Robotic Postural Intervention for Cerebral Palsy

Recruiting at 1 trial location

Overseen By Karen Chin, MA

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Teachers College, Columbia University

Must not be taking: Botulinum toxin

Disqualifiers: Recurrent seizures, Severe dyskinesia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

82 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of a new robotic device, the Trunk-Support-Trainer (TruST), in helping children with cerebral palsy (CP) improve posture and reach. Researchers compare it to a traditional method using static trunk support equipment. The goal is to determine if the robotic approach provides better support and coordination for children with specific types of CP who can sit with assistance. Suitable participants have CP affecting multiple limbs and can follow simple verbal instructions. As an unphased trial, this study offers children a unique opportunity to potentially benefit from innovative technology while contributing to groundbreaking research.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude participants with certain medical conditions or recent surgeries. It's best to discuss your specific medications with the trial coordinators.

What prior data suggests that the Robotic TruST-Postural Intervention is safe for children with cerebral palsy?

Previous studies of the Robotic Trunk-Support-Trainer (TruST) with children who have cerebral palsy showed no safety issues. Children using the TruST in these studies did not experience any serious problems. Research has shown that the treatment was well-tolerated, with no reported adverse side effects. This robotic method aims to improve posture and reaching, and it appears safe for use in children. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Robotic TruST-Postural Intervention because it offers a new approach to improving posture and motor control in individuals with cerebral palsy. Unlike traditional methods that often rely on static support or physical therapy alone, this intervention uses an advanced robotic system, the Robotic Trunk-Support-Trainer (TruST), to provide dynamic trunk support. This technology actively assists users in maintaining posture during reaching activities, potentially enhancing motor learning and functional independence. Additionally, the use of robotics allows for precise adjustments and personalized training, which could lead to better outcomes compared to conventional treatments.

What evidence suggests that the Robotic TruST-Postural Intervention is effective for cerebral palsy?

Research has shown that the robotic TruST-Postural Intervention, one of the treatments in this trial, can significantly aid children with cerebral palsy in improving their sitting posture and upper body control. A small initial study found that this robotic training helps children sit more steadily, making everyday tasks easier. Another study discovered that using the robotic Trunk-Support-Trainer increased the area in which children can move while sitting, enhancing their upper body control. This trial will compare the robotic intervention to a Static Trunk Support, and these findings suggest that the robotic intervention may offer better support and results than traditional trunk support methods. ^{1 5 6 7 8}

Who Is on the Research Team?

Sunil Agrawal, PhD

Principal Investigator

Columbia University

Andrew Gordon, PhD

Principal Investigator

Teachers College, Columbia University

Are You a Good Fit for This Trial?

Children aged 6-17 with bilateral cerebral palsy (diplegia, triplegia, or quadriplegia) and moderate to severe mobility limitations (GMFCS levels III or IV). They must be able to sit with support and follow basic instructions. Excluded are those with absent head control, recent major surgeries, severe spasticity or dyskinesia, spinal deformities, or recent chemodenervation therapy.

Inclusion Criteria

I need assistance with most of my daily physical activities.

I can sit with support from my mid-ribs to pelvis for at least 5 seconds.

I can understand and follow simple instructions.

Exclusion Criteria

I have daily seizures or epilepsy that doesn't respond to medication.

I have or plan to receive muscle relaxing injections in my limbs.

I haven't had any major surgeries in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive postural-reaching control intervention with either the Robotic Trunk-Support-Trainer (TruST) or Static Trunk Support Equipment

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Robotic TruST-Postural Intervention

Trial Overview

The trial is testing a robotic device called TruST against static trunk support equipment for improving postural and reaching abilities in children with cerebral palsy. The study aims to see if the motor learning intervention works better when delivered through this advanced technology.

How Is the Trial Designed?

Group I: Robotic Trunk-Support-Trainer (TruST) Experimental Treatment 1 Intervention

Postural-reaching control intervention with TruST

Group II: Static Trunk Support Active Control 1 Intervention

Postural-reaching control intervention with Rigid Trunk Support

Who Is Running the Clinical Trial?

Teachers College, Columbia University

Lead Sponsor

Trials

27

Recruited

6,100+

Columbia University

Collaborator

Trials

1,529

Recruited

2,832,000+

Published Research Related to This Trial

Foot-support significantly improved postural adjustments in children with cerebral palsy during reaching tasks, leading to increased trunk muscle activity and better reaching kinematics, as observed in a study of 19 children aged 6-12 years.

The 15° forward seat inclination did not have a notable effect on postural muscle activity, indicating that foot-support may be a more effective intervention for enhancing motor function in these children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of forward tilted seating and foot-support on postural adjustments in children with spastic cerebral palsy: An EMG-study. Angsupaisal, M., Dijkstra, LJ., la Bastide-van Gemert, S., et al.[2020]

An 8-week intervention using a Constraint Standing Training system significantly improved postural alignment and motor abilities in a 6-year-old girl with cerebral palsy, as evidenced by decreased knee hyperextension and improved Gross Motor Function Measure scores.

While muscle thickness did not change, the treatment led to positive morphological changes in the gluteus maximus muscle, suggesting that the training may enhance muscle function and contribute to better postural control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A New Method for Postural Misalignment of a 6-Year-Old Girl With Cerebral Palsy: A Case Report. Hou, Y., Zheng, H., Li, J., et al.[2022]

Robotic-assisted gait training (RAGT) significantly improves walking distance in children with cerebral palsy (CP), with these improvements maintained over the long term, as shown in a systematic review of seven studies.

