Gait Therapy for Cerebral Palsy

Overseen By Max J Kurz, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Father Flanagan's Boys' Home

Disqualifiers: Recent orthopedic surgery, Metal in body

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

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new gait therapy, a form of physical therapy aimed at improving gait, for adolescents and young adults with cerebral palsy (CP). The researchers aim to determine if this therapy enhances walking and movement abilities by comparing participants' progress to a group of neurotypical peers who will not receive the therapy. Participants will undergo various brain and mobility tests before and after the therapy to measure changes. Those with CP who have not had recent orthopedic surgery and have no metal in their body that could interfere with tests are suitable candidates for this trial. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance future therapies for cerebral palsy.

Do I need to stop my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this gait training protocol is safe for adolescents and young adults with cerebral palsy?

Research has shown that gait therapy is a safe treatment for people with cerebral palsy (CP). A review of studies found this therapy safe for children and young adults with CP. One study examined core stability training, a component of gait therapy, and assessed outcomes like walking speed and safety. This study confirmed the treatment's safety.

These findings suggest that gait therapy is generally well-tolerated, with no major safety concerns reported. It aims to improve walking and movement, which can benefit those with CP. Overall, gait therapy appears to be a safe option for enhancing mobility in people with CP. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about gait therapy for cerebral palsy because it offers a unique approach to improving mobility. Unlike traditional treatments, which often focus on surgeries or medications to manage symptoms, gait therapy directly targets the way individuals walk. This therapy involves specific exercises and techniques aimed at enhancing muscle coordination and balance, potentially offering a more hands-on and dynamic solution. This personalized method can lead to significant improvements in movement and quality of life, making it a promising option for those with cerebral palsy.

What evidence suggests that gait therapy is effective for cerebral palsy?

Research has shown that gait therapy, which participants in this trial may receive, can greatly improve walking in people with cerebral palsy. Studies have found that these treatments can increase both walking speed and duration. For instance, a review of several studies identified gait training as the most effective method for helping children with cerebral palsy walk faster. Other research highlights that various types of gait training, including those using robotic assistance, positively affect walking abilities. Overall, gait therapy offers a promising approach to enhancing mobility in people with cerebral palsy. ^{3 6 7 8 9}

Who Is on the Research Team?

Max J Kurz, PhD

Principal Investigator

Father Flanagan's Boys' Home

Are You a Good Fit for This Trial?

This trial is for adolescents and young adults with cerebral palsy who haven't had orthopedic surgery in the last 6 months and don't have metal implants that would affect MRI scans. Neurotypical individuals without conditions like autism or ADHD can participate as controls.

Inclusion Criteria

I have been diagnosed with Cerebral Palsy.

You do not have conditions like autism, Down Syndrome, or ADHD for the control group without cerebral palsy.

Exclusion Criteria

I haven't had any bone surgery in the past 6 months.

You do not have any metal in your body that would prevent you from having an MRI.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo MEG/EEG brain imaging, MRI spinal cord imaging, neurophysiological tests, cognitive testing, and clinical mobility assessments

1-2 weeks

Treatment

Participants with CP undergo an 8-week therapeutic gait training protocol

8 weeks

Post-Treatment Assessment

Participants repeat the same assessments completed at baseline to evaluate changes

1-2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Gait Therapy

Trial Overview The study tests a gait training protocol to improve walking in those with cerebral palsy. It includes brain imaging, neurophysiological tests, mobility assessments, and cognitive tests before and after the therapy.

How Is the Trial Designed?

Group I: Cerebral Palsy Youth/Young Adults Experimental Treatment 1 Intervention

Baseline and 8 week assessments; 8 week gait therapy

Group II: Neurotypical Youth/Young Adults Active Control 1 Intervention

No intervention administered. The controls will only undergo initial baseline assessments.

Who Is Running the Clinical Trial?

Father Flanagan's Boys' Home

Lead Sponsor

Trials

14

Recruited

1,600+

Published Research Related to This Trial

A new treadmill-based gait training intervention using functional electrical stimulation (FES) showed promising results in improving walking performance in two adolescents with cerebral palsy (CP) over 12 weeks, with training sessions three times a week.

Both participants demonstrated improvements in knee and ankle angles, step width, and stride length, with one participant showing enhanced walking endurance and peak oxygen uptake, indicating potential neurotherapeutic benefits from the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a Novel Functional Electrical Stimulation Gait Training System in 2 Adolescents With Cerebral Palsy: A Case Series Exploring Neurotherapeutic Changes. Behboodi, A., Zahradka, N., Alesi, J., et al.[2023]

The Gait Outcomes Assessment List (GOAL) is a valid tool for assessing gait function in children with cerebral palsy, effectively distinguishing between different Gross Motor Function Classification System (GMFCS) levels in a study of 105 children.

GOAL scores showed strong correlations with other functional mobility assessments and gait analysis, suggesting it can provide a comprehensive understanding of a child's mobility and help prioritize treatment goals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Gait Outcomes Assessment List (GOAL): validation of a new assessment of gait function for children with cerebral palsy. Thomason, P., Tan, A., Donnan, A., et al.[2022]

A retrospective study of 32 diplegic children who underwent gait improvement surgery showed that while initial improvements in gait function were observed, there was a general decrease in function over the first few years post-surgery.

The study suggests that evaluating gait improvements at least 3 years after surgery provides a more accurate prediction of long-term treatment outcomes, highlighting the need for extended follow-up in assessing the effectiveness of such surgical interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gait improvement surgery in diplegic children: how long do the improvements last? Saraph, V., Zwick, EB., Auner, C., et al.[2019]

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]

Gait disorders in patients with cerebral palsy lead to increased energy use due to issues like spasticity and poor biomechanics, which can be effectively assessed through instrumented gait analysis.

