Clinical trial NCT05098379: Tele-Rehabilitation Home Exercise Program for Ambulatory Adults With Cerebral Palsy
Official title: A Tele-Rehabilitation Home Exercise Program to Promote Fitness and Functional Mobility in Ambulatory Adults With Cerebral Palsy: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: Exercise
Telehealth
Rehabilitation
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2021-10-28
Enrollment: 6
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to determine if a tele-rehabilitation home exercise program is feasible to promote adherence to a fitness and mobility exercise program in ambulatory adults with cerebral palsy (GMFCS I, II, III) aged 21- 60 year old, and second, to determine if a tele-health exercise program improves fitness and functional mobility for participants.

Detailed description: Cerebral palsy (CP) is a non-progressive neurologic condition caused by a brain lesion(s) that occurs in the prenatal, perinatal or early postnatal period. Ambulatory adults with CP are at risk for gait deterioration and increased sedentary lifestyles due to their diagnosis, associated conditions and the impact of aging. Adults with CP often have limited access to physical therapy (PT) and community-based programs to sustain ambulation, reduce pain, prevent falls risk and increase fitness and physical activity. This Tele-Rehabilitation Home Exercise Program (TRHExP) is a prospective cohort study

Participants in this feasibility study will engage in 150 minutes of exercise per week (30 min/day for 5 days/week) for 8 weeks and will have weekly virtual Exercise Coaching sessions with a trained project team member.

Eligibility criteria: Inclusion Criteria:

* Primary diagnosis: Spastic Cerebral Palsy (unilateral or bilateral)
* Gross Motor Function Classification System (GMFCS) Level I to III
* No orthopedic surgery in past year
* No Botox in past 3 months
* Able to follow directions \& attend for 20-30 minutes
* Able to stand independently up to 1 minutes with or without an assistive device
* Able to walk independently up to 2 minutes with or without an assistive device
* Must have a laptop, tablet or smart phone to do the program

Exclusion Criteria:

* Visual, cognitive or attentional deficit that makes it too difficult to participate
* No technology to participate in Zoom tele-rehabilitation sessions
* Medical contraindications to participate in an Exercise Program (e.g., uncontrolled hypertension, diabetes, syncope, uncontrolled seizures)

Primary outcomes:
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: Baseline
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: 8 weeks (Post-Test)
Secondary outcomes:
measure: 30 Second Sit to Stand Test
timeFrame: Baseline, 8 weeks (Post-Test)
measure: 2 Minute Step Test
timeFrame: Baseline, 8 weeks (Post-Test)
measure: Single Leg Stance Measure
timeFrame: Baseline, 8 weeks (Post-Test)
measure: Patient-Reported Outcomes Measurement Information Systems (PROMIS) Pediatric Short Form (SF) v1.0 - Physical Activity 4a
timeFrame: Baseline, 8 weeks (Post-Test)
measure: PROMIS SF v2.0 - Physical Function 10a
timeFrame: Baseline, 8 weeks (Post-Test)
measure: PROMIS Scale v2.0 - Pain Intensity 3a
timeFrame: Baseline, 8 weeks (Post-Test)
measure: PROMIS SF v1.1-Pain Interference 8a
timeFrame: Baseline, 8 weeks (Post-Test)
measure: PROMIS SF v1.0 - Fatigue 8a
timeFrame: Baseline, 8 weeks (Post-Test)
Other outcomes:
Locations:
city: New York
country: United States
facility: Columbia University Irving Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Joel Stein, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rosenbaum P, Paneth N, Leviton A, Goldstein M, Bax M, Damiano D, Dan B, Jacobsson B. A report: the definition and classification of cerebral palsy April 2006. Dev Med Child Neurol Suppl. 2007 Feb;109:8-14.
citation: Turk MA. Health, mortality, and wellness issues in adults with cerebral palsy. Dev Med Child Neurol. 2009 Oct;51 Suppl 4:24-9. doi: 10.1111/j.1469-8749.2009.03429.x.
citation: Rimmer JH, Riley B, Wang E, Rauworth A, Jurkowski J. Physical activity participation among persons with disabilities: barriers and facilitators. Am J Prev Med. 2004 Jun;26(5):419-25. doi: 10.1016/j.amepre.2004.02.002.