Spinal Muscular AtrophyHIPOSMANCT05341453
Equine-Assisted Physiotherapy for Spinal Muscular Atrophy
A study testing Individual physiotherapy (SMA-SOC-N), Equine-Assisted Physiotherapy Based on Neuroproprioceptive Facilitation and Inhibition and Therapeutic grooming in people with Spinal Muscular Atrophy, run by Charles University, Czech Republic at 1 site in Czechia.
Trial summary
This prospective interventional study evaluates the immediate and sustained effects of intensive equine-assisted physiotherapy in children with spinal muscular atrophy (SMA). The study compares an intensive equine-assisted physiotherapy program (NEUROEQUIP-SMA) with an individualized physiotherapy program based on SMA… Read more about this study
- Who is it for?
- Ages 1 year to 10 years
- Conditions the study is for
- Spinal Muscular Atrophy
- What is being tested?
- Individual physiotherapy (SMA-SOC-N), Equine-Assisted Physiotherapy Based on Neuroproprioceptive Facilitation and Inhibition and Therapeutic grooming
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteCzechia
- Study dates
- 22 Apr 2022to 20 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 1 year to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- clinic diagnosis SMA (I, II, and III types)
- no changing medicine 6 months at least
- without another grave diseases
Who cannot join
- hip luxation
- allergies to horses and the environment of horse stables
- insurmountable fear of the horse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immediate and Sustained Effects of Intensive Equine-Assisted Physiotherapy in Children With Spinal Muscular Atrophy
This prospective interventional study evaluates the immediate and sustained effects of intensive equine-assisted physiotherapy in children with spinal muscular atrophy (SMA). The study compares an intensive equine-assisted physiotherapy program (NEUROEQUIP-SMA) with an individualized physiotherapy program based on SMA standard of care and neuroproprioceptive facilitation and inhibition principles (SMA-SOC-N). Both interventions are delivered as intensive 6-day rehabilitation programs. Outcomes include motor function, postural control, respiratory function, movement quality assessed by three-dimensional motion analysis, neuromuscular activity, quality of life, and selected molecular biomarkers. The study also evaluates the safety and tolerability of intensive rehabilitation in children with SMA.
Read the detailed description
Spinal muscular atrophy is rare neuromuscular disease, it is caused by gene mutation survival motor neuron 1 (SMN1). This gene encodes survival motor neuron (SMN) protein. This protein is most important to survive alfa-motoric neurons in spinal cord. When this protein doesn´t work, no signals go from brain to skeletal muscles and fazic muscles of body. In the end weakening breathing muscles and internal organs muscles.
Disease-modifying therapies have substantially changed the natural history of SMA. In the Czech Republic, currently available pharmacological treatment includes nusinersen (Spinraza), onasemnogene abeparvovec (Zolgensma) and risdiplam (Evrysdi). As survival and motor abilities of children with SMA improve, rehabilitation has become an increasingly important part of comprehensive care. Physiotherapy is one of the recommended rehabilitation types.
The use of rehabilitation procedures is common in clinical practice. In a 2016 study, 105 adults with SMA were asked how many of them used physiotherapy. A total of 86% of respondents received these services, yet the authors of the article conclude that further research is needed to understand the impact of physiotherapy in SMA.
Nevertheless, there is a lot of discussion if physiotherapy is really good for people and children with SMA. Some research shows us, that physiotherapy doesn´t worsen this disease. Researchers showed that strength training 3 times a week does not show side effects in children under 10 years of age, in some cases trends in improving muscle strength and motor functions have been observed.
Because in physiotherapy therapists work primarily with muscles, and a lot of activity can cause fatigue of skeletal muscles and worsen their function. But from clinical work scientists know that the effect of physiotherapy is extensive. There is a research on mice which shows the effect of physiotherapy on the strength activities and the aerobic activities.
Research to better elucidate the intensity of physiotherapy has not yet been published. Motes et al. monitored a total of 16 patients with SMA aged 10 - 55 years, who regularly underwent home autotherapy for 16 months - cycling and strengthening. The authors did not find any side effects of exercise on strength, function or fatigue during the study. However, the oxidation capacity has been reduced and according to the authors, further research is needed in this area.
