Impact of Muscular Fatigability on Spastic Co-contractions After Stroke Patients (COCON)

Impact of Muscular Fatigability on Spastic Co-contractions Between the Quadriceps and Hamstrings in Stroke Patients

This study evaluates the effects of an isokinetic fatigue protocol of the quadriceps on the amount of co-contractions of this last with the hamstrings during a maximal isometric flexion movement in hemiparetic stroke patients.

The effect of such a protocol on gait parameters and spasticity of the quadriceps will be evaluated also.

Study Overview

• Status: Completed
• Conditions: Stroke; Spasticity, Muscle; Gait, Hemiplegic; Muscle Fatigue
• Intervention / Treatment: Procedure: Muscle fatigue

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

Contacts and Locations

Study Locations

• France
  • Lille, France
    • Hôpital Swynghedauw, CHU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age between 18 and 80y
• Hemiparesis after a first-ever stroke > 3 months
• Spasticity of the quadriceps muscle
• Quadriceps strength at least at 3/5 (MRC testing)
• Subject able to walk at least 2min without rest
• Informed consent
• Social security affiliation

Exclusion Criteria:

• Severe comprehension troubles (language, cognitive or psychiatric disorders)
• History of previous stroke, locomotor or other neurological disorders
• Locomotor troubles affecting the paretic arm
• Contraindication to efforts : cardiac insufficiency, severe aortic valvular stenosis, recent heart failure, non treated high blood pressure, severe peripheral arterial disease
• Pregnancy or breastfeeding
• Adult subject to guardianship

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Quadriceps muscle fatigue	Procedure: Muscle fatigue; Isokinetic quadriceps muscle fatigue of the paretic lower limb

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cocontraction Index (CCI) between the rectus femoris and the semitendinosus	ratio of the RMS of a the rectus femoris when acting as antagonist to the effort intended (knee flexion) to the RMS of the same muscle when acting as an agonist during a reciprocal maximal isometric knee flexion effort (500 ms around the peak of rectified EMG	one day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cocontraction Index (CCI) between the other parts of the quadriceps and the semitendinosus muscle	ratio of the RMS of a the vastus medialis, lateralis and intermedius when acting as antagonist to the effort intended (knee flexion) to the RMS of the same muscle when acting as an agonist during a reciprocal maximal isometric knee flexion effort (500 ms around the peak of rectified EMG	one day
Agonist Recruitment Index of the semitendinosus	ratio of the RMS of a muscle acting as an agonist during a given period to its largest RMS value observed during the 500 ms around its agonist recruitment peak	one day
Isometric peak knee flexion torque	Isometric peak knee flexion torque assessed by a CONTREX dynamometer	one day
Spasticity of the quadriceps	Tardieu scale angle	one day
spatio-temporal gait parameters at comfortable speed	Gait speed	one day
spatio-temporal gait parameters at comfortable speed	Gait cadence	one day
spatio-temporal gait parameters at comfortable speed	Step length	one day
Isometric peak knee extension torque	Isometric peak knee extension torque assessed by a CONTREX dynamometer	one day
10 metre walk test (10MWT)	Assessment of max gait speed	one day
2 minute walk test (2MWT)	Assessment of max walking endurance	one day
perceived exertion at the end of the 2MWT (Borg Scale 6-20)		one day

Collaborators and Investigators

• Sponsor: University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2018
• Primary Completion (Actual): October 10, 2019
• Study Completion (Actual): October 10, 2019

Study Registration Dates

• First Submitted: October 16, 2017
• First Submitted That Met QC Criteria: November 14, 2017
• First Posted (Actual): November 17, 2017

Study Record Updates

• Last Update Posted (Actual): March 26, 2020
• Last Update Submitted That Met QC Criteria: March 25, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Stroke; Muscle Spasticity; Gait Disorders, Neurologic
• Other Study ID Numbers: 2016_50; 2017_A01605-48 (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

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