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

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Primary Purpose

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Tele-Rehabilitation Home Exercise Program

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring Exercise, Telehealth, Rehabilitation

Eligibility Criteria

21 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Columbia University Irving Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tele-Rehabilitation Home Exercise Program

Arm Description

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

Outcomes

Primary Outcome Measures

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).

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).

Secondary Outcome Measures

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.

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.

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).

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).

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.

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".

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".

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".

Full Information

NCT ID

NCT05098379

First Posted

October 15, 2021

Last Updated

September 16, 2022

Sponsor

Columbia University

1. Study Identification

Unique Protocol Identification Number

NCT05098379

Brief Title

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

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

October 31, 2021 (Actual)

Primary Completion Date

October 2024 (Anticipated)

Study Completion Date

October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Columbia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cerebral Palsy

Keywords

Exercise, Telehealth, Rehabilitation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

6 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tele-Rehabilitation Home Exercise Program

Arm Type

Experimental

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

Tele-Rehabilitation Home Exercise Program

Intervention Description

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.

Primary Outcome Measure Information:

Title

Canadian Occupational Performance Measure (COPM)

Description

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).

Time Frame

Baseline

Title

Canadian Occupational Performance Measure (COPM)

Description

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).

Time Frame

8 weeks (Post-Test)

Secondary Outcome Measure Information:

Title

30 Second Sit to Stand Test

Description

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.

Time Frame

Baseline, 8 weeks (Post-Test)

Title

2 Minute Step Test

Description

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.

Time Frame

Baseline, 8 weeks (Post-Test)

Title

Single Leg Stance Measure

Description

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).

Time Frame

Baseline, 8 weeks (Post-Test)

Title

Patient-Reported Outcomes Measurement Information Systems (PROMIS) Pediatric Short Form (SF) v1.0 - Physical Activity 4a

Description

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).

Time Frame

Baseline, 8 weeks (Post-Test)

Title

PROMIS SF v2.0 - Physical Function 10a

Description

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.

Time Frame

Baseline, 8 weeks (Post-Test)

Title

PROMIS Scale v2.0 - Pain Intensity 3a

Description

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".

Time Frame

Baseline, 8 weeks (Post-Test)

Title

PROMIS SF v1.1-Pain Interference 8a

Description

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".

Time Frame

Baseline, 8 weeks (Post-Test)

Title

PROMIS SF v1.0 - Fatigue 8a

Description

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".

Time Frame

Baseline, 8 weeks (Post-Test)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

No

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Joel Stein, MD

Organizational Affiliation

Columbia University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Columbia University Irving Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10034

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

17370477

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.

Results Reference

background

PubMed Identifier

19740207

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.

Results Reference

background

PubMed Identifier

15165658

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.

Results Reference

background

Cerebral Palsy

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial