NCT03342820

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 17, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

January 19, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2019

Completed
Last Updated

March 26, 2020

Status Verified

March 1, 2020

Enrollment Period

1.7 years

First QC Date

October 16, 2017

Last Update Submit

March 25, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • Cocontraction Index (CCI) between the other parts of the quadriceps and the semitendinosus muscle

    one day

  • Agonist Recruitment Index of the semitendinosus

    one day

  • Isometric peak knee flexion torque

    one day

  • Spasticity of the quadriceps

    one day

  • spatio-temporal gait parameters at comfortable speed

    one day

  • +6 more secondary outcomes

Study Arms (1)

Quadriceps muscle fatigue

EXPERIMENTAL

Quadriceps muscle fatigue

Procedure: Muscle fatigue

Interventions

Isokinetic quadriceps muscle fatigue of the paretic lower limb

Quadriceps muscle fatigue

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Swynghedauw, CHU

Lille, France

Location

MeSH Terms

Conditions

StrokeMuscle SpasticityGait Disorders, Neurologic

Interventions

Muscle Fatigue

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesMuscular DiseasesMusculoskeletal DiseasesMuscle HypertoniaNeuromuscular ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Etienne Allart, Md

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2017

First Posted

November 17, 2017

Study Start

January 19, 2018

Primary Completion

October 10, 2019

Study Completion

October 10, 2019

Last Updated

March 26, 2020

Record last verified: 2020-03

Locations