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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
No Placebo-Only Group

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.
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.
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 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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Box and Blocks Test (BBT) after intervention
Change in Modified Functional Reach Test (mFRT) after intervention
Interventional procedure
Secondary study objectives
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Find a Location

Who is running the clinical trial?

Teachers College, Columbia UniversityLead Sponsor
26 Previous Clinical Trials
5,957 Total Patients Enrolled
6 Trials studying Cerebral Palsy
291 Patients Enrolled for Cerebral Palsy
Columbia UniversityOTHER
1,486 Previous Clinical Trials
2,663,108 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
~35 spots leftby Dec 2026
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