Spinal Muscular Atrophy (SMA)NEUROEQUIPNCT07336602
Neuroproprioceptive Equine-Assisted Physiotherapy for Spinal Muscular Atrophy
A study testing Equine-Assisted Physiotherapy based on Neuro-proprioceptive "Facilitation and Inhibition", Standard Individual Outpatient Physiotherapy Based on Neuro-proprioceptive Facilitation and Inhibition and Therapeutic grooming in people with Spinal Muscular Atrophy (SMA), run by Charles University, Czech Republic at 4 sites in Czechia.
Trial 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). Read more about this study
- Who is it for?
- Ages 2 to 9 years
- Conditions the study is for
- Spinal Muscular Atrophy (SMA)
- What is being tested?
- Equine-Assisted Physiotherapy based on Neuro-proprioceptive "Facilitation and Inhibition", Standard Individual Outpatient Physiotherapy Based on Neuro-proprioceptive Facilitation and Inhibition and Therapeutic grooming
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 4 sitesCzechia
- Study dates
- 15 Apr 2026to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia4 sites
Mirákl Hippotherapy Center
Bohuslavice, 58856
College of Polytechnics Jihlava
Jihlava, 58601
Department of Medical Genetics, Third Faculty of Medicine, Charles University
Prague, 10000
Third Faculty of Medicine, Charles University
Prague, 10000
About this study
Official title: Immediate and Sustained Effects of Intensive Neuroproprioceptive Equine-Assisted Physiotherapy in Children With Spinal Muscular Atrophy: A Randomized Crossover Trial
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.
Read the detailed description
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
- Spinal Muscular Atrophy (SMA)
- Being tested
- Equine-Assisted Physiotherapy based on Neuro-proprioceptive "Facilitation and Inhibition", Standard Individual Outpatient Physiotherapy Based on Neuro-proprioceptive Facilitation and Inhibition, Therapeutic grooming
- Keywords
- Muscular atrophy, Spinal, Genetic Therapy, Equine-Assisted Therapy, Child, Pediatrics, Physical Therapy Modalities, RNA, Long Noncoding, Neuro-proprioceptive Principles
- Medical subject headings
- Muscular Atrophy, Spinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Equine-Assisted Physiotherapy based on Neuro-proprioceptive "Facilitation and Inhibition"Behavioural
Also called NEUROEQUIP-SMA
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 InhibitionBehavioural
Also called SMA-SOC-N
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 groomingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Relative expression of a predefined panel of long non-coding RNAs (lncRNAs) in peripheral blood, measured by quantitative PCR and normalized to reference genes. For reporting purposes, the mean fold change across the predefined lncRNA panel will be calculated and reported as a single outcome value.
Measured: 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
Median frequency of the surface electromyography (sEMG) signal recorded from the external oblique abdominal muscle during a standardized repetitive movement task. Lower median frequency values over repeated contractions indicate improved muscle efficiency and reduced fatigue.
Measured: 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)
The Trunk Control Measurement Scale (TCMS) is a clinical assessment tool that evaluates trunk control during static and dynamic sitting balance tasks. It measures selective movement control in the trunk and coordination between upper and lower body segments. Although validated primarily in children with cerebral palsy, it is also used to assess postural control in children with other neuromotor disorders such as SMA. The total score ranges from 0 to 58, with higher scores indicating better trunk control.
Measured: 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)
The Segmental Assessment of Trunk Control (SATCo) is a standardized test designed to identify the highest level of segmental trunk control in sitting. It assesses static, active, and reactive control at seven levels of trunk support. Although originally developed for children with cerebral palsy, it has been used in other pediatric neuromotor populations to evaluate trunk stability and postural development. Scores range from 0 to 20, with higher scores indicating better trunk control.
Measured: 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)
The Motor Function Measure-20 (MFM-20) is a validated quantitative scale assessing motor skills in children with neuromuscular disorders aged 2-7 years. It contains 20 items covering standing, transfer, axial and proximal motor functions, and distal motor control. The total score is expressed as a percentage of the maximum possible score, with higher scores indicating better motor performance. The MFM-20 has been validated in SMA and Duchenne muscular dystrophy and is sensitive to changes over time. Scores range from 0 to 100%, with higher scores indicating better motor function.
