Biofeedback-enhanced Interactive Computer-play for Youth With Cerebral Palsy
Primary Purpose
Cerebral Palsy
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Playing ICP game
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy
Eligibility Criteria
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.
Sites / Locations
- Holland Bloorview Kids Rehabilitation Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental arm
Arm Description
Outcomes
Primary Outcome Measures
Change in Active Range of Motion (AROM)
active wrist AROM
Change in Canadian Occupational Performance Measure (COPM)
Evaluates changes in perceived function and satisfaction of performance in self-identified goal areas.
Secondary Outcome Measures
Change in Assisting Hand Assessment (AHA)
a sequence of bimanual tasks through the semi-structured progression of a board game (~15 minutes).
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.
Full Information
NCT ID
NCT03677193
First Posted
July 31, 2018
Last Updated
January 29, 2020
Sponsor
Holland Bloorview Kids Rehabilitation Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03677193
Brief Title
Biofeedback-enhanced Interactive Computer-play for Youth With Cerebral Palsy
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
September 27, 2018 (Actual)
Primary Completion Date
March 14, 2019 (Actual)
Study Completion Date
March 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Holland Bloorview Kids Rehabilitation Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental arm
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Playing ICP game
Intervention Description
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 Outcome Measure Information:
Title
Change in Active Range of Motion (AROM)
Description
active wrist AROM
Time Frame
pre-intervention, each week of intervention (weeks 1-4 of the intervention)
Title
Change in Canadian Occupational Performance Measure (COPM)
Description
Evaluates changes in perceived function and satisfaction of performance in self-identified goal areas.
Time Frame
pre-intervention, post-intervention (5 weeks after pre-intervention)
Secondary Outcome Measure Information:
Title
Change in Assisting Hand Assessment (AHA)
Description
a sequence of bimanual tasks through the semi-structured progression of a board game (~15 minutes).
Time Frame
Pre-intervention, post-intervention (5 weeks after pre-intervention)
Title
Change in Box and Blocks Test (B&B)
Description
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.
Time Frame
Pre-intervention, post-intervention (5 weeks after pre-intervention)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elaine Biddiss, PhD
Organizational Affiliation
Bloorview Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Holland Bloorview Kids Rehabilitation Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4G 1R8
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32569284
Citation
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.
Results Reference
derived
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Biofeedback-enhanced Interactive Computer-play for Youth With Cerebral Palsy
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