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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.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

50

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

7年～85年 (子、大人、高齢者)

健康ボランティアの受け入れ

はい

受講資格のある性別

全て

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：基礎科学
  • 割り当て：なし
  • 介入モデル：単一グループの割り当て
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：Surface EMG-controlled Rehabilitation Game

Exergame
他の：Surface electromyography (sEMG)-controlled rehabilitation game

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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Muscle activation level
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Muscle activation
時間枠：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
時間枠：Day 1 : between game mode

Number of contractions performed
Day 1 : between game mode
Amount of activity performed
時間枠：Day 1 : between game mode

Total duration of muscle contractions
Day 1 : between game mode
Amount of activity performed
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Rennes University Hospital

捜査官

  • スタディディレクター：Sophie HAMEAU、Rennes University Hospital

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2027年1月1日

一次修了 (推定)

2028年7月1日

研究の完了 (推定)

2029年1月1日

試験登録日

最初に提出

2026年9月4日

QC基準を満たした最初の提出物

2026年9月17日

最初の投稿 (実際)

2026年9月24日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月24日

QC基準を満たした最後の更新が送信されました

2026年9月17日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 35RC24_8825_06_CONTRACTIV-1S
  • 2026-A00615-46 (その他の助成金/資金番号：ID-RCB)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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 共有時間枠

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

IPD 共有アクセス基準

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 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

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