Actively Recruiting

Phase Not Applicable
Age: 6Years - 17Years
All Genders
NCT04897347

Robotic TruST-Postural Intervention for Children With Cerebral Palsy

Led by Teachers College, Columbia University · Updated on 2023-12-22

82

Participants Needed

2

Research Sites

274 weeks

Total Duration

On this page

Sponsors

T

Teachers College, Columbia University

Lead Sponsor

C

Columbia University

Collaborating Sponsor

AI-Summary

What this Trial Is About

The purpose of this study is to test the efficacy of a motor learning-based postural and reaching control intervention delivered with the robotic Trunk-Support-Trainer (TruST) compared to the same motor learning-based intervention delivered with Static Trunk Support Equipment in children with cerebral palsy (CP) classified as III and IV with the Gross Motor Function Classification System (GMFCS).

CONDITIONS

Official Title

Robotic TruST-Postural Intervention for Children With Cerebral Palsy

Who Can Participate

Age: 6Years - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 6-17 years
  • Diagnosis of bilateral cerebral palsy: diplegia, triplegia, or quadriplegia
  • Gross Motor Function Classification System levels III or IV
  • Ability to sit with trunk support between mid-ribs and pelvis for at least 5 seconds (SATCo = 3-7)
  • Cognitive ability to follow basic verbal instructions
Not Eligible

You will not qualify if you...

  • Absent head control (SATCo = 1)
  • Current medical illness unrelated to cerebral palsy
  • Severe dyskinesia preventing sitting balance during reaching
  • History of daily seizures or drug-resistant epilepsy
  • Severe spinal deformities: scoliosis greater than 40 degrees and/or kyphosis greater than 45 degrees
  • Spinal osteosynthesis or orthopedic surgery on spine, upper or lower limbs in the last 6 months
  • Severe spasticity of biceps or triceps in both upper limbs (Modified Ashworth Scale = 4)
  • Local chemodenervation therapy (e.g., botulinum toxin) in upper or lower limbs in past 3 months or planned during study
  • Other major surgeries in past 6 months if medically contraindicated

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Columbia University

New York, New York, United States, 10027

Actively Recruiting

2

Teachers College, Columbia University

New York, New York, United States, 10027

Actively Recruiting

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Research Team

V

Victor Santamaria, PT, PhD

CONTACT

K

Karen Chin, MA

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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