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Clinical Trials/NCT05098379
NCT05098379
Completed
N/A

A Tele-Rehabilitation Home Exercise Program to Promote Fitness and Functional Mobility in Ambulatory Adults With Cerebral Palsy: A Feasibility Study

Columbia University1 site in 1 country6 target enrollmentOctober 31, 2021
ConditionsCerebral Palsy

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cerebral Palsy
Sponsor
Columbia University
Enrollment
6
Locations
1
Primary Endpoint
Canadian Occupational Performance Measure (COPM)
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 31, 2021
End Date
May 8, 2022
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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)

Outcomes

Primary Outcomes

Canadian Occupational Performance Measure (COPM)

Time Frame: 8 weeks (Post-Test)

The COPM is a semi-structured interview that measures participants' perspective of their performance and satisfaction of self-identified occupational performance problems in areas of self-care, productivity and leisure. Participants rate their performance and satisfaction of the occupational performance problems they identify using a 10 point scale. Scores range from 1 to 10, with 1 indicating poor performance/ low satisfaction and 10 indicating very good performance/ high satisfaction (better outcome).

Secondary Outcomes

  • PROMIS SF v1.0 - Fatigue 8a(Baseline, 8 weeks (Post-Test))
  • 30 Second Sit to Stand Test(Baseline, 8 weeks (Post-Test))
  • 2 Minute Step Test(Baseline, 8 weeks (Post-Test))
  • Single Leg Stance Measure(Baseline, 8 weeks (Post-Test))
  • Patient-Reported Outcomes Measurement Information Systems (PROMIS) Pediatric Short Form (SF) v1.0 - Physical Activity 4a(Baseline, 8 weeks (Post-Test))
  • PROMIS SF v2.0 - Physical Function 10a(Baseline, 8 weeks (Post-Test))
  • PROMIS SF v1.1-Pain Interference 8a(Baseline, 8 weeks (Post-Test))
  • PROMIS Scale v2.0 - Pain Intensity 3a(Baseline, 8 weeks (Post-Test))

Study Sites (1)

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