Preliminary Evaluation of the Effectiveness of FES Cycling in Terms of Training Performance, Morpho-functional Characteristics of the Leg Muscles and Bone Trophism After 6 Months of Training in Spinal Cord Injury Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Changes in the morpho-functional characteristics of the thigh muscles of the dominant limb
研究概览
简要总结
The goal of this clinical trial is to assess the effectiveness of FES cycling in terms of changes morpho-functional characteristics of the leg muscles, training performance and bone trophism in 5 subjects with Spinal Cord Injury after 6 months of training. The main question[s] it aims to answer are:
- Do the morpho-functional characteristics of the leg muscles improve after 3 and 6 months of training with FES cycling? If any, the morpho-functional improvements are maintained one month after the end of the training?
- Does the quality of the leg bones improve after 3 and 6 months of training with FES cycling?
- Does the training performance improve during the training with FES cycling?
- Do the data referred to the vegetative nervous system change after 3 and 6 months of training with FES cycling? If yes, the changes in the vegetative nervous system are maintained one month after the end of the training?
- Does the intestinal function change after 3 and 6 months of training with FES cycling? If yes, the changes are maintained one month after the end of the training?
- Does the level of spasticity of the lower limbs change after 3 and 6 months of training with FES cycling? If yes, the changes are maintained one month after the end of the training?
- Does the level of pain perceived by pilots change after 3 and 6 months of training with FES cycling? If yes, the changes are maintained one month after the end of the training?
- Does the Psychological General Well-Being of the pilots change after 3 and 6 months of training with FES cycling? If yes, the changes are maintained one month after the end of the training?
- Does the pilots' motivation in carrying out a sporting activity change between T1 (3 months after starting the training) and T2(6 months after starting the training)?
Participants will train for 6 months with FES-cycling twice a week. Each session includes at most 30 minutes of stimulation.
详细描述
Six months of FES-cycling trainings twice a week is performed for each pilot. Each session includes at most 30 minutes of stimulation.
At the beginning of training period, a conditioning phase is performed until the pilot reaches pedalling autonomy. This period is also used to define the stimulation parameters (minimum and maximum values of current intensity and pulse width), reference cadence and gear, specific for the ability of each pilot. Then the training period start and is performed indoor, setting the resistance of the smart trainer at 10% for all the participants. The sessions are organized as follows: a 3-minute warmup followed by four sets of 6 minutes of pedalling and a 3-minute cool down.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age of subjects between 18 and 65 years.
- •Subjects with paraplegia resulting from a SCI with both traumatic and non-traumatic origins occurred less than 5 years before the start of the study.
- •Complete loss of motor function in the lower limbs (level ≤ T3, American Spinal Injury Association (ASIA) scale A or B)
- •Adequate control of the trunk and sufficient muscle contraction using FES with surface electrodes.
- •Preference for subjects with an aptitude for sports practice.
- •Absence of a level of spasticity preventing device use and of disabling pain during training
排除标准
- •Critical osteoporosis
- •Skin lesions in interfaces parts with the trike,
- •Dysfunction of the autonomic nervous system, and
- •Psychopathological comorbidities
研究组 & 干预措施
FES cycling group
Six months of FES-cycling trainings twice a week were performed for each pilot. Each session includes at most 30 minutes of stimulation.
干预措施: FES Bike (Device)
结局指标
主要结局
Changes in the morpho-functional characteristics of the thigh muscles of the dominant limb
时间窗: After 6 months of training
The primary outcome is the changes in the morpho-functional characteristics of the thigh muscles of the dominant limb, which is investigated with the Magnetic Resonance Imaging (MRI) with multiparametric investigation methods.
次要结局
- Changes in the General Well Being of the pilots while training(One month after the end of the training)
- Pilots' motivation in carrying out a sporting activity(After 6 months of training)
- Changes in bone quality(After 6 months of training)
- Changes in data referring to the vegetative nervous system(One month after the end of the training)
- Changes in the level of pain perceived(One month after the end of the training)
- Changes in the morpho-functional characteristics of the thigh muscles of the dominant limb(One month after the end of the training)
- Changes in the intestinal function(One month after the end of the training)
- Changes in the level of spasticity of the lower limbs(One month after the end of the training)