Recruiting

TruST vs. Static Support

Sponsor:

Teachers College, Columbia University

Code:

NCT04897347

Conditions

Cerebral Palsy

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Not accepted

Interventions

Robotic Trunk-Support-Trainer (TruST)

Static Trunk Support

Study Details

Brief summary:

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

Study ID

NCT04897347

Start date

Feb 26, 2022

Status verified date

Dec, 2023

Completion date

Jun, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Not accepted

Inclusion 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")

Exclusion Criteria:

  • 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)

Study Design

Enrollment

82 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Robotic Trunk-Support-Trainer (TruST)

Postural-reaching control intervention with TruST

active comparator: Static Trunk Support

Postural-reaching control intervention with Rigid Trunk Support

Interventions

Robotic Trunk-Support-Trainer (TruST)

This will involve tailoring the level of postural assistance via force fields and systematically introduce postural task-progression across training sessions. Age-appropriate activities, including toys and games, will be used in training.

- Twelve 2hr training sessions (3 times per week for 4 weeks)

Static Trunk Support

This will involve static support for the trunk via a trained therapist. Age-appropriate activities, including toys and games, will be used in training.

- Twelve 2hr training sessions (3 times per week for 4 weeks)

Primary outcome measure

  • Change in Modified Functional Reach Test (mFRT) after intervention [ Time Frame: Through study completion, an average of 4 months ]
  • Change in Postural Star-Sitting Test (PSST) after intervention [ Time Frame: Through study completion, an average of 4 months ]
  • Change in Box and Blocks Test (BBT) after intervention [ Time Frame: Through study completion, an average of 4 months ]

Central Contacts and Locations

Central contacts

Victor Santamaria, PT, PhD

212.678.3332vs2578@columbia.edu

Karen Chin, MA

212.678.3332cpresearch@tc.columbia.edu

Locations

Columbia University

Recruiting

New York, New York, United States, 10027

Contacts

Victor Santamaria, PT, PhD

212-678-3332vs2578@columbia.edu

Teachers College, Columbia University

Recruiting

New York, New York, United States, 10027

Contacts

Karen Chin, MA

212-678-3332cpresearch@tc.columbia.edu

More Information

Sponsor

Teachers College, Columbia University

Last update posted

Dec 22, 2023

Last verified

Dec, 2023

Keywords

  • Posture
  • Reaching
  • Robotics
  • Motor Learning
  • Motor Control

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Teachers College, Columbia University on 2023-12-22.