Immediate and Sustained Effects of Intensive Neuroproprioceptive Equine-Assisted Physiotherapy in Children With Spinal Muscular Atrophy: A Randomized Crossover Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Children's Hospital of Philadelphia Infant Test of Neuromuscular Disorders
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 2 Years 至 9 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Children's Hospital of Philadelphia Infant Test of Neuromuscular Disorders
时间窗: 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.
次要结局
- Change in Relative Expression of Selected lncRNAs(Baseline measurement before the start of the 6-day intervention, follow-up measurement after the end of 28 days from the end of the intervention.)
- Change in Median Frequency of Surface EMG Signal(Baseline measurement before the start of the 6-day intervention, follow-up measurement after the end of the 6-day intervention.)
- The Trunk Control Measurement Scale (TCMS)(Baseline measurement before the start of the 6-day intervention, follow-up measurement after the end of the 6-day intervention.)
- The Segmental Assessment of Trunk Control (SATCo)(Baseline measurement before the start of the 6-day intervention, follow-up measurement after the end of the 6-day intervention.)
- Motor Function Measure-20 (MFM-20)(Baseline measurement before the start of the 6-day intervention, follow-up measurement after the end of the 6-day intervention.)
- The Functional Reach Test (FRT)(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)(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(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)(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(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(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(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(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™)(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(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)(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)(Baseline measurement before the start of the 6-day intervention and follow-up measurement after the end of the 6-day intervention.)
研究者
Kamila Řasová
proffesor
Charles University, Czech Republic