Robot-assisted Training for Cerebral Palsy

Overseen By Christos Papadelis, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Cook Children's Health Care System

Must not be taking: Psychoactive, Myorelaxant

Disqualifiers: Genetic syndrome, Brain operation, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 16

Duration: 2 weeks

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Cerebral palsy (CP) is the most common physical disability in early childhood causing serious motor and sensory impairments. Effective interventions for the recovery of motor functions are of profound significance to children with CP, their families, caregivers, and health professionals. Robot-assisted rehabilitation represents a frontier with potential to improve motor functions and induce brain reorganization in children with CP.

Will I have to stop taking my current medications?

The trial requires that participants do not take psychoactive or myorelaxant medications during the study. If you are on these types of medications, you may need to stop taking them to participate.

Is robot-assisted gait training safe for humans?

The research does not provide specific safety data, but robot-assisted gait training is widely used in various conditions like cerebral palsy and Parkinson's disease, suggesting it is generally considered safe for humans. ^{1 2 3 4 5}

How is robot-assisted training different from other treatments for cerebral palsy?

Robot-assisted training for cerebral palsy is unique because it uses robotic devices to provide intensive and guided gait training, allowing for longer sessions and more variable walking speeds compared to traditional physical therapy. This approach can enhance motor learning and improve gross motor skills, gait velocity, and endurance in children with cerebral palsy. ^{1 2 4 6 7}

What data supports the effectiveness of the treatment Robot-assisted Training for Cerebral Palsy?

Research shows that robot-assisted gait training (RAGT) can help improve motor skills, walking speed, and endurance in children with cerebral palsy. It is also used to treat motor dysfunction in other neurological conditions like Parkinson's disease, suggesting its potential benefits for cerebral palsy. ^{1 2 4 7 8}

Who Is on the Research Team?

Christos Papadelis, PhD

Principal Investigator

Cook Children's Health Care System

Are You a Good Fit for This Trial?

This trial is for children with Cerebral Palsy, a condition affecting movement and coordination. Specific eligibility criteria are not provided, but typically such trials require participants to have a certain level of motor function and no other health conditions that could interfere with the treatment.

Inclusion Criteria

I have been diagnosed with CP by a specialist.

I have good mobility and can move without much help.

I have never had a brain injury or neurological disorder.

Exclusion Criteria

I find it hard to stay still.

Metal implants

Baclofen pump

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Robot-assisted hand training with Amadeo for 14 successive days, 1 hour per day, including active and passive finger movements, haptic vibration, and interactive games

2 weeks

14 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at Day 15 and Day 60

8 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Robot-assisted Training

Trial Overview The study is testing robot-assisted training using a device called Amadeo. The goal is to see if this high-tech tool can help improve motor skills in children with CP by providing them with advanced rehabilitation exercises.

How Is the Trial Designed?

Group I: Experimental Group II Experimental Treatment 1 Intervention

Participants in this group will be between the ages of 7 and 18 years old and have no history of neurological disorder or brain injury. Amadeo will be used to train the non-dominant hand of participants in this group. The training will last approximately 1 hour per day for 14 successive days. Participants will be asked to first do active finger and passive finger moving, then receive haptic vibration, and finally play interactive games.

Group II: Experimental Group I Experimental Treatment 1 Intervention

Participants in this group will be between the ages of 7 and 18 years old and have a diagnosis of cerebral palsy. Amadeo will be used to train the more-affected hand of participants in this group. The training will last approximately 1 hour per day for 14 successive days. Participants will be asked to first do active finger and passive finger moving, then receive haptic vibration, and finally play interactive games.

Group III: Control Group I Active Control 1 Intervention

Participants in this group will be between the ages of 7 and 18 years old and have a diagnosis of cerebral palsy.

Group IV: Control Group II Active Control 1 Intervention

Participants in this group will be between the ages of 7 and 18 years old and have no history of neurological disorder or brain injury.

Robot-assisted Training is already approved in European Union, United States for the following indications:

Approved in European Union as Robot-assisted Gait Training for:

• Rehabilitation of walking abilities in children with cerebral palsy

Approved in United States as Robot-assisted Gait Training for:

• Rehabilitation of walking abilities in children with cerebral palsy

Who Is Running the Clinical Trial?

Cook Children's Health Care System

Lead Sponsor

Trials

11

Recruited

5,001,000+

Published Research Related to This Trial

Robot-assisted gait training (RAGT) significantly improves gross motor function in adolescents and adults with bilateral spastic cerebral palsy (CP) compared to conventional therapy, based on a study of 47 patients.

The benefits of RAGT not only showed significant improvements immediately after treatment but also persisted for 3-4 months, indicating its long-term efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of robot-assisted gait training on motor functions in adolescent and young adult patients with bilateral spastic cerebral palsy: A randomized controlled trial. Klobucká, S., Klobucký, R., Kollár, B.[2021]

In a study involving 14 children with cerebral palsy, robot-assisted gait training (RAGT) combined with conventional therapy significantly improved the total distance and mean distance covered during sessions, indicating enhanced motor performance and endurance.

