Neuroproprioceptive Equine-Assisted Physiotherapy for Spinal Muscular Atrophy

NCT07336602 | Not Yet Recruiting

• 4 other identifiers: 4424GAUK 4424/2024SVV 260533/SVV/2024Cooperatio Neurosciences
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Spinal Muscular Atrophy (SMA)

Keywords

Muscular atrophy, Spinal; Genetic Therapy; Equine-Assisted Therapy; Child; Pediatrics; Physical Therapy Modalities; RNA, Long Noncoding; Neuro-proprioceptive Principles

Outcome Measures

Primary Outcomes (1)

• Children's Hospital of Philadelphia Infant Test of Neuromuscular Disorders

  A clinical assessment tool used to evaluate motor function in infants with neuromuscular disorders measures their ability to perform specific movements and assesses the severity of motor impairments. Measurements are recorded during the test and are later evaluated by two independent physiotherapists. Scores range from 0 to 64, with higher scores indicating better motor function.

  Baseline measurement before the start of the 6-day intervention, follow-up measurement after the end of the 6-day intervention.

Secondary Outcomes (17)

• Change in Relative Expression of Selected lncRNAs

  Baseline measurement before the start of the 6-day intervention, follow-up measurement after the end of 28 days from the end of the intervention.

• Change in Median Frequency of Surface EMG Signal

  Baseline measurement before the start of the 6-day intervention, follow-up measurement after the end of the 6-day intervention.

• The Trunk Control Measurement Scale (TCMS)

  Baseline measurement before the start of the 6-day intervention, follow-up measurement after the end of the 6-day intervention.

• The Segmental Assessment of Trunk Control (SATCo)

  Baseline measurement before the start of the 6-day intervention, follow-up measurement after the end of the 6-day intervention.

• Motor Function Measure-20 (MFM-20)

  Baseline measurement before the start of the 6-day intervention, follow-up measurement after the end of the 6-day intervention.

Study Arms (2)

Sequence A

EXPERIMENTAL

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.

Behavioral: Equine-Assisted Physiotherapy based on Neuro-proprioceptive "Facilitation and Inhibition"; Behavioral: Standard Individual Outpatient Physiotherapy Based on Neuro-proprioceptive Facilitation and Inhibition; Behavioral: Therapeutic grooming

Sequence B

EXPERIMENTAL

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.

Behavioral: Equine-Assisted Physiotherapy based on Neuro-proprioceptive "Facilitation and Inhibition"; Behavioral: Standard Individual Outpatient Physiotherapy Based on Neuro-proprioceptive Facilitation and Inhibition; Behavioral: Therapeutic grooming

Interventions

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

Also known as: NEUROEQUIP-SMA

Sequence A; Sequence B

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

Also known as: SMA-SOC-N

Sequence A; Sequence B

Therapeutic grooming 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 A; Sequence B

Eligibility Criteria

• Age: 2 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charles University, Czech Republic: lead

Study Sites (4)

Mirákl Hippotherapy Center

Bohuslavice, 58856, Czechia

Location

College of Polytechnics Jihlava

Jihlava, 58601, Czechia

Location

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

Prague, 10000, Czechia

Location

Third Faculty of Medicine, Charles University

Prague, 10000, Czechia

Location

Related Publications (7)

• 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.

  PMID: 24675128 RESULT

• 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.

  PMID: 35671520 RESULT

• 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.

  PMID: 33565742 RESULT

• 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.

  PMID: 33741230 RESULT

• 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.

  PMID: 35927425 RESULT

• 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.

  PMID: 38671712 RESULT

• 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.

  PMID: 39210748 RESULT

Related Links

• Official website of the coordinating institution and study sponsor.
• Clinical site for equine-assisted physiotherapy (NEUROEQUIP-SMA).
• Reference for the ICF Core Set used in functional assessment.
• Information about the university grant funding the study.

MeSH Terms

Conditions

Muscular Atrophy, Spinal

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; Neuromuscular Diseases

Study Officials

• Katerina Marikova, master

  Charles University, Czech Republic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kamila Rasova, professor

CONTACT

+420 604 511 416; kamila.rasova@lf3.cuni.cz

Katerina Marikova, master

CONTACT

+420 607 616 104; katerina.marikova@3lf.cuni.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: proffesor

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: January 13, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 13, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After completion of data analysis and publication of primary results (expected 2026-2027); data will be available for at least 10 years thereafter.
• Access Criteria: De-identified individual participant data (IPD) will be shared only if permitted by the signed informed consent. Identifiable data will remain accessible solely to the study team and will not be shared. Qualified researchers may request access to de-identified IPD for scientific purposes by emailing the corresponding author with a brief proposal and data-use agreement. Data will be transferred securely and handled in compliance with GDPR and institutional policies; recipients must agree not to attempt re-identification.

Locations

CZ (4)