Specific Trunk Interventions for Cerebral Palsy

Overseen By Ming Wu

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Shirley Ryan AbilityLab

Disqualifiers: Severe contractures, fractures, cardiovascular instability, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

44 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how two different therapies can improve trunk posture and movement in children with cerebral palsy (CP). One group will participate in robotic hippotherapy, where children sit on a robotic horse to train balance and movement. The other group will engage in conventional physical therapy, including stretching, balance exercises, and treadmill walking. Children who have had CP from birth, can sit up without assistance, and have mild scoliosis may be suitable candidates. As an unphased trial, this study provides a unique opportunity for children to explore innovative therapies that could enhance their quality of life.

Will I have to stop taking my current medications?

The trial protocol does not specify whether participants must stop taking their current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that robotic hippotherapy, which uses a machine to simulate horse riding, is generally easy for children to handle. Studies have found that it improves muscle strength, balance, and movement skills in children with cerebral palsy (CP). These results suggest that the treatment is safe and beneficial for kids with CP, with no major safety issues reported.

Traditional physical therapy, which includes exercises like stretching and balance training, is also commonly used. It is considered safe and effective for children with CP. Both treatments aim to enhance movement and function and are generally well-received by patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about robotic hippotherapy for cerebral palsy because it offers a novel approach by using a robotic horse to simulate the movements of traditional horseback riding. This method is unique as it provides dynamic balance training by applying force perturbations in multiple directions, which could potentially enhance core stability and motor skills more effectively than conventional therapies. Unlike standard physical therapy, which typically includes static exercises like stretching and balance training, robotic hippotherapy offers a more engaging and potentially more effective way to improve trunk control in individuals with cerebral palsy.

What evidence suggests that this trial's treatments could be effective for cerebral palsy?

This trial will compare robotic hippotherapy with conventional physical therapy for children with cerebral palsy (CP). Research shows that robotic hippotherapy, which uses a mechanical horse-riding simulator, can improve balance, large muscle movements, and hip flexibility in children with CP. Studies have found that this therapy boosts muscle strength, movement skills, and overall functional ability. In contrast, traditional physical therapy, which includes exercises like stretching, balance training, and treadmill walking, is a well-known method for enhancing movement and posture in children with CP. Both treatments have demonstrated improvements in physical abilities and quality of life for children with CP. ^{1 2 3 5 6}

Who Is on the Research Team?

Ming Wu

Principal Investigator

Shirley Ryan AbilityLab

Are You a Good Fit for This Trial?

This trial is for children aged 4-12 with bilateral spastic cerebral palsy (CP), specifically those who can express discomfort, have mild scoliosis, and haven't had hippotherapy, Botulinum toxin treatment or surgeries like selective dorsal rhizotomy recently. It's not for kids with aggressive behaviors, severe leg issues, unhealed skin lesions on the legs, or serious cardiovascular conditions.

Inclusion Criteria

My child has CP due to premature birth complications.

GMFCS levels will be I to IV

My child can reliably indicate when they feel pain, fear, or discomfort.

Exclusion Criteria

Aggressive or self-harming behaviors

I have open sores on my legs that haven't healed.

I have severe joint stiffness, bone fractures, or weak bones in my legs.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either robotic hippotherapy or conventional physical therapy for 6 weeks. Robotic hippotherapy involves sitting astride a robotic horse with force perturbations, while conventional therapy includes stretching, balance training, and treadmill walking.

6 weeks

Follow-up

Participants are monitored for changes in walking speed, 6-minute walking distance, and trunk control after the treatment phase.

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Conventional Physical Therapy
• Robotic Hippotherapy

Trial Overview The study aims to see if robotic hippotherapy—a type of therapy using robot-assisted horseback riding movements—improves trunk posture and walking functions in children with CP compared to conventional physical therapy.

How Is the Trial Designed?

Group I: Robotic hippotherapy Experimental Treatment 1 Intervention

For the robotic training group, each subject will be trained for 40 minutes. Specifically, each participant will sit astride on a robotic horse with the force perturbation will be applied in the anterior-posterior direction and up/down direction.

Group II: Conventional physical therapy Active Control 1 Intervention

For the conventional physical therapy group, each subject will be trained for 40 minutes, which will include 10 minutes of stretching, followed by 10 minutes of sitting and 10 minutes of standing balance training, and 10 minutes of treadmill walking.

