Neuroproprioceptive Equine-Assisted Physiotherapy for Spinal Muscular Atrophy

NCT ID: NCT07336602

Last Updated: 2026-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-04-15

Study Completion Date

2026-06-30

Brief Summary

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This study investigates whether Equine-Assisted Physiotherapy based on Neuro-proprioceptive "Facilitation and Inhibition" (NEUROEQUIP-SMA) can improve movement, posture, breathing, and quality of life in children with spinal muscular atrophy (SMA). This therapy uses the horse's rhythmic movement together with targeted sensory and manual stimulation to trigger natural motor reactions starting from the pelvis, lower the threshold for muscle activation, and support coordinated motor patterns. The study compares this method with standard individual physiotherapy based on the same neuro-proprioceptive facilitation and inhibition principles, but performed without the horse. Twenty children aged 2 to 9 years will receive both therapies in two separate 6-day blocks, in random order (crossover design). The researchers will assess muscle fatigue, coordination, breathing function, movement quality and quantity, quality of life, and changes in selected blood biomarkers. The results may help develop better rehabilitation strategies for children with SMA who are receiving modern pharmacological or gene therapy.

Detailed Description

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Spinal Muscular Atrophy (SMA) is an autosomal recessive neuromuscular disorder caused by deletions or mutations of the SMN1 gene with retention of its paralog SMN2. Despite recent advances in disease-modifying treatments, SMA remains the leading genetic cause of infant mortality and continues to require multidisciplinary supportive care to achieve optimal outcomes. Physiotherapy is an integral part of this care, helping to maintain mobility, prevent contractures, and enhance quality of life.

Historically, physical activity was discouraged in SMA because of concerns that exercise might accelerate motor-neuron degeneration. Subsequent evidence has shown that inactivity contributes to weakness and fatigue, whereas appropriately dosed physical therapy improves postural control, endurance, and respiratory function. Modern rehabilitation therefore emphasizes functional mobility, balance training, and gait rehabilitation. Experimental studies have also demonstrated that specific exercise parameters can activate neuroprotective mechanisms independent of SMN protein expression, suggesting that motor-unit activation itself may support neuronal health.

Building on these findings, the present study introduces Equine-Assisted Physiotherapy Based on Neuro-proprioceptive "Facilitation and Inhibition" (NEUROEQUIP-SMA)-an innovative physiotherapeutic approach designed for children with SMA. This method combines the dynamic multisensory input of equine movement with the principles of neuroproprioceptive facilitation and inhibition, in which appropriate afferent stimuli modulate interneuronal excitability to optimize transmission within motor pathways. The technique aims to lower the excitability threshold of motor neurons so that impulses from the central nervous system can effectively induce muscular activation. Similar neurofacilitation strategies are routinely used in Czech neurorehabilitation for patients after stroke or with multiple sclerosis, but their potential in SMA has not yet been systematically studied.

The NEUROEQUIP-SMA method is compared with a standard physiotherapy program based on neuroproprioceptive facilitation and inhibition principles delivered in an outpatient setting. Both approaches target postural alignment, trunk stability, and functional motor control. The equine-assisted modality is expected to further enhance outcomes by promoting rhythmic pelvic activation, symmetric weight shifting, coordinated engagement of weakened muscle chains, and improved respiratory patterning through the horse's cyclic movement.

The study uses a randomized crossover design to evaluate short-term effects after an intensive six-day program. Primary outcomes include changes in motor function, postural control, and respiratory parameters, complemented by surface electromyography to monitor muscle fatigue. Secondary measures address quality of life, psychomotor development, and parent-reported well-being.

As an exploratory molecular component, peripheral blood will be analyzed for selected long non-coding RNAs (lncRNAs) such as SMN-AS1, MALAT1, PARTICLE, MEG3, NEAT1, H19, and GAS5. These transcripts are involved in motor-neuron development and chromatin regulation through PRC2-associated mechanisms. Their expression changes may serve as potential biomarkers reflecting neurophysiological effects of intensive physiotherapy in SMA.

