Hemiparesis;Poststroke/CVANCT06140381
Strengthening in Sub-acute Stroke Survivors: A Randomized Controlled Trial
A study testing Eccentric training and Conventional therapy in people with Hemiparesis;Poststroke/CVA, run by Clinique Du Parc de Belleville at 1 site in France.
Trial summary
The goal of this study is to compare between Eccentric training and conventional therapy in sub-acute stroke survivors. The primary objective of this study is to evaluate improvements in gait speed after four months of ET in comparison to conventional therapy for patients with sub-acute stroke. Read more about this study
- Who is it for?
- Ages 20 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemiparesis;Poststroke/CVA
- What is being tested?
- Eccentric training and Conventional therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 1 Dec 2023to 1 Oct 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 20 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subacute hemiparesis (> 3 months)
- BMI between 18.5 and 25
- Written consent to participate in the study.
Who cannot join
- Ankle impairment
- Botulinum toxin injections in PF within the last 4 months before study inclusion
- Medical contraindication for maximal effort
- Neurodegenerative disorders
- Cardiovascular disorders
- History of epilepsy.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Wael Maktouf
Créteil, 94000
WAEL MAKTOUF, DR, wael.maktouf@u-pec.fr
MUSTAPHA ZIDI, PR, zidi@u-pec.fr
About this study
Official title: Characterization of the Neuromuscular and Biomechanical Properties of Spastic Myopathy-affected Muscles During the Generation of Passive and Active Force: the Effect of a Management Program Based on Eccentric Exercises.
The goal of this study is to compare between Eccentric training and conventional therapy in sub-acute stroke survivors. The primary objective of this study is to evaluate improvements in gait speed after four months of ET in comparison to conventional therapy for patients with sub-acute stroke. Secondary objectives involve assessing: i) modifications in neuromuscular parameters of PF, ii) changes in muscle stiffness within PF during passive mobilization and active force generation, and iii) modifications in architectural parameters of PF.
Read the detailed description
This study will be a single-blinded, controlled, randomized design, wherein participants will be randomly assigned to one of two groups: the Conventional Therapy Group (CTG) or the Eccentric Training Group (ETG). Both groups will undergo a comprehensive series of assessments at three key time points: Ji (initial assessment), Jint (intermediate assessment), and Jf (final assessment). The study will commence with a recruitment phase, followed by a screening phase. Subsequently, there will be a 4-week period allocated for experimental testing before the intervention, and an additional 4 weeks for experimental testing after the intervention. These assessments will encompass a wide range of evaluations, including clinical health assessments, biomechanical assessments, neuromuscular evaluations, and functional assessments
- Conditions
- Hemiparesis;Poststroke/CVA
- Being tested
- Eccentric training, Conventional therapy
- Keywords
- Rehabilitation, Skeletal muscle, Eccentric strengthening
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eccentric trainingProcedure or surgery
The eccentric program will last for 16 weeks, with a frequency of 2 sessions per week, totalling 32 sessions. At least 1 day of rest will be required between two training sessions. The participants will be placed in the similar position of the neuromuscular assessments (reference position). The Biodex System 4 dynamometer settings for the exercise sessions were also like the settings used for the assessments. The training program will be divided into two phases: a familiarization phase and a progression phase
Conventional therapyProcedure or surgery
3 sessions per week of physical therapy with musculotendinous stretching and balance rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| CTG | Active comparator | In conventional therapy, the treatment plan is determined based on medical opinion. After admission, each patient undergoes several multidisciplinary assessments aimed at objectively determining the care based on their needs. In this group, patients received only conventional rehabilitation. This will carry out in the same manner as a regular practice of the clinic. 3 sessions per week Receives: Procedure: Conventional therapy |
| ETG | Experimental | In the absence of a standardized eccentric isokinetic training protocol established for hemiparetic subjects on the plantar flexor muscles, the protocol designed for this study drew inspiration from the one established by Clark and Patten. (2013) and by Harris-Love et al. (2017).This protocol allows the introduction of an eccentric stimulus for individuals who are new to this type of training and progressively advances their program to include workload levels sufficiently to stimulate muscle plasticity optimally, thereby inducing skeletal muscle adaptations. 3 sessions per week Receives: Procedure: Eccentric training; Procedure: Conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
gait speed (m/s) through the 10-meter walking test.
An analysis of the walking pattern will be conducted to quantify the evolution of spatio-temporal and barometric parameters of walking and their asymmetry.
Measured: initial assessment in the first week of the inclusion, intermediate assessment at 6 weeks of the inclusion, and final assessment at 12 weeks of the inclusion
Secondary outcomes (4)
Biomechanical proprieties
muscle stiffness, as expressed by the shear modulus (µ, in Kpa), will be assessed during passive ankle joint mobilization from dorsiflexion to plantar flexion and during maximal voluntary isometric contraction of Plantar flexors
Measured: initial assessment in the first week of the inclusion, intermediate assessment at 6 weeks of the inclusion, and final assessment at 12 weeks of the inclusion
Structural parameters
Fascicle length and thickness (mm) will be assessed using the ultrasound scanner.