Measured: Baseline measurement before the start of the 6-day intervention, follow-up measurement after the end of the 6-day intervention.
The Functional Reach Test (FRT)
The Functional Reach Test (FRT) is a simple, validated measure of dynamic sitting or standing balance that evaluates the maximal distance an individual can reach forward beyond arm's length while maintaining a fixed base of support. It is a reliable indicator of trunk stability and balance control in children with various neuromotor conditions, including SMA. Longer reach distances indicate better dynamic postural control and balance performance.
Measured: Baseline measurement before the start of the 6-day intervention, follow-up measurement after the end of the 6-day intervention.
The Selective Control of Lower Extremities (SCALE)
The SCALE test is a standardized clinical test used to assess selective voluntary motor control in the lower extremities. It assesses the ability to isolate joint movements during five tasks for each lower extremity. Each joint movement is scored from 0 to 2, and a higher total score indicates better selective motor control.
Measured: Baseline measurement before the start of the 6-day intervention, follow-up measurement after the end of the 6-day intervention.
Change in Angle of Trunk Rotation
Angle of trunk rotation (ATR) measured during standardized forward bending in the sitting position. The mean ATR value will be calculated from repeated measurements and reported as a single outcome value.
Measured: Baseline measurement before the start of the 6-day intervention, follow-up measurement after the end of the 6-day intervention.
Change in Forced Expiratory Volume in One Second (FEV₁)
Forced expiratory volume in one second (FEV₁) measured by standard spirometry. Higher values indicate better pulmonary function.
Measured: Baseline measurement before the start of the 6-day intervention, follow-up measurement after the end of the 6-day intervention.
Change in Maximum Displacement of Body Markers
Maximum displacement of predefined body markers from their initial position during a standardized reaching task performed in sitting. Greater displacement values indicate improved control of the center of gravity.
Measured: Baseline measurement before the start of the 6-day intervention, follow-up measurement after the end of the 6-day intervention.
Change in Abdominal Breathing Index
Abdominal breathing index calculated as the ratio of marker displacement at the lumbar level (L4) to displacement at the thoracic level during deep breathing. Higher values indicate a greater contribution of abdominal breathing.
Measured: Baseline measurement before the start of the 6-day intervention, follow-up measurement after the end of the 6-day intervention.
Change in Duration of Coordinated Trunk and Cervical Spine Movement
Duration of coordinated trunk and cervical spine movement during a standardized repetitive upper limb task performed in sitting. Longer durations without compensatory cervical spine extension indicate improved coordination.
Measured: Baseline measurement before the start of the 6-day intervention, follow-up measurement after the end of the 6-day intervention.
Quality of life questionnaire
Parents of children with SMA will complete a special questionnaire at the beginning and 28 days after the end of the rehabilitation. The ICF score set, specifically the ICF-based Documentation Form for the category "Children with Cerebral Palsy Brief" (for children under 6 years old), will be used to evaluate the quality of life. A Higher scores indicate better functioning and quality of life.
Measured: 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.
Pediatric Quality of Life Inventory Generic Core Scales (PedsQL™)
The assessment tool, designed to evaluate health-related quality of life in children, consists of 23 items across four domains (physical, emotional, social, and school functioning). It is used to monitor longitudinal changes in perceived quality of life and to evaluate the effectiveness of clinical and rehabilitative interventions. Scores range from 0 to 100, with higher scores indicating better health-related quality of life.
Measured: 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 Video-Based Motor Function Score
Motor function score derived from standardized evaluation of home video recordings by two independent physiotherapists. The score reflects the quality and extent of the child's movement. Scores range from 1 to 21, with higher scores indicating better motor function.
Measured: 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.
Strengths and Difficulties Questionnaire (SDQ)
The SDQ is a widely used behavioral screening tool assessing psychological attributes across five domains: emotional symptoms, conduct problems, hyperactivity/inattention, peer relationship problems, and prosocial behavior. It is suitable for children aged 2 to 17 years and provides a Total Difficulties Score reflecting overall psychosocial well-being. Although originally validated in the general pediatric population, it has been successfully applied in children with chronic or neuromuscular disorders to assess emotional and social adaptation related to health status. Scores range from 0 to 40, with higher scores indicating greater behavioral and emotional difficulties.
