Physical and Social Benefits of Multi-Player Interactive Computer Play Games in Youth With Cerebral Palsy

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Queen's University
Natural Sciences and Engineering Research Council, Canada
Information provided by (Responsible Party):
Holland Bloorview Kids Rehabilitation Hospital
ClinicalTrials.gov Identifier:
NCT01901211
First received: July 11, 2013
Last updated: December 11, 2013
Last verified: December 2013
  Purpose

As children with cerebral palsy (CP) become teenagers, they experience a decrease in their physical function and mobility. Decreased mobility leads to increased social isolation for the teens and impacts negatively on their quality of life. This loss of function is multifactorial, but poor physical fitness and muscle weakness secondary to disuse are significant contributors. Exercise video games are a novel approach to engage youth in physical exercise and social interaction with their peers. The objective of this study is to evaluate the impact of an exercise video gaming intervention to improve physical fitness and social wellbeing. Our over-arching research questions are whether "exergames" can provide health benefits (improved physical fitness) and improved social wellbeing in youth with CP.


Condition Intervention
Cerebral Palsy
Other: Exergaming Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: CP Fit 'n' Fun Project: Physical and Social Benefits of Multi-Player Interactive Computer Play Games in Youth With Cerebral Palsy

Resource links provided by NLM:


Further study details as provided by Holland Bloorview Kids Rehabilitation Hospital:

Primary Outcome Measures:
  • Change in the 7.5 meter Shuttle Run Test for Gross Motor Function Classification Scale (GMFCS) level III (SRT-III) [ Time Frame: Baseline (1-week pre-study arm 1), 11-weeks (post study arm 1), 17-weeks (post washout period), 28-weeks (post study arm 2) ] [ Designated as safety issue: No ]
    The 7.5m Shuttle Run test (SRT-III) is a maximal, running-based, field test that can assess cardiovascular fitness in children with CP GMFCS level III. In the tests, markers are placed 7.5m apart in a square formation. Participants walk from marker to marker according to progressively faster auditory cues from a music device.

  • Change in the Social Wellbeing Domain of the KINDL-R Quality of Life Questionnaire [ Time Frame: Baseline (1-week pre-study arm 1), 11-weeks (post study arm 1), 17-weeks (post washout period), 28-weeks (post study arm 2) ] [ Designated as safety issue: No ]
    Wellbeing Related to Friends/Peers domain of the KINDL-R is a four-item subscale focusing on time spent with friends, being perceived as a success with friends, getting along with friends and whether or not they felt different from peers over the past week. Individual items are scored on a five-point Likert scale and the subscale can be scored in isolation.


Secondary Outcome Measures:
  • Handheld dynamometry measures of knee flexors and knee extensors [ Time Frame: Baseline (1-week pre-study arm 1), 11-weeks (post study arm 1), 17-weeks (post washout period), 28-weeks (post study arm 2) ] [ Designated as safety issue: No ]
    Handheld dynamometry will be used to measure muscle strength for the quadriceps muscles and the hamstrings at 90˚ of knee flexion in both legs.

  • The 30-second Wingate Cycle Test [ Time Frame: Baseline (1-week pre-study arm 1), 11-weeks (post study arm 1), 17-weeks (post washout period), 28-weeks (post study arm 2) ] [ Designated as safety issue: No ]
    The 30-second Wingate Cycle Test is a measure of anaerobic power, a key component of physical fitness. The cycle test is performed when a participant uses a cycle ergometer and pedals as hard as they can for 30-seconds against a constant braking force.

  • Anthropometric measurements [ Time Frame: Baseline (1-week pre-study arm 1), 11-weeks (post study arm 1), 17-weeks (post washout period), 28-weeks (post study arm 2) ] [ Designated as safety issue: No ]
    Anthropometric measurements of waist circumference, triceps and subscapular skinfold thickness, height and weight will be used to assess body composition as indicators of physical fitness.

  • Total Score of the KINDL-R Questionnaire [ Time Frame: Baseline (1-week pre-study arm 1), 11-weeks (post study arm 1), 17-weeks (post washout period), 28-weeks (post study arm 2) ] [ Designated as safety issue: No ]
    The total score of the 24-item KINDL-R questionnaire will measure the participants' health-related quality of life.

