Clinical trial NCT06163950: The Decline in Walking Performance in Adults With Cerebral Palsy - Influence of Performance Fatigability
Official title: The Decline in Walking Performance in Adults With Cerebral Palsy - Influence of Performance Fatigability
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Muscle Spasticity
Paralysis; Cerebral
Keywords: Fatigue
fatigue-resistance
torque
power
Cerebral Palsy
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2023-12-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Neuromuscular fatigue
timeFrame: Week : 6
Secondary outcomes:
measure: Maximum voluntary force torque measurement of the knee flexor muscles
timeFrame: Week : 2
measure: Maximum voluntary force torque measurement of the plantar flexor
timeFrame: Week : 2
measure: Maximum voluntary force torque measurement of knee extensor muscles
timeFrame: Week : 4
measure: Level of voluntary activation measurement
timeFrame: Week : 6
measure: Measurement of joint amplitude (in °)
timeFrame: Week : 6
measure: Measurement of passive torque (in Nm)
timeFrame: Week : 6
measure: Evaluation of neuromuscular fatigue
timeFrame: Week : 6
measure: VO2max (in mL/min/kg)
timeFrame: Week : 6
measure: The distance covered (in m) in the 6-minute walking test
timeFrame: Week : 6
measure: Time (in seconds) taken during the 10-meter walk test
timeFrame: Week : 6
measure: Time (in s) taken in the "Get Up and Go" test
timeFrame: Week : 6
measure: Walking Quality evaluation
timeFrame: Week : 6
measure: Berg Balance Scale
timeFrame: Week : 6
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: Centre Hospitalier de Saint-Etienne
Study officials:
affiliation: CHU DE SAINT-ETIENNE
name: Bruno FERNANDEZ, MD
role: PRINCIPAL_INVESTIGATOR
References: