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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cerebral Palsy; Healthy (Controls); Hemiparesis; Poststroke/CVA
• Intervention / Treatment: Other: Surface electromyography (sEMG)-controlled rehabilitation game

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Isabelle LEROYER; Phone Number: +33 299282555; Email: isabelle.leroyer@chu-rennes.fr

Study Locations

• France
  • Rennes, France
    • CHU de RENNES
    • Contact: Sophie HAMEAU; Phone Number: +33 299284218; Email: sophie.hameau@chu-rennes.fr
    • Principal Investigator: Sophie HAMEAU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 85 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Surface EMG-controlled Rehabilitation Game; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Day 1 : between game mode
Amount of activity performed	Number of contractions performed	Day 1 : between game mode
Amount of activity performed	Total duration of muscle contractions	Day 1 : between game mode
Amount of activity performed	Duration and number of muscle contractions performed at predefined target muscle activation intensities	Day 1 : between game mode
Training volume	Area under the EMG activity curve	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.	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.	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	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)	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)	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)	Day 1 at the end of each game modality
Fatigability	Changes of frequency spectrum of the EMG signal recorded during maximal voluntary isometric contraction	Day 1 : before and after the game session
Fatigability	Changes of force produced during maximal voluntary isometric contraction recorded using a handheld dynamometer.	Day 1 : before and after the game session
Fatigability	Changes of Amplitude of the EMG signal recorded during maximal voluntary isometric contraction	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)	Day 1 : between each game modality
Usability	System Usability Scale (SUS) will be fulfilled by adult participants Ranging from 0 to 100.	Day 1 after the game session
Motivation	Intrinsic Motivation Inventory (IMI) ) will be fulfilled by adult participants Min = 25 and Max = 175	Day 1 after the game session.
Usability experience	Researcher-developed questionnaire will be completed by adult participants	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	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	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).	Day 1 before the game session

Collaborators and Investigators

• Sponsor: Rennes University Hospital
• Investigators: Study Director: Sophie HAMEAU, Rennes University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): January 1, 2029

Study Registration Dates

• First Submitted: September 4, 2026
• First Submitted That Met QC Criteria: September 17, 2026
• First Posted (Actual): September 24, 2026

Study Record Updates

• Last Update Posted (Actual): September 24, 2026
• Last Update Submitted That Met QC Criteria: September 17, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: hemiparesis; cerebral palsy; surface electromyography; Poststroke CVA; rehabilitation game
• Additional Relevant MeSH Terms: Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Cerebral Palsy; Paresis
• Other Study ID Numbers: 35RC24_8825_06_CONTRACTIV-1S; 2026-A00615-46 (Other Grant/Funding Number: ID-RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

IPD Sharing Time Frame

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

IPD Sharing 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.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No