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The Decline in Walking Performance in Adults With Cerebral Palsy - Influence of Performance Fatigability

The Decline in Walking Performance in Adults With Cerebral Palsy - Influence of Performance Fatigability

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06163950
Acronym
FAT-GAIT
Enrollment
30
Registered
2023-12-11
Start date
2023-05-02
Completion date
2024-07-10
Last updated
2024-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Muscle Spasticity, Paralysis; Cerebral

Keywords

Fatigue, fatigue-resistance, torque, power, Cerebral Palsy

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.

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.

Interventions

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.

Sponsors

Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Neuromuscular fatigueWeek : 6Neuromuscular fatigue, defined as the decrease in maximal voluntary force (in % of the resting value) developed in isometric knee extension following a standardized fatigue protocol.

Secondary

MeasureTime frameDescription
Maximum voluntary force torque measurement of the plantar flexorWeek : 2Measurement of the (in Nm) of the plantar flexor in isometric and dynamic contraction.
Maximum voluntary force torque measurement of knee extensor musclesWeek : 4Measurement of the (in Nm) of the knee extensor muscles in isometric and dynamic contraction.
Level of voluntary activation measurementWeek : 6Measurement 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.
Measurement of joint amplitude (in °)Week : 6Evaluation of the passive muscular properties of the dominant leg, on the knee flexor muscles, and on the plantar flexor and knee extensor muscles
Measurement of passive torque (in Nm)Week : 6Evaluation of the passive muscular properties of the dominant leg, on the knee flexor muscles, and on the plantar flexor and knee extensor muscles
Evaluation of neuromuscular fatigueWeek : 6The decrease in muscle twitch evoked by electrical nerve stimulation (in %) (peripheral fatigue)
Maximum voluntary force torque measurement of the knee flexor musclesWeek : 2Measurement of the (in Nm) of the knee flexor muscles in isometric and dynamic contraction.
The distance covered (in m) in the 6-minute walking testWeek : 6Quantitative walking performance will be assessed by measuring the distance covered (in m) in the 6-minute walking test
Time (in seconds) taken during the 10-meter walk testWeek : 6Quantitative walking performance will be assessed by measuring the time (in seconds) taken during the 10-meter walk test
Time (in s) taken in the Get Up and Go testWeek : 6Quantitative walking performance will be assessed by measuring the time (in s) taken in the Get Up and Go test
Walking Quality evaluationWeek : 6The 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.
Berg Balance ScaleWeek : 6Postural 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
VO2max (in mL/min/kg)Week : 6Cardiorespiratory capacity will be assessed by measuring maximal oxygen consumption (VO2max (in mL/min/kg)) in an incremental cyclo-ergometer test.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026