Characterization of Muscle Activity During a Surface EMG-controlled Rehabilitation Game (CONTRACTIV-1S)
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Isabelle LEROYER
- Numéro de téléphone: +33 299282555
- E-mail: isabelle.leroyer@chu-rennes.fr
Lieux d'étude
-
-
-
Rennes, France
- CHU de RENNES
-
Contact:
- Sophie HAMEAU
- Numéro de téléphone: +33 299284218
- E-mail: sophie.hameau@chu-rennes.fr
-
Chercheur principal:
- Sophie HAMEAU
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Muscle activation level
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Muscle activation
Délai: 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
Délai: Day 1 : between game mode
|
Number of contractions performed |
Day 1 : between game mode
|
|
Amount of activity performed
Délai: Day 1 : between game mode
|
Total duration of muscle contractions |
Day 1 : between game mode
|
|
Amount of activity performed
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Sophie HAMEAU, Rennes University Hospital
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 35RC24_8825_06_CONTRACTIV-1S
- 2026-A00615-46 (Autre subvention/numéro de financement: ID-RCB)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
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.
Délai de partage IPD
Data availability after the primary publication of the results and until the database is deleted
Critères d'accès au partage IPD
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.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- CIF
- ANALYTIC_CODE
- RSE
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .