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NCT Number: NCT03342820

Impact of Muscular Fatigability on Spastic Co-contractions After 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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Gait Disorders, Neurologic Gait, Hemiplegic Muscle Fatigue Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Spasticity, Muscle Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Swynghedauw, CHU

Lille, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Muscle fatigue

Procedure

Isokinetic quadriceps muscle fatigue of the paretic lower limb

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

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

Acronym: COCON

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 17, 2017
Registry last updated
Mar 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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