Modern orthopedic treatments, including muscle lengthening and joint stabilization, aim to correct these gait issues by rebalancing muscle strength and length, often using multilevel corrections to minimize rehabilitation time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Measures to improve gait in patients with cerebral palsy]. Brunner, R.[2021]

Children with cerebral palsy often exhibit abnormal knee motion during walking due to factors like spasticity and muscle contractures, which can significantly affect their mobility.

A comprehensive evaluation, including three-dimensional motion analysis, is essential to identify specific gait patterns (like 'crouch' or 'stiff knee') and to tailor effective treatment options such as physiotherapy, spasticity management, and orthopedic interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of functional limitations at the knee in ambulatory children with cerebral palsy. Chambers, HG.[2019]

A new rehabilitation tool significantly improved step length symmetry in a 47-year-old male stroke patient, with a 72% improvement observed after a 5-minute training session and rest period.

Gait velocity also increased by 5.5% following the 5-minute training, suggesting that this tool may enhance both spatial and temporal aspects of gait in stroke rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The immediate effects of a novel auditory and proprioceptive training device on gait after stroke. Johnson, EG., Lohman, EB., Rendon, A., et al.[2021]

The study analyzed 20 randomized controlled trials involving 516 individuals with cerebral palsy and found that partial body weight supported treadmill training (BWSTT) significantly improved gait velocity more than other interventions, including over ground gait training and conventional physical therapy.

Robot-assisted gait training (RAGT) was shown to be the most effective method for improving gross motor function measures (GMFM), particularly in dimension E, compared to conventional therapy, indicating that different training methods can have specific benefits for individuals with cerebral palsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Which gait training intervention can most effectively improve gait ability in patients with cerebral palsy? A systematic review and network meta-analysis. Qian, G., Cai, X., Xu, K., et al.[2023]

A new robotic walking aid (NF-Walker®) was successfully used to enable an 11-year-old child with spastic tetraplegic cerebral palsy to move independently, achieving measurable distances in walking tests.

The device showed potential for improving gait training in non-ambulatory children, although the energy cost of locomotion was higher than normal, indicating that further research is needed to optimize its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Applicability of a new robotic walking aid in a patient with cerebral palsy. Case report. Smania, N., Gandolfi, M., Marconi, V., et al.[2012]

A systematic review of 50 studies involving 985 subjects revealed that adverse events (AEs) occurred in 18 studies, with over 169 device-related AEs reported, primarily soft tissue injuries and musculoskeletal issues, particularly in end-effector and exoskeleton devices.

The most common risks associated with stationary robot-assisted gait training include excessive pressure and shear at the interface between the device and the user, as well as misalignments that increase forces on the musculoskeletal system, highlighting the need for improved reporting and safety measures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Occurrence and Type of Adverse Events During the Use of Stationary Gait Robots-A Systematic Literature Review. Bessler, J., Prange-Lasonder, GB., Schulte, RV., et al.[2021]

Gait training using visual and auditory feedback cues significantly improved walking speed and stride length in patients with cerebral palsy, with visual feedback leading to a 21.70% increase in speed and 8.72% in stride length, while auditory feedback resulted in a 25.43% increase in speed and 13.58% in stride length.

In contrast, age-matched healthy individuals showed no improvement in walking speed or stride length after similar training, highlighting the specific benefits of this intervention for patients with gait disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gait improvement in patients with cerebral palsy by visual and auditory feedback. Baram, Y., Lenger, R.[2022]

A systematic review of nine studies with 499 chronic stroke patients found no significant overall benefit of overground gait training on primary gait function, indicating that this common therapy may not improve walking ability as hoped.

However, there were small improvements in specific performance measures, such as a 0.07 m/s increase in gait speed and a 26.06 meter increase in the six-minute walk test, suggesting that while the overall impact may be limited, some aspects of mobility could see slight benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overground physical therapy gait training for chronic stroke patients with mobility deficits. States, RA., Pappas, E., Salem, Y.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5131187/

Effectiveness of Rehabilitation Interventions to Improve ... The results of the meta-analysis suggest that interventions focused on gait training were the most effective in improving gait speed for children with CP. In ...

2. frontiersin.org frontiersin.org/journals/neurology/articles/10.3389/fneur.2022.1005485/full

Which gait training intervention can most effectively ... This study suggested that BWSTT was optimal in increasing the gait velocity and RAGT was optimal in optimizing GMFM in persons with CP.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02391324

NCT02391324 | Effectiveness of Robotic Gait Training and ... Robot assisted gait training is seen as a promising intervention for improving the walking abilities of children with cerebral palsy, but research to ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0966636223011359

The effects of different types of gait training on ... All gait training interventions had positive impact in gait related outcomes, mainly in walking speed and gait endurance.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/27313240/

Effectiveness of Rehabilitation Interventions to Improve Gait ... Conclusions: Gait training was the most effective intervention in improving gait speed for ambulatory children with CP. Strength training, even if properly ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9871496/

Which gait training intervention can most effectively improve ... This study suggested that BWSTT was optimal in increasing the gait velocity and RAGT was optimal in optimizing GMFM in persons with CP.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2324242623000311

Recent advancements in interventions for cerebral palsy Rhythmic auditory stimulation has also shown positive results during 3 weeks of gait training, with an increase in step length, stride length, and walking ...

8. journals.lww.com journals.lww.com/md-journal/fulltext/2020/01100/efficacy_and_safety_of_core_stability_training_on.30.aspx

Efficacy and safety of core stability training on gait of... The study will evaluate the effect of CST on gait of children with CP from multiple outcomes, including walking speed, endurance, stride length, and safety.

9. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/dmcn.13708

The efficacy of functional gait training in children and ... The results of this review confirm that functional gait training in children and young adults with CP is a safe treatment intervention to target ...