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Robotic Trunk-Support-Trainer (TruST) for Children with Cerebral Palsy

This study is testing two different ways to help children with cerebral palsy (CP) improve their sitting balance and arm movements. One group will use a robotic device called the Robotic Trunk-Support-Trainer (TruST), which provides adjustable support and challenges during activities. The other group will receive similar support from a trained therapist. Both groups will participate in fun, age-appropriate activities and games. Researchers want to see if either method helps children improve their functional reach (how far they can reach), sitting balance, and hand dexterity. Children aged 6 to 17 with certain types of CP (bilateral CP, GMFCS levels III or IV) who can sit for at least 5 seconds with some trunk support can join. The study aims to enroll 82 participants, but its current recruitment status is unclear.

Study design
This is a randomized controlled trial, meaning participants will be randomly assigned to one of two groups. The study plans to enroll 82 children.
What's involved
Participants will have 12 training sessions, each lasting 2 hours, over 4 weeks (3 times per week).
Compensation
Not stated in the trial record.
Follow-up
Participants will be assessed for changes in their abilities through study completion, which is an average of 4 months after the intervention.

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NCT04897347

Robotic TruST-Postural Intervention for Children With Cerebral Palsy

Recruiting
NAAges 6–17InterventionalTreatment
Teachers College, Columbia University
~82 participants
Updated 2023-12-22 on ClinicalTrials.gov
What's tested:Robotic Trunk-Support-Trainer (TruST)Static Trunk Support

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Modified Functional Reach Test (mFRT) after intervention
Measured over Through study completion, an average of 4 months
+2 more outcomes measured

Conditions

Cerebral Palsy

Explore related trials

Cerebral Palsy

Where it's being run

2 sites across 1 states
New York2

Study leadership

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

Who to contact

Victor Santamaria, PT, PhD
[email protected]
212.678.3332
Email the study team

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Eligibility criteria

Inclusion

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

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)

What this trial measures

  • Change in Modified Functional Reach Test (mFRT) after interventionThrough study completion, an average of 4 months

    The mFRT measures proactive postural control during maximum reaching distance. It is a valid and reliable tool in CP; and it discriminates GMFCS levels.

  • Change in Postural Star-Sitting Test (PSST) after interventionThrough study completion, an average of 4 months

    The PSST will be performed before and after interventions to monitor sitting control progression in both TruST- and control-intervention groups. The investigators have several motivations that rationalize this customized measurement. It: 1) is age-appropriate, 2) is goal-oriented, 3) directly measures sitting based on trunk control improvements, 4) is responsive to capture sitting workspace area increases, and 5) offers data with a straightforward functional interpretation.

  • Change in Box and Blocks Test (BBT) after interventionThrough study completion, an average of 4 months

    The BBT examines manual dexterity. The child moves the maximum number of blocks (2.5cm2), one at a time, between the compartments of a partitioned box within 60s. B\&B is sensitive to post-intervention changes with the more- and less-affected hand. Arm displacement and grasping will be analyzed with Datavyu. An instruction manual has been created to standardize video-coding procedures and define the reaching variables. Grasping will be defined from the moment the hand contacts the block to the time this is lifted from the surface. Arm displacement will be defined from end of grasping to block release. Reaching performance will be the summation of grasping and arm displacement. Two coders will be used to determine video-coding reliability.