In the United States, the "Standard of Care" (SMA-SOC) has been developed for SMA, which regulates the rehabilitation care of children and adults with SMA according to the degree of mobility. In the framework of the said directive, the stretching of contractures, swimming, water therapy, light strength exercises and a verticalization stand are recommended within the framework of physiotherapy, and horse riding is also mentioned - but without more detailed information. Vibration techniques and positioning are recommended to improve breathing. Recommended exercises for seated persons also include concentric and eccentric exercises and aerobic and general fitness exercises with and without resistance. According to the directive, the duration of therapy should be adapted to the individual patient. For walkers, the exercise program may include some forms of balance exercises, dynamic and static.
In a study from 2021, physiotherapists were asked about their knowledge of SMA-SOC and its use in practice. Most of them stated that after individuals with SMA started disease-modifying pharmacotherapy, they would recommend increasing the frequency and duration of therapeutic interventions. The authors agree that in practice there are differences in the care of people with SMA, especially in the frequency and duration of specific interventions. At the same time, they state that these findings can identify future research needs and thus extend SMA-SOC to rehabilitation management best practices.
The aim of this study is to evaluate the effects of intensive rehabilitation in children with spinal muscular atrophy receiving disease-modifying therapy. The study evaluates changes in motor function, postural control, respiratory function, movement quality, neuromuscular activity, quality of life and selected molecular biomarkers following intensive rehabilitation.
The secondary intention of the research is to determine an appropriate intensity of rehabilitation so that unwanted muscle fatigue does not occur.
Investigators will therefore investigate the neurophysiological mechanisms of rehabilitation that investigators will monitor using long non-coding RNAs (lncRNAs) involved in important cellular regulation, including regulation of genomic imprinting, epigenetic chromatin modification, transcriptional interference, and nuclear export. The lncRNA, SMN-antisense 1 (SMN-AS1), has been shown to repress the expression of the duplicate survival motor neuron 2 (SMN2) gene by binding Polycomb repressive complex 2 (PRC2) to its locus. Increasing the transcriptional activity of an almost identical SMN2 gene can functionally compensate for the loss of SMN1, increase the amount of SMN protein and thus improve the prognosis of the disease. Chemically modified oligonucleotides have been proposed that disrupt the interaction between SMN-AS1 and PRC2, which inhibits the action of PRC2 and thus leads to increased SMN2 expression.
Investigation of lncRNAs involved in the processes of gene regulation of these genes may help to understand the neurophysiological effects of rehabilitation of children with SMA.
- Conditions
- Spinal Muscular Atrophy
- Being tested
- Individual physiotherapy (SMA-SOC-N), Equine-Assisted Physiotherapy Based on Neuroproprioceptive Facilitation and Inhibition, Therapeutic grooming
- Keywords
- hippotherapy, children, psychomotor development, physiotherapy, quality of life, posture, motor skills, therapeutic riding, muscle fatigue
- 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.
Individual physiotherapy (SMA-SOC-N)Procedure or surgery
Therapeutic procedures according to the international Standard of Care (SMA-SOC) recommendations, complemented by the principles of neuroproprioceptive facilitation and inhibition, will be used during therapy. Elements of breathing gymnastics, vibration techniques, stretching, eccentric and concentric exercise procedures will be combined. Individual physiotherapy will be conducted on the basis of set goals from the kinesiological examination, it will be adapted to the individuality of the child - his cooperation, fatigue and sleep time.
Equine-Assisted Physiotherapy Based on Neuroproprioceptive Facilitation and InhibitionProcedure or surgery
Also called Hippotherapy by the children with cerebral palsy (HT by CP)
HT by CP is an accredited form of hippotherapy, whose methodology is based on the clinical picture of cerebral palsy. In this study, the accredited HT by CP methodology was applied to children with spinal muscular atrophy and complemented by principles of neuroproprioceptive facilitation and inhibition.
Based on a special type of examination, this method precisely determines the "type / breed" of the horse according to the biomechanics of the movement of its back in the step, the position of the child and the neurophysiological function of the back - differentiation or sensorimotor skills. Furthermore, according to the course of therapy, the physiotherapist determines the pace of the horse's step, its length, selects special manual contacts according to the current situation and adjusts the duration of therapy to the client's fatigue.
Therapy will be performed by therapists with professional competence to perform hippotherapy by children with CP.
Therapeutic groomingProcedure or surgery
In order to influence the psychomotor development in a comprehensive way, the psychosocial activity of therapeutic grooming will also be included in the study. Its goal is to support children's communication, their interaction with the environment, the ability to establish contact with the horse and the overall emotional support of children with SMA. The purpose of this activity is to clean the horse, its possible guide, stroking and contact with the horse, work from the ground.
| Study group | Role | What they receive |
|---|---|---|
| Individual physiotherapy (SMA-SOC-N) | Active comparator | Individual physiotherapy will be performed according to the SMA-SOC-N protocol, based on the principles of the international Standard of Care (SMA-SOC) recommendations and adapted to the individual needs of children with spinal muscular atrophy. Receives: Procedure: Individual physiotherapy (SMA-SOC-N) |
| Equine-Assisted Physiotherapy Based on Neuroproprioceptive Facilitation and Inhibition | Experimental | Equine-assisted physiotherapy based on neuroproprioceptive facilitation and inhibition is an accredited form of hippotherapy. Its methodology was originally developed based on the clinical presentation of children with cerebral palsy; however, its therapeutic principles are applicable to a broader group of children with neurological disabilities, including children with spinal muscular atrophy. Receives: Procedure: Equine-Assisted Physiotherapy Based on Neuroproprioceptive Facilitation and Inhibition |
| Therapeutic grooming | Other | In order to influence the psychomotor development in a comprehensive way, the psychosocial activity of therapeutic grooming will also be included in the study. Its goal is to support children's communication, their interaction with the environment, the ability to establish contact with the horse and the overall emotional support of children with SMA. Receives: Procedure: Therapeutic grooming |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abdominal Breathing Ability Test
The child performs deep breathing while sitting astride a therapy cylinder. Reflective markers attached to predefined anatomical landmarks are recorded using the Qualisys Motion Capture System during a 30-second measurement. The test evaluates thoracic and abdominal movement during breathing. Improved function is reflected by greater abdominal contribution to the breathing pattern.
Measured: Baseline and end Day 7
Test of Trunk and Cervical Spine Coordination Ability
The child performs repeated back-and-forth upper limb movements while sitting on a therapy cylinder (typically 3-6 repetitions). The test evaluates trunk and cervical spine coordination by analyzing the synchronization of markers placed on the dorsum of the hand, C7 vertebra, and temporomandibular joint. Improved function is reflected by better coordination of trunk, upper limb, and cervical spine movements with reduced compensatory cervical spine extension.
Measured: Baseline and Day 7
Ability to Work With the Center of Gravity
While sitting on a therapy cylinder, the child performs repeated reaching movements with one upper limb (3-6 repetitions during a 30-second recording). The test evaluates postural stability and control of the center of gravity by analyzing displacement of body markers during the task. Improved function is reflected by greater controlled displacement of the center of gravity while maintaining postural stability.
Measured: Baseline and day 7
Muscle fatigue
Investigators will measure muscle fatigue after physical activity using surface EMG. The child will lie on his back, therapist will provide a toy in the area of his opposite knee. The child will reach for a toy. This act will be 30 s. Investigators will evaluate activity m.obliquus externus abdominis at the beginning and end of this specific activity. Goal is to evaluate muscle fatigue. Investigators assume, that after intensive therapeutic program will be muscle fatigue lower.
Measured: Baseline and Day 7
Children's Hospital of Philadelphia Infant Test of Neuromuscular Disorders (CHOP INTEND)
The CHOP INTEND is a validated clinical scale designed to assess motor function in infants and young children with spinal muscular atrophy. It consists of 16 items. Total scores range from 0 to 64, with higher scores indicating better motor function.
Measured: Baseline and Day 7
Hammersmith function scale for children with spinal muscular atrophy
The examination will follow a standardized procedure. The maximum score of the standardized test is 64 points on each side, the minimum is 0 points. A higher score means an improvement in the child's movement possibilities.
Measured: Baseline and Day 7
Deep neck flexor endurance test
The examination will follow a standardized procedure. Longer holding in the position means a better result, the exact holding time is not standardized for this test.
Measured: Baseline and Day 7
Neck extensor endurance test
The examination will follow a standardized procedure. Longer holding in the position means a better result, the exact holding time is not standardized for this test.
