Cerebral Palsy, SpasticHEPCPNCT04423653
The Feasibility of Telehealth HEP for CP (HEP: Home Exercise Program), (CP: Cerebral Palsy)
A study testing Telehealth home exercise program in people with Cerebral Palsy, Spastic and Telemedicine, run by University of Kansas Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 18 years
- Conditions the study is for
- Cerebral Palsy, Spastic, Telemedicine
- What is being tested?
- Telehealth home exercise program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2020to Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Wen Liu, PhD contact
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
Sakher Obaidat, Bsc, 913-203-5178, s934o589@kumc.edu
Wen Liu, PhD, wliu@kumc.edu
About this study
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
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).
- Conditions
- Cerebral Palsy, Spastic, Telemedicine
- Being tested
- Telehealth home exercise program
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telehealth home exercise programBehavioural
The intervention will include videos of exercises and also live coaching using telehealth system.
| Study group | Role | What they receive |
|---|---|---|
| Tele-coaching group | Experimental | 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. Receives: Behavioral: Telehealth home exercise program |
| Self-monitored group | Active comparator | This group will receive exercises videos, 3 sessions a week to be done on participant's own with out any supervision. Receives: Behavioral: Telehealth home exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: post-intervention (after end of 8-weeks)
Adherence Rate
Adherence will be calculated as numbers: practice days, sessions, exercises, and repetitions.
Measured: 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.
Measured: 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)
Measured: Baseline, Post-intervention (after end of 8-weeks)
Secondary outcomes (7)
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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, Post-intervention (after end of 8-weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study startJul 2020 (estimated)
- Primary completionJul 2021 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cerebral Palsy, SpasticStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04423653
- Sponsor's protocol ID
- STUDY00145690
- Acronym
- HEPCP
- Status last verified
- Jun 2020
- First submitted
- 5 Jun 2020
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Will share only aggregate and overall project results through poster and/or oral presentations at local, regional and national meetings.
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.
PubMed 19841838Lai 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.
PubMed 28398967Fauzi 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.
PubMed 31227664Novak 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.
PubMed 25317927Novak 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.
PubMed 21831927
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04423653
- Acronym / sponsor ID
- HEPCP / STUDY00145690
- Conditions
- Cerebral Palsy, Spastic, Telemedicine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- Jul 2020 (estimated)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tele-coaching group | Experimental | Behavioral: Telehealth home exercise programThis 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 comparator | Behavioral: Telehealth home exercise programThis group will receive exercises videos, 3 sessions a week to be done on participant's own with out any supervision. |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telehealth home exercise programThe intervention will include videos of exercises and also live coaching using telehealth system. | Behavioural | Self-monitored group, Tele-coaching group |
Primary outcome
Recruitment Rate
Time frame: post-intervention (after end of 8-weeks)
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
Time frame: post-intervention (after end of 8-weeks)
Adherence will be calculated as numbers: practice days, sessions, exercises, and repetitions.
Compliance Rate
Time frame: post-intervention (after end of 8-weeks)
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
Time frame: Baseline, Post-intervention (after end of 8-weeks)
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)
7 secondary outcomes
The physical activity questionnaire for children (PAQ-C) and for Adolescents (PAQ-A)
Time frame: Baseline, Post-intervention (after end of 8-weeks)
The Physical Activity and Enjoyment Scale (PACES)
Time frame: Baseline, Post-intervention (after end of 8-weeks)
The Cerebral Palsy Quality of Life Questionnaire (CP-QOL)
Time frame: Baseline, Post-intervention (after end of 8-weeks)
The Correctness of Exercise Performance (COEP)
Time frame: Baseline, halfway of intervention (after end of 4-weeks), Post-intervention (after end of 8-weeks)
Telehealth Usability Questionnaire (TUQ)
Time frame: Post-intervention (after end of 8-weeks)
pediatric pain questionnaire (PPQ)
Time frame: Baseline, Post-intervention (after end of 8-weeks)
Children Sleep Habits Questionnaire(CSHQ)
Time frame: Baseline, Post-intervention (after end of 8-weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- Background: PubMed 19841838Buffart 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.
- Background: PubMed 28398967Lai 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.
- Background: PubMed 31227664Fauzi 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.
- Background: PubMed 25317927Novak 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.
- Background: PubMed 21831927Novak 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.
- Individual participant dataSharing planned: No. Will share only aggregate and overall project results through poster and/or oral presentations at local, regional and national meetings.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wen Liu, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telehealth home exercise program in people with Cerebral Palsy, Spastic and Telemedicine, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sakher Obaidat, Bsc (9132035178, obaidatsakher@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Rate (time frame: post-intervention (after end of 8-weeks)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04423653, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2020.