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

NCT ID: NCT04423653

Last Updated: 2020-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-31

Study Completion Date

2022-07-31

Brief Summary

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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).

Detailed Description

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Conditions

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Cerebral Palsy, Spastic Telemedicine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Telehealth home exercise program

Intervention Type BEHAVIORAL

The intervention will include videos of exercises and also live coaching using telehealth system.

Self-monitored group

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

Group Type ACTIVE_COMPARATOR

Telehealth home exercise program

Intervention Type BEHAVIORAL

The intervention will include videos of exercises and also live coaching using telehealth system.

Interventions

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Telehealth home exercise program

The intervention will include videos of exercises and also live coaching using telehealth system.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

11 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Kansas Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Countries

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United States

Central Contacts

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Sakher Obaidat, Bsc

Role: CONTACT

9132035178

Wen Liu, PhD

Role: CONTACT

Facility Contacts

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Sakher Obaidat, Bsc

Role: primary

913-203-5178

Wen Liu, PhD

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 19841838 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28398967 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31227664 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25317927 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21831927 (View on PubMed)

Other Identifiers

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STUDY00145690

Identifier Type: -

Identifier Source: org_study_id

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