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Completed

NCT Number: NCT03677193

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

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.

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Key information

Conditions

Cerebral Palsy Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Holland Bloorview Kids Rehabilitation Hospital

Toronto, Ontario, M4G 1R8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of Cerebral Palsy.
  • Age: 8-18 years. This age range was selected given the popularity of video games and the size of the muscle sensors available.
  • Manual Abilities Classification System levels I-III.
  • Have a goal relating to improving hand / wrist function.
  • Dominantly spastic presentation
  • 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.
  • Having passive ROM of at least 10° greater than AROM.

Exclusion criteria

  • 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.
  • Has received a Botulinum Toxin treatment within 3 months or constraint-based movement therapy within 6 months of the study enrollment.
  • 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.
  • Dominantly dystonic presentation
  • Unable to commit an estimated minimum of 10 hours to their training plan over four weeks.

Treatment and study plan

Playing ICP game

Behavioral

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.

Primary outcomes

  1. Change in Active Range of Motion (AROM)

    Time frame: pre-intervention, each week of intervention (weeks 1-4 of the intervention)

    active wrist AROM

  2. 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.

Secondary outcomes

  1. 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).

  2. 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.

Sponsors and collaborators

Lead sponsor

Holland Bloorview Kids Rehabilitation Hospital

Other

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 19, 2018
Registry last updated
Jan 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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