However, clinical outcomes such as speed and overall motor function did not show improvement after treatment, suggesting that while RAGT may help with certain aspects of mobility, further research is needed to fully understand its benefits compared to traditional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvement of motor performance in children with cerebral palsy treated with exoskeleton robotic training: A retrospective explorative analysis. Digiacomo, F., Tamburin, S., Tebaldi, S., et al.[2020]

This study is a randomized controlled trial comparing robotic-assisted gait training (RAGT) to traditional physiotherapy (PT) in children with cerebral palsy, aiming to assess improvements in gross motor function and walking endurance over 16 weeks with twice-weekly sessions.

The trial will evaluate key outcomes such as gross motor functional ability and walking distance, providing valuable insights into the effectiveness of RAGT compared to standard PT, which could influence rehabilitation practices for children with CP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of a robotic-assisted gait training program with a program of functional gait training for children with cerebral palsy: design and methods of a two group randomized controlled cross-over trial. Hilderley, AJ., Fehlings, D., Lee, GW., et al.[2022]

Robot-assisted gait training (RAGT) significantly improves motor function and balance in patients with Parkinson's disease, as shown in a meta-analysis of 14 randomized controlled trials involving 572 participants.

Compared to conventional training, RAGT led to notable improvements in various motor function assessments, including the 10-Meter Walk Test (10MWT), 6-Minute Walk Test (6MWT), Timed Up and Go (TUG), and the Unified Parkinson's Disease Rating Scale (UPDRS III).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of rehabilitation robot-assisted gait training on lower extremity dyskinesia in patients with Parkinson's disease: A systematic review and meta-analysis. Xue, X., Yang, X., Deng, Z.[2023]

Robot-assisted gait therapy (RAGT) significantly improves gait speed, walking distance, and overall mobility skills (walking, running, and jumping) in children with cerebral palsy compared to conventional therapy (CT), based on a systematic review of 15 controlled clinical trials involving 413 participants.

While RAGT shows clear benefits over CT, it does not demonstrate significant differences in other measures when compared to treadmill therapy (TT), indicating that while RAGT is effective, it may not be superior to all forms of therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Robot-Assisted Gait Therapy Compared to Conventional Therapy or Treadmill Training in Children with Cerebral Palsy: A Systematic Review with Meta-Analysis. Cortés-Pérez, I., González-González, N., Peinado-Rubia, AB., et al.[2022]

Robotic-assisted gait training (RAGT) shows some positive benefits for children with cerebral palsy, particularly in improving standing ability, walking speed, and distance, but the overall evidence is weak and inconsistent, especially for other diagnoses.

A meta-analysis of randomized controlled trials did not confirm significant benefits of RAGT, indicating the need for more rigorous studies with larger sample sizes and standardized training schedules to better assess its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of robotic-assisted gait training for paediatric gait disorders: systematic review. Lefmann, S., Russo, R., Hillier, S.[2023]

Participants in a 6-week robotic-assisted gait training (RAGT) intervention using the HAL exoskeleton reported that the training was demanding but beneficial, highlighting the importance of support and feedback from therapists for motivation.

The study suggests that while RAGT can inspire confidence and improvement in walking ability after stroke, further development of exoskeletons is needed to enhance comfort and promote active participation in various environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Users' experiences of intensive robotic-assisted gait training post-stroke - "a push forward or feeling pushed around?" Nedergård, H., Sandlund, M., Häger, CK., et al.[2023]

Children with cerebral palsy had mixed feelings about robotic gait training with the Lokomat, often feeling uncertain about what to expect and sometimes anxious about participating, indicating a need for better engagement strategies in rehabilitation.

Despite the potential benefits of robotic training, children did not express a strong desire to achieve 'normal' walking patterns, suggesting that rehabilitation goals should align more closely with children's personal expectations and experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What is it like to walk with the help of a robot? Children's perspectives on robotic gait training technology. Phelan, SK., Gibson, BE., Wright, FV.[2018]

Citations

1. Netherlands pubmed.ncbi.nlm.nih.gov

Effect of robot-assisted gait training on motor functions in adolescent and young adult patients with bilateral spastic cerebral palsy: A randomized controlled trial. [2021]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Improvement of motor performance in children with cerebral palsy treated with exoskeleton robotic training: A retrospective explorative analysis. [2020]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Comparison of a robotic-assisted gait training program with a program of functional gait training for children with cerebral palsy: design and methods of a two group randomized controlled cross-over trial. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Efficacy of rehabilitation robot-assisted gait training on lower extremity dyskinesia in patients with Parkinson's disease: A systematic review and meta-analysis. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Efficacy of Robot-Assisted Gait Therapy Compared to Conventional Therapy or Treadmill Training in Children with Cerebral Palsy: A Systematic Review with Meta-Analysis. [2022]

6. England pubmed.ncbi.nlm.nih.gov

The effectiveness of robotic-assisted gait training for paediatric gait disorders: systematic review. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Users' experiences of intensive robotic-assisted gait training post-stroke - "a push forward or feeling pushed around?" [2023]

8. England pubmed.ncbi.nlm.nih.gov

What is it like to walk with the help of a robot? Children's perspectives on robotic gait training technology. [2018]