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

17 september 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

50

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

7 jaar tot 85 jaar (Kind, Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Fundamentele wetenschap
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Surface EMG-controlled Rehabilitation Game

Exergame
Ander: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Muscle activation level
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Muscle activation
Tijdsspanne: 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
Tijdsspanne: Day 1 : between game mode

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

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Rennes University Hospital

Onderzoekers

  • Studie directeur: Sophie HAMEAU, Rennes University Hospital

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 januari 2027

Primaire voltooiing (Geschat)

1 juli 2028

Studie voltooiing (Geschat)

1 januari 2029

Studieregistratiedata

Eerst ingediend

4 september 2026

Eerst ingediend dat voldeed aan de QC-criteria

17 september 2026

Eerst geplaatst (Werkelijk)

24 september 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

24 september 2026

Laatste update ingediend die voldeed aan QC-criteria

17 september 2026

Laatst geverifieerd

1 september 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 35RC24_8825_06_CONTRACTIV-1S
  • 2026-A00615-46 (Ander subsidie-/financieringsnummer: ID-RCB)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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-tijdsbestek voor delen

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

IPD-toegangscriteria voor delen

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 delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • MVO

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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