Spinal Cord InjuredRenfExcNCT06099340
Effects of an Eccentric Muscle Strengthening Protocol on Force Moment, Muscle Activation and Plantar Flexor Structure of Patients With Central Nervous System Injuries.
A study testing muscle-strengthening program in people with Spinal Cord Injured and Post-stroke, run by Nantes University Hospital at 1 site in France.
Trial summary
Neurological disorders [such as Cerebral Vascular Accident (CVA) or Spinal Cord Injury (SCI)] are among the most costly health problems to society in industrialized countries. For those affected, they generate severe restrictions in mobility, significantly altering their quality of life. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Spinal Cord Injured, Post-stroke
- What is being tested?
- muscle-strengthening program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2024to Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 between 18 and 80 years
- Patient with stroke< 6 months or Patient with spinal cord injury American Spinal Injury Association (ASIA) Impairment Scale C or D (incomplete motor impairment) < 6 months (second secondary criterion).
- Patient hospitalized for primary rehabilitation in the neurological PRM department of Nantes University Hospital.
- Patient with voluntary motricity rated between 2 and 4 on the MRC (Medical Research Council) scale
Who cannot join
- History of functional surgery <3 months or intramuscular injection into plantar flexors <6 months
- Patient with osteoarticular lesions contraindicating rehabilitation
- Patient unlikely to adhere to protocol (severe cognitive impairment) and/or non-compliant
- Patient with a progressive pathology contraindicating efforts (syrinx, cancer, cardiovascular instability, etc.)
- Minors, protected adults, adults unable to give consent or pregnant women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Guillaume Le Sant contact
France1 site
Chu de Nantes
Nantes, 44400
Raphael GROSS, 0240846208, raphael.gross@chu-nantes.fr
About this study
Official title: Effects of an Eccentric Muscle Strengthening Protocol on Force Moment, Muscle Activation and Plantar Flexor Structure in Patients With Central Nervous System Injuries. A Randomized Controlled Trial in Post-stroke Patients and a Pilot Study in Spinal Cord Injured Patients.
Neurological disorders [such as Cerebral Vascular Accident (CVA) or Spinal Cord Injury (SCI)] are among the most costly health problems to society in industrialized countries. For those affected, they generate severe restrictions in mobility, significantly altering their quality of life.
Deterioration in motor function after stroke or BM is closely linked to the level of force produced at joint level. This is influenced by adaptations (neurological and tissue) inherent to the pathophysiology of the injury, and characterized by the presence of a spastic paresis syndrome.
Read more
A great deal of effort is devoted to motor neurorehabilitation (particularly physiotherapy) in the days and weeks following neurological injury. This so-called sub-acute rehabilitation phase is designed to have a positive impact on the patient's motor recovery (to prevent the development of spastic paresis), and to prevent future severe limitations in the long term.
Disorders observed in the chronic phase (partial recovery of strength, severe orthopedic deformities) demonstrate the limits of current therapies. In view of the results obtained in healthy subjects, eccentric training now seems to be one of the most promising physiotherapy methods for recovering muscle strength and countering neurological disorders.
However, its use in the sub-acute rehabilitation phase has never been evaluated in post-stroke or post-BM patients, either in terms of its effects on the strength developed in the strengthened muscles, or more locally on the neurological and tissue disorders found in these patients in the context of spastic paresis.
The aim of this project is to evaluate the effects of an eccentric muscle-strengthening exercise protocol on neurological patients in the sub-acute phase of their neurological impairment. The protocol will be applied to the ankle joint, given its importance for walking and the significant deficits found at this level in neurological populations.We hypothesize that the strengthening protocol will improve muscle strength at the ankle, and generate beneficial adaptations to combat the spastic paresis syndrome (improved muscle activation, increased muscle length, muscle volume, etc.).
- Conditions
- Spinal Cord Injured, Post-stroke
- Being tested
- muscle-strengthening program
- Keywords
- Neurological rehabilitation, Physiotherapy, Eccentric muscle strengthening, Strength, Spastic paresis, Stroke, Spinal cord injury
- Medical subject headings
- Stroke, Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
muscle-strengthening programOther
a muscle-strengthening program applied to the ankle muscles (triceps surae and dorsal flexors) in physiotherapy, as a complement to conventional rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Experimental " EXC " | Experimental | eccentric strengthening + conventional rehabilitation Receives: Other: muscle-strengthening program |
| Comparator " CONC " | Active comparator | concentric strengthening + conventional rehabilitation Receives: Other: muscle-strengthening program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum joint force moment
The force-generating capacity of the plantar flexors will be studied by measuring the maximum joint force moment on an isokinetic ergometer
Measured: 10 weeks after the start of the muscle-strengthening protocol
Secondary outcomes (2)
Measurement of joint force moment
Measurement of joint force moment, performed on an isokinetic ergometer, in isometric condition
Measured: 14 weeks after the start of the muscle-strengthening protocol
Measurement of joint force moment
Measurement of joint force moment, performed on an isokinetic ergometer, in isometric condition
Measured: 10 weeks after the start of the muscle-strengthening protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study startSep 2024 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuredStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06099340
- Sponsor's protocol ID
- RC22_0475
- Acronym
- RenfExc
- Status last verified
- Aug 2024
- First submitted
- 9 Oct 2023
- Last updated
- 16 Aug 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 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Eccentric Muscle Strengthening Protocol on Force Moment, Muscle Activation and Plantar Flexor Structure in Patients With Central Nervous System Injuries. A Randomized Controlled Trial in Post-stroke Patients and a Pilot Study in Spinal Cord Injured Patients.
