Cerebral PalsyCONTRACTIV-1SNCT07838688
Characterization of Muscle Activity During a Surface EMG-controlled Rehabilitation Game
A study of Cerebral Palsy and Hemiparesis; Poststroke/CVA, run by Rennes University Hospital at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 7 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Palsy, Hemiparesis; Poststroke/CVA, Healthy (Controls)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2027to 1 Jan 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 85 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
CHU de RENNES
Rennes
Sophie HAMEAU, 299284218 ext. +33, sophie.hameau@chu-rennes.fr
Sophie HAMEAU
About this study
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.
Read the detailed description
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.
- Being tested
- Surface electromyography (sEMG)-controlled rehabilitation game
- Keywords
- surface electromyography, hemiparesis, Poststroke CVA, cerebral palsy, rehabilitation game
- Medical subject headings
- Cerebral Palsy, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surface electromyography (sEMG)-controlled rehabilitation gameOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Surface EMG-controlled Rehabilitation Game | Experimental | Exergame Receives: Other: Surface electromyography (sEMG)-controlled rehabilitation game |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1 : during the rhythm game in the individual mode
Secondary outcomes (21)
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
Measured: Day 1 : between game mode
Amount of activity performed
Number of contractions performed
Measured: Day 1 : between game mode
Amount of activity performed
Total duration of muscle contractions
Measured: Day 1 : between game mode
Amount of activity performed
Duration and number of muscle contractions performed at predefined target muscle activation intensities
Measured: Day 1 : between game mode
Training volume
Area under the EMG activity curve
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Day 1 at the end of each game modality
Fatigability
Changes of frequency spectrum of the EMG signal recorded during maximal voluntary isometric contraction
Measured: Day 1 : before and after the game session
Fatigability
Changes of force produced during maximal voluntary isometric contraction recorded using a handheld dynamometer.
Measured: Day 1 : before and after the game session
Fatigability
Changes of Amplitude of the EMG signal recorded during maximal voluntary isometric contraction
Measured: 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)
Measured: Day 1 : between each game modality
Usability
System Usability Scale (SUS) will be fulfilled by adult participants Ranging from 0 to 100.
Measured: Day 1 after the game session
Motivation
Intrinsic Motivation Inventory (IMI) ) will be fulfilled by adult participants Min = 25 and Max = 175
Measured: Day 1 after the game session.
Usability experience
Researcher-developed questionnaire will be completed by adult participants
Measured: 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
Measured: 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
Measured: 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).
Measured: Day 1 before the game session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study start1 Jan 2027 (estimated)
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 3 groups of participants : cerebral palsy kids, hemiparetic adults and healthy controls
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie HAMEAU, Study director, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07838688
- Sponsor's protocol ID
- 35RC24_8825_06_CONTRACTIV-1S
- Other IDs
- 2026-A00615-46
- Acronym
- CONTRACTIV-1S
- Status last verified
- Sep 2026
- First submitted
- 4 Sep 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.