Is EMG-based Serious Games Effective in Improving Gait in Children With Cerebral Palsy ? Interest of Electromyography Feedback (EMG)

Cerebral Palsy Clinical Trial

— SERIOUS GAME  

Official title:

Is EMG-based Serious Games Effective in Improving Gait in Children With Cerebral Palsy ? Interest of Electromyography Feedback (EMG)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03628261
• Other study ID #: 2017-63
• Secondary ID: 2018-A00831-54
• Status: Completed
• Phase: N/A
• Start date: July 23, 2019
• Est. completion date: March 1, 2022

Study information

• Verified date: July 2022
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 1, 2022
• Est. primary completion date: January 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 10 Years

Eligibility

Inclusion Criteria:

• Children aged 2 to 10 years,

• Hemiparetic child (left or right) by cerebral palsy, (scoring Level 1 or 2 on the Gross Motor Function Classification System),

• Initial contact during gait (just before the stance phase) with Equinovarus or Equinovalgus ,

• Child with cognitive functions compatible with the instructions of serious games,

• Children with parents (or legal guardians) authorizing participation in the study and a signed informed consent form,

• Children affiliated with medical insurance.

Exclusion Criteria:

• Children under 2 years old and over 10 years old,

• Children who have had orthopedic surgery and / or administration of botulinum toxin to the calf muscles within six months prior to study participation.

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Device:
• Serious Game
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.

Other:
• physical therapy
Children receive the regular rehabilitation for the treatment of ankle plantar flexor muscle overactivity and the paresis of ankle dorsal flexor muscle

Locations

Country	Name	City	State
France	Assistance Publique Hôpitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of muscle was activated during gait	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.	12 months