Cycle to Fun - 'Exergames' for Inpatient Rehabilitation for Children/Youth With CP

NCT ID: NCT03769077

Last Updated: 2019-11-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-27
• Study Completion Date: 2019-08-13

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).

Conditions

Cerebral Palsy; Orthopedic Surgery

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Exergaming (Case) Group

Participants assigned to the exergame condition will play the exergames for 30 minutes, 5 days a week for 3 weeks (15 exergame sessions). Outcomes will be acquired at baseline (before intervention), and at the end of every week during the 3 week intervention phase. Participants will also receive the current standard PT care at the Specialized Orthopedic and Developmental Rehab (SODR) inpatient unit at Holland Bloorview Kids Rehabilitation Hospital.

The research participants will be asked to complete the following self-report questionnaires: Patient Reported Outcome Measurement Information System Pediatric Pain Interference Scale (PROMIS-PI), the KIDSCREEN-27, Faces Pain Scale-Revised (FPS-R) and the Self-Reported Experiences of Activity Settings (SEAS).

Group Type: EXPERIMENTAL

Exergaming

Intervention Type: DEVICE

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.

Comparison Group

Participants will receive the current standard PT care at the Specialized Orthopedic and Developmental Rehab (SODR) inpatient unit at Holland Bloorview Kids Rehabilitation Hospital and will complete questionnaires and assessments at the same time points during study participation.

The research participants will be asked to complete the following self-report questionnaires: Patient Reported Outcome Measurement Information System Pediatric Pain Interference Scale (PROMIS-PI), the KIDSCREEN-27, Faces Pain Scale-Revised (FPS-R) and the Self-Reported Experiences of Activity Settings (SEAS).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Exergaming

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Queen's University

OTHER

Sponsor Role: collaborator

Holland Bloorview Kids Rehabilitation Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Darcy Fehlings, MD

Role: PRINCIPAL_INVESTIGATOR

Holland Bloorview Kids Rehabilitation Hospital

Locations

Holland Bloorview Kids Rehabilitation Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

REB # 18-772

Identifier Type: -

Identifier Source: org_study_id