Clinical trial NCT03769077: Cycle to Fun - 'Exergames' for Inpatient Rehabilitation for Children/Youth With CP
Official title: Cycle to Fun - 'Exergames' for Inpatient Rehabilitation for Children/Youth With CP
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Orthopedic Surgery
Keywords: Cerebral Palsy
Orthopedic Surgery
Exergames
Motor Function
Rehabilitation
GMFCS
Pain Reduction
Cycling
Lead sponsor: Holland Bloorview Kids Rehabilitation Hospital
Sponsor class: OTHER
Collaborators: name: Queen's University
First posted: 2018-12-07
Enrollment: 10
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Eligibility criteria: Inclusion Criteria:

* Children/youth diagnosed with CP admitted to Holland Bloorview Kids Rehabilitation Hospital for inpatient rehabilitation following lower extremity orthopedic surgery
* Between 7 to 18 years of age
* Pre-operative Gross Motor Functional Classification Scale (GMFCS) level I - III
* Willingness and ability to operate a hand-held controller and pedal on the Liberi Exergames system
* Ability to self-report on the Faces Pain Scale-Revised (FPS-R)
* Documentation of informed consent by participant and/or representative and/or caregiver

Exclusion Criteria:

- Presence of unmanaged medical conditions (like exercise-induced asthma, heart condition, and uncontrolled seizures) that might prevent ability to train with the Liberi Exergames system

Primary outcomes:
measure: Percentage of eligible participants recruited [Feasibility]
timeFrame: 4 months
measure: Percentage of participants who complete the Faces Pain Scale-Revised at baseline and at the end of the third week of the intervention phase [Feasibility]
timeFrame: End of week 3 of the intervention phase
measure: Percentage of participants who complete at least 12 of 15 Liberi Exergame Sessions [Feasibility]
timeFrame: End of week 3 of the intervention phase
Secondary outcomes:
measure: Faces Pain Scale-Revised (FPS-R)
timeFrame: Baseline, end of weeks 1, 2, and 3 of the intervention phase
measure: Patient Reported Outcome Measurement Information Systems Pediatric Pain Interference Scale (PROMIS-PI)
timeFrame: Baseline, end of weeks 1, 2, and 3 of the intervention phase
measure: KIDSCREEN-27
timeFrame: Baseline, end of week 3 of the intervention phase
measure: Change in Lower Limb Passive Range of Motion (PROM)
timeFrame: Baseline, end of week 3 of the intervention phase
measure: Pediatric Rehabilitation Intervention Measure of Engagement-Observation (PRIME-O)
timeFrame: End of week 2 of the intervention phase
measure: Self-Reported Experiences of Activity Settings (SEAS)
timeFrame: End of week 2 of the intervention phase
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Holland Bloorview Kids Rehabilitation Hospital
state: Ontario
Study officials:
affiliation: Holland Bloorview Kids Rehabilitation Hospital
name: Darcy Fehlings, MD
role: PRINCIPAL_INVESTIGATOR
References: