Assistance Publique Hôpitaux de Marseille
Marseille, 13354, France
NCT Number: NCT03628261
Cerebral palsy (CP) is a major motor dysfunction manifesting early in childhood, with severe consequences to performance in daily functions. CP children are typically unable to voluntarily activate individual muscles, hindering motor coordination and therefore the ability to produce movements as smooth as those seen in control cohorts. Muscles spanning distal joints are more likely affected by CP, resulting in abnormal gait patterns.
While commercially available and customised games have been considered for CP rehabilitation in the last decade, they are mainly based on the analysis of movement kinematics and none seems to deal directly with the key source of motor impairment: the skeletal muscle. Surface electromyograms (EMGs), on the other hand, provide clinicians with the possibility of directly assessing and controlling the neural drive or command to muscles.
The benefits of surface EMG as a feedback tool for improving posture control and for stroke rehabilitation are well established.
The treatment with EMG-based "serious games" is expected to assist CP children in activating the ankle muscles in both paretic and healthy limbs at similar instants within the gait cycle. Given such EMG-oriented rehabilitation applies directly to the muscle, its effect on muscle and therefore gait function is likely to be greater than that achieved with conventional means. If this hypothesis is verified, it will be further expect to observe a smoother gait, that is smoother changes in gait kinematics and morphology of the paretic foot, in CP children treated with EMG-based serious game than otherwise.
Primary objective consists in verifying whether Surface electromyography (sEMG)-based games are effective in reducing the degree of muscular hyperactivity in the ankle plantar flexor and thus improve the ankle dorsi flexor function in children with cerebral palsy.
The study design is an open, prospective, monocentric, randomized and controlled trial. Participants will be randomly assigned to either the first group or to the second group.
For the first group, the design will be: "physical therapy + serious games" during the first month then "physical therapy" during the second month.
For second group, the the design will be: "physical therapy" during the first month then "physical therapy + serious games" during the second month.
Looking for future studies?
Notify Me2 year–10 year
All sexes
Interventional
Not applicable
Marseille, 13354, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Surface EMG detection for the myoelectric control of the EMG-based serious games and for the EMG assessment during gait will be performed with a wireless system.This device is composed of seven modules (sensor units), each detecting and transmitting two bipolar EMGs at 2 kilo Hertz (kHz). During the evaluation protocol EMGs will be detected from peroneus longus, gastrocnemius medialis, soleus and tibialis anterior muscles of both limbs using pre-gelled electrodes.
Children receive the regular rehabilitation for the treatment of ankle plantar flexor muscle overactivity and the paresis of ankle dorsal flexor muscle
Time frame: 12 months
Onsets of muscle activation will be estimated using a semi-automated method, with activation instants being defined by when the rectified, raw EMG exceeds 20 millivolt (mV). The timing of muscle activity will be expressed as a percentage of gait cycle.
Assistance Publique Hopitaux De Marseille
Other
Acronym: SERIOUS GAME
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View the official ClinicalTrials.gov record (opens in a new tab)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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