ParalysisRE PAR EXNCT05415514
Feasibility Study of the Instrumented Evaluation of Eccentric Strengthening in Paresis Patients
A study testing Instrumented assessment of muscle function in people with Paralysis, run by Nantes University Hospital at 1 site in France.
Trial summary
he aim of the "RE PAR EX" research is to evaluate the feasibility of the instrumented examination of the effects of eccentric muscle strengthening in paralytic patients. This project is part of the research axis of the movement analysis laboratory. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Paralysis
- What is being tested?
- Instrumented assessment of muscle function
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2022to 7 Mar 2024
- 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
- Patient aged 18 to 80 years;
- Validation by the medical team of an eccentric strengthening protocol:
- presence of a paresis of the studied muscle considered as functionally (triceps surae rated at 2 or more on the MRC scale), more or less associated with HAM and muscl retraction;
- Patient with a traumatic or ischemic spinal cord injury of grade Asia Impairment Scale (AIS) C or D (incomplete motor impairment) < 6 months or stroke < 6 months;
- Patient is competent to consent (Boston Diagnostic Aphasia Examination [BDAE] score greater than or equal to 2);
- Patient hospitalized in the neurological PRM service of the Nantes University Hospital.
Who cannot join
- History of functional surgery < 3 months ;
- Patient with osteoarticular lesions considered as a contraindication to to rehabilitation;
- Patient who is unlikely to adhere to the study program and/or not compliant compliant in the judgment of the investigator or refusing to participate in the study;
- Patients with a progressive pathology that contraindicates major muscular efforts (syrinx, cancer, etc.) (syrinx, cancer, cardiovascular instability...);
- Patients who are minors, protected adults, adults unable to express their consent or pregnant woman.
Trial locations and contacts
1 site in 1 country.
About this study
he aim of the "RE PAR EX" research is to evaluate the feasibility of the instrumented examination of the effects of eccentric muscle strengthening in paralytic patients. This project is part of the research axis of the movement analysis laboratory.
Following a stroke or spinal cord injury, patients develop a spastic paresis syndrome, which is characterized by the appearance of paresis, musculo-tendinous retractions and muscular hyperactivities.
Read more
If the traditional treatments proposed (stretching, motor work) show limits, the use of eccentric muscle strengthening in paresis patients has been developing for about ten years, with results superior to the usual treatments. The results of the studies evaluating it are focused on clinical evaluations and do not make it possible to identify the precise origin of the observed responses.
A pathophysiological understanding of the therapeutic effects of eccentric strengthening would be possible through instrumented examination of muscle structure and function, combining dynamometry, ultrasound, elastrography and electromyography (EMG). However, the feasibility of this quantified instrumental examination in paretic patients during a strengthening protocol has not been evaluated.
The feasibility of a quantified instrumented examination in this setting is the aim of this research, a necessary prerequisite for a larger interventional study to evaluate the biomechanical and neurophysiological effects of eccentric muscle strengthening in paretic patients.
- Conditions
- Paralysis
- Being tested
- Instrumented assessment of muscle function
- Medical subject headings
- Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instrumented assessment of muscle functionOther
During the instrumented evaluations, we will evaluate the possibility of measuring the passive and active function of the muscle using: - an isokinetic dynamometer, an ultrasound and elastography device, an electrical stimulation of the calf nerve
| Study group | Role | What they receive |
|---|---|---|
| Instrumented assessment of muscle function | Other | During the instrumented evaluations, the investigators will evaluate the possibility of measuring the passive and active function of the muscle using: - an isokinetic dynamometer, an ultrasound and elastography device, an electrical stimulation of the calf nerve Receives: Other: Instrumented assessment of muscle function |
What is being measured
The primary outcome is the main question the study is designed to answer.