While RAGT showed large clinical effects on gait speed and functionality, the specific results for gait speed were not statistically significant, indicating that while RAGT is beneficial, its impact on speed may vary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical effects of assisted robotic gait training in walking distance, speed, and functionality are maintained over the long term in individuals with cerebral palsy: a systematic review and meta-analysis. Volpini, M., Aquino, M., Holanda, AC., et al.[2022]

A meta-analysis of eight studies involving 188 individuals with cerebral palsy found that robotic gait training did not significantly improve mobility compared to standard care methods like physical therapy.

The study assessed various mobility outcomes, including walking speed and endurance, and concluded that tethered robotic devices do not offer additional benefits over traditional treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is robotic gait training effective for individuals with cerebral palsy? A systematic review and meta-analysis of randomized controlled trials. Conner, BC., Remec, NM., Lerner, ZF.[2023]

The robotic Trunk-Support-Trainer (TruST) intervention significantly improved trunk stability and increased sitting workspace in children with cerebral palsy (GMFCS III-IV) after two training blocks of 12 sessions, indicating its potential effectiveness for enhancing postural control.

Post-training, children no longer required pelvic strapping to prevent falls, demonstrating improved safety and independence in their seated postural abilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting Functional and Independent Sitting in Children With Cerebral Palsy Using the Robotic Trunk Support Trainer. Santamaria, V., Khan, M., Luna, T., et al.[2022]

In a study of 17 children with cerebral palsy, those with moderate trunk control performed better in reaching tasks when provided with higher trunk support (at axillae or mid-ribs) compared to pelvic support.

Children with severe trunk dysfunction struggled to maintain posture with pelvic support and showed significant postural deficiencies with mid-ribs support, highlighting the importance of matching external assistance to the child's level of trunk control for optimal motor performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Segmental Trunk Support on Posture and Reaching in Children With Cerebral Palsy. Santamaria, V., Rachwani, J., Saavedra, S., et al.[2018]

Children with severe cerebral palsy (GMFCS V) struggle with head alignment and stabilization, but they benefit from external support, showing a response similar to typically developing infants, indicating delayed postural control.

In contrast, children with moderate cerebral palsy (GMFCS IV) exhibited unique trunk control strategies when supported, which differ from typical developmental patterns, highlighting the need for tailored interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Segmental Contributions to Trunk Control in Children With Moderate-to-Severe Cerebral Palsy. Saavedra, SL., Woollacott, MH.[2018]

A randomized controlled trial will assess the efficacy of a motor learning-based intervention using a robotic Trunk-Support-Trainer (TruST) in improving sitting and reaching abilities in 82 children with cerebral palsy classified as GMFCS levels III-IV, over 4 weeks with sessions three times a week.

The study aims to compare the TruST intervention with a static trunk support system, measuring various functional outcomes to determine which method better enhances postural control and overall functional performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study protocol for a randomised controlled trial to determine the efficacy of an intensive seated postural intervention delivered with robotic and rigid trunk support systems. Santamaria, V., Ai, X., Chin, K., et al.[2023]

In a study of 31 non-ambulatory children with cerebral palsy, combining robot-assisted gait training (RAGT) with standard physiotherapy led to significant improvements in trunk control and posture after 6 weeks of treatment.

The RAGT group showed greater enhancements in trunk impairment and sitting balance compared to the control group receiving only physiotherapy, indicating that RAGT can be an effective addition to traditional therapy for these children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of robotic rehabilitation on posture and trunk control in non-ambulatory cerebral palsy. Abidin, N., Ünlü Akyüz, E., Cankurtaran, D., et al.[2022]

Citations

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Study protocol for a randomised controlled trial to determine ...

We propose a randomised controlled trial to test the efficacy of the motor intervention delivered with robotic TruST compared with a static trunk support ...

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engineering.columbia.edu/about/news/robotic-trunk-support-trainer-improves-upper-body-control-children-cerebral-palsy

Robotic Trunk Support Trainer Improves Upper Body Control ...

Pilot study demonstrates that robotic training helps children with CP to sit more stably.

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withpower.com

withpower.com/trial/phase-cerebral-palsy-7-2021-eb089

Robotic Postural Intervention for Cerebral Palsy

The robotic Trunk-Support-Trainer (TruST) intervention significantly improved trunk stability and increased sitting workspace in children with cerebral palsy ( ...

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reporter.nih.gov

reporter.nih.gov/search/kJPOT1QdmEmaz1JRo3BaKA/project-details/10911992

Improving seated postural control and upper ... - NIH RePORTER

This study will compare the efficacy of a motorized Trunk-Support- Trainer (TruST) to engage children in play-oriented practice with skill progression with ...

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Postural Control Intervention With the Robotic Trunk- ...

STUDY TITLE: Postural Control Intervention With the Robotic Trunk-Support-Trainer (TruST) in Children with. Cerebral Palsy: A Randomized ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10441060/

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We propose a randomised controlled trial to test the efficacy of the motor intervention delivered with robotic TruST compared with a static trunk support ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9700847/

A motor learning-based postural intervention with a robotic ...

Objectives. To improve seated postural control in a participant with spinal cord injury (SCI) with a robotic Trunk-Support-Trainer (TruST).