The study was reviewed and approved by the Ethics Committee of the Third Faculty of Medicine, Charles University, Prague, Czech Republic. The intervention is short-lasting, low-risk, and non-pharmacological; therefore, a formal Data Monitoring Committee was not required. The findings are expected to contribute to evidence-based recommendations for physiotherapeutic management of SMA and to provide insight into the molecular correlates of motor-function improvement.

Conditions

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Spinal Muscular Atrophy (SMA)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Sequence A

Participants first receive NEUROEQUIP-SMA (Equine-Assisted Physiotherapy Based on Neuro-proprioceptive Facilitation and Inhibition) for six consecutive days, followed by a washout period of 6 weeks to 3 months, and then Standard Individual Outpatient Physiotherapy Based on Neuro-proprioceptive Facilitation and Inhibition (SMA-SOC-N) for six consecutive days. Each phase includes standardized Therapeutic Grooming.

Group Type EXPERIMENTAL

Equine-Assisted Physiotherapy based on Neuro-proprioceptive "Facilitation and Inhibition"

Intervention Type BEHAVIORAL

Equine-assisted physiotherapy applying the principles of neuro-proprioceptive facilitation and inhibition. Conducted twice daily for 15 minutes over six consecutive days under the supervision of a certified physiotherapist and a trained horse leader. The intervention utilizes the horse's rhythmic, three-dimensional movement to generate dynamic proprioceptive, vestibular, and tactile stimuli that activate physiological postural reactions and coordinated muscle chains. The goal is to improve trunk stability, breathing control, movement symmetry, and functional motor coordination in children with spinal muscular atrophy. The therapy is delivered in a controlled equine environment, using manual facilitation and specific body positioning to modulate neuronal excitability and enhance neuromuscular function.

Standard Individual Outpatient Physiotherapy Based on Neuro-proprioceptive Facilitation and Inhibition

Intervention Type BEHAVIORAL

Standardized outpatient physiotherapy program based on neuro-proprioceptive facilitation and inhibition, performed once daily for 30 minutes over six consecutive days. Delivered by an experienced physiotherapist in a clinical setting, the intervention includes active and assisted movement exercises, breathing techniques, stretching, postural correction, and positioning strategies to prevent contractures, maintain range of motion, and support trunk and respiratory control. The therapy applies targeted afferent stimuli to modulate motoneuron excitability and improve voluntary activation of motor units. The approach follows international standards of SMA rehabilitation, focusing on optimizing postural alignment, movement efficiency, and overall motor performance.

Therapeutic grooming

Intervention Type BEHAVIORAL

Structured horse-care activity included in both treatment periods to control for psychosocial and environmental effects of horse interaction. Conducted once daily for approximately 20 minutes under therapist supervision, therapeutic grooming involves guided brushing, tactile contact, and communication with the horse in a safe and supportive setting. The activity promotes sensory integration, body awareness, and emotional regulation, while preparing the child for subsequent equine-assisted sessions. Although not a primary therapeutic modality, it standardizes the environmental exposure across study arms and supports comfort, motivation, and engagement in children participating in physiotherapeutic interventions.

Sequence B

Participants first undergo six days of standard individual outpatient physiotherapy based on neuro-proprioceptive facilitation and inhibition (SMA-SOC-N), followed by a washout period of 6-12 weeks, and then six days of equine-assisted physiotherapy based on neuro-proprioceptive facilitation and inhibition (NEUROEQUIP-SMA). Each phase includes a standardized therapeutic grooming component.

Group Type EXPERIMENTAL

Equine-Assisted Physiotherapy based on Neuro-proprioceptive "Facilitation and Inhibition"

Intervention Type BEHAVIORAL

Equine-assisted physiotherapy applying the principles of neuro-proprioceptive facilitation and inhibition. Conducted twice daily for 15 minutes over six consecutive days under the supervision of a certified physiotherapist and a trained horse leader. The intervention utilizes the horse's rhythmic, three-dimensional movement to generate dynamic proprioceptive, vestibular, and tactile stimuli that activate physiological postural reactions and coordinated muscle chains. The goal is to improve trunk stability, breathing control, movement symmetry, and functional motor coordination in children with spinal muscular atrophy. The therapy is delivered in a controlled equine environment, using manual facilitation and specific body positioning to modulate neuronal excitability and enhance neuromuscular function.