  • The Self-Worth Domain of the KINDL-R Questionnaire [ Time Frame: Baseline (1-week pre-study arm 1), 11-weeks (post study arm 1), 17-weeks (post washout period), 28-weeks (post study arm 2) ] [ Designated as safety issue: No ]
    The 4-item Self-worth Domain of the KINDL-R will be used as an indicator of self-esteem.

  • Gaming data [ Time Frame: 10-weeks of the exergaming intervention ] [ Designated as safety issue: No ]
    Gaming data will be collected as measures of effectiveness of the games' balancing techniques, engagement and adherence. The games will be instrumented to automatically collect usage data including: time and frequency of play; amount of time within HR zones; pedaling cadence information; minigames played; and location of the player's avatar in the virtual world.

  • StepWatch Activity Monitors [ Time Frame: Baseline (1-week pre-study arm 1), 11-weeks (post study arm 1), 17-weeks (post washout period), 28-weeks (post study arm 2) ] [ Designated as safety issue: No ]
    StepWatch Activity Monitors will be used to measure activity levels and motor participation. The StepWatch is a two-plane accelerometer that is worn around the ankle in a knit cuff. The StepWatch measures ambulatory activity (i.e. total daily step count) and acts as an indicator of motor participation in the community.


Enrollment: 11
Study Start Date: September 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exergaming
In this arm, the participants will participate in the exergaming intervention.
Other: Exergaming Intervention
The exergaming system will be installed into the participants' homes. Players will pedal the exergame bike in order to move their game avatar. Headsets allow players to communicate with each other in real-time. Participants will play the games 3 to 5 times per week, during scheduled game times. Players will wear a heart rate (HR) monitor and will achieve game benefits for reaching their target HR. They will be asked to exercise in a target HR zone of 40-65%HR reserve. Each week, participants will receive a call from a research assistant (RA), who will provide feedback on their exercise progress and a HR goal for each week. The RA will also record physical and social activities engaged in and any difficulties like leg pain or technical issues.
No Intervention: Comparison Arm
In this arm of the study, participants will engage in their typical physical activity routines for the ten week duration. Participants will receive a call from the RA each week. The RA will ask the child to report on all the physical and social activities that they engaged in for that week.

Detailed Description:

The primary objectives of this study are to evaluate the impact of exergaming on cardiovascular fitness and social wellbeing related to friends/peers in youths with CP. The secondary objectives of the study will be to evaluate the impact of the exergaming intervention on additional components of physical fitness including anaerobic fitness, and muscle strength. In addition, the effect of the exergaming intervention on overall health-related quality of life (HRQL), self-esteem and motor participation will also be measured. Finally, the effectiveness of a technique for balancing performance in multiplayer exergames will be evaluated. The objectives will be investigated using a randomized crossover study design.Outcomes will be measured a total of four times: at study entry and after the first ten-week period (either comparison or intervention), at the end of a six-week washout period, then again after second period (either intervention or comparison). Outcomes will be assessed by physiotherapists and research staff members who will be blinded to the condition of the participants.

  Eligibility

Ages Eligible for Study:   9 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of CP and GMFCS level III
  • Between 9 and 18 years of age inclusive
  • Ability to operate a handheld videogame controller
  • High-speed internet in the home
  • Able to commit for the entire study duration

Exclusion Criteria:

  • Orthopedic surgery in the preceding six months
  • Exercise-induced asthma
  • Any underlying heart condition
  • Seizure disorder
  • Visual, auditory or cognitive disabilities that will interfere with game play
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01901211

Locations
Canada, Ontario
Holland Bloorview Kids Rehabilitation Hospital
Toronto, Ontario, Canada, M4G1R8
Sponsors and Collaborators
Holland Bloorview Kids Rehabilitation Hospital
Queen's University
Natural Sciences and Engineering Research Council, Canada
Investigators
Principal Investigator: Darcy Fehlings, MD, MSc, FRCPC Holland Bloorview Kids Rehabilitation Hospital
Principal Investigator: T.C. Nicholas Graham, PhD Queen's University
  More Information

No publications provided

Responsible Party: Holland Bloorview Kids Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT01901211     History of Changes
Other Study ID Numbers: 13-423
Study First Received: July 11, 2013
Last Updated: December 11, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Holland Bloorview Kids Rehabilitation Hospital:
Cerebral palsy
Interactive computer play
Multi-player gaming
Exercise

Additional relevant MeSH terms:
Cerebral Palsy
Paralysis
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on October 20, 2014