The Decline in Walking Performance in Adults With Cerebral Palsy - Influence of Performance Fatigability (FAT-GAIT)

October 24, 2024 updated by: Centre Hospitalier Universitaire de Saint Etienne
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

One of the hypotheses to explain the decline in walking capacities in adults with CP is their greater fatigability, that could be related to energy overconsumption (due to the specific biomechanical constraints of their walking pattern) and/or the occurrence of early sarcopenia affecting the compensatory muscle mechanisms commonly seen in children to compensate for architectural disorders and posture alterations. To optimize prevention and/or therapy in these patients, it is crucial to better understand the aetiology of fatigability and its role in the decline in walking performance.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Saint-Étienne, France, 42055
        • CENTRE HOSPITALIER DE SAINT-ETIENNE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Patients with cerebral palsy
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
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.
Active Comparator: Healthy people
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Neuromuscular fatigue
Time Frame: Week : 6
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maximum voluntary force torque measurement of the knee flexor muscles
Time Frame: Week : 2
Measurement of the (in Nm) of the knee flexor muscles in isometric and dynamic contraction.
Week : 2
Maximum voluntary force torque measurement of the plantar flexor
Time Frame: Week : 2
Measurement of the (in Nm) of the plantar flexor in isometric and dynamic contraction.
Week : 2
Maximum voluntary force torque measurement of knee extensor muscles
Time Frame: Week : 4
Measurement of the (in Nm) of the knee extensor muscles in isometric and dynamic contraction.
Week : 4
Level of voluntary activation measurement
Time Frame: Week : 6
Measurement of the level of voluntary activation (in %) determined by the force increment obtained following electrical stimulation of the motor nerve during a muscle condition of maximum contraction.
Week : 6
Measurement of joint amplitude (in °)
Time Frame: Week : 6
Evaluation of the passive muscular properties of the dominant leg, on the knee flexor muscles, and on the plantar flexor and knee extensor muscles
Week : 6
Measurement of passive torque (in Nm)
Time Frame: Week : 6
Evaluation of the passive muscular properties of the dominant leg, on the knee flexor muscles, and on the plantar flexor and knee extensor muscles
Week : 6
Evaluation of neuromuscular fatigue
Time Frame: Week : 6
The decrease in muscle twitch evoked by electrical nerve stimulation (in %) (peripheral fatigue)
Week : 6
VO2max (in mL/min/kg)
Time Frame: Week : 6
Cardiorespiratory capacity will be assessed by measuring maximal oxygen consumption (VO2max (in mL/min/kg)) in an incremental cyclo-ergometer test.
Week : 6
The distance covered (in m) in the 6-minute walking test
Time Frame: Week : 6
Quantitative walking performance will be assessed by measuring the distance covered (in m) in the 6-minute walking test
Week : 6
Time (in seconds) taken during the 10-meter walk test
Time Frame: Week : 6
Quantitative walking performance will be assessed by measuring the time (in seconds) taken during the 10-meter walk test
Week : 6
Time (in s) taken in the "Get Up and Go" test
Time Frame: Week : 6
Quantitative walking performance will be assessed by measuring the time (in s) taken in the "Get Up and Go" test
Week : 6
Walking Quality evaluation
Time Frame: Week : 6
The quality of walking will be evaluated (only in CP subjects) by a Quantified Gait Analysis (QGA) allowing the measurement of spatio-temporal parameters, joint kinematics and kinetics as well as muscle activity during walking. will be evaluated (only in CP subjects) by a Quantified Gait Analysis (QGA) allowing the measurement of spatio-temporal parameters, joint kinematics and kinetics as well as muscle activity during walking.
Week : 6
Berg Balance Scale
Time Frame: Week : 6

Postural control (or balance) will be assessed (only in CP subjects) by the Berg Balance Scale (BBS) score. This score, ranging from 0 to 56, is an index to measure functional balance.

0 means high risk of falling; person needs a wheelchair 56 means no risk of falling; the person has functional balance
Week : 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Saint Etienne

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Bruno FERNANDEZ, MD, CHU de Saint-Etienne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 2, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 10, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 10, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 1, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 11, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 26, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 22CH527
  • 2022-A02510-43 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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