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

January 22, 2025 updated by: Columbia University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10034
        • Columbia University Irving Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Tele-Rehabilitation Home Exercise Program
Subjects will participate in an 8-week customized home exercise program with weekly virtual exercise coaching sessions.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Canadian Occupational Performance Measure (COPM)
Time Frame: Baseline
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)
Time Frame: 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).
8 weeks (Post-Test)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
30 Second Sit to Stand Test
Time Frame: 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.
Baseline, 8 weeks (Post-Test)
2 Minute Step Test
Time Frame: 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.
Baseline, 8 weeks (Post-Test)
Single Leg Stance Measure
Time Frame: 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).
Baseline, 8 weeks (Post-Test)
Patient-Reported Outcomes Measurement Information Systems (PROMIS) Pediatric Short Form (SF) v1.0 - Physical Activity 4a
Time Frame: 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).
Baseline, 8 weeks (Post-Test)
PROMIS SF v2.0 - Physical Function 10a
Time Frame: 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.
Baseline, 8 weeks (Post-Test)
PROMIS Scale v2.0 - Pain Intensity 3a
Time Frame: 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".
Baseline, 8 weeks (Post-Test)
PROMIS SF v1.1-Pain Interference 8a
Time Frame: 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".
Baseline, 8 weeks (Post-Test)
PROMIS SF v1.0 - Fatigue 8a
Time Frame: 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".
Baseline, 8 weeks (Post-Test)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Columbia University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Joel Stein, MD, Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 31, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 8, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 8, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 15, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 27, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 28, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AAAT5675

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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