Robotic TruST-Postural Intervention for Children With Cerebral Palsy

Part of paid clinical trials in New York, New York.

Sponsor
Teachers College, Columbia University
Study ID
NCT04897347
Status
Recruiting
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Conditions

  • Cerebral Palsy

Eligibility Criteria

Sex
ALL
Age
6 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Robotic Trunk-Support-Trainer (TruST) — DEVICE
    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 — DEVICE
    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)

Study Details

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).

Key Dates

Start date
Feb 26, 2022
Status verified
Dec 2023
Primary completion
Dec 31, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
82 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

Primary Outcome Measure

Change in Modified Functional Reach Test (mFRT) after intervention [ Time Frame: Through study completion, an average of 4 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Columbia UniversityNew YorkNew York10027
Victor Santamaria, PT, PhD
[email protected]
212-678-3332
Teachers College, Columbia UniversityNew YorkNew York10027
Karen Chin, MA
[email protected]
212-678-3332

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