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

NCT05098379 | Completed

• 1 other identifier: AAAT5675
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Keywords

Exercise; Telehealth; Rehabilitation

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (8)

• 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)

Study Arms (1)

Tele-Rehabilitation Home Exercise Program

EXPERIMENTAL

Subjects will participate in an 8-week customized home exercise program with weekly virtual exercise coaching sessions.

Behavioral: Tele-Rehabilitation Home Exercise Program

Interventions

Tele-Rehabilitation Home Exercise Program BEHAVIORAL

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.

Tele-Rehabilitation Home Exercise Program

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10034, United States

Location

Related Publications (3)

• 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.

  PMID: 17370477 BACKGROUND

• 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.

  PMID: 19740207 BACKGROUND

• 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.

  PMID: 15165658 BACKGROUND

MeSH Terms

Conditions

Cerebral Palsy; Motor Activity

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Behavior

Study Officials

• Joel Stein, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2021
• First Posted: October 28, 2021
• Study Start: October 31, 2021
• Primary Completion: May 8, 2022
• Study Completion: May 8, 2022
• Last Updated: January 23, 2025

Record last verified: 2025-01

Locations

US (1)