RECRUITING

Robotic TruST-Postural Intervention for Children With Cerebral Palsy

Conditions

Cerebral Palsy Posture Reaching Robotics Motor Learning Motor Control

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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

Quick Facts

Study Start:2022-02-26

Study Completion:2027-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04897347

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.

Ages Eligible for Study:6 Years to 17 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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)

Inclusion Criteria

Exclusion 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)

Contacts and Locations

Study Contact

Victor Santamaria, PT, PhD

CONTACT

212.678.3332

vs2578@columbia.edu

Karen Chin, MA

CONTACT

212.678.3332

cpresearch@tc.columbia.edu

Principal Investigator

Sunil Agrawal, PhD

PRINCIPAL_INVESTIGATOR

Columbia University

Andrew Gordon, PhD

PRINCIPAL_INVESTIGATOR

Teachers College, Columbia University

Study Locations (Sites)

Columbia University

New York, New York, 10027

United States

Teachers College, Columbia University

New York, New York, 10027

United States

Collaborators and Investigators

Sponsor: Teachers College, Columbia University

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

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 Registration Dates

Study Start Date2022-02-26

Study Completion Date2027-06

Study Record Updates

Study Start Date2022-02-26

Study Completion Date2027-06

Terms related to this study

Keywords Provided by Researchers

Posture
Reaching
Robotics
Motor Learning
Motor Control

Additional Relevant MeSH Terms

Cerebral Palsy