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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03342820
Other study ID # 2016_50
Secondary ID 2017_A01605-48
Status Completed
Phase N/A
First received
Last updated
Start date January 19, 2018
Est. completion date October 10, 2019

Study information

Verified date March 2020
Source University Hospital, Lille
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date October 10, 2019
Est. primary completion date October 10, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design


Intervention

Procedure:
Muscle fatigue
Isokinetic quadriceps muscle fatigue of the paretic lower limb

Locations

Country Name City State
France Hôpital Swynghedauw, CHU Lille

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

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