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

Primary Purpose

Stroke, Spasticity, Muscle, Muscle Fatigue

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Muscle fatigue
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Stroke

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Swynghedauw, CHU

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Quadriceps muscle fatigue

Arm Description

Quadriceps muscle fatigue

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
Isometric peak knee flexion torque
Isometric peak knee flexion torque assessed by a CONTREX dynamometer
Spasticity of the quadriceps
Tardieu scale angle
spatio-temporal gait parameters at comfortable speed
Gait speed
spatio-temporal gait parameters at comfortable speed
Gait cadence
spatio-temporal gait parameters at comfortable speed
Step length
Isometric peak knee extension torque
Isometric peak knee extension torque assessed by a CONTREX dynamometer
10 metre walk test (10MWT)
Assessment of max gait speed
2 minute walk test (2MWT)
Assessment of max walking endurance
perceived exertion at the end of the 2MWT (Borg Scale 6-20)

Full Information

First Posted
October 16, 2017
Last Updated
March 25, 2020
Sponsor
University Hospital, Lille
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1. Study Identification

Unique Protocol Identification Number
NCT03342820
Brief Title
Impact of Muscular Fatigability on Spastic Co-contractions After Stroke Patients
Acronym
COCON
Official Title
Impact of Muscular Fatigability on Spastic Co-contractions Between the Quadriceps and Hamstrings in Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
January 19, 2018 (Actual)
Primary Completion Date
October 10, 2019 (Actual)
Study Completion Date
October 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Spasticity, Muscle, Muscle Fatigue, Gait, Hemiplegic

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Quadriceps muscle fatigue
Arm Type
Experimental
Arm Description
Quadriceps muscle fatigue
Intervention Type
Procedure
Intervention Name(s)
Muscle fatigue
Intervention Description
Isokinetic quadriceps muscle fatigue of the paretic lower limb
Primary Outcome Measure Information:
Title
Cocontraction Index (CCI) between the rectus femoris and the semitendinosus
Description
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
Time Frame
one day
Secondary Outcome Measure Information:
Title
Cocontraction Index (CCI) between the other parts of the quadriceps and the semitendinosus muscle
Description
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
Time Frame
one day
Title
Agonist Recruitment Index of the semitendinosus
Description
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
Time Frame
one day
Title
Isometric peak knee flexion torque
Description
Isometric peak knee flexion torque assessed by a CONTREX dynamometer
Time Frame
one day
Title
Spasticity of the quadriceps
Description
Tardieu scale angle
Time Frame
one day
Title
spatio-temporal gait parameters at comfortable speed
Description
Gait speed
Time Frame
one day
Title
spatio-temporal gait parameters at comfortable speed
Description
Gait cadence
Time Frame
one day
Title
spatio-temporal gait parameters at comfortable speed
Description
Step length
Time Frame
one day
Title
Isometric peak knee extension torque
Description
Isometric peak knee extension torque assessed by a CONTREX dynamometer
Time Frame
one day
Title
10 metre walk test (10MWT)
Description
Assessment of max gait speed
Time Frame
one day
Title
2 minute walk test (2MWT)
Description
Assessment of max walking endurance
Time Frame
one day
Title
perceived exertion at the end of the 2MWT (Borg Scale 6-20)
Time Frame
one day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Etienne Allart, Md
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Swynghedauw, CHU
City
Lille
Country
France

12. IPD Sharing Statement

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

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