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

Muscle Spasticity Clinical Trial

— FAT-GAIT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06163950
• Other study ID #: 22CH527
• Secondary ID: 2022-A02510-43
• Status: Recruiting
• Phase: N/A
• Start date: May 2, 2023
• Est. completion date: October 31, 2024

Study information

• Verified date: December 2023
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: Bruno FERNANDEZ, MD
• Phone: (0)4 77 12 04 67
• Email: bruno.fernandez[@]chu-st-etienne.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: October 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Palsy
• Muscle Spasticity
• Paralysis

Intervention

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.

Locations

Country	Name	City	State
France	Centre Hospitalier de Saint-Etienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Week : 6
Secondary	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.	Week : 2
Secondary	Maximum voluntary force torque measurement of the plantar flexor	Measurement of the (in Nm) of the plantar flexor in isometric and dynamic contraction.	Week : 2
Secondary	Maximum voluntary force torque measurement of knee extensor muscles	Measurement of the (in Nm) of the knee extensor muscles in isometric and dynamic contraction.	Week : 4
Secondary	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.	Week : 6
Secondary	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	Week : 6
Secondary	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	Week : 6
Secondary	Evaluation of neuromuscular fatigue	The decrease in muscle twitch evoked by electrical nerve stimulation (in %) (peripheral fatigue)	Week : 6
Secondary	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.	Week : 6
Secondary	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	Week : 6
Secondary	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	Week : 6
Secondary	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	Week : 6
Secondary	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.	Week : 6
Secondary	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	Week : 6