Measured: Baseline and Day 7
Spirometric measure
The spirometer will be used to determine the forced expiratory volume in one second (FEV1) value, i.e. the volume of air exhaled after maximal inspiration with the greatest effort within the first second and peak expiratory flow (PEF). The change in both parameters at the beginning and end of the rehabilitation stay will be evaluated.
Measured: Baseline and Day 7
Secondary outcomes (3)
ICF-based assessment
Parents of child with SMA will fill an adapted parent-reported ICF-based Documentation Form at the beginning and 28 days after completion of the rehabilitation. The form is based on the Brief ICF Core Set for Children with Cerebral Palsy (below 6 years of age), supplemented by selected items from the basic rehabilitation set, will be used to evaluate the quality of life.
Measured: Baseline; 28 days after completion of rehabilitation
Monitoring of molecular biological indicators of rehabilitation
Samples treated in this way can be safely stored at room temperature for longer periods of time (up to three days or more). Blood samples stored in Ribonucleic acid (RNAlater)® Solution achieve RNA quality comparable to the quality of samples processed immediately according to commercial websites. The expected average total RNA yields will be about 2-4 /g / 0.5 ml all blood. Total RNA will be transcribed into complementary deoxyribonucleic acid complementary (cDNA) by reverse transcriptase. To avoid error, the expression of human lncRNA and internal endogenous gene (e.g., GAPDH) will be quantified using RNA obtained from blinded samples (i.e., concealment of sample origin allocation).
Measured: Baseline and Day 7
Home video recording
Standardized home video recordings of selected motor activities performed in the child's natural environment. Videos will be obtained at baseline and 28 days after rehabilitation and will be used for qualitative assessment of changes in motor performance.
Measured: Baseline; 28 days after completion of rehabilitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start22 Apr 2022
- Primary completion25 Sep 2024
- Study completion20 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Muscular AtrophyStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- A prospective non-randomized interventional study. Participants will undergo intensive rehabilitation consisting of either individualized physiotherapy according to the SMA-SOC-N protocol or intensive equine-assisted physiotherapy, based on parental preference, the child's ability to tolerate the intervention, and program availability. Participants both groups will undergo 12 therapies, twice a day, 15 minutes long. Before the intervention and on Day 7, all participants will be examined by a blinded independent clinician.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 21 participants (actual)
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
- Kamila Rasova, as.prof.Dr., Study director, Clinic of rheumatology and rehabilitation, Third medical faculty CU and Faculty Thomayer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05341453
- Sponsor's protocol ID
- 18032022
- Acronym
- HIPOSMA
- Status last verified
- Jul 2026
- First submitted
- 18 Apr 2022
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Clinical Study Report (CSR) and Analytic Code will be shared when data is collected. Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF) are shared as attachment of this registration.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate and Sustained Effects of Intensive Equine-Assisted Physiotherapy in Children With Spinal Muscular Atrophy
- ClinicalTrials.gov ID
- NCT05341453
- Acronym / sponsor ID
- HIPOSMA / 18032022
- Conditions
- Spinal Muscular Atrophy
- Keywords
- hippotherapy, children, psychomotor development, physiotherapy, quality of life, posture, motor skills, therapeutic riding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- 22 Apr 2022 (actual)
- Primary completion
- 25 Sep 2024 (actual)
- Study completion
- 20 Oct 2024 (actual)
- First posted
- 22 Apr 2022 (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 prospective interventional study evaluates the immediate and sustained effects of intensive equine-assisted physiotherapy in children with spinal muscular atrophy (SMA). The study compares an intensive equine-assisted physiotherapy program (NEUROEQUIP-SMA) with an individualized physiotherapy program based on SMA standard of care and neuroproprioceptive facilitation and inhibition principles (SMA-SOC-N). Both interventions are delivered as intensive 6-day rehabilitation programs. Outcomes include motor function, postural control, respiratory function, movement quality assessed by three-dimensional motion analysis, neuromuscular activity, quality of life, and selected molecular biomarkers. The study also evaluates the safety and tolerability of intensive rehabilitation in children with SMA.
Detailed description
Spinal muscular atrophy is rare neuromuscular disease, it is caused by gene mutation survival motor neuron 1 (SMN1). This gene encodes survival motor neuron (SMN) protein. This protein is most important to survive alfa-motoric neurons in spinal cord. When this protein doesn´t work, no signals go from brain to skeletal muscles and fazic muscles of body. In the end weakening breathing muscles and internal organs muscles.