Measured: Baseline measurement before the start of the 6-day intervention, follow-up measurement after the end of the 28-day intervention.
Change in Peak Expiratory Flow (PEF)
Peak expiratory flow (PEF) measured by standard spirometry. Higher values indicate better pulmonary function.
Measured: Baseline measurement before the start of the 6-day intervention and follow-up measurement after the end of the 6-day intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start15 Apr 2026 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Spinal Muscular Atrophy (SMA)Studies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kamila Řasová, Charles University, Czech Republic
- Investigators
- Katerina Marikova, master, Principal investigator, Charles University, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07336602
- Sponsor's protocol ID
- 4424
- Other IDs
- GAUK 4424/2024, SVV 260533/SVV/2024, Cooperatio Neurosciences
- Acronym
- NEUROEQUIP
- Status last verified
- Dec 2025
- First submitted
- 19 Nov 2025
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) that underlie the results reported in publications (after de-identification) may be shared. This includes anonymized outcome data, demographic characteristics, and relevant clinical variables used for statistical analysis. The study involves a short-lasting, low-risk, non-pharmacological intervention; therefore, no Data Monitoring Committee (DMC) is established. After completion of data analysis, de-identified datasets will be available upon reasonable request to the corresponding author. Data will be shared for legitimate scientific purposes, such as meta-analyses and systematic reviews, in compliance with ethical and institutional regulations. The results of the study will also be disseminated through peer-reviewed publications and conference presentations.
Publications
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.
PubMed 24675128Pantera 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.
PubMed 35671520Rasova 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.
PubMed 33565742Trenkle 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.
PubMed 33741230Mercuri 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.
PubMed 35927425Voight 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.
PubMed 38671712Shin 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.
PubMed 39210748Marikova K, Reissigova J, Vilimek M, Cerna M, Pokorna M, Rasova K. Immediate and Sustained Effects of Intensive Equine-Assisted Physiotherapy Based on Neuroproprioceptive "Facilitation and Inhibition" on Psychomotor Development, Clinical Functions, Quality of Life, and Molecular Biological Indicators in Children With Spinal Muscular Atrophy: Protocol for a Crossover Randomized Controlled Trial. JMIR Res Protoc. 2026 Feb 19;15:e83266. doi: 10.2196/83266.
PubMed 41712782
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate and Sustained Effects of Intensive Neuroproprioceptive Equine-Assisted Physiotherapy in Children With Spinal Muscular Atrophy: A Randomized Crossover Trial
- ClinicalTrials.gov ID
- NCT07336602
- Acronym / sponsor ID
- NEUROEQUIP / 4424
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- 15 Apr 2026 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 13 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence A | Experimental | 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 groomingParticipants 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. |
| Sequence B | Experimental | 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 groomingParticipants 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. |
Who may qualify
- Ages
- 2 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Equine-Assisted Physiotherapy based on Neuro-proprioceptive "Facilitation and Inhibition"Also: NEUROEQUIP-SMAEquine-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. | Behavioural | Sequence A, Sequence B |
| Standard Individual Outpatient Physiotherapy Based on Neuro-proprioceptive Facilitation and InhibitionAlso: SMA-SOC-NStandardized 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. | Behavioural | Sequence A, Sequence B |
| Therapeutic groomingStructured 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. | Behavioural | Sequence A, Sequence B |
Primary outcome
Children's Hospital of Philadelphia Infant Test of Neuromuscular Disorders
Time frame: Baseline measurement before the start of the 6-day intervention, follow-up measurement after the end of the 6-day intervention.
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.
17 secondary outcomes
Change in Relative Expression of Selected lncRNAs
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Baseline measurement before the start of the 6-day intervention, follow-up measurement after the end of the 6-day intervention.
The Functional Reach Test (FRT)
Time frame: Baseline measurement before the start of the 6-day intervention, follow-up measurement after the end of the 6-day intervention.