Conventional Physical Therapy is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Physical Therapy for:

• Musculoskeletal injuries
• Neurological conditions
• Pediatric conditions
• Cardiopulmonary conditions
• Geriatric conditions

Approved in United States as Physical Therapy for:

• Musculoskeletal injuries
• Neurological conditions
• Pediatric conditions
• Cardiopulmonary conditions
• Geriatric conditions

Approved in Canada as Physiotherapy for:

• Musculoskeletal injuries
• Neurological conditions
• Pediatric conditions
• Cardiopulmonary conditions
• Geriatric conditions

Who Is Running the Clinical Trial?

Shirley Ryan AbilityLab

Lead Sponsor

Trials

212

Recruited

17,900+

Published Research Related to This Trial

This randomized clinical study will evaluate the effects of a hippotherapy simulator on 37 children with cerebral palsy, focusing on motor development, balance control, hip abduction range of motion, and muscle activity.

The study aims to provide the first comprehensive analysis of hippotherapy simulators in this population, potentially leading to effective rehabilitation strategies for children with cerebral palsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study of the therapeutic effects of an advanced hippotherapy simulator in children with cerebral palsy: a randomised controlled trial. Herrero, P., Asensio, A., García, E., et al.[2022]

A study involving 45 children with cerebral palsy showed that hippotherapy significantly improved posture and body function, particularly in head position control, arm function, and trunk control after 12 weeks of therapy.

Children participating in hippotherapy sessions twice a week demonstrated greater improvements compared to those attending once a week, indicating that more frequent sessions may enhance therapeutic outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Influence of Hippotherapy on the Body Posture in a Sitting Position among Children with Cerebral Palsy. Matusiak-Wieczorek, E., Dziankowska-Zaborszczyk, E., Synder, M., et al.[2023]

Equine Assisted Physiotherapy (EAPT) led to measurable improvements in trunk control in two children with cerebral palsy, particularly when riding bareback, while riding in a saddle resulted in reduced trunk control.

The study highlighted that EAPT not only improved trunk control but also encouraged symmetry in movement, adaptation to rhythm, and mastery of riding skills, with the quality of feedback from therapists playing a significant role in these outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Facilitating new movement strategies: Equine assisted physiotherapy for children with cerebral palsy. Norrud, BC., Råheim, M., Sudmann, TT., et al.[2021]

The author addresses concerns regarding the risks of serious adverse events associated with orthopaedic manual therapy, paracetamol, and NSAID treatments for neck pain, emphasizing the need for careful consideration of these risks in clinical practice.

The response highlights the importance of balancing treatment efficacy with safety, suggesting that while these interventions can be effective for neck pain, practitioners should remain vigilant about potential adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Response to the Letter to the Editor-in-Chief. Rushton, A., Carlesso, LC., Flynn, T., et al.[2023]

A pilot study involving 12 children (6 with spastic diplegia and 6 without disabilities) showed that hippotherapy (HPOT) significantly improved head and trunk stability in children with cerebral palsy after 12 weeks of treatment.

Children with cerebral palsy experienced notable reductions in head rotation and anterior-posterior translation, indicating enhanced stability, and their post-treatment measurements were comparable to those of children without disabilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in trunk and head stability in children with cerebral palsy after hippotherapy: a pilot study. Shurtleff, TL., Engsberg, JR.[2010]

Hippotherapy utilizes the movement of horses as a therapeutic tool to help clients with neuromusculoskeletal dysfunction, such as those with cerebral palsy, by improving their functional abilities through engaging and enjoyable activities.

The controlled environment of hippotherapy allows therapists to adjust the horse's movements and sensory inputs, which can enhance neurological function and sensory processing, benefiting clients in their daily activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hippotherapy. Meregillano, G.[2020]

A comparison of physical therapy with hippotherapy and physical therapy alone in 315 children and adolescents with cerebral palsy showed that both interventions had similar effects on gross motor function, including measures like gait speed and stride length.

While the group receiving hippotherapy showed slightly greater improvements, these changes were not significant enough to be considered clinically meaningful, indicating that both therapies are effective but may not differ substantially in outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical therapy with hippotherapy compared to physical therapy alone in children with cerebral palsy: systematic review and meta-analysis. Santos de Assis, G., Schlichting, T., Rodrigues Mateus, B., et al.[2022]

Hippotherapy has been shown to effectively improve muscle symmetry in the trunk and hip for children with cerebral palsy, supported by Level 2a evidence from the systematic review.

