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

torstai 17. syyskuuta 2026 päivittänyt: 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.

Tutkimuksen yleiskatsaus

Yksityiskohtainen kuvaus

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.

Opintotyyppi

Interventio

Ilmoittautuminen (Arvioitu)

50

Vaihe

  • Ei sovellettavissa

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskeluyhteys

Opiskelupaikat

      • Rennes, Ranska
        • CHU de RENNES
        • Ottaa yhteyttä:
        • Päätutkija:
          • Sophie HAMEAU

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

7 vuotta - 85 vuotta (Lapsi, Aikuinen, Vanhempi Aikuinen)

Hyväksyy terveitä vapaaehtoisia

Joo

Sukupuolet, jotka voivat opiskella

Kaikki

Kuvaus

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

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Perustiede
  • Jako: Ei käytössä
  • Inventiomalli: Yksittäinen ryhmätehtävä
  • Naamiointi: Ei mitään (avoin tarra)

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: 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.

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Muscle activation level
Aikaikkuna: 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

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Muscle activation
Aikaikkuna: 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
Aikaikkuna: Day 1 : between game mode

Number of contractions performed

Day 1 : between game mode
Amount of activity performed
Aikaikkuna: Day 1 : between game mode

Total duration of muscle contractions

Day 1 : between game mode
Amount of activity performed
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Tutkijat

  • Opintojohtaja: Sophie HAMEAU, Rennes University Hospital

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus (Arvioitu)

Perjantai 1. tammikuuta 2027

Ensisijainen valmistuminen (Arvioitu)

Lauantai 1. heinäkuuta 2028

Opintojen valmistuminen (Arvioitu)

Maanantai 1. tammikuuta 2029

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Perjantai 4. syyskuuta 2026

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Torstai 17. syyskuuta 2026

Ensimmäinen Lähetetty (Todellinen)

Torstai 24. syyskuuta 2026

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Torstai 24. syyskuuta 2026

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Torstai 17. syyskuuta 2026

Viimeksi vahvistettu

Tiistai 1. syyskuuta 2026

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Yksittäisten osallistujien tietojen suunnitelma (IPD)

Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?

JOO

IPD-suunnitelman kuvaus

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-jaon aikakehys

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

IPD-jaon käyttöoikeuskriteerit

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-jakamista tukeva tietotyyppi

  • STUDY_PROTOCOL
  • MAHLA
  • ICF
  • ANALYTIC_CODE
  • CSR

Lääke- ja laitetiedot, tutkimusasiakirjat

Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta

Ei

Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta

Ei

Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .

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