The Selective Control of Lower Extremities (SCALE)
Time frame: Baseline measurement before the start of the 6-day intervention, follow-up measurement after the end of the 6-day intervention.
Change in Angle of Trunk Rotation
Time frame: Baseline measurement before the start of the 6-day intervention, follow-up measurement after the end of the 6-day intervention.
Change in Forced Expiratory Volume in One Second (FEV₁)
Time frame: Baseline measurement before the start of the 6-day intervention, follow-up measurement after the end of the 6-day intervention.
Change in Maximum Displacement of Body Markers
Time frame: Baseline measurement before the start of the 6-day intervention, follow-up measurement after the end of the 6-day intervention.
Change in Abdominal Breathing Index
Time frame: Baseline measurement before the start of the 6-day intervention, follow-up measurement after the end of the 6-day intervention.
Change in Duration of Coordinated Trunk and Cervical Spine Movement
Time frame: Baseline measurement before the start of the 6-day intervention, follow-up measurement after the end of the 6-day intervention.
Quality of life questionnaire
Time frame: 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.
Pediatric Quality of Life Inventory Generic Core Scales (PedsQL™)
Time frame: 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 Video-Based Motor Function Score
Time frame: 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.
Strengths and Difficulties Questionnaire (SDQ)
Time frame: Baseline measurement before the start of the 6-day intervention, follow-up measurement after the end of the 28-day intervention.
Change in Peak Expiratory Flow (PEF)
Time frame: Baseline measurement before the start of the 6-day intervention and follow-up measurement after the end of the 6-day intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Results publication: PubMed 24675128Lemke 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.
- Results publication: PubMed 35671520Pantera 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.
- Results publication: PubMed 33565742Rasova 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.
- Results publication: PubMed 33741230Trenkle 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.
- Results publication: PubMed 35927425Mercuri 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.
- Results publication: PubMed 38671712Voight 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.
- Results publication: PubMed 39210748Shin 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.
- Derived from this study: PubMed 41712782Marikova K, Reissigova J, Vilimek M, Cerna M, Pokorna M, Rasova K. Immediate and Sustained Effects of Intensive Equine-Assisted Physiotherapy Based on Neuroproprioceptive "Facilitation and Inhibition" on Psychomotor Development, Clinical Functions, Quality of Life, and Molecular Biological Indicators in Children With Spinal Muscular Atrophy: Protocol for a Crossover Randomized Controlled Trial. JMIR Res Protoc. 2026 Feb 19;15:e83266. doi: 10.2196/83266.
- Official website of the coordinating institution and study sponsor.Link provided by the sponsor.
- Clinical site for equine-assisted physiotherapy (NEUROEQUIP-SMA).Link provided by the sponsor.
- Reference for the ICF Core Set used in functional assessment.Link provided by the sponsor.
- Information about the university grant funding the study.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) that underlie the results reported in publications (after de-identification) may be shared. This includes anonymized outcome data, demographic characteristics, and relevant clinical variables used for statistical analysis. The study involves a short-lasting, low-risk, non-pharmacological intervention; therefore, no Data Monitoring Committee (DMC) is established. After completion of data analysis, de-identified datasets will be available upon reasonable request to the corresponding author. Data will be shared for legitimate scientific purposes, such as meta-analyses and systematic reviews, in compliance with ethical and institutional regulations. The results of the study will also be disseminated through peer-reviewed publications and conference presentations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Katerina Marikova, master principal investigator
Charles University, Czech Republic
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Equine-Assisted Physiotherapy based on Neuro-proprioceptive "Facilitation and Inhibition", Standard Individual Outpatient Physiotherapy Based on Neuro-proprioceptive Facilitation and Inhibition and Therapeutic grooming in people with Spinal Muscular Atrophy (SMA), run by Charles University, Czech Republic at 4 sites in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kamila Rasova, professor (+420 604 511 416, kamila.rasova@lf3.cuni.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Children's Hospital of Philadelphia Infant Test of Neuromuscular Disorders (time frame: Baseline measurement before the start of the 6-day intervention, follow-up measurement after the end of the 6-day intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07336602, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.