Cycle to Fun - 'Exergames' for Inpatient Rehabilitation for Children/Youth With CP
Condition: Cerebral Palsy; Orthopedic Surgery
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      This study is designed to evaluate the feasibility and primary responses of a 3-week
      exergaming cycling program called Liberi Exergames for pediatric inpatients with cerebral
      palsy who are recovering from orthopedic surgery. This study involves the use of multiplayer
      exercise video games or 'exergames' that incorporate an avatar powered by pedalling a
      recumbent stationary bicycle. The Liberi suite of exergames contains six mini-games,
      including a combination of cooperative games, competitive games and individual games designed
      to be fast-paced, action-oriented, and enjoyable for youth with special needs. Standardized
      questionnaires and assessments investigating post-operative pain, gross motor function,
      quality of life, and study engagement are also administered. Five participants will engage in
      'exergaming' sessions every weekday for 3 weeks, and five participants will only complete the
      assessments and questionnaires. All participants will receive the standard of care
      physiotherapy.
    

Detailed description: 
      As children with ambulatory CP become teenagers, they experience a decrease in their physical
      function and mobility. Many children/youth with CP develop contractures (i.e., shortening of
      their muscles) and bony deformities (e.g., hip subluxation) that require lower limb
      orthopedic surgery at some point between the ages of 7-16 years. Post-operatively this is
      followed by intensive rehabilitation to regain motor function. These youths often engage in
      sedentary activities and have low motivation to actively participate in physiotherapy thereby
      limiting their mobility, fitness, and overall well-being. Furthermore, pain is common during
      the post-surgical recovery period and is aggravated by muscle spasms.

      Cycling is often incorporated into post-orthopedic rehabilitation programs in adults and has
      shown to reduce muscle spasms and improve range of motion post-hip replacement surgery.
      However, studies have yet to look at the role of cycling post-orthopedic surgery in youth
      with CP. Exercise video games or 'exergames' are a novel approach to engage youth with
      special needs in physical exercise and social interaction with their peers. To date the
      investigator's team of rehabilitation and computer scientists has developed an accessible and
      functional recumbent bicycling-based exergaming station, called the Liberi Exergames. These
      multiplayer exergames are designed to be fast-paced, action-oriented and enjoyable for youth
      with special needs and have been developed specifically for youth with CP.

      The purpose of this case comparison study is to compare exergaming and standard physiotherapy
      to standard physiotherapy alone, in children with CP who are recovering from orthopedic
      surgery in an inpatient setting. This study is designed to evaluate the feasibility and
      primary responses to cycling with the Liberi Exergames. The primary outcomes are recruitment
      capability and acceptability as well as satisfaction of the intervention. Secondary outcomes
      are pain, health-related quality of life, and lower limb passive range of motion.

      The first five participants will be recruited into the 'comparison' group and will
      participate in all study procedures except for the 'Exergaming' sessions. This will be
      followed by recruitment of 5 participants into the 'case' group, who will participate in the
      'Exergaming' sessions as well as completing standardized assessments and questionnaires. All
      participants will receive physiotherapy as per standard of care.

      Children/youth in the case group will play the Liberi Exergames for approximately 30 minutes
      per session in the afternoon, 5 days a week for three weeks. With the appropriate warm
      up/cool down, plus transfer on and off the unit, the total time for each training session
      will be approximately 45 minutes. The exergames will be supervised by a therapeutic
      recreation specialist and research staff, with transfers on and off the bike supervised by
      physiotherapy and/or nursing staff. The participants will not start the 3 week Exergame
      sessions until after they have started weight-bearing (i.e. for children who have received
      soft-tissue releases this is anticipated immediately post-operatively; for children who have
      had bony procedures this is anticipated at 4 weeks post-operatively).

      Each exergaming station involves a specialized seat equipped with a seatbelt and lateral
      support that is connected to a MagneTrainer pedaling unit (3D Innovations, Greely, Colorado).
      The cycling unit is connected to a Toshiba DX730 computer. During the first session of the
      intervention, the bicycles will be fit to the participants by adjusting their length, the
      pedals, the position of the lateral supports, and their pedaling resistance.

      The Liberi suite of exergames contains six mini-games, including a combination of cooperative
      games, competitive games and games that can be played individually. At the beginning of the 3
      weeks training, research staff will make sure that the children/youth understand the games to
      be played. The participants will be situated in the same room when playing together.
      Participants will also wear a wireless heart rate (HR) monitor that can communicate with the
      gaming station using Bluetooth technology.

      Participants will also be asked to complete questionnaires at the end of every week during
      the intervention phase. These assess post-operative pain (FPS-R, PROMS-PI), quality of life
      (KIDSCREEN-27), and activity engagement (SEAS) for all participants. A lower limb passive
      Range of Motion (PROM) will be conducted prior to the first exergaming session and after the
      final exergaming session. Participants will also be evaluated by the physiotherapist on their
      engagement in the standard of care physiotherapy sessions received by both groups (PRIME-O).
    

Intervention name(s): Exergaming
Intervention type(s): Device
Intervention description(s): This study involves the use of multiplayer exercise video games or 'exergames' that incorporate an avatar powered by pedaling a recumbent stationary bicycle. The Liberi suite of exergames contains six mini-games, including a combination of cooperative games, competitive games and individual games designed to be fast-paced, action-oriented, and enjoyable for youth with special needs.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cerebral Palsy; Orthopedic Surgery; Exergames; Motor Function; Rehabilitation; GMFCS; Pain Reduction; Cycling