proportion of usable data collected (ultrasound and elastographic images, EMG, force curves, etc.) compared to the expected usable data
Measured: 14 weeks
Secondary outcomes (3)
To measure the duration of the examinations
Measured: 14 weeks
the average length of stay of included patients
Measured: 14 weeks
the patient's opinion through a self-questionnaire of satisfaction
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2022
- Study start1 Dec 2022
- Primary completion7 Mar 2024
- Study completion7 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParalysisStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- instrumented evaluations
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Lecharte, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05415514
- Sponsor's protocol ID
- RC22_0173
- Acronym
- RE PAR EX
- Status last verified
- Jul 2024
- First submitted
- 7 Jun 2022
- Last updated
- 12 Jul 2024
- 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 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of the Instrumented Evaluation of Eccentric Strengthening in Paresis Patients
- ClinicalTrials.gov ID
- NCT05415514
- Acronym / sponsor ID
- RE PAR EX / RC22_0173
- Conditions
- Paralysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 7 Mar 2024 (actual)
- Study completion
- 7 Mar 2024 (actual)
- First posted
- 13 Jun 2022 (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.
he aim of the "RE PAR EX" research is to evaluate the feasibility of the instrumented examination of the effects of eccentric muscle strengthening in paralytic patients. This project is part of the research axis of the movement analysis laboratory.
Following a stroke or spinal cord injury, patients develop a spastic paresis syndrome, which is characterized by the appearance of paresis, musculo-tendinous retractions and muscular hyperactivities.
If the traditional treatments proposed (stretching, motor work) show limits, the use of eccentric muscle strengthening in paresis patients has been developing for about ten years, with results superior to the usual treatments. The results of the studies evaluating it are focused on clinical evaluations and do not make it possible to identify the precise origin of the observed responses.
A pathophysiological understanding of the therapeutic effects of eccentric strengthening would be possible through instrumented examination of muscle structure and function, combining dynamometry, ultrasound, elastrography and electromyography (EMG). However, the feasibility of this quantified instrumental examination in paretic patients during a strengthening protocol has not been evaluated.
The feasibility of a quantified instrumented examination in this setting is the aim of this research, a necessary prerequisite for a larger interventional study to evaluate the biomechanical and neurophysiological effects of eccentric muscle strengthening in paretic patients.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- instrumented evaluations
| Arm | Type | Receives |
|---|---|---|
| Instrumented assessment of muscle function | Other | Other: Instrumented assessment of muscle functionDuring the instrumented evaluations, the investigators will evaluate the possibility of measuring the passive and active function of the muscle using: - an isokinetic dynamometer, an ultrasound and elastography device, an electrical stimulation of the calf nerve |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient aged 18 to 80 years;
- Validation by the medical team of an eccentric strengthening protocol:
- presence of a paresis of the studied muscle considered as functionally (triceps surae rated at 2 or more on the MRC scale), more or less associated with HAM and muscl retraction;
- Patient with a traumatic or ischemic spinal cord injury of grade Asia Impairment Scale (AIS) C or D (incomplete motor impairment) < 6 months or stroke < 6 months;
- Patient is competent to consent (Boston Diagnostic Aphasia Examination [BDAE] score greater than or equal to 2);
Key exclusion criteria (5 listed)
- History of functional surgery < 3 months ;
- Patient with osteoarticular lesions considered as a contraindication to to rehabilitation;
- Patient who is unlikely to adhere to the study program and/or not compliant compliant in the judgment of the investigator or refusing to participate in the study;
- Patients with a progressive pathology that contraindicates major muscular efforts (syrinx, cancer, etc.) (syrinx, cancer, cardiovascular instability...);
- Patients who are minors, protected adults, adults unable to express their consent or pregnant woman.
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 |
|---|---|---|
| Instrumented assessment of muscle functionDuring the instrumented evaluations, we will evaluate the possibility of measuring the passive and active function of the muscle using: - an isokinetic dynamometer, an ultrasound and elastography device, an electrical stimulation of the calf nerve | Other | Instrumented assessment of muscle function |
Primary outcome
proportion of usable data collected (ultrasound and elastographic images, EMG, force curves, etc.) compared to the expected usable data
Time frame: 14 weeks
3 secondary outcomes
To measure the duration of the examinations
Time frame: 14 weeks
the average length of stay of included patients
Time frame: 14 weeks
the patient's opinion through a self-questionnaire of satisfaction
Time frame: 14 weeks
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 12 Jul 2024.
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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.
Thomas Lecharte principal investigator
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Instrumented assessment of muscle function in people with Paralysis, run by Nantes University Hospital 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 6 inclusion and 5 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 12 Jul 2024. 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?
proportion of usable data collected (ultrasound and elastographic images, EMG, force curves, etc.) compared to the expected usable data (time frame: 14 weeks). 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 12 Jul 2024.