An interventional study of Surface electromyography (sEMG)-controlled rehabilitation game in Cerebral Palsy, Hemiparesis; Poststroke/CVA and Healthy (Controls), sponsored by Rennes University Hospital. Not yet recruiting at 1 site in France. Open to participants aged 7 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Rennes University Hospital · Not applicable, Interventional, and Basic science
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.
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.
1,936 studies on the registry are indexed under Cerebral Palsy; 458 are open to participants now.
This study's planned enrollment of 50 is above the median of 34 across 1,431 interventional studies indexed under Cerebral Palsy.
Browse Cerebral Palsy studies →Rennes University Hospital is the lead sponsor of 451 studies on the registry; 51 are open to participants now.
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Inclusion Criteria for children with cerebral palsy:
Inclusion Criteria for adults with hemiparesis
Inclusion Criteria for Healthy subjects matched for age to the group of participants with hemiparesis
Exclusion Criteria:
Exergame
Other: 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.
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
Time frame: Day 1 : during the rhythm game in the individual mode
Muscle activation
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
Time frame: Day 1 : between game mode
Amount of activity performed
Number of contractions performed
Time frame: Day 1 : between game mode
Amount of activity performed
Total duration of muscle contractions
Time frame: Day 1 : between game mode
Amount of activity performed
Duration and number of muscle contractions performed at predefined target muscle activation intensities
Time frame: Day 1 : between game mode
Training volume
Area under the EMG activity curve
Time frame: Day 1 : between game mode
Co-contraction intensity of the Tibialis Anterior/Lateral 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.
Time frame: Day 1 : between game mode
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 : I = (area of overlap under the curve / total area of the two muscles) × 100.
Time frame: Day 1 : between game mode
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
Time frame: Day 1 : between game mode
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. Min 0 (not at all) et max 10 (extremely)
Time frame: Day 1 : at the end of each game modality
Satisfaction level
Visual analogue scale of satisfaction will be completed by adult participants Min 0 (not at all) et max 10 (extremely)
Time frame: Day 1 : at the end of each game modality
Flow status
Game Experience Questionnaire (Flow component) completed by adult participants Five questions scored from 0 (not at all) to 4 (extremely)
Time frame: Day 1 at the end of each game modality
Fatigability
Changes of frequency spectrum of the EMG signal recorded during maximal voluntary isometric contraction
Time frame: Day 1 : before and after the game session
Fatigability
Changes of force produced during maximal voluntary isometric contraction recorded using a handheld dynamometer.
Time frame: Day 1 : before and after the game session
Fatigability
Changes of Amplitude of the EMG signal recorded during maximal voluntary isometric contraction
Time frame: Day 1 : before and after the game session
Fatigability
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)
Time frame: Day 1 : between each game modality
Usability
System Usability Scale (SUS) will be fulfilled by adult participants Ranging from 0 to 100.
Time frame: Day 1 after the game session
Motivation
Intrinsic Motivation Inventory (IMI) ) will be fulfilled by adult participants Min = 25 and Max = 175
Time frame: Day 1 after the game session.
Usability experience
Researcher-developed questionnaire will be completed by adult participants
Time frame: Day 1 after the game session
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
Time frame: Day 1 : between game mode
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
Time frame: Day 1 : between game mode
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).
Time frame: Day 1 before the game session
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Data availability after the primary publication of the results and until the database is deleted
Access criteria: 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.
No publications or documents are linked to this record.
Start is estimated for Jan 2027; primary completion for Jul 2028, 18 months later.
Of 902 non-industry interventional studies with no phase under Cerebral Palsy, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 31. This study's planned 18 months is above that.
Counting every sponsor, half of 921 studies reached it within 12 months; a quarter within 5 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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