Clinical trial NCT04423653: The Feasibility of Telehealth HEP for CP (HEP: Home Exercise Program), (CP: Cerebral Palsy)
Official title: The Feasibility and Trend of Functional Changes by Using Home-based Exercise Program Delivered Through Telehealth With Coaching for Adolescents With Spastic Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebral Palsy, Spastic
Telemedicine
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 20
Sex: ALL
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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.

Primary outcomes:
measure: Recruitment Rate
timeFrame: post-intervention (after end of 8-weeks)
measure: Adherence Rate
timeFrame: post-intervention (after end of 8-weeks)
measure: Compliance Rate
timeFrame: post-intervention (after end of 8-weeks)
measure: Canadian occupational performance measure score change
timeFrame: Baseline, Post-intervention (after end of 8-weeks)
Secondary outcomes:
measure: The physical activity questionnaire for children (PAQ-C) and for Adolescents (PAQ-A)
timeFrame: Baseline, Post-intervention (after end of 8-weeks)
measure: The Physical Activity and Enjoyment Scale (PACES)
timeFrame: Baseline, Post-intervention (after end of 8-weeks)
measure: The Cerebral Palsy Quality of Life Questionnaire (CP-QOL)
timeFrame: Baseline, Post-intervention (after end of 8-weeks)
measure: The Correctness of Exercise Performance (COEP)
timeFrame: Baseline, halfway of intervention (after end of 4-weeks), Post-intervention (after end of 8-weeks)
measure: Telehealth Usability Questionnaire (TUQ)
timeFrame: Post-intervention (after end of 8-weeks)
measure: pediatric pain questionnaire (PPQ)
timeFrame: Baseline, Post-intervention (after end of 8-weeks)
measure: Children Sleep Habits Questionnaire(CSHQ)
timeFrame: Baseline, Post-intervention (after end of 8-weeks)
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
References:
citation: 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.
citation: Lai 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.
citation: Fauzi 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.
citation: Novak 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.
citation: Novak 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.