An interventional study of Fatigability assessment in Muscle Spasticity and Paralysis; Cerebral, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Terminated at 1 site in France. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-26.
Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Not applicable, Interventional, and Other
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.
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.
704 studies on the registry are indexed under Muscle Spasticity; 149 are open to participants now.
This study's enrollment of 30 is below the median of 36 across 525 interventional studies indexed under Muscle Spasticity.
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Common for CP and healthy volunteers:
Specific for the CP group
Exclusion Criteria:
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
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.
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.
Time frame: Week : 6
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: Week : 6
Evaluation of neuromuscular fatigue
The decrease in muscle twitch evoked by electrical nerve stimulation (in %) (peripheral fatigue)
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: Week : 6
Plan to share: No
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Centre Hospitalier Universitaire de Saint Etienne