- ClinicalTrials.gov ID
- NCT06099340
- Acronym / sponsor ID
- RenfExc / RC22_0475
- Conditions
- Spinal Cord Injured, Post-stroke
- Keywords
- Neurological rehabilitation, Physiotherapy, Eccentric muscle strengthening, Strength, Spastic paresis, Stroke, Spinal cord injury
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 25 Oct 2023 (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.
Neurological disorders [such as Cerebral Vascular Accident (CVA) or Spinal Cord Injury (SCI)] are among the most costly health problems to society in industrialized countries. For those affected, they generate severe restrictions in mobility, significantly altering their quality of life.
Deterioration in motor function after stroke or BM is closely linked to the level of force produced at joint level. This is influenced by adaptations (neurological and tissue) inherent to the pathophysiology of the injury, and characterized by the presence of a spastic paresis syndrome.
A great deal of effort is devoted to motor neurorehabilitation (particularly physiotherapy) in the days and weeks following neurological injury. This so-called sub-acute rehabilitation phase is designed to have a positive impact on the patient's motor recovery (to prevent the development of spastic paresis), and to prevent future severe limitations in the long term.
Disorders observed in the chronic phase (partial recovery of strength, severe orthopedic deformities) demonstrate the limits of current therapies. In view of the results obtained in healthy subjects, eccentric training now seems to be one of the most promising physiotherapy methods for recovering muscle strength and countering neurological disorders.
However, its use in the sub-acute rehabilitation phase has never been evaluated in post-stroke or post-BM patients, either in terms of its effects on the strength developed in the strengthened muscles, or more locally on the neurological and tissue disorders found in these patients in the context of spastic paresis.
The aim of this project is to evaluate the effects of an eccentric muscle-strengthening exercise protocol on neurological patients in the sub-acute phase of their neurological impairment. The protocol will be applied to the ankle joint, given its importance for walking and the significant deficits found at this level in neurological populations.We hypothesize that the strengthening protocol will improve muscle strength at the ankle, and generate beneficial adaptations to combat the spastic paresis syndrome (improved muscle activation, increased muscle length, muscle volume, etc.).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental " EXC " | Experimental | Other: muscle-strengthening programeccentric strengthening + conventional rehabilitation |
| Comparator " CONC " | Active comparator | Other: muscle-strengthening programconcentric strengthening + conventional rehabilitation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient aged between 18 and 80 years
- Patient with stroke< 6 months or Patient with spinal cord injury American Spinal Injury Association (ASIA) Impairment Scale C or D (incomplete motor impairment) < 6 months (second secondary criterion).
- Patient hospitalized for primary rehabilitation in the neurological PRM department of Nantes University Hospital.
- Patient with voluntary motricity rated between 2 and 4 on the MRC (Medical Research Council) scale
Key exclusion criteria (5 listed)
- History of functional surgery <3 months or intramuscular injection into plantar flexors <6 months
- Patient with osteoarticular lesions contraindicating rehabilitation
- Patient unlikely to adhere to protocol (severe cognitive impairment) and/or non-compliant
- Patient with a progressive pathology contraindicating efforts (syrinx, cancer, cardiovascular instability, etc.)
- Minors, protected adults, adults unable to give consent or pregnant women.
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-strengthening programa muscle-strengthening program applied to the ankle muscles (triceps surae and dorsal flexors) in physiotherapy, as a complement to conventional rehabilitation | Other | Comparator " CONC ", Experimental " EXC " |
Primary outcome
Maximum joint force moment
Time frame: 10 weeks after the start of the muscle-strengthening protocol
The force-generating capacity of the plantar flexors will be studied by measuring the maximum joint force moment on an isokinetic ergometer
2 secondary outcomes
Measurement of joint force moment
Time frame: 14 weeks after the start of the muscle-strengthening protocol
Measurement of joint force moment
Time frame: 10 weeks after the start of the muscle-strengthening protocol
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 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.
Guillaume Le Sant contact
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-strengthening program in people with Spinal Cord Injured and Post-stroke, 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 4 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: opening soon, as of the sponsor's last update on 16 Aug 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Raphael Gross, PU-PH (02.40.84.62.08, raphael.gross@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum joint force moment (time frame: 10 weeks after the start of the muscle-strengthening protocol). 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 16 Aug 2024.