Characterization of Muscle Activity During a Surface EMG-controlled Rehabilitation Game
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Muscle activation level
研究概览
简要总结
The aim of this pilot study is to evaluate muscular activity during a single session of surface electromyography controlled exergame (muscle activation, number of contraction…) in cerebral palsy kids, hemiparetic adults and healthy controls.
Secondary aims are to assess different game mode (one-player, coactive two-player or competitive two-player and different gameplay (a rhythm and a platform gameplay) on muscle activation, number of contraction and on participant's experiences. Another aim is to assess enjoyment, motivation, flow and usability in hemiparetics adults.
详细描述
During the game session, participants will be paired in advance of the visit (an adult participant with hemiparesis paired with another adult participant with hemiparesis, or a healthy volunteer and a child with cerebral palsy paired with another child with a cerebral palsy) to allow for testing of different conditions for the electromyography-controlled rehabilitation game. The estimated duration for each participant is 1 hour and 30 minutes, including a 30-minute game session.
Participants will play the rehabilitation game under different modalities : individually, in pairs in a co-active mode, or in a competitive mode.
In individual mode, they play two different games a rythm game (following the musical tempo by alternating agonist/antagonist contractions) and a target game (the participant controls a rocket that must hit targets based on the intensity of muscle contractions and the muscle being activated....).
The game modalities will be presented in a randomized order.
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
- 7 Years 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for children with cerebral palsy:
- •Participants with cerebral palsy who are able to walk, GMFCS stages I through III, hemiplegic, diplegic, or quadriplegic
- •Aged 7 to 17 years
- •With palpable contractions of the target muscles (triceps surae and tibialis anterior) (≥ 1 on the Medical Research Council [MRC] scale)
- •Having received verbal and written information about the protocol, having agreed to participate in this study, and having signed a consent form if the participant is 15 years of age or older
- •Signed consent for participation from the participant's legal guardians
- •Enrolled, either personally or through their parents, in a social security program
- •Inclusion Criteria for adults with hemiparesis
- •Stroke in the subacute or chronic phase
- •Aged 18 to 85 years
- •With palpable contractions of the target muscles (triceps surae and tibialis anterior) (≥ 1 on the Medical Research Council [MRC] scale)
- •Having received verbal and written information about the protocol and having signed a consent form to participate in this study
- •Enrolled in a social security program
- •Inclusion Criteria for Healthy subjects matched for age to the group of participants with hemiparesis
- •Aged 18 to 85
- •No neurological disorders
- •Who received verbal and written information about the protocol and signed a consent form to participate in this study.
排除标准
- •Surgery on the lower extremities within the past 6 months
- •A botulinum toxin injection into the triceps surae and/or the tibialis anterior within the past 3 months
- •Pain during dorsiflexion or plantarflexion of the ankle joint
- •Cognitive impairments limiting participation
- •A person referred to in Articles L1121-5, L1121-6, L2121-8, L1121-9 of the Public Health Code
- •Participating in another therapeutic or drug intervention study that could affect this study
研究组 & 干预措施
Surface EMG-controlled Rehabilitation Game
Exergame
干预措施: Surface electromyography (sEMG)-controlled rehabilitation game (Other)
结局指标
主要结局
Muscle activation level
时间窗: Day 1 : during the rhythm game in the individual mode
calculated as the mean of the maximum values of the normalized RMS envelope of the EMG signal during each muscle contraction of the Tibialis Anterior and Lateral Gastrocnemius muscles
次要结局
- Amount of activity performed(Day 1 : between game mode)
- Muscle activation(Day 1 : between game mode)
- Training volume(Day 1 : between game mode)
- Co-contraction intensity of the Tibialis Anterior/Lateral Gastrocnemius muscle(Day 1 : between game mode)
- Co-contraction index(Day 1 : between game mode)
- Muscular fatigability(Day 1 : between game mode)
- Perceived fatigue(Day 1 : at the end of each game modality)
- Satisfaction level(Day 1 : at the end of each game modality)
- Flow status(Day 1 at the end of each game modality)
- Fatigability(Day 1 : before and after the game session)
- Fatigability(Day 1 : between each game modality)
- Usability(Day 1 after the game session)
- Motivation(Day 1 after the game session.)
- Usability experience(Day 1 after the game session)
- Link between satisfaction and amount of activity(Day 1 : between game mode)
- Link between flow and amount of activity(Day 1 : between game mode)
- Validation of a seated position for maximal voluntary isometric contractions test(Day 1 before the game session)