HemiparesisEXC-AVCNCT06790446
Plantar Flexor Eccentric Training in Chronic Hemiparesis
A study testing Eccentric training group (ECC) and Conventional therapy in people with Hemiparesis, run by Neuroloco at 1 site in France.
Trial summary
The goal of this clinical trial is to assess the effects of a plantar flexor eccentric training on muscle health of these muscles and teir descending command in chronic spastic hemiparesis. The effects of the strength and lower limb function will also be explored. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hemiparesis
- What is being tested?
- Eccentric training group (ECC) and Conventional therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 14 Sep 2021to 27 Feb 2022
- 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
- adults with chronic hemiparesis (> 6 months)
- XV1-GAS<100°
- walking speed > 0.2 m/sec
- unassisted over 10m
- stable hemiparesis with plantar flexor involvement
- written consent
Who cannot join
- cognitive impairment (MoCa<26),
- orthopedic or traumatic ankle involvement,
- medical contraindication to maximal effort,
- follow-up of another research program,
- sural triceps toxin injection < 3 months,
- adjacent neurological pathology,
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- pregnant women,
- women of childbearing age who are not on effective contraception, either mechanical (IUD) or hormonal (pill),
- wearing a pacemaker or implanted defibrillator,
- persistent cardiovascular disorders following a cardiac accident,
- wearing an implanted medical device
- a history of epilepsy
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpitaux Universitaires Henri Mondor
Créteil, Île-de-France Region, 94010
About this study
Official title: Plantar-flexor Structural and Neural Changes in Chronic Hemiparesis Following Two Months of Eccentric Training: a Pilot, Randomized Controlled Trial
The goal of this clinical trial is to assess the effects of a plantar flexor eccentric training on muscle health of these muscles and teir descending command in chronic spastic hemiparesis. The effects of the strength and lower limb function will also be explored.
The main question of this study is : do MG and SOL fascicle length and thickness can be modified after 2-months of eccentric training ? The experimental treatment will be compared to conventional therapy group (Gold standard).
Read more
At D1, participants will be randomized into 2 groups: eccentric training versus conventional therapy for 8-weeks. Every participant will be assessed by blinded investigators at D1 and W8.
In the eccentric training, patients will receive 3 sessions/week of a customized isokinetic eccentric program. in the control group, patients will follow their sessions of rehabilitation as before their inclusion.
Read the detailed description
Background: Functional deficits in stroke patients with hemiparesis result from muscular damage, known as spastic myopathy, and neurological damage, combining agonist paresis and antagonist hyperactivity. In the chronic phase, it has been shown that conventional rehabilitation does not improve function beyond an average 0.04 m/sec increase in walking speed in hemiparesis patients. On the other hand, eccentric exercise has been shown in healthy subjects to markedly improve muscle extensibility, neuronal efficiency and muscle strength. However, its effects on spastic muscles in the chronic post-stroke phase, and in particular on plantar flexors, remain poorly documented and contradictory. Such an intervention, targeting the plantar flexor muscles of the subjects, could act both on spastic myopathy by reducing passive stiffness and increasing length and thickness, but also on propulsion capacity in walking, thus improving their walking speed.
Primary objective: To evaluate the effect on plantar flexor architectural parameters of an isokinetic eccentric exercise protocol targeting these muscles compared with conventional rehabilitation.
Secondary objectives: To compare each of the changes in the secondary endpoints in subjects with chronic post-stroke hemiparesis after 8 weeks of a plantar flexor eccentric exercise program compared with conventional rehabilitation (W8-D1).
Participants: 20 subjects with hemiparesis will be recruited and randomly assigned to 2 groups: eccentric training (ECC) versus conventional rehabilitation (CONV) Inclusion criteria are (a) adults aged 18 to 80 years, (b) chronic hemiparesis (> 6 months), (c) walking speed > 0.2 m/sec, unassisted over 10m, (d) stable hemiparesis with plantar flexor involvement, (e) written consent.
Intervention: The plantar flexor eccentric training group will carry out its sessions on an isokinetic dynamometer (Contrex) at a rate of 3 sessions per week for 8 weeks. Each session will consist of a warm-up (10 concentric plantar flexions at 30°/s). The rehabilitation protocol will be carried out in 2 parts. The first 2 weeks will be a period of familiarization and adaptation to the contraction mode, to minimize risks and optimize tissue adaptations. Then, during the following 6 weeks, the intensity of the exercises will gradually increase, modifying the speed, the load and the volume (number of repetitions). Quantification of the subject's load and pain status will be assessed using the force curves of the isokinetic dynamometer and a visual analog scale, respectively.
