[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657430":3},{"organization":4,"outcomesModule":7,"designInfo":80,"detailedDescription":87,"studyPopulation":79,"armGroups":88,"interventions":95,"overallOfficials":99,"centralContacts":103,"locations":110,"responsibleParty":128,"collaborators":79,"id":130,"slug":131,"hasResults":132,"nctId":133,"briefTitle":134,"officialTitle":134,"acronym":135,"eligibilityCriteria":136,"healthyVolunteers":137,"sex":138,"minAge":139,"maxAge":140,"enrollmentInfo":141,"targetDuration":79,"studyType":144,"phases":145,"briefSummary":146,"conditions":147,"keywords":151,"overallStatus":157,"whyStopped":79,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":167},{"fullName":5,"class":6},"Rennes University Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":79},[9],{"measure":10,"description":11,"timeFrame":12},"Muscle activation level","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",[14,17,20,22,24,27,30,33,36,40,43,47,51,53,55,58,62,66,69,72,75],{"measure":15,"description":11,"timeFrame":16},"Muscle activation","Day 1 : between game mode",{"measure":18,"description":19,"timeFrame":16},"Amount of activity performed","Number of contractions performed",{"measure":18,"description":21,"timeFrame":16},"Total duration of muscle contractions",{"measure":18,"description":23,"timeFrame":16},"Duration and number of muscle contractions performed at predefined target muscle activation intensities",{"measure":25,"description":26,"timeFrame":16},"Training volume","Area under the EMG activity curve",{"measure":28,"description":29,"timeFrame":16},"Co-contraction intensity of the Tibialis Anterior\u002FLateral Gastrocnemius muscle","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.",{"measure":31,"description":32,"timeFrame":16},"Co-contraction index","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 :\n\nI = (area of overlap under the curve \u002F total area of the two muscles) × 100.",{"measure":34,"description":35,"timeFrame":16},"Muscular fatigability","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",{"measure":37,"description":38,"timeFrame":39},"Perceived fatigue","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.\n\nMin 0 (not at all) et max 10 (extremely)","Day 1 : at the end of each game modality",{"measure":41,"description":42,"timeFrame":39},"Satisfaction level","Visual analogue scale of satisfaction will be completed by adult participants Min 0 (not at all) et max 10 (extremely)",{"measure":44,"description":45,"timeFrame":46},"Flow status","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",{"measure":48,"description":49,"timeFrame":50},"Fatigability","Changes of frequency spectrum of the EMG signal recorded during maximal voluntary isometric contraction","Day 1 : before and after the game session",{"measure":48,"description":52,"timeFrame":50},"Changes of force produced during maximal voluntary isometric contraction recorded using a handheld dynamometer.",{"measure":48,"description":54,"timeFrame":50},"Changes of Amplitude of the EMG signal recorded during maximal voluntary isometric contraction",{"measure":48,"description":56,"timeFrame":57},"Changes of Co-contraction index and intensity of the tibialis anterior\u002Flateral gastrocnemius muscle pair (between the first five and the last five contractions of each game modality)","Day 1 : between each game modality",{"measure":59,"description":60,"timeFrame":61},"Usability","System Usability Scale (SUS) will be fulfilled by adult participants Ranging from 0 to 100.","Day 1 after the game session",{"measure":63,"description":64,"timeFrame":65},"Motivation","Intrinsic Motivation Inventory (IMI) ) will be fulfilled by adult participants Min = 25 and Max = 175","Day 1 after the game session.",{"measure":67,"description":68,"timeFrame":61},"Usability experience","Researcher-developed questionnaire will be completed by adult participants",{"measure":70,"description":71,"timeFrame":16},"Link between satisfaction and amount of activity","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",{"measure":73,"description":74,"timeFrame":16},"Link between flow and amount of activity","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",{"measure":76,"description":77,"timeFrame":78},"Validation of a seated position for maximal voluntary isometric contractions test","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",null,{"allocation":81,"interventionModel":82,"interventionModelDescription":83,"primaryPurpose":84,"observationalModel":79,"timePerspective":79,"maskingInfo":85},"NA","SINGLE_GROUP","3 groups of participants : cerebral palsy kids, hemiparetic adults and healthy controls","BASIC_SCIENCE",{"masking":86,"maskingDescription":79,"whoMasked":79},"NONE","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.