Standard Individual Outpatient Physiotherapy Based on Neuro-proprioceptive Facilitation and Inhibition

Intervention Type BEHAVIORAL

Standardized outpatient physiotherapy program based on neuro-proprioceptive facilitation and inhibition, performed once daily for 30 minutes over six consecutive days. Delivered by an experienced physiotherapist in a clinical setting, the intervention includes active and assisted movement exercises, breathing techniques, stretching, postural correction, and positioning strategies to prevent contractures, maintain range of motion, and support trunk and respiratory control. The therapy applies targeted afferent stimuli to modulate motoneuron excitability and improve voluntary activation of motor units. The approach follows international standards of SMA rehabilitation, focusing on optimizing postural alignment, movement efficiency, and overall motor performance.

Therapeutic grooming

Intervention Type BEHAVIORAL

Structured horse-care activity included in both treatment periods to control for psychosocial and environmental effects of horse interaction. Conducted once daily for approximately 20 minutes under therapist supervision, therapeutic grooming involves guided brushing, tactile contact, and communication with the horse in a safe and supportive setting. The activity promotes sensory integration, body awareness, and emotional regulation, while preparing the child for subsequent equine-assisted sessions. Although not a primary therapeutic modality, it standardizes the environmental exposure across study arms and supports comfort, motivation, and engagement in children participating in physiotherapeutic interventions.

Interventions

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Equine-Assisted Physiotherapy based on Neuro-proprioceptive "Facilitation and Inhibition"

Equine-assisted physiotherapy applying the principles of neuro-proprioceptive facilitation and inhibition. Conducted twice daily for 15 minutes over six consecutive days under the supervision of a certified physiotherapist and a trained horse leader. The intervention utilizes the horse's rhythmic, three-dimensional movement to generate dynamic proprioceptive, vestibular, and tactile stimuli that activate physiological postural reactions and coordinated muscle chains. The goal is to improve trunk stability, breathing control, movement symmetry, and functional motor coordination in children with spinal muscular atrophy. The therapy is delivered in a controlled equine environment, using manual facilitation and specific body positioning to modulate neuronal excitability and enhance neuromuscular function.

Intervention Type BEHAVIORAL

Standard Individual Outpatient Physiotherapy Based on Neuro-proprioceptive Facilitation and Inhibition

Standardized outpatient physiotherapy program based on neuro-proprioceptive facilitation and inhibition, performed once daily for 30 minutes over six consecutive days. Delivered by an experienced physiotherapist in a clinical setting, the intervention includes active and assisted movement exercises, breathing techniques, stretching, postural correction, and positioning strategies to prevent contractures, maintain range of motion, and support trunk and respiratory control. The therapy applies targeted afferent stimuli to modulate motoneuron excitability and improve voluntary activation of motor units. The approach follows international standards of SMA rehabilitation, focusing on optimizing postural alignment, movement efficiency, and overall motor performance.

Intervention Type BEHAVIORAL

Therapeutic grooming

Structured horse-care activity included in both treatment periods to control for psychosocial and environmental effects of horse interaction. Conducted once daily for approximately 20 minutes under therapist supervision, therapeutic grooming involves guided brushing, tactile contact, and communication with the horse in a safe and supportive setting. The activity promotes sensory integration, body awareness, and emotional regulation, while preparing the child for subsequent equine-assisted sessions. Although not a primary therapeutic modality, it standardizes the environmental exposure across study arms and supports comfort, motivation, and engagement in children participating in physiotherapeutic interventions.

Intervention Type BEHAVIORAL

Other Intervention Names

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NEUROEQUIP-SMA SMA-SOC-N

Eligibility Criteria

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Inclusion Criteria

* Age between 2 and 9 years
* Clinical diagnosis of spinal muscular atrophy (SMA) type I, II, or III
* Stable health condition for at least 6 months prior to enrollment
* Ability to participate in the study procedures
* Written informed consent provided by a parent or legal guardian

Exclusion Criteria

* Hip dislocation
* Known allergy to horses or the stable environment
* Severe fear of horses that would prevent participation in equine-assisted physiotherapy

Any other medical condition that, in the investigator's opinion, would interfere with safe participation in the study
Minimum Eligible Age

