Tele-Rehabilitation Home Exercise Program for Ambulatory Adults With Cerebral Palsy
- Conditions
- Cerebral Palsy
- Interventions
- Behavioral: Tele-Rehabilitation Home Exercise Program
- Registration Number
- NCT05098379
- Lead Sponsor
- Columbia University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Tele-Rehabilitation Home Exercise Program Tele-Rehabilitation Home Exercise Program Subjects will participate in an 8-week customized home exercise program with weekly virtual exercise coaching sessions.
- Primary Outcome Measures
Name Time Method Canadian Occupational Performance Measure (COPM) 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 Outcome Measures
Name Time Method PROMIS SF v1.0 - Fatigue 8a Baseline, 8 weeks (Post-Test) This is an 8-item questionnaire that asks participants about how much they were affected by fatigue in the past 7 days. Items are scored on a 5-point scale.
Score range from 8-40 with 8 indicating "not at all" (better outcome) and 40 indicating "very much".30 Second Sit to Stand Test Baseline, 8 weeks (Post-Test) The participant is asked to stand up from a standard chair without using their arms as many times as possible within 30 seconds. The number of full stands are counted.
2 Minute Step Test Baseline, 8 weeks (Post-Test) The participant is asked to stand next to the wall, and a piece of tape is placed on the wall halfway between the participant's iliac crest and patella. The participant is asked to step in place for 2 minutes, raising each knee to the mark on the wall for each step, for as many times as possible within that period. The number of times the right knee reaches the required height are counted.
Single Leg Stance Measure Baseline, 8 weeks (Post-Test) The participant is asked to stand unassisted on one leg with eyes open and hands on hips. The amount of time in seconds the participant can maintain this position is measured (up to 30 seconds).
Patient-Reported Outcomes Measurement Information Systems (PROMIS) Pediatric Short Form (SF) v1.0 - Physical Activity 4a Baseline, 8 weeks (Post-Test) This is a 4-item questionnaire that asks participants about their level of physical activity in the past 7 days. Items are scored on a 5-point scale. Scores range from 4 to 20 with 4 indicating low physical activity and 20 indicating high physical activity (better outcome).
PROMIS SF v2.0 - Physical Function 10a Baseline, 8 weeks (Post-Test) This is a 10-item questionnaire that asks participants about their level of physical function. Items are scored on a 5-point scale. Scores range from 10 to 50 with 10 indicating high physical function (better outcome) and 50 indicating low physical function.
PROMIS SF v1.1-Pain Interference 8a Baseline, 8 weeks (Post-Test) This is an 8-item questionnaire that asks participants about how much pain interferes with daily life. Items are scored on a 5-point scale. Scores range from 8 to 40, with 8 indicating "not at all" (better outcome) and 40 indicating "very much".
PROMIS Scale v2.0 - Pain Intensity 3a Baseline, 8 weeks (Post-Test) This is a 3-item questionnaire that asks participants about their pain intensity. Items are scored on a 5-point scale. Scores range from 3 to 15 with 3 indicating "no pain" (better outcome) and 15 indicating "very severe pain".
Trial Locations
- Locations (1)
Columbia University Irving Medical Center
🇺🇸New York, New York, United States