The Decline in Walking Performance in Adults With Cerebral Palsy - Influence of Performance Fatigability (FAT-GAIT)

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.

Study Overview

• Status: Terminated
• Conditions: Muscle Spasticity; Paralysis; Cerebral
• Intervention / Treatment: Other: Fatigability assessment

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint-Étienne, France, 42055
    • CENTRE HOSPITALIER DE SAINT-ETIENNE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with cerebral palsy; 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.
Active Comparator: Healthy people; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
Evaluation of neuromuscular fatigue	The decrease in muscle twitch evoked by electrical nerve stimulation (in %) (peripheral fatigue)	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.	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	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	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	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.	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	Week : 6

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Bruno FERNANDEZ, MD, Chu de Saint-Etienne

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2023
• Primary Completion (Actual): July 10, 2024
• Study Completion (Actual): July 10, 2024

Study Registration Dates

• First Submitted: December 1, 2023
• First Submitted That Met QC Criteria: December 1, 2023
• First Posted (Actual): December 11, 2023

Study Record Updates

• Last Update Posted (Actual): October 26, 2024
• Last Update Submitted That Met QC Criteria: October 24, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Cerebral Palsy; Fatigue; torque; power; fatigue-resistance
• Additional Relevant MeSH Terms: Neurologic Manifestations; Musculoskeletal Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Muscular Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Brain Damage, Chronic; Muscle Spasticity; Cerebral Palsy; Paralysis
• Other Study ID Numbers: 22CH527; 2022-A02510-43 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No