2 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charles University, Czech Republic

OTHER

Sponsor Role lead

Responsible Party

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Kamila Řasová

proffesor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Katerina Marikova, master

Role: PRINCIPAL_INVESTIGATOR

Charles University, Czech Republic

Locations

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Mirákl Hippotherapy Center

Bohuslavice, , Czechia

Site Status

College of Polytechnics Jihlava

Jihlava, , Czechia

Site Status

Department of Medical Genetics, Third Faculty of Medicine, Charles University

Prague, , Czechia

Site Status

Third Faculty of Medicine, Charles University

Prague, , Czechia

Site Status

Countries

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Czechia

Central Contacts

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Kamila Rasova, professor

Role: CONTACT

+420 604 511 416

Katerina Marikova, master

Role: CONTACT

+420 607 616 104

References

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Lemke D, Rothwell E, Newcomb TM, Swoboda KJ. Perceptions of equine-assisted activities and therapies by parents and children with spinal muscular atrophy. Pediatr Phys Ther. 2014 Summer;26(2):237-44. doi: 10.1097/PEP.0000000000000027.

Reference Type RESULT
PMID: 24675128 (View on PubMed)

Pantera E, Froment P, Vernay D. Does Hippotherapy Improve the Functions in Children with Cerebral Palsy? Systematic Review Based on the International Classification of Functioning. J Integr Complement Med. 2022 Sep;28(9):705-720. doi: 10.1089/jicm.2021.0417. Epub 2022 Jun 7.

Reference Type RESULT
PMID: 35671520 (View on PubMed)

Rasova K, Buckova B, Prokopiusova T, Prochazkova M, Angel G, Markova M, Hruskova N, Stetkarova I, Spanhelova S, Mares J, Tintera J, Zach P, Musil V, Hlinka J. A Three-Arm Parallel-group Exploratory Trial documents balance improvement without much evidence of white matter integrity changes in people with multiple sclerosis following two months ambulatory neuroproprioceptive "facilitation and inhibition" physical therapy. Eur J Phys Rehabil Med. 2021 Dec;57(6):889-899. doi: 10.23736/S1973-9087.21.06701-0. Epub 2021 Feb 10.

Reference Type RESULT
PMID: 33565742 (View on PubMed)

Trenkle J, Brugman J, Peterson A, Roback K, Krosschell KJ. Filling the gaps in knowledge translation: Physical therapy recommendations for individuals with spinal muscular atrophy compared to standard of care guidelines. Neuromuscul Disord. 2021 May;31(5):397-408. doi: 10.1016/j.nmd.2021.02.011. Epub 2021 Feb 16.

Reference Type RESULT
PMID: 33741230 (View on PubMed)

Mercuri E, Sumner CJ, Muntoni F, Darras BT, Finkel RS. Spinal muscular atrophy. Nat Rev Dis Primers. 2022 Aug 4;8(1):52. doi: 10.1038/s41572-022-00380-8.

Reference Type RESULT
PMID: 35927425 (View on PubMed)

Voight S, Arya K. Considerations for Treatment in Clinical Care of Spinal Muscular Atrophy Patients. Children (Basel). 2024 Apr 20;11(4):495. doi: 10.3390/children11040495.

Reference Type RESULT
PMID: 38671712 (View on PubMed)

Shin HI. Rehabilitation Strategies for Patients With Spinal Muscular Atrophy in the Era of Disease-Modifying Therapy. Ann Rehabil Med. 2024 Aug;48(4):229-238. doi: 10.5535/arm.240046. Epub 2024 Aug 30.

Reference Type RESULT
PMID: 39210748 (View on PubMed)

Related Links

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https://www.lf3.cuni.cz/

Official website of the coordinating institution and study sponsor.

https://www.chmirakl.cz/

Clinical site for equine-assisted physiotherapy (NEUROEQUIP-SMA).

https://www.icf-research-branch.org/

Reference for the ICF Core Set used in functional assessment.

https://cuni.cz/UK-9291.html

Information about the university grant funding the study.

Other Identifiers

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GAUK 4424/2024

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

SVV 260533/SVV/2024

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Cooperatio Neurosciences

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

4424

Identifier Type: -

Identifier Source: org_study_id

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