StrokeCOCONNCT03342820
Impact of Muscular Fatigability on Spastic Co-contractions After Stroke Patients
A study testing Muscle fatigue in people with Stroke and Spasticity, Muscle, run by University Hospital, Lille at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke, Spasticity, Muscle, Muscle Fatigue
- What is being tested?
- Muscle fatigue
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 19 Jan 2018to 10 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Muscular Fatigability on Spastic Co-contractions Between the Quadriceps and Hamstrings in 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.
- Conditions
- Stroke, Spasticity, Muscle, Muscle Fatigue, Gait, Hemiplegic
- Being tested
- Muscle fatigue
- Medical subject headings
- Stroke, Muscle Spasticity, Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle fatigueProcedure or surgery
Isokinetic quadriceps muscle fatigue of the paretic lower limb
| Study group | Role | What they receive |
|---|---|---|
| Quadriceps muscle fatigue | Experimental | Quadriceps muscle fatigue Receives: Procedure: Muscle fatigue |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one day
Secondary outcomes (11)
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
Measured: one day
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
Measured: one day
Isometric peak knee flexion torque
Isometric peak knee flexion torque assessed by a CONTREX dynamometer
Measured: one day
Spasticity of the quadriceps
Tardieu scale angle
Measured: one day
spatio-temporal gait parameters at comfortable speed
Gait speed
Measured: one day
spatio-temporal gait parameters at comfortable speed
Gait cadence
Measured: one day
spatio-temporal gait parameters at comfortable speed
Step length
Measured: one day
Isometric peak knee extension torque
Isometric peak knee extension torque assessed by a CONTREX dynamometer
Measured: one day
10 metre walk test (10MWT)
Assessment of max gait speed
Measured: one day
2 minute walk test (2MWT)
Assessment of max walking endurance
Measured: one day
perceived exertion at the end of the 2MWT (Borg Scale 6-20)
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start19 Jan 2018
- Primary completion10 Oct 2019
- Study completion10 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Etienne Allart, Md, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03342820
- Sponsor's protocol ID
- 2016_50
- Other IDs
- 2017_A01605-48
- Acronym
- COCON
- Status last verified
- Mar 2020
- First submitted
- 16 Oct 2017
- Last updated
- 26 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Muscular Fatigability on Spastic Co-contractions Between the Quadriceps and Hamstrings in Stroke Patients
- ClinicalTrials.gov ID
- NCT03342820
- Acronym / sponsor ID
- COCON / 2016_50
- Conditions
- Stroke, Spasticity, Muscle, Muscle Fatigue, Gait, Hemiplegic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 19 Jan 2018 (actual)
- Primary completion
- 10 Oct 2019 (actual)
- Study completion
- 10 Oct 2019 (actual)
- First posted
- 17 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Quadriceps muscle fatigue | Experimental | Procedure: Muscle fatigueQuadriceps muscle fatigue |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Muscle fatigueIsokinetic quadriceps muscle fatigue of the paretic lower limb | Procedure or surgery | Quadriceps muscle fatigue |
Primary outcome
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
11 secondary outcomes
Cocontraction Index (CCI) between the other parts of the quadriceps and the semitendinosus muscle
Time frame: one day
Agonist Recruitment Index of the semitendinosus
Time frame: one day
Isometric peak knee flexion torque
Time frame: one day
Spasticity of the quadriceps
Time frame: one day
spatio-temporal gait parameters at comfortable speed
Time frame: one day
spatio-temporal gait parameters at comfortable speed
Time frame: one day
spatio-temporal gait parameters at comfortable speed
Time frame: one day
Isometric peak knee extension torque
Time frame: one day
10 metre walk test (10MWT)
Time frame: one day
2 minute walk test (2MWT)
Time frame: one day
perceived exertion at the end of the 2MWT (Borg Scale 6-20)
Time frame: one day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2020.
Related trials for Stroke
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Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Etienne Allart, Md principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Muscle fatigue in people with Stroke and Spasticity, Muscle, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cocontraction Index (CCI) between the rectus femoris and the semitendinosus (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2020.