The Feasibility of Telehealth HEP for CP (HEP: Home Exercise Program), (CP: Cerebral Palsy)
HEPCP
The Feasibility and Trend of Functional Changes by Using Home-based Exercise Program Delivered Through Telehealth With Coaching for Adolescents With Spastic Cerebral Palsy
1 other identifier
interventional
20
1 country
1
Brief Summary
This study will provide exercise videos and live consultation sessions for adolescents with spastic cerebral palsy. We will recruit 20 participants with 10-18 years old and will be randomized into an experimental or control group. The experimental group will receive exercises videos 2 times a week and one time live consultation session for 8 weeks. The Control group will receive exercise videos 3 times a week for 8 weeks. Both groups will use HIPAA compliant telehealth provider (Physitrack website/ app).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 5, 2020
CompletedFirst Posted
Study publicly available on registry
June 9, 2020
CompletedStudy Start
First participant enrolled
July 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2022
CompletedJune 9, 2020
June 1, 2020
1 year
June 5, 2020
June 8, 2020
Conditions
Outcome Measures
Primary Outcomes (4)
Recruitment Rate
Recruitment rate will be calculated as the total number of patients recruited, divided by the maximum number of sites and then divided by the average number of months recruiting
post-intervention (after end of 8-weeks)
Adherence Rate
Adherence will be calculated as numbers: practice days, sessions, exercises, and repetitions.
post-intervention (after end of 8-weeks)
Compliance Rate
Compliance rate will be calculated by number of participants who will complete the whole intervention duration and be examined post-intervention.
post-intervention (after end of 8-weeks)
Canadian occupational performance measure score change
Achievements of individualized goals will be measured using the adapted version of COPM. For our study, 1-3 individualized goals are determined together by the parents/guardians, physical therapist, and investigators during the 2nd baseline visit. Children/parents will rate the current level of performance of each goal on scale 1-10 and satisfaction level of performance on scale 1-10, during the videoconferencing session along with physical therapist and investigators. The change in scores will be calculated (post-intervention score - Baseline score)
Baseline, Post-intervention (after end of 8-weeks)
Secondary Outcomes (7)
The physical activity questionnaire for children (PAQ-C) and for Adolescents (PAQ-A)
Baseline, Post-intervention (after end of 8-weeks)
The Physical Activity and Enjoyment Scale (PACES)
Baseline, Post-intervention (after end of 8-weeks)
The Cerebral Palsy Quality of Life Questionnaire (CP-QOL)
Baseline, Post-intervention (after end of 8-weeks)
The Correctness of Exercise Performance (COEP)
Baseline, halfway of intervention (after end of 4-weeks), Post-intervention (after end of 8-weeks)
Telehealth Usability Questionnaire (TUQ)
Post-intervention (after end of 8-weeks)
- +2 more secondary outcomes
Study Arms (2)
Tele-coaching group
EXPERIMENTALThis group will receive exercises videos, 2 sessions a week to be done on participant's own and the 3rd session will be live video conference session for training, supervision, and consultation purposes.
Self-monitored group
ACTIVE COMPARATORThis group will receive exercises videos, 3 sessions a week to be done on participant's own with out any supervision.
Interventions
The intervention will include videos of exercises and also live coaching using telehealth system.
Eligibility Criteria
You may qualify if:
- Must be diagnosed with spastic CP diagnosis, Gross Motor Functional Classification System (GMFCS) levels I-III) which will be confirmed by GMFCS-Extended Revised.
- Between the ages of 11 and 18 years old.
- Having a stable health status for 6 weeks prior to screening.
- Having the cognitive ability to follow an exercise instruction in either written or electronic format, with or without support from their parents.
- With an approval from parents/guardians for participating in this study.
- Having access to the internet at home and access to the exercise's website/app via Personal computer (PC), laptop, or mobile app.
- Being able to understand and follow verbal commands in English. The intervention and the questionnaires are available in English only.
You may not qualify if:
- Subjects will be excluded if they have:
- unstable medical condition during past 6 weeks,
- had other neurological disorders that may cause further decline in balance and walking abilities (head injury, vestibular dysfunction, or Spinal cord injury),
- or any musculoskeletal condition that would interfere with the safe performance of the exercise intervention or testing protocol,
- scheduled surgical operations or castings during study period,
- scheduled for intensive rehabilitation during 8 weeks of intervention.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Related Publications (5)
Buffart LM, Westendorp T, van den Berg-Emons RJ, Stam HJ, Roebroeck ME. Perceived barriers to and facilitators of physical activity in young adults with childhood-onset physical disabilities. J Rehabil Med. 2009 Nov;41(11):881-5. doi: 10.2340/16501977-0420.
PMID: 19841838BACKGROUNDLai B, Young HJ, Bickel CS, Motl RW, Rimmer JH. Current Trends in Exercise Intervention Research, Technology, and Behavioral Change Strategies for People With Disabilities: A Scoping Review. Am J Phys Med Rehabil. 2017 Oct;96(10):748-761. doi: 10.1097/PHM.0000000000000743.
PMID: 28398967BACKGROUNDFauzi AA, Khayat MM, Sabirin S, Haron N, Mohamed MNA, Davis GM. Structured home-based exercise program for improving walking ability in ambulant children with cerebral palsy. J Pediatr Rehabil Med. 2019;12(2):161-169. doi: 10.3233/PRM-180538.
PMID: 31227664BACKGROUNDNovak I, Berry J. Home program intervention effectiveness evidence. Phys Occup Ther Pediatr. 2014 Nov;34(4):384-9. doi: 10.3109/01942638.2014.964020. Epub 2014 Oct 15. No abstract available.
PMID: 25317927BACKGROUNDNovak I. Effective home programme intervention for adults: a systematic review. Clin Rehabil. 2011 Dec;25(12):1066-85. doi: 10.1177/0269215511410727. Epub 2011 Aug 10.
PMID: 21831927BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2020
First Posted
June 9, 2020
Study Start
July 1, 2020
Primary Completion
July 1, 2021
Study Completion
July 1, 2022
Last Updated
June 9, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share
Will share only aggregate and overall project results through poster and/or oral presentations at local, regional and national meetings.