Outcome measures: Assessments will be made at the first and last sessions. The primary outcome will be the structural changes (fascicular length and thickness) of medial gastrocnemius and soleus (through ultrasound). Secondary endpoints will be , biomechanical (change in peak isometric force of plantar flexors during maximal voluntary contraction, neurophysiological (changes in the agonist and the antagonist activation of the medial gastrocnemius and soleus, and functional (change in maximum barefoot walking speed over 10m (AT10)). Also, correlations between change in gait speed and change in fascicular length of the medial gastrocnemius and soleus on the paretic side, as well as between change in gait speed and change in peak force of the paretic plantar flexors will be investigated.
- Conditions
- Hemiparesis
- Being tested
- Eccentric training group (ECC), Conventional therapy
- Keywords
- Spastic myopathy, Eccentric training, Plantar flexors, Spastic cocontraction, Paresis
- Medical subject headings
- Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eccentric training group (ECC)Other
The first, preparatory phase, lasts two weeks, aiming at making the participant familiar with the principles of eccentric training. Participants first experience the muscle recruitment patterns (during two sessions), then are prepared to induce protective response from the plantar flexors, conditioning these muscles for higher subsequent eccentric intensities.
The aim of the second, training phase per se, which lasts six weeks, is to induce muscular and neurological adaptations through a steady increase in work intensity to stimulate muscle plasticity until the end of the program - varying volume, load and speed.
Perceived exertion is quantified using Borg's scale (expected rating between 3 and 6) to ensure sufficient work intensity and prevent excessive fatigue. Musculoskeletal pain is assessed before and after each session through a Visual Analog Scale (0-10). Verbal encouragements and advising on correct exercise execution are provided by the therapist along each session.
Conventional therapyOther
The participant visits a physiotherapist depending on the prescription, as in current practice
| Study group | Role | What they receive |
|---|---|---|
| Eccentric training group (ECC) | Experimental | In this group, participants come three times a week during 8 weeks at the Henri Mondor University Hospital to complete their isokinetic eccentric training sessions Receives: Other: Eccentric training group (ECC) |
| Conventional therapy group | Active comparator | In this group, participants continue on the routine community-based therapy carried out in private practice or at home. Quantitative and qualitative description of this rehabilitation will be collected using questionnaires at the end of the experimental phase Receives: Other: Conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
MG and SOL Architectural parameters
To quantify thickness and fascicle length (Lƒ) of soleus, then of medial gastrocnemius, participants were seated in the isokinetic ergometer: hip flexion at 45°, paretic knee extended, and the paretic ankle positioned at 80% of XV1-GAS (i.e. 80% of maximal clinical extensibility of the gastro-soleus complex). Three ultrasound images for each muscle are collected under passive conditions. Prior detection of skin landmarks allows standardization of the probe location. For collection of MG muscle images, the probe is positioned midway along the muscle body. For SOL, the probe is placed directly below the MTJ-MG.
Measured: Day 0 ; Month 2
Secondary outcomes (3)
peaktorque in dorsiflexion / plantarflexion
Following the collection of ultrasound images, the subject in the ergometer was asked to perform isometric Maximal Voluntary Contraction (MVC) into plantar flexion, then into dorsiflexion, through three consecutive trials at a 90° position of XV1-GAS (ankle at 90°). Each measurement is applied in a standardized manner including a warm-up effort before the first trial, one maximal effort to be held for five seconds, and two minutes of rest before the next trial. The best of the three peak torque measurements is collected
Measured: Day 0 ; Month 2
MG and SOL Coefficients of agonist activation and antagonist activation
EMG activities of soleus and gastrocnemius are recorded during each trial of isometric Maximal Voluntary Contraction (MVC) into plantar flexion, and into dorsiflexion.
Coefficients of AGonist activation (CAG-SO, CAG-MG) and of ANtagonist activation (CAN-SO, CAN-MG) during maximal voluntary efforts are calculated for MG and SOL muscles. CAG-MG and CAG-SOL are defined as the ratio between the RMS-EMG of the maximal activity of the muscle during MVC over its Mmax obtained through supramaximal neurostimulation, using a classic technique of incremental stimulations until no more increase in the M response occurs. Coefficients of ANtagonist activation CAN-SO, CAN-MG are quantified as the ratio of the RMS (500 ms) of the muscle EMG activity during maximal dorsiflexion (co-activation) over its Mmax. Importantly, the Mmax obtained at baseline (Day 0) is kept as the reference for a given muscle throughout measurements, whether at Day 0 or Month 2.
Measured: Day 0 ; Month 2
Ambulation speed
Maximal barefoot ambulation speed is measured over ten meters without technical aid, following the conditions of the AT10 (10-meter Ambulation Test) with start and end seated
Measured: Day 0 ; Month 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start14 Sep 2021
- Primary completion27 Feb 2022
- Study completion27 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemiparesisStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neuroloco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06790446
- Sponsor's protocol ID
- 2020-061
- Other IDs
- 2021-A01201-40
- Acronym
- EXC-AVC
- Status last verified
- Jan 2025
- First submitted
- 14 Jan 2025
- Last updated
- 24 Jan 2025
- 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 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plantar-flexor Structural and Neural Changes in Chronic Hemiparesis Following Two Months of Eccentric Training: a Pilot, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06790446
- Acronym / sponsor ID
- EXC-AVC / 2020-061
- Conditions
- Hemiparesis
- Keywords
- Spastic myopathy, Eccentric training, Plantar flexors, Spastic cocontraction, Paresis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- NeurolocoUniversity, hospital or other
- Study start
- 14 Sep 2021 (actual)
- Primary completion
- 27 Feb 2022 (actual)
- Study completion
- 27 Feb 2022 (actual)
- First posted
- 24 Jan 2025 (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.
The goal of this clinical trial is to assess the effects of a plantar flexor eccentric training on muscle health of these muscles and teir descending command in chronic spastic hemiparesis. The effects of the strength and lower limb function will also be explored.
The main question of this study is : do MG and SOL fascicle length and thickness can be modified after 2-months of eccentric training ? The experimental treatment will be compared to conventional therapy group (Gold standard).
At D1, participants will be randomized into 2 groups: eccentric training versus conventional therapy for 8-weeks. Every participant will be assessed by blinded investigators at D1 and W8.
In the eccentric training, patients will receive 3 sessions/week of a customized isokinetic eccentric program. in the control group, patients will follow their sessions of rehabilitation as before their inclusion.
Detailed description
Background: Functional deficits in stroke patients with hemiparesis result from muscular damage, known as spastic myopathy, and neurological damage, combining agonist paresis and antagonist hyperactivity. In the chronic phase, it has been shown that conventional rehabilitation does not improve function beyond an average 0.04 m/sec increase in walking speed in hemiparesis patients. On the other hand, eccentric exercise has been shown in healthy subjects to markedly improve muscle extensibility, neuronal efficiency and muscle strength. However, its effects on spastic muscles in the chronic post-stroke phase, and in particular on plantar flexors, remain poorly documented and contradictory. Such an intervention, targeting the plantar flexor muscles of the subjects, could act both on spastic myopathy by reducing passive stiffness and increasing length and thickness, but also on propulsion capacity in walking, thus improving their walking speed.
Primary objective: To evaluate the effect on plantar flexor architectural parameters of an isokinetic eccentric exercise protocol targeting these muscles compared with conventional rehabilitation.
Secondary objectives: To compare each of the changes in the secondary endpoints in subjects with chronic post-stroke hemiparesis after 8 weeks of a plantar flexor eccentric exercise program compared with conventional rehabilitation (W8-D1).
Participants: 20 subjects with hemiparesis will be recruited and randomly assigned to 2 groups: eccentric training (ECC) versus conventional rehabilitation (CONV) Inclusion criteria are (a) adults aged 18 to 80 years, (b) chronic hemiparesis (> 6 months), (c) walking speed > 0.2 m/sec, unassisted over 10m, (d) stable hemiparesis with plantar flexor involvement, (e) written consent.