Disease-modifying therapies have substantially changed the natural history of SMA. In the Czech Republic, currently available pharmacological treatment includes nusinersen (Spinraza), onasemnogene abeparvovec (Zolgensma) and risdiplam (Evrysdi). As survival and motor abilities of children with SMA improve, rehabilitation has become an increasingly important part of comprehensive care. Physiotherapy is one of the recommended rehabilitation types.
The use of rehabilitation procedures is common in clinical practice. In a 2016 study, 105 adults with SMA were asked how many of them used physiotherapy. A total of 86% of respondents received these services, yet the authors of the article conclude that further research is needed to understand the impact of physiotherapy in SMA.
Nevertheless, there is a lot of discussion if physiotherapy is really good for people and children with SMA. Some research shows us, that physiotherapy doesn´t worsen this disease. Researchers showed that strength training 3 times a week does not show side effects in children under 10 years of age, in some cases trends in improving muscle strength and motor functions have been observed.
Because in physiotherapy therapists work primarily with muscles, and a lot of activity can cause fatigue of skeletal muscles and worsen their function. But from clinical work scientists know that the effect of physiotherapy is extensive. There is a research on mice which shows the effect of physiotherapy on the strength activities and the aerobic activities.
Research to better elucidate the intensity of physiotherapy has not yet been published. Motes et al. monitored a total of 16 patients with SMA aged 10 - 55 years, who regularly underwent home autotherapy for 16 months - cycling and strengthening. The authors did not find any side effects of exercise on strength, function or fatigue during the study. However, the oxidation capacity has been reduced and according to the authors, further research is needed in this area.
In the United States, the "Standard of Care" (SMA-SOC) has been developed for SMA, which regulates the rehabilitation care of children and adults with SMA according to the degree of mobility. In the framework of the said directive, the stretching of contractures, swimming, water therapy, light strength exercises and a verticalization stand are recommended within the framework of physiotherapy, and horse riding is also mentioned - but without more detailed information. Vibration techniques and positioning are recommended to improve breathing. Recommended exercises for seated persons also include concentric and eccentric exercises and aerobic and general fitness exercises with and without resistance. According to the directive, the duration of therapy should be adapted to the individual patient. For walkers, the exercise program may include some forms of balance exercises, dynamic and static.
In a study from 2021, physiotherapists were asked about their knowledge of SMA-SOC and its use in practice. Most of them stated that after individuals with SMA started disease-modifying pharmacotherapy, they would recommend increasing the frequency and duration of therapeutic interventions. The authors agree that in practice there are differences in the care of people with SMA, especially in the frequency and duration of specific interventions. At the same time, they state that these findings can identify future research needs and thus extend SMA-SOC to rehabilitation management best practices.
The aim of this study is to evaluate the effects of intensive rehabilitation in children with spinal muscular atrophy receiving disease-modifying therapy. The study evaluates changes in motor function, postural control, respiratory function, movement quality, neuromuscular activity, quality of life and selected molecular biomarkers following intensive rehabilitation.
The secondary intention of the research is to determine an appropriate intensity of rehabilitation so that unwanted muscle fatigue does not occur.
Investigators will therefore investigate the neurophysiological mechanisms of rehabilitation that investigators will monitor using long non-coding RNAs (lncRNAs) involved in important cellular regulation, including regulation of genomic imprinting, epigenetic chromatin modification, transcriptional interference, and nuclear export. The lncRNA, SMN-antisense 1 (SMN-AS1), has been shown to repress the expression of the duplicate survival motor neuron 2 (SMN2) gene by binding Polycomb repressive complex 2 (PRC2) to its locus. Increasing the transcriptional activity of an almost identical SMN2 gene can functionally compensate for the loss of SMN1, increase the amount of SMN protein and thus improve the prognosis of the disease. Chemically modified oligonucleotides have been proposed that disrupt the interaction between SMN-AS1 and PRC2, which inhibits the action of PRC2 and thus leads to increased SMN2 expression.
