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Behavioural Intervention

Robotic Postural Intervention for Cerebral Palsy

N/A

Recruiting

Led By Sunil Agrawal, PhD

Research Sponsored by Teachers College, Columbia University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 6-17 years

Diagnosis of Bilateral CP: diplegia, triplegia, or quadriplegia

Must not have

Ability to maintain head and upper-thorax steady for 10s during supported sitting at mid-ribs or on-lower ribs: SATCo ≥ 3-4

Cognitive capacity to follow basic verbal instructions (i.e., "do not put your hands on your lap" or "follow and reach the toy")

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 4 months

Awards & highlights

Study Summary

This trial will compare two types of therapy for children with cerebral palsy to see which is more effective.

Who is the study for?

Children aged 6-17 with bilateral cerebral palsy (diplegia, triplegia, or quadriplegia) and moderate to severe mobility limitations (GMFCS levels III or IV). They must be able to sit with support and follow basic instructions. Excluded are those with absent head control, recent major surgeries, severe spasticity or dyskinesia, spinal deformities, or recent chemodenervation therapy.Check my eligibility

What is being tested?

The trial is testing a robotic device called TruST against static trunk support equipment for improving postural and reaching abilities in children with cerebral palsy. The study aims to see if the motor learning intervention works better when delivered through this advanced technology.See study design

What are the potential side effects?

Since this trial involves physical support devices rather than medication, side effects may include discomfort from using the equipment or fatigue from the exercises. There's also a small risk of injury if not used properly under supervision.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 6 and 17 years old.

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I have been diagnosed with cerebral palsy affecting both sides of my body.

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I need assistance with most of my daily physical activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I can keep my head and upper chest steady while sitting.

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I can understand and follow simple instructions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 4 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 4 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 4 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Box and Blocks Test (BBT) after intervention

Change in Modified Functional Reach Test (mFRT) after intervention

Interventional procedure

Secondary outcome measures

Change in Canadian Occupational Performance Measure (COPM) after intervention

Change in Gross Motor Function Measure-Item Set (GMFM-IS) after intervention

Change in Participation and Environment Measure - Children and Youth (PEM-CY) after intervention

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Robotic Trunk-Support-Trainer (TruST)Experimental Treatment1 Intervention

Postural-reaching control intervention with TruST

Group II: Static Trunk SupportActive Control1 Intervention

Postural-reaching control intervention with Rigid Trunk Support

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Teachers College, Columbia UniversityLead Sponsor

24 Previous Clinical Trials

5,775 Total Patients Enrolled

6 Trials studying Cerebral Palsy

291 Patients Enrolled for Cerebral Palsy

Columbia UniversityOTHER

1,433 Previous Clinical Trials

2,447,177 Total Patients Enrolled

5 Trials studying Cerebral Palsy

1,039 Patients Enrolled for Cerebral Palsy

Sunil Agrawal, PhDPrincipal InvestigatorColumbia University

1 Previous Clinical Trials

12 Total Patients Enrolled

Media Library

Robotic TruST-Postural Intervention (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04897347 — N/A

Cerebral Palsy Research Study Groups: Robotic Trunk-Support-Trainer (TruST), Static Trunk Support

Cerebral Palsy Clinical Trial 2023: Robotic TruST-Postural Intervention Highlights & Side Effects. Trial Name: NCT04897347 — N/A

Robotic TruST-Postural Intervention (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04897347 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this study include participants of a younger age bracket?

"The enrolment criteria for this trial mandates that applicants be aged between 6 to 17 years old. There are currently 140 clinical trials open to individuals who have not yet reached their 18th birthday, and 26 studies recruiting patients above the age of 65."

Answered by AI

What is the total number of participants being treated in this clinical experiment?

"Affirmative. The records hosted on clinicaltrials.gov demonstrate that this medical trial, which was first submitted on February 26th 2022, is actively recruiting. As of now, 82 participants need to be recruited from 2 different healthcare facilities."

Answered by AI

Is enrollment still open for the trial at this time?

"Affirmative. According to clinicaltrials.gov, this medical investigation was initially posted on February 26th 2022 and has since been updated on October 26th 2022. The trial is actively recruiting 82 patients from two distinct sites."

Answered by AI

What purpose does this experiment seek to fulfill?

"The primary outcome of this medical trial, which will be evaluated over an average of 4 months until study completion, is the Change in Modified Functional Reach Test (mFRT) after intervention. Secondary objectives include evaluating the Canadian Occupational Performance Measure (COPM), Gross Motor Function Measure-Item Set (GMFM-IS) and Postural and Reaching Kinematics after receiving the treatment. These measurements assess motor impediments to participation, gross motor abilities in CP patients, as well as postural orientation control during active reaches at 90° angles and anticipatory adjustments when changing direction."

Answered by AI

Does my profile match the criteria for joining this medical study?

"This clinical study is currently enrolling 82 individuals with cerebral palsy aged between 6 and 17. Criteria for enrolment include meeting the Gross Motor Function Classification Systems-Expanded & Review (GMFCS) levels III or IV, cognitive aptitude to follow basic verbal instructions, and able to keep head steady for 10 seconds when supported in mid-ribs/lower ribs (SATCo≥ 3-4)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Robotic TruST-Postural Intervention for Children With Cerebral Palsy

2022. "Robotic TruST-Postural Intervention for Children With Cerebral Palsy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04897347.

All > Cerebral Palsy