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

Biofeedback-enhanced Interactive Computer-play for Youth With Cerebral Palsy: a Feasibility Pilot Study Measuring the Effect of Play on Wrist and Hand Activity

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy
• Intervention / Treatment: Behavioral: Playing ICP game

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4G 1R8
      • Holland Bloorview Kids Rehabilitation Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Active Range of Motion (AROM)	active wrist AROM	pre-intervention, each week of intervention (weeks 1-4 of the intervention)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)

Collaborators and Investigators

• Sponsor: Holland Bloorview Kids Rehabilitation Hospital
• Investigators: Principal Investigator: Elaine Biddiss, PhD, Bloorview Research Institute

Publications and helpful links

General Publications

• MacIntosh A, Desailly E, Vignais N, Vigneron V, Biddiss E. A biofeedback-enhanced therapeutic exercise video game intervention for young people with cerebral palsy: A randomized single-case experimental design feasibility study. PLoS One. 2020 Jun 22;15(6):e0234767. doi: 10.1371/journal.pone.0234767. eCollection 2020.

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2018
• Primary Completion (Actual): March 14, 2019
• Study Completion (Actual): March 15, 2019

Study Registration Dates

• First Submitted: July 31, 2018
• First Submitted That Met QC Criteria: September 18, 2018
• First Posted (Actual): September 19, 2018

Study Record Updates

• Last Update Posted (Actual): January 31, 2020
• Last Update Submitted That Met QC Criteria: January 29, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: 18-785

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No