CHU de RENNES
Rennes, France
NCT Number: NCT07838688
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.
Trial opening soon.
Get Notified7 year–85 year
All sexes
Interventional
Not applicable
Rennes, France
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
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.
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
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
Time frame: Day 1 : between game mode
Number of contractions performed
Time frame: Day 1 : between game mode
Total duration of muscle contractions
Time frame: Day 1 : between game mode
Duration and number of muscle contractions performed at predefined target muscle activation intensities
Time frame: Day 1 : between game mode
Area under the EMG activity curve
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.
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.
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
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)
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)
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)
Time frame: Day 1 : before and after the game session
Changes of frequency spectrum of the EMG signal recorded during maximal voluntary isometric contraction
Time frame: Day 1 : before and after the game session
Changes of force produced during maximal voluntary isometric contraction recorded using a handheld dynamometer.
Time frame: Day 1 : before and after the game session
Changes of Amplitude of the EMG signal recorded during maximal voluntary isometric contraction
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)
Time frame: Day 1 after the game session
System Usability Scale (SUS) will be fulfilled by adult participants Ranging from 0 to 100.
Time frame: Day 1 after the game session.
Intrinsic Motivation Inventory (IMI) ) will be fulfilled by adult participants Min = 25 and Max = 175
Time frame: Day 1 after the game session
Researcher-developed questionnaire will be completed by adult participants
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
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
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).
Trial opening soon.
Get NotifiedRennes University Hospital
Other
Acronym: CONTRACTIV-1S
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