Training of Persons With Complete Spinal Cord Injury for Pedaling on a Tricycle, Induced by Electrical Stimulation of the Paralysed Muscles: a Case Series
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Change in Maximum Cycling-Distance in [m]
研究概览
简要总结
The main objective of this study is to validate the effectivity of a simple home-based training for cycling with functional electrical stimulation (FES). The training is designed to progressively increase strength and endurance of the paralysed muscles of a person with complete spinal cord injury. After a limited period of only several months, performance will be assessed during FES-assisted cycling on a recumbent tricycle over flat ground. The outcomes of this study should provide evidence for the effectivity of FES-cycling as potential rehabilitation method.
详细描述
People with spinal cord injuries suffer from numerous comorbidities, linked in particular to immobility and sedentariness. Studies have shown the benefits of training and reconditioning to adapted effort in spinal cord injured people. Among other innovative techniques, functional electrical stimulation (FES) is aimed primarily at mobilizing as many muscles as possible. Concerning electro-stimulated pedaling on a tricycle, it would allow individuals with paraplegia or tetraplegia to practise physical activity in perspective of experiencing pleasure during training.
In 2016, our team carried out a pilot study aiming at using a recumbent tricylce powered by the lower limbs of a person with complete paraplegia under electrostimulation. The participant was trained for 12 months, whit the objective to participate at an international competition (Cybathlon 2016). This first study has opened up prospects and identified avenues for improvement.
The main objective of this study is to significantly improve, over a limited period of time, the pedalling performance on a tricycle by using electrical stimulation of the sub-lesional muscles of people with spinal cord injuries. Secondary focusses will be: physical and psychological tolerance to training; influence on pain, cardio-respiratory functions, body composition regarding muscle trophicity and bone metabolism; psycho-social impact; impact of modification of stimulation parameters (frequency, phase width, intensity, waveform, contact location) in performance optimization and delay of muscle fatigue; performance impact of mechanical modifications performed on the tricycle.
This is a prospective case study: patients suffering from a complete traumatic injury and followed at the Centre de Rééducation et de Réadaptation Fonctionnelle (CRRF) La Châtaigneraie (Menucourt) will be recruited by the investigating physician during a consultation for a period of approximately 6 months. The centre specialised in the management of acute and chronic neurological lesions. The eligibility criteria are predefined to ensure the participants safety. After verification of the criteria and before the start of the programme, an exercise test (monitoring of the evolution of VO2max) will be carried out in the Sports Medicine department of the CHI of Saint-Germain-en-Laye. The first phase (V1) consists of a one-month home-based isometric muscle training programme by electrostimulation followed by a two-month programme (phase V2) of home-based muscle training by electrostimulation on an ergocycle including one training per week at the CRRF. The home ergocycle electro-stimulation muscle training, will be continued once or twice a week and complemented in the third phase (V3) by training at the CRRF on a tricycle for one month. Only the patient selected to participate in the Cybathlon 2020 will continue with the final phase (V4), which includes, over a period of 2 to 4 months, muscle training by electrostimulation on an ergocycle at home, electrostimulation sessions on a tricycle up to 3 times a week at the CRRF. In this phase, the optimization of the stimulation and electrical patterns and the mechanics of the tricycle will take place in order to maximize the pilots overall performance. Finally, the pilot will take part in the tricycle FES-Cycling race at the Cybathlon 2020 in Zurich, i.e. an international competition and technological challenge, requiring to master 1200 metres in a maximum time of 8 minutes. The different training programs are based on sport-scientific principles and a physiotherapist will follow up on the home sessions. The collaborating teams (engineers and researchers from INRIA, the French National Institute for Research in Computer Science and Control) will measure performance in a bimonthly frequency.
This research should demonstrate that the safety, acceptability, satisfaction, self-esteem and quality of life induced by the practice of FES-assisted pedalling, opens a new way of training in rehabilitation centres and at home with the perspective of improving certain physiological functions in the long-term.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •informed written consent
- •complete spinal cord injury AIS A or B
- •neurological level of lesion C6 - T12
- •post-lesion duration > 12 moths
- •paralysed muscles stimulable
- •joints of lower limb freely moveable
- •stable medical condition (absence of infectious respiratory or urinary event of cutaneous pathology confining the patient to bed and warranting treatment).
