerebral Palsy||Behavioral: Playing ICP game||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||The study will be conducted a single-case experimental design (SCED). Participants will be randomly assigned to begin the intervention at staggered starting-points.|
|Masking:||None (Open Label)|
|Official Title:||Biofeedback-enhanced Interactive Computer-play for Youth With Cerebral Palsy: a Feasibility Pilot Study Measuring the Effect of Play on Wrist and Hand Activity|
|Estimated Study Start Date :||September 2018|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||July 2019|
|Experimental: Experimental arm||
Behavioral: Playing ICP game
Participants will play the ICP game from their home this is expected to be 30 min * 5 days / week for 4 weeks. Once per week, participants will play the ICP game with a researcher.
- Change in Active Range of Motion (AROM) [ Time Frame: pre-intervention, each week of intervention (weeks 1-4 of the intervention) ]active wrist AROM
- Change in Canadian Occupational Performance Measure (COPM) [ Time Frame: pre-intervention, post-intervention (5 weeks after pre-intervention) ]Evaluates changes in perceived function and satisfaction of performance in self-identified goal areas.
- Change in Assisting Hand Assessment (AHA) [ Time Frame: Pre-intervention, post-intervention (5 weeks after pre-intervention) ]a sequence of bimanual tasks through the semi-structured progression of a board game (~15 minutes).
- Change in Box and Blocks Test (B&B) [ Time Frame: Pre-intervention, post-intervention (5 weeks after pre-intervention) ]the participant has one minute to move blocks from one side of a box, over a center divider, and place on the other side of the box.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03677193
|Contact: Elaine Biddiss, PhDemail@example.com|
|Contact: Ajmal Khan, MScfirstname.lastname@example.org|
|Principal Investigator:||Elaine Biddiss, PhD||Bloorview Research Institute|