Biofeedback-enhanced Interactive Computer-play for Youth With Cerebral Palsy

Cerebral Palsy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03677193
• Other study ID #: 18-785
• Status: Completed
• Phase: N/A
• Start date: September 27, 2018
• Est. completion date: March 15, 2019

Study information

• Verified date: January 2020
• Source: Holland Bloorview Kids Rehabilitation Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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:

1. Phase 1. Participants will speak with therapists / researchers in an Initial Dialogue to:

1. Introduce the study/game and what it offers types of daily activities

2. Set Performance goal areas (Canadian Occupational Performance Measure (COPM)), and

3. Develop an action plan to facilitate the successful achievement of their goals.

2. Phase 2. Participants will perform baseline functional assessments including: active range of motion (AROM), Assisting Hand Assessment (AHA), Box and Blocks Test (B&B).

3. 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.

4. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: March 15, 2019
• Est. primary completion date: March 14, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

Inclusion Criteria:

1. Clinical diagnosis of Cerebral Palsy.

2. Age: 8-18 years. This age range was selected given the popularity of video games and the size of the muscle sensors available.

3. Manual Abilities Classification System levels I-III.

4. Have a goal relating to improving hand / wrist function.

5. Dominantly spastic presentation

6. Able to co-operate, understand, and follow simple instructions for game play. This will be assessed during the information and assent process by the researcher.

7. Having passive ROM of at least 10° greater than AROM.

Exclusion Criteria:

1. History of unmanaged epilepsy. Video game systems are not recommended for individuals with a history of epilepsy as per manufacturer's Health and Safety Precautions.

2. Has received a Botulinum Toxin treatment within 3 months or constraint-based movement therapy within 6 months of the study enrollment.

3. Visual, cognitive or auditory disability at a level that would interfere with game play. The child must have normal or corrected to normal vision and hearing.

4. Dominantly dystonic presentation

5. Unable to commit an estimated minimum of 10 hours to their training plan over four weeks.

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

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.

Locations

Country	Name	City	State
Canada	Holland Bloorview Kids Rehabilitation Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Holland Bloorview Kids Rehabilitation Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Active Range of Motion (AROM)	active wrist AROM	pre-intervention, each week of intervention (weeks 1-4 of the intervention)
Primary	Change in Canadian Occupational Performance Measure (COPM)	Evaluates changes in perceived function and satisfaction of performance in self-identified goal areas.	pre-intervention, post-intervention (5 weeks after pre-intervention)
Secondary	Change in Assisting Hand Assessment (AHA)	a sequence of bimanual tasks through the semi-structured progression of a board game (~15 minutes).	Pre-intervention, post-intervention (5 weeks after pre-intervention)
Secondary	Change in Box and Blocks Test (B&B)	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.	Pre-intervention, post-intervention (5 weeks after pre-intervention)