Intervention: The plantar flexor eccentric training group will carry out its sessions on an isokinetic dynamometer (Contrex) at a rate of 3 sessions per week for 8 weeks. Each session will consist of a warm-up (10 concentric plantar flexions at 30°/s). The rehabilitation protocol will be carried out in 2 parts. The first 2 weeks will be a period of familiarization and adaptation to the contraction mode, to minimize risks and optimize tissue adaptations. Then, during the following 6 weeks, the intensity of the exercises will gradually increase, modifying the speed, the load and the volume (number of repetitions). Quantification of the subject's load and pain status will be assessed using the force curves of the isokinetic dynamometer and a visual analog scale, respectively.
Outcome measures: Assessments will be made at the first and last sessions. The primary outcome will be the structural changes (fascicular length and thickness) of medial gastrocnemius and soleus (through ultrasound). Secondary endpoints will be , biomechanical (change in peak isometric force of plantar flexors during maximal voluntary contraction, neurophysiological (changes in the agonist and the antagonist activation of the medial gastrocnemius and soleus, and functional (change in maximum barefoot walking speed over 10m (AT10)). Also, correlations between change in gait speed and change in fascicular length of the medial gastrocnemius and soleus on the paretic side, as well as between change in gait speed and change in peak force of the paretic plantar flexors will be investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eccentric training group (ECC) | Experimental | Other: Eccentric training group (ECC)In this group, participants come three times a week during 8 weeks at the Henri Mondor University Hospital to complete their isokinetic eccentric training sessions |
| Conventional therapy group | Active comparator | Other: Conventional therapyIn this group, participants continue on the routine community-based therapy carried out in private practice or at home. Quantitative and qualitative description of this rehabilitation will be collected using questionnaires at the end of the experimental phase |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- adults with chronic hemiparesis (> 6 months)
- XV1-GAS<100°
- walking speed > 0.2 m/sec
- unassisted over 10m
- stable hemiparesis with plantar flexor involvement
Key exclusion criteria (12 listed)
- cognitive impairment (MoCa<26),
- orthopedic or traumatic ankle involvement,
- medical contraindication to maximal effort,
- follow-up of another research program,
- sural triceps toxin injection < 3 months,
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 |
|---|---|---|
| Eccentric training group (ECC)The first, preparatory phase, lasts two weeks, aiming at making the participant familiar with the principles of eccentric training. Participants first experience the muscle recruitment patterns (during two sessions), then are prepared to induce protective response from the plantar flexors, conditioning these muscles for higher subsequent eccentric intensities. The aim of the second, training phase per se, which lasts six weeks, is to induce muscular and neurological adaptations through a steady increase in work intensity to stimulate muscle plasticity until the end of the program - varying volume, load and speed. Perceived exertion is quantified using Borg's scale (expected rating between 3 and 6) to ensure sufficient work intensity and prevent excessive fatigue. Musculoskeletal pain is assessed before and after each session through a Visual Analog Scale (0-10). Verbal encouragements and advising on correct exercise execution are provided by the therapist along each session. | Other | Eccentric training group (ECC) |
| Conventional therapyThe participant visits a physiotherapist depending on the prescription, as in current practice | Other | Conventional therapy group |
Primary outcome
MG and SOL Architectural parameters
Time frame: Day 0 ; Month 2
To quantify thickness and fascicle length (Lƒ) of soleus, then of medial gastrocnemius, participants were seated in the isokinetic ergometer: hip flexion at 45°, paretic knee extended, and the paretic ankle positioned at 80% of XV1-GAS (i.e. 80% of maximal clinical extensibility of the gastro-soleus complex). Three ultrasound images for each muscle are collected under passive conditions. Prior detection of skin landmarks allows standardization of the probe location. For collection of MG muscle images, the probe is positioned midway along the muscle body. For SOL, the probe is placed directly below the MTJ-MG.
3 secondary outcomes
peaktorque in dorsiflexion / plantarflexion
Time frame: Day 0 ; Month 2
MG and SOL Coefficients of agonist activation and antagonist activation
Time frame: Day 0 ; Month 2
Ambulation speed
Time frame: Day 0 ; Month 2
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 24 Jan 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eccentric training group (ECC) and Conventional therapy in people with Hemiparesis, run by Neuroloco 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 12 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 24 Jan 2025. 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?
MG and SOL Architectural parameters (time frame: Day 0 ; Month 2). 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 24 Jan 2025.