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

120 Participants Needed

Trial Summary

What is the purpose of this trial?

The study design will consist of a cohort of adolescents and young adults with cerebral palsy (CP) that will undergo a gait training protocol. All participants will complete MEG or EEG baseline brain imaging measures of their sensorimotor cortical activity, MRI brain/spinal cord imaging (previous MRI or template brain may be substituted), neurophysiological tests of the spinal cord H-reflex, and a series of mobility clinical tests and cognitive tests. Participants with metal in their body that would interfere with the MEG (e.g., braces on teeth, permanent retainer) will not undergo the MEG tests but will undergo the EEG assessments. Those who complete the MEG assessments will not undergo the EEG assessments. After completing the baseline tests, the participants with CP will undergo the therapeutic gait training. After completing all of the therapeutic gait training sessions, the participants with CP will repeat the same assessments that were completed at baseline. Separately, a cohort of neurotypical adolescents and young adults will also complete the baseline assessments. The neurotypical participants will not undergo the therapeutic gait training, but will be used as a normative group for interpreting if the changes seen in the participants with CP after therapy are in fact moving the system toward a normative state.

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 data supports the idea that Gait Therapy for Cerebral Palsy is an effective treatment?

The available research shows that Gait Therapy can improve walking speed and overall movement abilities in people with cerebral palsy. One study reviewed different gait training methods and found that they can help increase how fast someone with cerebral palsy can walk. Another study explored a new type of Gait Therapy using electrical stimulation and found it helped two teenagers with cerebral palsy improve their walking. Compared to surgery, which also aims to improve walking, Gait Therapy is less invasive and can be adjusted to fit individual needs. While surgery can lead to improvements, these may decrease over time, as shown in a study where children experienced a decline in walking ability a few years after surgery. This suggests that Gait Therapy might be a more sustainable option for improving walking in cerebral palsy. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Gait Therapy, Gait Training, Physical Therapy for Gait Improvement in patients with cerebral palsy?

Research shows that gait training interventions can improve walking speed and overall motor function in people with cerebral palsy. A study using a new treadmill-based gait training with electrical stimulation showed positive changes in two adolescents with cerebral palsy, suggesting potential benefits of such therapies. ^{1 2 3 4 5}

What safety data exists for gait therapy in cerebral palsy?

Safety data for gait therapy in cerebral palsy includes reports of adverse events (AEs) from robot-assisted gait training (RAGT) devices. A systematic review found 169 device-related AEs in 18 out of 50 studies involving 985 subjects. Common AEs included soft tissue injuries, musculoskeletal issues, and physiological changes like blood pressure fluctuations. These were often due to excessive pressure, shear, and misalignments between the robot and human. More structured AE reporting is needed to improve safety. ^{5 6 7 8 9}

Is gait therapy safe for humans?

Gait therapy, including robot-assisted gait training, is generally safe but can cause some side effects like skin discomfort, muscle issues, and changes in blood pressure. These effects are often related to the equipment used, and more detailed safety reporting is needed to improve device safety. ^{5 6 7 8 9}

Is Gait Therapy a promising treatment for Cerebral Palsy?

Yes, Gait Therapy is a promising treatment for Cerebral Palsy. It helps improve walking by addressing muscle imbalances and enhancing motor skills. Techniques like robotic-assisted training and functional electrical stimulation can lead to better walking patterns and increased endurance. ^{3 5 10 11 12}

How is Gait Therapy different from other treatments for cerebral palsy?

Gait Therapy for cerebral palsy is unique because it often involves the use of advanced techniques like functional electrical stimulation (FES) and robotic-assisted devices, which can provide more precise and varied training compared to traditional physical therapy. These methods aim to improve walking patterns and motor learning by offering longer training durations and more controlled environments. ^{3 5 10 11 12}

Research Team

Max J Kurz, PhD

Principal Investigator

Father Flanagan's Boys' Home

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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 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 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]

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]

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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

The Gait Outcomes Assessment List (GOAL): validation of a new assessment of gait function for children with cerebral palsy. [2022]

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

Gait improvement surgery in diplegic children: how long do the improvements last? [2019]

3. Germany pubmed.ncbi.nlm.nih.gov

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

4. Switzerland 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. [2023]

5. United States 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. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Occurrence and Type of Adverse Events During the Use of Stationary Gait Robots-A Systematic Literature Review. [2021]

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

Gait improvement in patients with cerebral palsy by visual and auditory feedback. [2022]

8. Italy pubmed.ncbi.nlm.nih.gov

Applicability of a new robotic walking aid in a patient with cerebral palsy. Case report. [2012]

9. Switzerland pubmed.ncbi.nlm.nih.gov

The immediate effects of a novel auditory and proprioceptive training device on gait after stroke. [2021]

10. 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]

11. England pubmed.ncbi.nlm.nih.gov

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

12. England pubmed.ncbi.nlm.nih.gov

Overground physical therapy gait training for chronic stroke patients with mobility deficits. [2021]