Tele-Rehabilitation Home Exercise Program for Ambulatory Adults With Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05098379
• Other study ID #: AAAT5675
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 31, 2021
• Est. completion date: October 31, 2024

Study information

• Verified date: April 2024
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 6
• Est. completion date: October 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Behavioral:
• Tele-Rehabilitation Home Exercise Program
Participants 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. Customized home exercise programs will be reviewed weekly during the coaching sessions and will be modified as needed to ensure participants can complete their exercises safely and effectively. Exercise coaches will send weekly messages to 'check-in' with participants in order to motivate and remind participants to adhere to their tailored home exercise programs. During weekly exercise coaching sessions, exercises will be reviewed for form, safety, and progression. Exercises will be revised as needed to ensure that they are in line with participants' goals, needs, and preferences.

Locations

Country	Name	City	State
United States	Columbia University Irving Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. Erratum In: Dev Med Child Neurol. 2007 Jun;49(6):480. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Canadian Occupational Performance Measure (COPM)	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).	Baseline
Primary	Canadian Occupational Performance Measure (COPM)	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).	8 weeks (Post-Test)
Secondary	30 Second Sit to Stand 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.	Baseline, 8 weeks (Post-Test)
Secondary	2 Minute Step 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.	Baseline, 8 weeks (Post-Test)
Secondary	Single Leg Stance Measure	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).	Baseline, 8 weeks (Post-Test)
Secondary	Patient-Reported Outcomes Measurement Information Systems (PROMIS) Pediatric Short Form (SF) v1.0 - Physical Activity 4a	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).	Baseline, 8 weeks (Post-Test)
Secondary	PROMIS SF v2.0 - Physical Function 10a	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.	Baseline, 8 weeks (Post-Test)
Secondary	PROMIS Scale v2.0 - Pain Intensity 3a	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".	Baseline, 8 weeks (Post-Test)
Secondary	PROMIS SF v1.1-Pain Interference 8a	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".	Baseline, 8 weeks (Post-Test)
Secondary	PROMIS SF v1.0 - Fatigue 8a	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".	Baseline, 8 weeks (Post-Test)