Neuroproprioceptive Equine-Assisted Physiotherapy for Spinal Muscular Atrophy
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Equine-Assisted Physiotherapy based on Neuro-proprioceptive "Facilitation and Inhibition", Standard Individual Outpatient Physiotherapy Based on Neuro-proprioceptive Facilitation and Inhibition, Therapeutic grooming.
- Кому может быть актуально
- Состояния в реестре: Spinal Muscular Atrophy (SMA). Базовые параметры: 2 лет — 9 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Чехия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Immediate and Sustained Effects of Intensive Neuroproprioceptive Equine-Assisted Physiotherapy in Children With Spinal Muscular Atrophy: A Randomized Crossover Trial
Обзор
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.
Подробное описание
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.
Вмешательства
- Поведенческое Equine-Assisted Physiotherapy based on Neuro-proprioceptive "Facilitation and Inhibition"
Equine-assisted physiotherapy applying the principles of neuro-proprioceptive facilitation and inhibition. Conducted twice daily for 15 minutes over six consecutive days under the supervision of a certified physiotherapist and a trained horse leader. The intervention utilizes the horse's rhythmic, three-dimensional movement to generate dynamic proprioceptive, vestibular, and tactile stimuli that activate physiological postural reactions and coordinated muscle chains. The goal is to improve trunk - Поведенческое Standard Individual Outpatient Physiotherapy Based on Neuro-proprioceptive Facilitation and Inhibition
Standardized outpatient physiotherapy program based on neuro-proprioceptive facilitation and inhibition, performed once daily for 30 minutes over six consecutive days. Delivered by an experienced physiotherapist in a clinical setting, the intervention includes active and assisted movement exercises, breathing techniques, stretching, postural correction, and positioning strategies to prevent contractures, maintain range of motion, and support trunk and respiratory control. The therapy applies tar - Поведенческое Therapeutic grooming
Structured horse-care activity included in both treatment periods to control for psychosocial and environmental effects of horse interaction. Conducted once daily for approximately 20 minutes under therapist supervision, therapeutic grooming involves guided brushing, tactile contact, and communication with the horse in a safe and supportive setting. The activity promotes sensory integration, body awareness, and emotional regulation, while preparing the child for subsequent equine-assisted sessio
Первичные конечные точки
- Children's Hospital of Philadelphia Infant Test of Neuromuscular Disorders [Срок оценки: Baseline measurement before the start of the 6-day intervention, follow-up measurement after the end of the 6-day intervention.]
Вторичные конечные точки (12)
- Change in Relative Expression of Selected lncRNAs [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Baseline measurement before the start of the 6-day intervention, follow-up measurement after the end of the 6-day intervention.]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Перекрёстный дизайн
- Маскирование
- Двойное слепое
- Основная цель
- Лечение
Центры проведения
Чехия · 4 центра
- Mirákl Hippotherapy Center — Bohuslavice
- College of Polytechnics Jihlava — Jihlava
- Department of Medical Genetics, Third Faculty of Medicine, Charles University — Prague
- Third Faculty of Medicine, Charles University — Prague
Публикации
- 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
- 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
- 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 inhibi PMID 33565742
- 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
- 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
- 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
- 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
Идентификаторы
NCT: NCT07336602 · 4424 · GAUK 4424/2024 · SVV 260533/SVV/2024 · Cooperatio Neurosciences