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Cerebral PalsyNCT05098379

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

A study testing Tele-Rehabilitation Home Exercise Program in people with Cerebral Palsy, run by Columbia University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 21 to 60 years
Conditions the study is for
Cerebral Palsy
What is being tested?
Tele-Rehabilitation Home Exercise Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteUnited States
Study dates
31 Oct 2021to 8 May 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Columbia University Irving Medical Center

    New York, New York, 10034

Other trials in United States

About this study

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

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.

Read the 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.

Conditions
Cerebral Palsy
Being tested
Tele-Rehabilitation Home Exercise Program
Keywords
Exercise, Telehealth, Rehabilitation
Medical subject headings
Cerebral Palsy, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tele-Rehabilitation Home Exercise ProgramBehavioural

    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.

Study groups in NCT05098379
Study groupRoleWhat they receive
Tele-Rehabilitation Home Exercise ProgramExperimentalSubjects will participate in an 8-week customized home exercise program with weekly virtual exercise coaching sessions.
Receives: Behavioral: Tele-Rehabilitation Home Exercise Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Baseline

  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).

    Measured: 8 weeks (Post-Test)

Secondary outcomes (8)

  1. 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.

    Measured: Baseline, 8 weeks (Post-Test)

  2. 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.

    Measured: Baseline, 8 weeks (Post-Test)

  3. 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).

    Measured: Baseline, 8 weeks (Post-Test)

  4. 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).

    Measured: Baseline, 8 weeks (Post-Test)

  5. 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.

    Measured: Baseline, 8 weeks (Post-Test)

  6. 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".

    Measured: Baseline, 8 weeks (Post-Test)

  7. 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".

    Measured: Baseline, 8 weeks (Post-Test)

  8. 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".

    Measured: Baseline, 8 weeks (Post-Test)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2021
  2. Study start31 Oct 2021
  3. Primary completion8 May 2022
  4. Study completion8 May 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05098379
Sponsor's protocol ID
AAAT5675
Status last verified
Jan 2025
First submitted
15 Oct 2021
Last updated
23 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 17370477

  • 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.

    PubMed 19740207

  • 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.

    PubMed 15165658

Questions about this trial

What is this clinical trial studying?

A study testing Tele-Rehabilitation Home Exercise Program in people with Cerebral Palsy, run by Columbia University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Canadian Occupational Performance Measure (COPM) (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05098379, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2025.

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