search
Back to results

The Feasibility of Telehealth HEP for CP (HEP: Home Exercise Program), (CP: Cerebral Palsy) (HEPCP)

Primary Purpose

Cerebral Palsy, Spastic, Telemedicine

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telehealth home exercise program
Sponsored by
University of Kansas Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy, Spastic

Eligibility Criteria

11 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Kansas Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tele-coaching group

Self-monitored group

Arm Description

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.

This group will receive exercises videos, 3 sessions a week to be done on participant's own with out any supervision.

Outcomes

Primary Outcome Measures

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
Adherence Rate
Adherence will be calculated as numbers: practice days, sessions, exercises, and repetitions.
Compliance Rate
Compliance rate will be calculated by number of participants who will complete the whole intervention duration and be examined post-intervention.
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)

Secondary Outcome Measures

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.
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).
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.
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.
Telehealth Usability Questionnaire (TUQ)
TUQ is 21 questions with a score ranging from 1 to 7 for each question.
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.
Children Sleep Habits Questionnaire(CSHQ)
is a 45-item, parent-rated questionnaire that assesses the frequency of behaviors associated with common pediatric sleep difficulties.

Full Information

First Posted
June 5, 2020
Last Updated
June 8, 2020
Sponsor
University of Kansas Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT04423653
Brief Title
The Feasibility of Telehealth HEP for CP (HEP: Home Exercise Program), (CP: Cerebral Palsy)
Acronym
HEPCP
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

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 2020 (Anticipated)
Primary Completion Date
July 2021 (Anticipated)
Study Completion Date
July 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Kansas Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy, Spastic, Telemedicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tele-coaching group
Arm Type
Experimental
Arm Description
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.
Arm Title
Self-monitored group
Arm Type
Active Comparator
Arm Description
This group will receive exercises videos, 3 sessions a week to be done on participant's own with out any supervision.
Intervention Type
Behavioral
Intervention Name(s)
Telehealth home exercise program
Intervention Description
The intervention will include videos of exercises and also live coaching using telehealth system.
Primary Outcome Measure Information:
Title
Recruitment Rate
Description
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
Time Frame
post-intervention (after end of 8-weeks)
Title
Adherence Rate
Description
Adherence will be calculated as numbers: practice days, sessions, exercises, and repetitions.
Time Frame
post-intervention (after end of 8-weeks)
Title
Compliance Rate
Description
Compliance rate will be calculated by number of participants who will complete the whole intervention duration and be examined post-intervention.
Time Frame
post-intervention (after end of 8-weeks)
Title
Canadian occupational performance measure score change
Description
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)
Time Frame
Baseline, Post-intervention (after end of 8-weeks)
Secondary Outcome Measure Information:
Title
The physical activity questionnaire for children (PAQ-C) and for Adolescents (PAQ-A)
Description
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.
Time Frame
Baseline, Post-intervention (after end of 8-weeks)
Title
The Physical Activity and Enjoyment Scale (PACES)
Description
This questionnaire consists of 16 statements that are scored on a five-point rating scale (1 = disagree a lot, 5 = agree a lot).
Time Frame
Baseline, Post-intervention (after end of 8-weeks)
Title
The Cerebral Palsy Quality of Life Questionnaire (CP-QOL)
Description
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.
Time Frame
Baseline, Post-intervention (after end of 8-weeks)
Title
The Correctness of Exercise Performance (COEP)
Description
(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.
Time Frame
Baseline, halfway of intervention (after end of 4-weeks), Post-intervention (after end of 8-weeks)
Title
Telehealth Usability Questionnaire (TUQ)
Description
TUQ is 21 questions with a score ranging from 1 to 7 for each question.
Time Frame
Post-intervention (after end of 8-weeks)
Title
pediatric pain questionnaire (PPQ)
Description
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.
Time Frame
Baseline, Post-intervention (after end of 8-weeks)
Title
Children Sleep Habits Questionnaire(CSHQ)
Description
is a 45-item, parent-rated questionnaire that assesses the frequency of behaviors associated with common pediatric sleep difficulties.
Time Frame
Baseline, Post-intervention (after end of 8-weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sakher Obaidat, Bsc
Phone
9132035178
Email
obaidatsakher@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Wen Liu, PhD
Email
wliu@kumc.edu
Facility Information:
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sakher Obaidat, Bsc
Phone
913-203-5178
Email
s934o589@kumc.edu
First Name & Middle Initial & Last Name & Degree
Wen Liu, PhD
Email
wliu@kumc.edu
First Name & Middle Initial & Last Name & Degree
Wen Liu, PhD
First Name & Middle Initial & Last Name & Degree
Sakher Obaidat, Bsc

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Will share only aggregate and overall project results through poster and/or oral presentations at local, regional and national meetings.
Citations:
PubMed Identifier
19841838
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.
Results Reference
background
PubMed Identifier
28398967
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.
Results Reference
background
PubMed Identifier
31227664
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.
Results Reference
background
PubMed Identifier
25317927
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.
Results Reference
background
PubMed Identifier
21831927
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.
Results Reference
background

Learn more about this trial

The Feasibility of Telehealth HEP for CP (HEP: Home Exercise Program), (CP: Cerebral Palsy)

We'll reach out to this number within 24 hrs