Muscle SpasticityFAT-GAITNCT06163950
The Decline in Walking Performance in Adults With Cerebral Palsy - Influence of Performance Fatigability
A study testing Fatigability assessment in people with Muscle Spasticity and Paralysis; Cerebral, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Muscle Spasticity, Paralysis; Cerebral
- What is being tested?
- Fatigability assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 2 May 2023to 10 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Muscle Spasticity, Paralysis; Cerebral
- Being tested
- Fatigability assessment
- Keywords
- Fatigue, fatigue-resistance, torque, power, Cerebral Palsy
- Medical subject headings
- Muscle Spasticity, Cerebral Palsy, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Fatigability assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week : 6
Secondary outcomes (13)
Maximum voluntary force torque measurement of the knee flexor muscles
Measurement of the (in Nm) of the knee flexor muscles in isometric and dynamic contraction.
Measured: Week : 2
Maximum voluntary force torque measurement of the plantar flexor
Measurement of the (in Nm) of the plantar flexor in isometric and dynamic contraction.
Measured: Week : 2
Maximum voluntary force torque measurement of knee extensor muscles
Measurement of the (in Nm) of the knee extensor muscles in isometric and dynamic contraction.
Measured: Week : 4
Level of voluntary activation measurement
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.
Measured: Week : 6
Measurement of joint amplitude (in °)
Evaluation of the passive muscular properties of the dominant leg, on the knee flexor muscles, and on the plantar flexor and knee extensor muscles
Measured: Week : 6
Measurement of passive torque (in Nm)
Evaluation of the passive muscular properties of the dominant leg, on the knee flexor muscles, and on the plantar flexor and knee extensor muscles
Measured: Week : 6
Evaluation of neuromuscular fatigue
The decrease in muscle twitch evoked by electrical nerve stimulation (in %) (peripheral fatigue)
Measured: Week : 6
VO2max (in mL/min/kg)
Cardiorespiratory capacity will be assessed by measuring maximal oxygen consumption (VO2max (in mL/min/kg)) in an incremental cyclo-ergometer test.
Measured: Week : 6
The distance covered (in m) in the 6-minute walking test
Quantitative walking performance will be assessed by measuring the distance covered (in m) in the 6-minute walking test
Measured: Week : 6
Time (in seconds) taken during the 10-meter walk test
Quantitative walking performance will be assessed by measuring the time (in seconds) taken during the 10-meter walk test
Measured: Week : 6
Time (in s) taken in the "Get Up and Go" test
Quantitative walking performance will be assessed by measuring the time (in s) taken in the "Get Up and Go" test
Measured: Week : 6
Walking Quality evaluation
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.
Measured: Week : 6
Berg Balance Scale
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
Measured: Week : 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start2 May 2023
- Primary completion10 Jul 2024
- Study completion10 Jul 2024
Why it stopped: Lack of inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Muscle SpasticityStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bruno FERNANDEZ, MD, Principal investigator, CHU DE SAINT-ETIENNE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06163950
- Sponsor's protocol ID
- 22CH527
- Other IDs
- 2022-A02510-43
- Acronym
- FAT-GAIT
- Status last verified
- Oct 2024
- First submitted
- 1 Dec 2023
- Last updated
- 26 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39609007
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Decline in Walking Performance in Adults With Cerebral Palsy - Influence of Performance Fatigability
- ClinicalTrials.gov ID
- NCT06163950
- Acronym / sponsor ID
- FAT-GAIT / 22CH527
- Conditions
- Muscle Spasticity, Paralysis; Cerebral
- Keywords
- Fatigue, fatigue-resistance, torque, power, Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of inclusion
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 2 May 2023 (actual)
- Primary completion
- 10 Jul 2024 (actual)
- Study completion
- 10 Jul 2024 (actual)
- First posted
- 11 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with cerebral palsy | Experimental | Other: Fatigability assessmentA 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. |
| Healthy people | Active comparator | Other: Fatigability assessmentA 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fatigability assessmentAn 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 | Healthy people, Patients with cerebral palsy |
Primary outcome
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.
13 secondary outcomes
Maximum voluntary force torque measurement of the knee flexor muscles
Time frame: Week : 2
Maximum voluntary force torque measurement of the plantar flexor
Time frame: Week : 2
Maximum voluntary force torque measurement of knee extensor muscles
Time frame: Week : 4
Level of voluntary activation measurement
Time frame: Week : 6
Measurement of joint amplitude (in °)
Time frame: Week : 6
Measurement of passive torque (in Nm)
Time frame: Week : 6
Evaluation of neuromuscular fatigue
Time frame: Week : 6
VO2max (in mL/min/kg)
Time frame: Week : 6
The distance covered (in m) in the 6-minute walking test
Time frame: Week : 6
Time (in seconds) taken during the 10-meter walk test
Time frame: Week : 6
Time (in s) taken in the "Get Up and Go" test
Time frame: Week : 6
Walking Quality evaluation
Time frame: Week : 6
Berg Balance Scale
Time frame: Week : 6
Results and safety
The study was stopped early (reason given: Lack of inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
- Derived from this study: PubMed 39609007Gravholt 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruno FERNANDEZ, MD principal investigator
CHU DE SAINT-ETIENNE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fatigability assessment in people with Muscle Spasticity and Paralysis; Cerebral, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of inclusion). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuromuscular fatigue (time frame: Week : 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06163950, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2024.