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

17 de septiembre de 2026 actualizado por: 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.

Descripción general del estudio

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

50

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

      • Rennes, Francia
        • CHU de RENNES
        • Contacto:
        • Investigador principal:
          • Sophie HAMEAU

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

7 años a 85 años (Niño, Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Ciencia básica
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Muscle activation level
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Muscle activation
Periodo de tiempo: 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
Periodo de tiempo: Day 1 : between game mode

Number of contractions performed

Day 1 : between game mode
Amount of activity performed
Periodo de tiempo: Day 1 : between game mode

Total duration of muscle contractions

Day 1 : between game mode
Amount of activity performed
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Director de estudio: Sophie HAMEAU, Rennes University Hospital

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de enero de 2027

Finalización primaria (Estimado)

1 de julio de 2028

Finalización del estudio (Estimado)

1 de enero de 2029

Fechas de registro del estudio

Enviado por primera vez

4 de septiembre de 2026

Primero enviado que cumplió con los criterios de control de calidad

17 de septiembre de 2026

Publicado por primera vez (Actual)

24 de septiembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

24 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

17 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan 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.

Marco de tiempo para compartir IPD

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

Criterios de acceso compartido de 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.

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA
  • CIF
  • CÓDIGO_ANALÍTICO
  • RSC

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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