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Characterization of Muscle Activity During a Surface EMG-controlled Rehabilitation Game (CONTRACTIV-1S)

2026年9月17日 更新者:Rennes University Hospital

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.

研究概览

详细说明

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.

研究类型

介入性

注册 (估计的)

50

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

7年 至 85年 (孩子、成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria 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.

Exclusion Criteria:

  • 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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:基础科学
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Surface EMG-controlled Rehabilitation Game

Exergame

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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Muscle activation level
大体时间: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

Day 1 : during the rhythm game in the individual mode

次要结果测量

结果测量
措施说明
大体时间
Muscle activation
大体时间:Day 1 : between game 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

Day 1 : between game mode
Amount of activity performed
大体时间:Day 1 : between game mode

Number of contractions performed

Day 1 : between game mode
Amount of activity performed
大体时间:Day 1 : between game mode

Total duration of muscle contractions

Day 1 : between game mode
Amount of activity performed
大体时间:Day 1 : between game mode

Duration and number of muscle contractions performed at predefined target muscle activation intensities

Day 1 : between game mode
Training volume
大体时间:Day 1 : between game mode

Area under the EMG activity curve

Day 1 : between game mode
Co-contraction intensity of the Tibialis Anterior/Lateral Gastrocnemius muscle
大体时间:Day 1 : between game mode

The intensity of co-contractions is measured as the ratio of the antagonist's EMG activity during agonist contractions while playing, relative to the EMG activity recorded during the antagonist's MVIC performed before the gaming session.

Day 1 : between game mode
Co-contraction index
大体时间:Day 1 : between game mode

The co-contraction index between the tibialis anterior and lateral gastrocnemius muscles will be calculated as the ratio between the area of overlap under the activation curves and the total area corresponding to the activation of both muscles, expressed as a percentage :

I = (area of overlap under the curve / total area of the two muscles) × 100.

Day 1 : between game mode
Muscular fatigability
大体时间:Day 1 : between game mode

A wavelet analysis will be performed by comparing the first five contractions with the last five contractions. This analysis will allow to detect potential changes in muscle activity associated with muscular fatigue

Day 1 : between game mode
Perceived fatigue
大体时间:Day 1 : at the end of each game modality

Children's Effort Rating Table (CERT) will be used to assess the child's perceived exertion and Borg Rating of Perceived Exertion Scale will be used for adult participants.

Min 0 (not at all) et max 10 (extremely)

Day 1 : at the end of each game modality
Satisfaction level
大体时间:Day 1 : at the end of each game modality

Visual analogue scale of satisfaction will be completed by adult participants Min 0 (not at all) et max 10 (extremely)

Day 1 : at the end of each game modality
Flow status
大体时间:Day 1 at the end of each game modality

Game Experience Questionnaire (Flow component) completed by adult participants Five questions scored from 0 (not at all) to 4 (extremely)

Day 1 at the end of each game modality
Fatigability
大体时间:Day 1 : before and after the game session

Changes of frequency spectrum of the EMG signal recorded during maximal voluntary isometric contraction

Day 1 : before and after the game session
Fatigability
大体时间:Day 1 : before and after the game session

Changes of force produced during maximal voluntary isometric contraction recorded using a handheld dynamometer.

Day 1 : before and after the game session
Fatigability
大体时间:Day 1 : before and after the game session

Changes of Amplitude of the EMG signal recorded during maximal voluntary isometric contraction

Day 1 : before and after the game session
Fatigability
大体时间:Day 1 : between each game modality

Changes of Co-contraction index and intensity of the tibialis anterior/lateral gastrocnemius muscle pair (between the first five and the last five contractions of each game modality)

Day 1 : between each game modality
Usability
大体时间:Day 1 after the game session

System Usability Scale (SUS) will be fulfilled by adult participants Ranging from 0 to 100.

Day 1 after the game session
Motivation
大体时间:Day 1 after the game session.

Intrinsic Motivation Inventory (IMI) ) will be fulfilled by adult participants Min = 25 and Max = 175

Day 1 after the game session.
Usability experience
大体时间:Day 1 after the game session

Researcher-developed questionnaire will be completed by adult participants

Day 1 after the game session
Link between satisfaction and amount of activity
大体时间:Day 1 : between game mode

Correlation between satisfaction (Visual analogue sclae of satisfaction from 0 to 10) and activation levels (calculated as the mean of the maximum values of the normalized RMS envelope of the EMG signal during each muscle contraction) in adult participants

Day 1 : between game mode
Link between flow and amount of activity
大体时间:Day 1 : between game mode

Correlation between flow (Game experience questionnaire 5 question from 0 to 4) and activation levels ( calculated as the mean of the maximum values of the normalized RMS envelope of the EMG signal during each muscle contraction) in adult participants

Day 1 : between game mode
Validation of a seated position for maximal voluntary isometric contractions test
大体时间:Day 1 before the game session

Mesures performed by a dynamometer Analyse of Correlation between maximal voluntary isometric force of the dorsiflexor and plantar flexor muscles assessed using a handheld dynamometer in two testing positions : In the seated position, with the knee flexed at 90° and the ankle at 10° of plantar flexion (i.e., the gaming position) and in the supine position, with the knee flexed at 90° and the ankle positioned at 10° of plantar flexion (standard position).

Day 1 before the game session

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 研究主任:Sophie HAMEAU、Rennes University Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2027年1月1日

初级完成 (估计的)

2028年7月1日

研究完成 (估计的)

2029年1月1日

研究注册日期

首次提交

2026年9月4日

首先提交符合 QC 标准的

2026年9月17日

首次发布 (实际的)

2026年9月24日

研究记录更新

最后更新发布 (实际的)

2026年9月24日

上次提交的符合 QC 标准的更新

2026年9月17日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

其他研究编号

  • 35RC24_8825_06_CONTRACTIV-1S
  • 2026-A00615-46 (其他赠款/资助编号:ID-RCB)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

All of the individual participant data collected during the trial will be available, after the primary publication of the results, to any researchers who provide a methodologically sound proposal. Proposals should be directed to dri@churennes.fr. to gain access, data requestors will need to sign a data access agreement; depending on the case, additional formalities may be required.

IPD 共享时间框架

Data availability after the primary publication of the results and until the database is deleted

IPD 共享访问标准

Any researchers who provide a methodologically sound proposal will be able to access the IPD ans supporting information. To gain access, data requestors will need to sign a data access agreement; depending on the case, additional formalities may be required.

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会
  • 分析代码
  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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