Therapeutic horseback riding also demonstrated significant improvements in gross motor function compared to regular therapy or waiting list controls, indicating its potential as a beneficial intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Horseback riding as therapy for children with cerebral palsy: is there evidence of its effectiveness? Snider, L., Korner-Bitensky, N., Kammann, C., et al.[2018]

Patients define adverse events (AEs) from manual therapy (MT) based on pain severity, functional impact, duration, and the exclusion of other causes, highlighting a more nuanced understanding of AEs than previously recognized.

The study emphasizes the importance of incorporating patient perspectives in defining AEs in MT practices, suggesting that current frameworks may overlook critical aspects of patient experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Defining adverse events in manual therapy: an exploratory qualitative analysis of the patient perspective. Carlesso, LC., Cairney, J., Dolovich, L., et al.[2022]

Orthopaedic physical therapy is generally considered safe, but there is a lack of high-quality data documenting its safety, particularly regarding cervical manipulation, highlighting the need for more rigorous research on potential harms.

Current research shows poor reporting standards for adverse events in orthopaedic physical therapy, indicating a need for standardized terminology and better documentation practices to ensure informed consent and clinical decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standardization of adverse event terminology and reporting in orthopaedic physical therapy: application to the cervical spine. Carlesso, LC., Macdermid, JC., Santaguida, LP.[2022]

A systematic review of 283 reviews on spinal manipulative therapy (SMT) found that while 46% deemed SMT safe, 13% considered it harmful, indicating a significant divide in opinions on its safety.

Serious adverse events (SAEs) associated with SMT, such as stroke and vertebral artery dissection, were reported, with incidence estimates ranging from 1 in 20,000 to 1 in 250,000,000 manipulations, highlighting that some risk is present.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The risk associated with spinal manipulation: an overview of reviews. Nielsen, SM., Tarp, S., Christensen, R., et al.[2022]

In a pilot study involving 20 patients treated by Canadian orthopaedic manual physiotherapists, adverse events from cervical manipulation and mobilization were mostly benign and transient, with 95.6% occurring within 0-12 hours and lasting 0-2 days.

The study faced significant challenges in recruitment and data collection, highlighting the need for improved methods in future larger trials, but it confirmed that no serious adverse events were reported during the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Determining adverse events in patients with neck pain receiving orthopaedic manual physiotherapy: a pilot and feasibility study. Carlesso, LC., Macdermid, JC., Santaguida, PL., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12566273/

The Effect of Hippotherapy Simulator-Assisted Therapy on ... All of these therapies are effective in improving gross motor function, balance, gait, and functional ability in children with CP [7]. In ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9774556/

Effectiveness of Mechanical Horse-Riding Simulator-Based ... Horse-riding simulator-based therapy is an effective therapy to improve gross motor function, functional balance and abduction pelvic ROM in children with CP.

3. mdpi.com mdpi.com/2077-0383/14/1/283

Effects of Hippotherapy and Horse-Riding Simulators on ... Conventional hippotherapy and horse-riding simulators (HRS) have shown promising results on gross motor function in populations with neurological disorders.

4. researchgate.net researchgate.net/publication/396397092_The_Effect_of_Hippotherapy_Simulator-Assisted_Therapy_on_Motor_and_Functional_Outcomes_in_Children_with_Cerebral_Palsy

The Effect of Hippotherapy Simulator-Assisted Therapy on ... Conclusions: HRS integrated with conventional NDT may improve muscle tone, motor function, balance, gait, and functional independence in ...

5. commons.und.edu commons.und.edu/cgi/viewcontent.cgi?article=1388&context=ot-grad

The Efficacy of Hippotherapy for Physical Rehabilitation Some improvements noted in the area of client factors included muscle symmetry, muscle stability, muscle control, muscle tone functions, muscle strength, ...

6. aetna.com aetna.com/cpb/medical/data/100_199/0151.html

Hippotherapy - Medical Clinical Policy Bulletins The authors concluded that results of this study suggest that hippotherapy has a positive effect on the functional motor performance of children with CP.