Investigation of lncRNAs involved in the processes of gene regulation of these genes may help to understand the neurophysiological effects of rehabilitation of children with SMA.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- A prospective non-randomized interventional study. Participants will undergo intensive rehabilitation consisting of either individualized physiotherapy according to the SMA-SOC-N protocol or intensive equine-assisted physiotherapy, based on parental preference, the child's ability to tolerate the intervention, and program availability. Participants both groups will undergo 12 therapies, twice a day, 15 minutes long. Before the intervention and on Day 7, all participants will be examined by a blinded independent clinician.
| Arm | Type | Receives |
|---|---|---|
| Individual physiotherapy (SMA-SOC-N) | Active comparator | Procedure: Individual physiotherapy (SMA-SOC-N)Individual physiotherapy will be performed according to the SMA-SOC-N protocol, based on the principles of the international Standard of Care (SMA-SOC) recommendations and adapted to the individual needs of children with spinal muscular atrophy. |
| Equine-Assisted Physiotherapy Based on Neuroproprioceptive Facilitation and Inhibition | Experimental | Procedure: Equine-Assisted Physiotherapy Based on Neuroproprioceptive Facilitation and InhibitionEquine-assisted physiotherapy based on neuroproprioceptive facilitation and inhibition is an accredited form of hippotherapy. Its methodology was originally developed based on the clinical presentation of children with cerebral palsy; however, its therapeutic principles are applicable to a broader group of children with neurological disabilities, including children with spinal muscular atrophy. |
| Therapeutic grooming | Other | Procedure: Therapeutic groomingIn order to influence the psychomotor development in a comprehensive way, the psychosocial activity of therapeutic grooming will also be included in the study. Its goal is to support children's communication, their interaction with the environment, the ability to establish contact with the horse and the overall emotional support of children with SMA. |
Who may qualify
- Ages
- 1 year to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- clinic diagnosis SMA (I, II, and III types)
- no changing medicine 6 months at least
- without another grave diseases
Key exclusion criteria (3 listed)
- hip luxation
- allergies to horses and the environment of horse stables
- insurmountable fear of the horse
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 |
|---|---|---|
| Individual physiotherapy (SMA-SOC-N)Therapeutic procedures according to the international Standard of Care (SMA-SOC) recommendations, complemented by the principles of neuroproprioceptive facilitation and inhibition, will be used during therapy. Elements of breathing gymnastics, vibration techniques, stretching, eccentric and concentric exercise procedures will be combined. Individual physiotherapy will be conducted on the basis of set goals from the kinesiological examination, it will be adapted to the individuality of the child - his cooperation, fatigue and sleep time. | Procedure or surgery | Individual physiotherapy (SMA-SOC-N) |
| Equine-Assisted Physiotherapy Based on Neuroproprioceptive Facilitation and InhibitionAlso: Hippotherapy by the children with cerebral palsy (HT by CP)HT by CP is an accredited form of hippotherapy, whose methodology is based on the clinical picture of cerebral palsy. In this study, the accredited HT by CP methodology was applied to children with spinal muscular atrophy and complemented by principles of neuroproprioceptive facilitation and inhibition. Based on a special type of examination, this method precisely determines the "type / breed" of the horse according to the biomechanics of the movement of its back in the step, the position of the child and the neurophysiological function of the back - differentiation or sensorimotor skills. Furthermore, according to the course of therapy, the physiotherapist determines the pace of the horse's step, its length, selects special manual contacts according to the current situation and adjusts the duration of therapy to the client's fatigue. Therapy will be performed by therapists with professional competence to perform hippotherapy by children with CP. | Procedure or surgery | Equine-Assisted Physiotherapy Based on Neuroproprioceptive Facilitation and Inhibition |
| Therapeutic groomingIn order to influence the psychomotor development in a comprehensive way, the psychosocial activity of therapeutic grooming will also be included in the study. Its goal is to support children's communication, their interaction with the environment, the ability to establish contact with the horse and the overall emotional support of children with SMA. The purpose of this activity is to clean the horse, its possible guide, stroking and contact with the horse, work from the ground. | Procedure or surgery | Therapeutic grooming |
Primary outcome
Abdominal Breathing Ability Test
Time frame: Baseline and end Day 7
The child performs deep breathing while sitting astride a therapy cylinder. Reflective markers attached to predefined anatomical landmarks are recorded using the Qualisys Motion Capture System during a 30-second measurement. The test evaluates thoracic and abdominal movement during breathing. Improved function is reflected by greater abdominal contribution to the breathing pattern.
