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

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).

Study Overview

• Status: Unknown
• Conditions: Telemedicine; Cerebral Palsy, Spastic
• Intervention / Treatment: Behavioral: Telehealth home exercise program

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sakher Obaidat, Bsc; Phone Number: 9132035178; Email: obaidatsakher@gmail.com
• Study Contact Backup: Name: Wen Liu, PhD; Email: wliu@kumc.edu

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center
      • Contact: Wen Liu, PhD; Email: wliu@kumc.edu
      • Contact: Sakher Obaidat, Bsc; Phone Number: 913-203-5178; Email: s934o589@kumc.edu
      • Principal Investigator: Wen Liu, PhD
      • Sub-Investigator: Sakher Obaidat, Bsc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Tele-coaching group; This 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.	Behavioral: Telehealth home exercise program; The intervention will include videos of exercises and also live coaching using telehealth system.
ACTIVE_COMPARATOR: Self-monitored group; This group will receive exercises videos, 3 sessions a week to be done on participant's own with out any supervision.	Behavioral: Telehealth home exercise program; The intervention will include videos of exercises and also live coaching using telehealth system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The physical activity questionnaire for children (PAQ-C) and for Adolescents (PAQ-A)	The physical activity questionnaire for children (PAQ-C) and for Adolescents (PAQ-A) versions will be used to evaluate Physical activity level. The PAQ is self-administered, 7-day recall instrument. It is to assess general levels of physical activity in school students between 8-19. PAQ-C has 9 items while PAQ-A has 8 items, and each item is ranked on a 5-point scale. Both versions showed validity and reliability.	Baseline, Post-intervention (after end of 8-weeks)
The Physical Activity and Enjoyment Scale (PACES)	This questionnaire consists of 16 statements that are scored on a five-point rating scale (1 = disagree a lot, 5 = agree a lot).	Baseline, Post-intervention (after end of 8-weeks)
The Cerebral Palsy Quality of Life Questionnaire (CP-QOL)	The Cerebral Palsy Quality of Life Questionnaire for Children (CP QOL-Child) and Cerebral Palsy Quality of Life Questionnaire for Adolescents (CP QOL-Teen) will be utilized to evaluate the QOL either using the self-reported version or proxy-parent report. The CP QOL-Child is to assess the quality of life of children with cerebral palsy aged 4-12 years. An adolescent version, the CP QOL-Teen, has recently been developed for adolescents aged 13-18 years. It assesses different domains including social wellbeing & acceptance, Feelings about functioning, Participation & physical health, Emotional wellbeing & self-esteem, Access to services, Pain & impact of disability, Family health.	Baseline, Post-intervention (after end of 8-weeks)
The Correctness of Exercise Performance (COEP)	(COEP) scale will be used to grade the quality of performance based on three criteria: 1) the performance has been carried out so well that the goal of the exercise is reached, 2) the exercise is not performed correctly and the goal is not reached, although no negative effect is to be expected, and 3) the exercise is carried out incorrectly, the goal is not reached and there is reason to assume that the exercise causes harm. Participants will be videotaped while they are performing the prescribed exercises at home, by parents and videos will be shared with investigator.	Baseline, halfway of intervention (after end of 4-weeks), Post-intervention (after end of 8-weeks)
Telehealth Usability Questionnaire (TUQ)	TUQ is 21 questions with a score ranging from 1 to 7 for each question.	Post-intervention (after end of 8-weeks)
pediatric pain questionnaire (PPQ)	To assess pain intensity and location and the sensory, affective, and evaluative qualities of pain, appropriate for children and adolescents. Visual Analogue scale (VAS) describing pain intensity, body outline to describe location of pain, and words describing pain to assess qualities of pain.	Baseline, Post-intervention (after end of 8-weeks)
Children Sleep Habits Questionnaire(CSHQ)	is a 45-item, parent-rated questionnaire that assesses the frequency of behaviors associated with common pediatric sleep difficulties.	Baseline, Post-intervention (after end of 8-weeks)

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 1, 2020
• Primary Completion (ANTICIPATED): July 1, 2021
• Study Completion (ANTICIPATED): July 1, 2022

Study Registration Dates

• First Submitted: June 5, 2020
• First Submitted That Met QC Criteria: June 8, 2020
• First Posted (ACTUAL): June 9, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 9, 2020
• Last Update Submitted That Met QC Criteria: June 8, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Brain Damage, Chronic; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Cerebral Palsy; Muscle Spasticity
• Other Study ID Numbers: STUDY00145690

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Will share only aggregate and overall project results through poster and/or oral presentations at local, regional and national meetings.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No