NCT07838688

Brief Summary

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 Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
24mo left

Started Jan 2027

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 4, 2026

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 24, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2027

Expected
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2028

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2029

Last Updated

September 24, 2026

Status Verified

September 1, 2026

Enrollment Period

1.5 years

First QC Date

September 4, 2026

Last Update Submit

September 17, 2026

Conditions

Cerebral PalsyHemiparesis; Poststroke/CVAHealthy (Controls)

Keywords

surface electromyographyhemiparesisPoststroke CVAcerebral palsyrehabilitation game

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (21)

  • Muscle activation

    Day 1 : between game mode

  • Amount of activity performed

    Day 1 : between game mode

  • Amount of activity performed

    Day 1 : between game mode

  • Amount of activity performed

    Day 1 : between game mode

  • Training volume

    Day 1 : between game mode

  • +16 more secondary outcomes

Study Arms (1)

Surface EMG-controlled Rehabilitation Game

EXPERIMENTAL

Exergame

Other: Surface electromyography (sEMG)-controlled rehabilitation game

Interventions

Surface electromyography (sEMG)-controlled rehabilitation gameOTHER

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.

Surface EMG-controlled Rehabilitation Game

Eligibility Criteria

Age7 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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
  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de RENNES

Rennes, France

Location

MeSH Terms

Conditions

Cerebral PalsyParesis

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sophie HAMEAU

    Rennes University Hospital

    STUDY DIRECTOR

Central Study Contacts

Isabelle LEROYER

CONTACT

299282555isabelle.leroyer@chu-rennes.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: 3 groups of participants : cerebral palsy kids, hemiparetic adults and healthy controls
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2026

First Posted

September 24, 2026

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

July 1, 2028

Study Completion (Estimated)

January 1, 2029

Last Updated

September 24, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Data availability after the primary publication of the results and until the database is deleted
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.

Locations

FR(1)