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

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ClinicalTrials.gov Identifier: NCT03342820
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : April 25, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

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.


Condition or disease Intervention/treatment Phase
Stroke Spasticity, Muscle Muscle Fatigue Gait, Hemiplegic Procedure: Muscle fatigue Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Impact of Muscular Fatigability on Spastic Co-contractions Between the Quadriceps and Hamstrings in Stroke Patients
Actual Study Start Date : January 19, 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue

Arm Intervention/treatment
Experimental: Quadriceps muscle fatigue
Quadriceps muscle fatigue
Procedure: Muscle fatigue
Isokinetic quadriceps muscle fatigue of the paretic lower limb




Primary Outcome Measures :
  1. Cocontraction Index (CCI) between the rectus femoris and the semitendinosus [ Time Frame: one day ]
    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 :
  1. Cocontraction Index (CCI) between the other parts of the quadriceps and the semitendinosus muscle [ Time Frame: one day ]
    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

  2. Agonist Recruitment Index of the semitendinosus [ Time Frame: one day ]
    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

  3. Isometric peak knee flexion torque [ Time Frame: one day ]
    Isometric peak knee flexion torque assessed by a CONTREX dynamometer

  4. Spasticity of the quadriceps [ Time Frame: one day ]
    Tardieu scale angle

  5. spatio-temporal gait parameters at comfortable speed [ Time Frame: one day ]
    Gait speed

  6. spatio-temporal gait parameters at comfortable speed [ Time Frame: one day ]
    Gait cadence

  7. spatio-temporal gait parameters at comfortable speed [ Time Frame: one day ]
    Step length

  8. Isometric peak knee extension torque [ Time Frame: one day ]
    Isometric peak knee extension torque assessed by a CONTREX dynamometer

  9. 10 metre walk test (10MWT) [ Time Frame: one day ]
    Assessment of max gait speed

  10. 2 minute walk test (2MWT) [ Time Frame: one day ]
    Assessment of max walking endurance

  11. perceived exertion at the end of the 2MWT (Borg Scale 6-20) [ Time Frame: one day ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03342820


Contacts
Contact: Etienne Allart, MD, PhD 3 20 44 48 71 ext +33 etienne.allart@chru-lille.fr

Locations
France
Hôpital Swynghedauw, CHU Recruiting
Lille, France
Principal Investigator: Etienne ALLART, MD         
Sponsors and Collaborators
University Hospital, Lille
Investigators
Principal Investigator: Etienne Allart, Md University Hospital, Lille

Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT03342820     History of Changes
Other Study ID Numbers: 2016_50
2017_A01605-48 ( Other Identifier: ID-RCB number, ANSM )
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: April 25, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Gait Disorders, Neurologic
Stroke
Fatigue
Muscle Spasticity
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations