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NCT Number: NCT07838688

Characterization of Muscle Activity During a Surface EMG-controlled Rehabilitation Game

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.

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Key information

Age range

7 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de RENNES

Rennes, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surface electromyography (sEMG)-controlled rehabilitation game

Other

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.

Primary outcomes

  1. Muscle activation level

    Time frame: 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

Secondary outcomes

  1. Muscle activation

    Time frame: 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

  2. Amount of activity performed

    Time frame: Day 1 : between game mode

    Number of contractions performed

  3. Amount of activity performed

    Time frame: Day 1 : between game mode

    Total duration of muscle contractions

  4. Amount of activity performed

    Time frame: Day 1 : between game mode

    Duration and number of muscle contractions performed at predefined target muscle activation intensities

  5. Training volume

    Time frame: Day 1 : between game mode

    Area under the EMG activity curve

  6. Co-contraction intensity of the Tibialis Anterior/Lateral Gastrocnemius muscle

    Time frame: 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.

  7. Co-contraction index

    Time frame: 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.

  8. Muscular fatigability

    Time frame: 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

  9. Perceived fatigue

    Time frame: 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)

  10. Satisfaction level

    Time frame: 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)

  11. Flow status

    Time frame: 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)

  12. Fatigability

    Time frame: Day 1 : before and after the game session

    Changes of frequency spectrum of the EMG signal recorded during maximal voluntary isometric contraction

  13. Fatigability

    Time frame: Day 1 : before and after the game session

    Changes of force produced during maximal voluntary isometric contraction recorded using a handheld dynamometer.

  14. Fatigability

    Time frame: Day 1 : before and after the game session

    Changes of Amplitude of the EMG signal recorded during maximal voluntary isometric contraction

  15. Fatigability

    Time frame: 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)

  16. Usability

    Time frame: Day 1 after the game session

    System Usability Scale (SUS) will be fulfilled by adult participants Ranging from 0 to 100.

  17. Motivation

    Time frame: Day 1 after the game session.

    Intrinsic Motivation Inventory (IMI) ) will be fulfilled by adult participants Min = 25 and Max = 175

  18. Usability experience

    Time frame: Day 1 after the game session

    Researcher-developed questionnaire will be completed by adult participants

  19. Link between satisfaction and amount of activity

    Time frame: 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

  20. Link between flow and amount of activity

    Time frame: 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

  21. Validation of a seated position for maximal voluntary isometric contractions test

    Time frame: 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).

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Acronym: CONTRACTIV-1S

Important dates

Study start
2027
Primary completion
2028
Study completion
2029
First posted
Sep 24, 2026
Registry last updated
Sep 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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