Robotic TruST-Postural Intervention for Children With Cerebral Palsy

Description

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

Cerebral Palsy

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Study Overview

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Study Details

Study overview

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).

Postural Control Intervention With the Robotic Trunk-Support-Trainer (TruST) in Children With Cerebral Palsy: A Randomized Controlled Trial

Robotic TruST-Postural Intervention for Children With Cerebral Palsy

Condition
Cerebral Palsy
Intervention / Treatment

-

Contacts and Locations

New York

Columbia University, New York, New York, United States, 10027

New York

Teachers College, Columbia University, New York, New York, United States, 10027

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Age 6-17 years
  • * Diagnosis of Bilateral CP: diplegia, triplegia, or quadriplegia
  • * Gross Motor Function Classification Systems-Expanded \& Review (GMFCS) levels III or IV
  • * Ability to sit 5s with trunk support between mid-ribs and pelvis (SATCo = 3-7)
  • * Cognitive capacity to follow basic verbal instructions (i.e., "do not put your hands on your lap" or "follow and reach the toy")
  • * Absent head control (SATCo = 1)
  • * Current medical illness unrelated to CP at the time of the study
  • * Severe dyskinesia that prevents the child from maintaining sitting and recovering balance during reaching movements
  • * History of recurrent seizures (daily) or drug-resistance epilepsy
  • * Severe Spinal Deformities: scoliosis \>40◦ and/or kyphosis \>45◦
  • * Spinal osteosynthesis or orthopedic surgery of spine, upper or lower extremities in the last 6 months
  • * Severe spasticity of biceps/triceps in both upper extremities (Modified Ashworth Scale = 4)
  • * Local chemodenervation therapy in spastic muscles (e.g., botulinum toxin or phenol injections) in upper or lower extremities in the previous 3 months or planned during the study
  • * Other major surgeries in the previous 6 months (if medically contraindicated)

Ages Eligible for Study

6 Years to 17 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Teachers College, Columbia University,

Sunil Agrawal, PhD, PRINCIPAL_INVESTIGATOR, Columbia University

Andrew Gordon, PhD, PRINCIPAL_INVESTIGATOR, Teachers College, Columbia University

Study Record Dates

2027-06