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

Primary Purpose

Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Serious Game
physical therapy
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy

Eligibility Criteria

2 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Assistance Publique Hôpitaux de Marseille

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

physical therapy then serious games

serious games then physical therapy

Arm Description

Children will receive four weeks of treatment with EMG-based serious games in addition to the conventional physiotherapy

Children will receive four weeks of treatment with EMG-based serious games in addition to the conventional physiotherapy

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
August 9, 2018
Last Updated
July 27, 2022
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT03628261
Brief Title
Is EMG-based Serious Games Effective in Improving Gait in Children With Cerebral Palsy ? Interest of Electromyography Feedback (EMG)
Acronym
SERIOUS GAME
Official Title
Is EMG-based Serious Games Effective in Improving Gait in Children With Cerebral Palsy ? Interest of Electromyography Feedback (EMG)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
July 23, 2019 (Actual)
Primary Completion Date
January 4, 2022 (Actual)
Study Completion Date
March 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
physical therapy then serious games
Arm Type
Other
Arm Description
Children will receive four weeks of treatment with EMG-based serious games in addition to the conventional physiotherapy
Arm Title
serious games then physical therapy
Arm Type
Other
Arm Description
Children will receive four weeks of treatment with EMG-based serious games in addition to the conventional physiotherapy
Intervention Type
Device
Intervention Name(s)
Serious Game
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
physical therapy
Intervention Description
Children receive the regular rehabilitation for the treatment of ankle plantar flexor muscle overactivity and the paresis of ankle dorsal flexor muscle
Primary Outcome Measure Information:
Title
number of muscle was activated during gait
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Olivier ARNAUD, Director
Organizational Affiliation
Assistance Publique des Hôpitaux de Marseille
Official's Role
Study Director
Facility Information:
Facility Name
Assistance Publique Hôpitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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