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

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ClinicalTrials.gov Identifier: NCT03769077
Recruitment Status : Recruiting
First Posted : December 7, 2018
Last Update Posted : July 10, 2019
Sponsor:
Collaborator:
Queen's University
Information provided by (Responsible Party):
Holland Bloorview Kids Rehabilitation Hospital

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.

Condition or disease Intervention/treatment Phase
Cerebral Palsy Orthopedic Surgery Device: Exergaming Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cycle to Fun - 'Exergames' for Inpatient Rehabilitation for Children/Youth With CP
Actual Study Start Date : November 27, 2018
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : August 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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).

Device: 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.

No Intervention: 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).




Primary Outcome Measures :
  1. Percentage of eligible participants recruited [Feasibility] [ Time Frame: 4 months ]
    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.

  2. 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] [ Time Frame: End of week 3 of the intervention phase ]
    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.

  3. Percentage of participants who complete at least 12 of 15 Liberi Exergame Sessions [Feasibility] [ Time Frame: End of week 3 of the intervention phase ]
    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.


Secondary Outcome Measures :
  1. Faces Pain Scale-Revised (FPS-R) [ Time Frame: Baseline, end of weeks 1, 2, and 3 of the intervention phase ]
    The FPS-R is a faces scale used to obtain self-reported pain intensity scores. The FPS-R consists of six gender- and race-neutral faces portraying expressions from 'no pain' (scored "0") to 'very much pain' (scored "10") placed horizontally. The child is asked to point to the face that indicates how much pain she/he feels, and her/his reported pain is consequently scored using 2-point intervals (i.e., 0, 2, 4, 6, 8, and 10) for the six faces.

  2. Patient Reported Outcome Measurement Information Systems Pediatric Pain Interference Scale (PROMIS-PI) [ Time Frame: Baseline, end of weeks 1, 2, and 3 of the intervention phase ]
    The PROMIS-PI is an 8-item questionnaire that measures "pain interference" or the extend to which pain hinders physical, psychological, and socio-emotional functioning in daily activities. Each item has a five-option response scale ranging in value from 1 to 5, where '1=never' and '5=almost always'. All responses are summed to obtain a total raw score and score conversion tables are used to translate the total raw score into a T-score metric (mean= 50, standard deviation=10) for each participant. Higher scores indicate greater symptoms of pain or higher level of impairment.

  3. KIDSCREEN-27 [ Time Frame: Baseline, end of week 3 of the intervention phase ]
    The KIDSCREEN-27 is a globally used standardized health-related quality of life questionnaire measuring five Rasch scaled dimensions of wellbeing including: (1) Physical Well-being (5 items), (2) Psychological Well-being (7 items), (3) Autonomy and Parents (7 items), (4) Peers and Social Support (4 items), and (5) School Environment (4 items). Responses are indicated using a 5-point ordinal scale with responses ranging from 'never' to 'always', 'not at all' to 'extremely', or 'poor' to 'excellent'.

  4. Change in Lower Limb Passive Range of Motion (PROM) [ Time Frame: Baseline, end of week 3 of the intervention phase ]
    Passive range of motion of 16 joints will be recorded using standardized protocol and a universal goniometer. Hip flexion, extension, abduction, adduction, internal and external rotation of the hip, knee flexion and extension, and ankle dorsiflexion and plantar flexion will be measured bilaterally for each participant. Increased motion (as measured in degrees of rotation) is considered to be a better result.

  5. Pediatric Rehabilitation Intervention Measure of Engagement-Observation (PRIME-O) [ Time Frame: End of week 2 of the intervention phase ]
    The PRIME-O is a 10-item survey that asks the therapists to rate signs of engagement for the child/youths, themselves, and the child-PT interaction during therapy sessions. The PRIME-O is a tool developed for evaluating a child's engagement in pediatric rehabilitation interventions by capturing observations on three components of engagement: affective, cognitive and behavioral. The PRIME-O items are presented using a 5-point ordinal scale with responses ranging from '0 = Not at All' to '4 = To a Great Extent', with increased responses indicating increased interest and enthusiasm.

  6. Self-Reported Experiences of Activity Settings (SEAS) [ Time Frame: End of week 2 of the intervention phase ]
    The SEAS index is targeted toward children, including children with disabilities, and provides self-assessment of experience during an activity. Questions capture mood, enjoyment, sense of control, and sense of belonging within a group. Participants are asked to indicate agreement with a series of statements and responses are provided using a 7-point ordinal scale with responses ranging from 'Strongly Agree' to 'Strongly Disagree'.



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Ages Eligible for Study:   7 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03769077


Contacts
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Contact: Daniel Warner, BScH 416 425 6220 ext 6482 dwarner@hollandbloorview.ca

Locations
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Canada, Ontario
Holland Bloorview Kids Rehabilitation Hospital Recruiting
Toronto, Ontario, Canada, M4G1R8
Contact: Daniel Warner, BScH    416-454-2700 ext 6482    dwarner@hollandbloorview.ca   
Principal Investigator: Darcy Fehlings, MD         
Sponsors and Collaborators
Holland Bloorview Kids Rehabilitation Hospital
Queen's University
Investigators
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Principal Investigator: Darcy Fehlings, MD Holland Bloorview Kids Rehabilitation Hospital

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Responsible Party: Holland Bloorview Kids Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT03769077     History of Changes
Other Study ID Numbers: REB # 18-772
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Holland Bloorview Kids Rehabilitation Hospital:
Cerebral Palsy
Orthopedic Surgery
Exergames
Motor Function
Rehabilitation
GMFCS
Pain Reduction
Cycling

Additional relevant MeSH terms:
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Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases