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

University of Kansas

Status: Unknown

Conditions: Cerebral Palsy, Spastic; Telemedicine

Treatments: Behavioral: Telehealth home exercise program

Study type: Interventional

Funder types: Other

Identifiers

NCT04423653

STUDY00145690

Details and patient eligibility

About

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).

Enrollment: 20 estimated patients

Sex: All

Ages: 11 to 18 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Tele-coaching group

Experimental group

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.

Treatment:

Behavioral: Telehealth home exercise program

Self-monitored group

Active Comparator group

Description:

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

Treatment:

Behavioral: Telehealth home exercise program