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

NCT03769077 | Completed

• 1 other identifier: REB # 18-772
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy; Orthopedic Surgery

Keywords

Cerebral Palsy; Orthopedic Surgery; Exergames; Motor Function; Rehabilitation; GMFCS; Pain Reduction; Cycling

Outcome Measures

Primary Outcomes (3)

• Percentage of eligible participants recruited [Feasibility]

  Patients must meet all eligibility criteria in order to be included in the analysis of this outcome measure. A higher proportion of eligible patients recruited is considered to be a better outcome.

  4 months

• 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]

  Good adherence with the assessments and outcome measures will be demonstrated if 100% of participants complete the FPS-R obtained at baseline and at the end of the third week of the intervention phase.

  End of week 3 of the intervention phase

• Percentage of participants who complete at least 12 of 15 Liberi Exergame Sessions [Feasibility]

  Adherence with the intervention protocol will aim for completion of \>12 sessions out of 15 30-minute sessions administered over 3 weeks for each participant in the case group.

  End of week 3 of the intervention phase

Secondary Outcomes (6)

• Faces Pain Scale-Revised (FPS-R)

  Baseline, end of weeks 1, 2, and 3 of the intervention phase

• Patient Reported Outcome Measurement Information Systems Pediatric Pain Interference Scale (PROMIS-PI)

  Baseline, end of weeks 1, 2, and 3 of the intervention phase

• KIDSCREEN-27

  Baseline, end of week 3 of the intervention phase

• Change in Lower Limb Passive Range of Motion (PROM)

  Baseline, end of week 3 of the intervention phase

• Pediatric Rehabilitation Intervention Measure of Engagement-Observation (PRIME-O)

  End of week 2 of the intervention phase

Study Arms (2)

Exergaming (Case) Group

EXPERIMENTAL

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).

Device: Exergaming

Comparison Group

NO INTERVENTION

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).

Interventions

Exergaming 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.

Exergaming (Case) Group

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Holland Bloorview Kids Rehabilitation Hospital: lead
• Queen's University: collaborator

Study Sites (1)

Holland Bloorview Kids Rehabilitation Hospital

Toronto, Ontario, M4G1R8, Canada

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Darcy Fehlings, MD

  Holland Bloorview Kids Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2018
• First Posted: December 7, 2018
• Study Start: November 27, 2018
• Primary Completion: August 13, 2019
• Study Completion: August 13, 2019
• Last Updated: November 22, 2019

Record last verified: 2018-11

Locations

CA (1)