NCT06163950

Brief Summary

Due to an early brain injury occurring in antenatal or postnatal, cerebral palsy (CP) causes alteration in motor function with posture and gait disorders. It is commonly observed motor performance degradation during adulthood, and the underlying pathophysiology remains poorly known.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2023

Geographic Reach
1 country

1 active site

Status
terminated

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

Study Start

First participant enrolled

May 2, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 1, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 11, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2024

Completed
Last Updated

October 26, 2024

Status Verified

October 1, 2024

Enrollment Period

1.2 years

First QC Date

December 1, 2023

Last Update Submit

October 24, 2024

Conditions

Muscle SpasticityParalysis; Cerebral

Keywords

Fatiguefatigue-resistancetorquepowerCerebral Palsy

Outcome Measures

Primary Outcomes (1)

  • Neuromuscular fatigue

    Neuromuscular fatigue, defined as the decrease in maximal voluntary force (in % of the resting value) developed in isometric knee extension following a standardized fatigue protocol.

    Week : 6

Secondary Outcomes (13)

  • Maximum voluntary force torque measurement of the knee flexor muscles

    Week : 2

  • Maximum voluntary force torque measurement of the plantar flexor

    Week : 2

  • Maximum voluntary force torque measurement of knee extensor muscles

    Week : 4

  • Level of voluntary activation measurement

    Week : 6

  • Measurement of joint amplitude (in °)

    Week : 6

  • +8 more secondary outcomes

Study Arms (2)

Patients with cerebral palsy

EXPERIMENTAL

A specially adapted recumbent cycle ergometer with the ability to quickly transform into an isometric dynamometer will be used to assess fatigability development during a task to failure. Throughout the task, which consists of blocks of 3 minutes, neuromuscular assessments will take place to determine the evolution of fatigability and its peripheral and central determinants.

Other: Fatigability assessment

Healthy people

ACTIVE COMPARATOR

A specially adapted recumbent cycle ergometer with the ability to quickly transform into an isometric dynamometer will be used to assess fatigability development during a task to failure. Throughout the task, which consists of blocks of 3 minutes, neuromuscular assessments will take place to determine the evolution of fatigability and its peripheral and central determinants.

Other: Fatigability assessment

Interventions

Fatigability assessmentOTHER

An isometric dynamometer will be used to assess fatigability development during a task to failure. Throughout the task, which consists of blocks of 3 minutes, neuromuscular assessments will take place to determine the evolution of fatigability and its peripheral and central determinants.

Healthy peoplePatients with cerebral palsy

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Common for CP and healthy volunteers:
  • Capable of walking for six minutes without stopping
  • Capable of consenting to the tests
  • Specific for the CP group
  • GMFCS I or II at age 18
  • Spastic diplegic cerebral palsy

You may not qualify if:

  • Counter-indications to the test procedures
  • Mental retardation or intelligence quotient (IQ) below 80
  • Accompanying diseases not allowing for the test setup
  • Major surgeries altering performance in the last six months
  • Injection of botulin altering maximal force production in the last three months
  • Refusing to sign the consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier de Saint-Etienne

Saint-Etienne, 42055, France

Location

Related Publications (1)

  • Gravholt A, Fernandez B, Rimaud D, Zeghoudi N, Bessaguet H, Espeit L, Feasson L, Millet GY, Buizer AI, Lapole T. Unravelling age-related gait decline in cerebral palsy: insights into physiological changes and functional implications through an observational study-a French study protocol in a laboratory setting. BMJ Open. 2024 Nov 27;14(11):e090096. doi: 10.1136/bmjopen-2024-090096.

    PMID: 39609007DERIVED

MeSH Terms

Conditions

Muscle SpasticityCerebral PalsyFatigue

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBrain Damage, ChronicBrain DiseasesCentral Nervous System Diseases

Study Officials

  • Bruno FERNANDEZ, MD

    CHU DE SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2023

First Posted

December 11, 2023

Study Start

May 2, 2023

Primary Completion

July 10, 2024

Study Completion

July 10, 2024

Last Updated

October 26, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)