Test of Trunk and Cervical Spine Coordination Ability
Time frame: Baseline and Day 7
The child performs repeated back-and-forth upper limb movements while sitting on a therapy cylinder (typically 3-6 repetitions). The test evaluates trunk and cervical spine coordination by analyzing the synchronization of markers placed on the dorsum of the hand, C7 vertebra, and temporomandibular joint. Improved function is reflected by better coordination of trunk, upper limb, and cervical spine movements with reduced compensatory cervical spine extension.
Ability to Work With the Center of Gravity
Time frame: Baseline and day 7
While sitting on a therapy cylinder, the child performs repeated reaching movements with one upper limb (3-6 repetitions during a 30-second recording). The test evaluates postural stability and control of the center of gravity by analyzing displacement of body markers during the task. Improved function is reflected by greater controlled displacement of the center of gravity while maintaining postural stability.
Muscle fatigue
Time frame: Baseline and Day 7
Investigators will measure muscle fatigue after physical activity using surface EMG. The child will lie on his back, therapist will provide a toy in the area of his opposite knee. The child will reach for a toy. This act will be 30 s. Investigators will evaluate activity m.obliquus externus abdominis at the beginning and end of this specific activity. Goal is to evaluate muscle fatigue. Investigators assume, that after intensive therapeutic program will be muscle fatigue lower.
Children's Hospital of Philadelphia Infant Test of Neuromuscular Disorders (CHOP INTEND)
Time frame: Baseline and Day 7
The CHOP INTEND is a validated clinical scale designed to assess motor function in infants and young children with spinal muscular atrophy. It consists of 16 items. Total scores range from 0 to 64, with higher scores indicating better motor function.
Hammersmith function scale for children with spinal muscular atrophy
Time frame: Baseline and Day 7
The examination will follow a standardized procedure. The maximum score of the standardized test is 64 points on each side, the minimum is 0 points. A higher score means an improvement in the child's movement possibilities.
Deep neck flexor endurance test
Time frame: Baseline and Day 7
The examination will follow a standardized procedure. Longer holding in the position means a better result, the exact holding time is not standardized for this test.
Neck extensor endurance test
Time frame: Baseline and Day 7
The examination will follow a standardized procedure. Longer holding in the position means a better result, the exact holding time is not standardized for this test.
Spirometric measure
Time frame: Baseline and Day 7
The spirometer will be used to determine the forced expiratory volume in one second (FEV1) value, i.e. the volume of air exhaled after maximal inspiration with the greatest effort within the first second and peak expiratory flow (PEF). The change in both parameters at the beginning and end of the rehabilitation stay will be evaluated.
3 secondary outcomes
ICF-based assessment
Time frame: Baseline; 28 days after completion of rehabilitation
Monitoring of molecular biological indicators of rehabilitation
Time frame: Baseline and Day 7
Home video recording
Time frame: Baseline; 28 days after completion of rehabilitation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: Yes. Clinical Study Report (CSR) and Analytic Code will be shared when data is collected. Study Protocol, Statistical Analysis Plan (SAP), Informed Consent Form (ICF) are shared as attachment of this registration.
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Metastatic Castration Resistant Prostate Cancer
RecruitingObservational study
An International Federated Model for Wearable-derived Remote Longitudinal Motor Monitoring in Young Children With Spinal Muscular Atrophy Compared With Healthy Controls: Active-NBS Study (UK)
Spinal Muscular Atrophy (SMA)
RecruitingPhase 4
A Study Evaluating the Effectiveness and Safety of Risdiplam Administered as an Early Intervention in Pediatric Participants With Spinal Muscular Atrophy After Gene Therapy
Muscular Atrophy, Spinal
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. This study is not recruiting at the moment.
Kamila Rasova, as.prof.Dr. study director
Clinic of rheumatology and rehabilitation, Third medical faculty CU and Faculty Thomayer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individual physiotherapy (SMA-SOC-N), Equine-Assisted Physiotherapy Based on Neuroproprioceptive Facilitation and Inhibition and Therapeutic grooming in people with Spinal Muscular Atrophy, run by Charles University, Czech Republic at 1 site 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abdominal Breathing Ability Test (time frame: Baseline and end Day 7). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jul 2026.