\n\nParticipants will play the rehabilitation game under different modalities : individually, in pairs in a co-active mode, or in a competitive mode.\n\nIn individual mode, they play two different games a rythm game (following the musical tempo by alternating agonist\u002Fantagonist 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....).\n\nThe game modalities will be presented in a randomized order.",[89],{"label":90,"type":91,"description":92,"interventionNames":93},"Surface EMG-controlled Rehabilitation Game","EXPERIMENTAL","Exergame",[94],"Other: Surface electromyography (sEMG)-controlled rehabilitation game",[96],{"type":6,"name":97,"description":87,"armGroupLabels":98,"otherNames":79},"Surface electromyography (sEMG)-controlled rehabilitation game",[90],[100],{"name":101,"affiliation":5,"role":102},"Sophie HAMEAU","STUDY_DIRECTOR",[104],{"name":105,"role":106,"phone":107,"phoneExt":108,"email":109},"Isabelle LEROYER","CONTACT","299282555","+33","isabelle.leroyer@chu-rennes.fr",[111],{"facility":112,"status":79,"city":113,"state":79,"zip":79,"country":114,"countryCode":115,"cosmosGeoPoint":116,"geoPoint":121,"contacts":122},"CHU de RENNES","Rennes","France","FR",{"type":117,"coordinates":118},"Point",[119,120],-1.67431,48.11109,{"lat":120,"lon":119},[123,126],{"name":101,"role":106,"phone":124,"phoneExt":108,"email":125},"299284218","sophie.hameau@chu-rennes.fr",{"name":101,"role":127,"phone":79,"phoneExt":79,"email":79},"PRINCIPAL_INVESTIGATOR",{"type":129,"investigatorFullName":79,"investigatorTitle":79,"investigatorAffiliation":79,"oldNameTitle":79,"oldOrganization":79},"SPONSOR","100657430","characterization-of-muscle-activity-during-a-surface-emg-controlled-rehabilitation-game-100657430",false,"NCT07838688","Characterization of Muscle Activity During a Surface EMG-controlled Rehabilitation Game","CONTRACTIV-1S","Inclusion Criteria for children with cerebral palsy:\n\n* Participants with cerebral palsy who are able to walk, GMFCS stages I through III, hemiplegic, diplegic, or quadriplegic\n* Aged 7 to 17 years\n* With palpable contractions of the target muscles (triceps surae and tibialis anterior) (≥ 1 on the Medical Research Council \\[MRC\\] scale)\n* 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\n* Signed consent for participation from the participant's legal guardians\n* Enrolled, either personally or through their parents, in a social security program\n\nInclusion Criteria for adults with hemiparesis\n\n* Stroke in the subacute or chronic phase\n* Aged 18 to 85 years\n* With palpable contractions of the target muscles (triceps surae and tibialis anterior) (≥ 1 on the Medical Research Council \\[MRC\\] scale)\n* Having received verbal and written information about the protocol and having signed a consent form to participate in this study\n* Enrolled in a social security program\n\nInclusion Criteria for Healthy subjects matched for age to the group of participants with hemiparesis\n\n* Aged 18 to 85\n* No neurological disorders\n* Who received verbal and written information about the protocol and signed a consent form to participate in this study.\n\nExclusion Criteria:\n\n* Surgery on the lower extremities within the past 6 months\n* A botulinum toxin injection into the triceps surae and\u002For the tibialis anterior within the past 3 months\n* Pain during dorsiflexion or plantarflexion of the ankle joint\n* Cognitive impairments limiting participation\n* A person referred to in Articles L1121-5, L1121-6, L2121-8, L1121-9 of the Public Health Code\n* Participating in another therapeutic or drug intervention study that could affect this study",true,"ALL","7 Years","85 Years",{"count":142,"type":143},50,"ESTIMATED","INTERVENTIONAL",[81],"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.\n\nSecondary 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.",[148,149,150],"Cerebral Palsy","Hemiparesis; Poststroke\u002FCVA","Healthy (Controls)",[152,153,154,155,156],"surface electromyography","hemiparesis","Poststroke CVA","cerebral palsy","rehabilitation game","NOT_YET_RECRUITING","2026-09-17",{"date":160,"type":161},"2026-09-24","ACTUAL",{"date":163,"type":143},"2027-01-01",{"date":165,"type":143},"2029-01-01",{"name":5,"class":6},1]