排除标准
- •Not affiliated to a social security scheme, beneficiary or not such a plan
- •Refusal to participate in the study (withdraw from study possible at any time)
- •Inability to give consent
- •body mass index higher or equal to 30
- •flaccid paralysis (denervation)
- •Inability to give consent
- •neurogenic para-osteoarthropathy
- •active thrombophlebitis
- •muscular disease
- •cardiovascular disease including coronary antecedent
- •bone mineral density T-score below -2.5
- •treatment with a drug known to have an effect on bone (< 3 months)
- •Aids in the lower limbs
- •Orthostatic hypotension
- •Fractures of the lower limbs older (< 12 months)
- •Pacemakers or other implants contraindicating the use of FES
- •Pregnancy (women)
结局指标
主要结局
Change in Maximum Cycling-Distance in [m]
时间窗: Change between 4 months of training (end of V3) and 6 months of training (end of V4)
Change in maximum distance cycled on flat ground on a tricycle
Change in Maximum Cycling-Speed in [km/h]
时间窗: Change between 4 months of training (end of V3) and 6 months of training (end of V4)
Change in maximum speed during cycling over flat ground on a tricycle
Change in Maximum Pedaling-Cadence in [RPM]
时间窗: Change between 4 months of training (end of V3) and 6 months of training (end of V4)
Change in maximum pedaling-cadence during cycling over flat ground on a tricycle
Change in Average Pedaling-Cadence in [RPM]
时间窗: Change between 4 months of training (end of V3) and 6 months of training (end of V4)
Change in average pedaling-cadence during cycling over flat ground on a tricycle
Change in Average Cycling-Speed in [km/h]
时间窗: Change between 4 months of training (end of V3) and 6 months of training (end of V4)
Change in average speed during cycling over flat ground on a tricycle
Change in Maximum Cycling-duration in [hh:mm:ss]
时间窗: Change between 4 months of training (end of V3) and 6 months of training (end of V4)
Change in maximum duration during cycling over flat ground on a tricycle
Ability to cycle 1200m in less than 8min
时间窗: After 6 months of training (end of V4)
Qualification criterion Cybathlon 2020. It will be assessed it the pilot is able to cycle 1200m in less than 8min over flat ground on a tricycle.
次要结局
- Change of blood pressure during training(through study completion (up to one year), an average throughout the study-duration)
- Change of heart rate during training(through study completion (up to one year), an average throughout the study-duration)
- Maximum heart rate during training(through study completion (up to one year), an average throughout the study-duration)
- Average heart rate during training(through study completion (up to one year), an average throughout the study-duration)
- Cutaneous status(through study completion (up to one year))
- Psychological: Acceptability(through study completion (up to one year), every 30 days)
- General Fatigue(through study completion (up to one year), an average throughout the study-duration)
- Psycho-Social: Self-Esteem(through study completion (up to one year), every 15 days)
- Psychological: Satisfaction(through study completion (up to one year), an average throughout the study-duration)
- Musculo-skeletal pain or inflammation(through study completion (up to one year))
- Psycho-Social: Quality of Life(through study completion (up to one year), every 30 days)
- Cardio-Respiratory Fitness: Maximal Heartrate(Change between timepoint before first training, after 4 months of training (end of V3) and after 6 months of training (end of V4))
- Musculo-skeletal changes: Thigh perimeter(Change between timepoint before first training and after end of study (end of V5, ~ 7 months))
- Cardio-Respiratory Fitness: VO2max(Change between timepoint before first training, after 4 months of training (end of V3) and after 6 months of training (end of V4))
- Musculo-skeletal changes: Bone mineral density(Change between timepoint before first training and after end of study (end of V5, ~ 7 months))
- Musculo-skeletal changes: Body composition(Change between timepoint before first training and after end of study (end of V5, ~ 7 months))
- Occurrence of spasms : after training(through study completion (up to one year), an average throughout the study-duration)
- Occurrence of spasms: before training(through study completion (up to one year), an average throughout the study-duration)