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?

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).

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.

Is the Robotic Trunk Support Trainer (TruST) safe for use in humans?

The Robotic Trunk Support Trainer (TruST) has been used in studies with children with cerebral palsy, and no safety issues were reported. The intervention was feasible, and children improved in trunk stability and sitting balance without any noted adverse effects. ^{1 2 3 4 5}

How is the Robotic TruST-Postural Intervention treatment different from other treatments for cerebral palsy?

The Robotic TruST-Postural Intervention is unique because it uses a motorized belt to provide active-assistive support to the trunk, helping children with cerebral palsy improve their sitting balance and trunk control. This approach is tailored to each child's needs and focuses on enhancing independent sitting, which is not commonly addressed by other treatments. ^{1 2 3 6 7}

What data supports the effectiveness of the treatment Robotic TruST-Postural Intervention for children with cerebral palsy?

Research shows that the Robotic Trunk-Support-Trainer (TruST) can help children with cerebral palsy improve their ability to sit independently. After using TruST, children showed better trunk stability and increased their sitting workspace, indicating improved postural control. ^{1 3 5 8 9}

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

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Promoting Functional and Independent Sitting in Children With Cerebral Palsy Using the Robotic Trunk Support Trainer. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

A New Method for Postural Misalignment of a 6-Year-Old Girl With Cerebral Palsy: A Case Report. [2022]

3. England 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. [2023]

4. England 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. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

The effect of robotic rehabilitation on posture and trunk control in non-ambulatory cerebral palsy. [2022]

6. England 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. [2023]

7. England 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. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Effect of Segmental Trunk Support on Posture and Reaching in Children With Cerebral Palsy. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Segmental Contributions to Trunk Control in Children With Moderate-to-Severe Cerebral Palsy. [2018]