Measured: initial assessment in the first week of the inclusion, intermediate assessment at 6 weeks of the inclusion, and final assessment at 12 weeks of the inclusion
Neuromuscular parameters
Peak force (N/m), submaximal force (N/m) and rate of force development (N/m) will be evaluated using the BIODEX isokinetic device during maximal volontary contraction
Measured: initial assessment in the first week of the inclusion, intermediate assessment at 6 weeks of the inclusion, and final assessment at 12 weeks of the inclusion
Functional parameters
maximal range of motion (deg/s) , defined as the extent of stretch that the participant can comfortably endure during the stretching maneuver, will be measured using the BIODEX isokinetic device
Measured: initial assessment in the first week of the inclusion, intermediate assessment at 6 weeks of the inclusion, and final assessment at 12 weeks of the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2023
- Study start1 Dec 2023 (estimated)
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemiparesis;Poststroke/CVAStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinique Du Parc de Belleville
- Sponsor type
- University, hospital or other
- Collaborators
- Henri Mondor University Hospital
- Responsible party
- Principal investigator, Belghith Kalthoum, Clinique Du Parc de Belleville
- Investigators
- Fedele Jean Michel, Investigator, Principal investigator, Clinique Du Parc de Belleville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06140381
- Sponsor's protocol ID
- 2022-A00436-37
- Status last verified
- Nov 2023
- First submitted
- 6 Nov 2023
- Last updated
- 20 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be shared upon request from researchers
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of the Neuromuscular and Biomechanical Properties of Spastic Myopathy-affected Muscles During the Generation of Passive and Active Force: the Effect of a Management Program Based on Eccentric Exercises.
- ClinicalTrials.gov ID
- NCT06140381
- Acronym / sponsor ID
- 2022-A00436-37
- Conditions
- Hemiparesis;Poststroke/CVA
- Keywords
- Rehabilitation, Skeletal muscle, Eccentric strengthening
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Clinique Du Parc de BellevilleUniversity, hospital or other
- Collaborators
- Henri Mondor University Hospital
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 20 Nov 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.
The goal of this study is to compare between Eccentric training and conventional therapy in sub-acute stroke survivors. The primary objective of this study is to evaluate improvements in gait speed after four months of ET in comparison to conventional therapy for patients with sub-acute stroke. Secondary objectives involve assessing: i) modifications in neuromuscular parameters of PF, ii) changes in muscle stiffness within PF during passive mobilization and active force generation, and iii) modifications in architectural parameters of PF.
Detailed description
This study will be a single-blinded, controlled, randomized design, wherein participants will be randomly assigned to one of two groups: the Conventional Therapy Group (CTG) or the Eccentric Training Group (ETG). Both groups will undergo a comprehensive series of assessments at three key time points: Ji (initial assessment), Jint (intermediate assessment), and Jf (final assessment). The study will commence with a recruitment phase, followed by a screening phase. Subsequently, there will be a 4-week period allocated for experimental testing before the intervention, and an additional 4 weeks for experimental testing after the intervention. These assessments will encompass a wide range of evaluations, including clinical health assessments, biomechanical assessments, neuromuscular evaluations, and functional assessments
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CTG | Active comparator | Procedure: Conventional therapyIn conventional therapy, the treatment plan is determined based on medical opinion. After admission, each patient undergoes several multidisciplinary assessments aimed at objectively determining the care based on their needs. In this group, patients received only conventional rehabilitation. This will carry out in the same manner as a regular practice of the clinic. 3 sessions per week |
| ETG | Experimental | Procedure: Eccentric training, Procedure: Conventional therapyIn the absence of a standardized eccentric isokinetic training protocol established for hemiparetic subjects on the plantar flexor muscles, the protocol designed for this study drew inspiration from the one established by Clark and Patten. (2013) and by Harris-Love et al. (2017).This protocol allows the introduction of an eccentric stimulus for individuals who are new to this type of training and progressively advances their program to include workload levels sufficiently to stimulate muscle plasticity optimally, thereby inducing skeletal muscle adaptations. 3 sessions per week |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subacute hemiparesis (> 3 months)
- BMI between 18.5 and 25
- Written consent to participate in the study.
Key exclusion criteria (6 listed)
- Ankle impairment
- Botulinum toxin injections in PF within the last 4 months before study inclusion
- Medical contraindication for maximal effort
- Neurodegenerative disorders
- Cardiovascular disorders
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 trainingThe eccentric program will last for 16 weeks, with a frequency of 2 sessions per week, totalling 32 sessions. At least 1 day of rest will be required between two training sessions. The participants will be placed in the similar position of the neuromuscular assessments (reference position). The Biodex System 4 dynamometer settings for the exercise sessions were also like the settings used for the assessments. The training program will be divided into two phases: a familiarization phase and a progression phase | Procedure or surgery | ETG |
| Conventional therapy3 sessions per week of physical therapy with musculotendinous stretching and balance rehabilitation | Procedure or surgery | CTG, ETG |
Primary outcome
gait speed (m/s) through the 10-meter walking test.
Time frame: initial assessment in the first week of the inclusion, intermediate assessment at 6 weeks of the inclusion, and final assessment at 12 weeks of the inclusion
An analysis of the walking pattern will be conducted to quantify the evolution of spatio-temporal and barometric parameters of walking and their asymmetry.
4 secondary outcomes
Biomechanical proprieties
Time frame: initial assessment in the first week of the inclusion, intermediate assessment at 6 weeks of the inclusion, and final assessment at 12 weeks of the inclusion
Structural parameters
Time frame: initial assessment in the first week of the inclusion, intermediate assessment at 6 weeks of the inclusion, and final assessment at 12 weeks of the inclusion
Neuromuscular parameters
Time frame: initial assessment in the first week of the inclusion, intermediate assessment at 6 weeks of the inclusion, and final assessment at 12 weeks of the inclusion
Functional parameters
Time frame: initial assessment in the first week of the inclusion, intermediate assessment at 6 weeks of the inclusion, and final assessment at 12 weeks of the inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2023.
- Individual participant dataSharing planned: No. Data will be shared upon request from researchers
Related trials for Hemiparesis;Poststroke/CVA
Active, not recruiting
Comparative Effects of CIMT and TOT on Hand Function Recovery in Post Stroke Patients
Poststroke/CVA Hemiparesis
Not yet recruiting
Characterization of Muscle Activity During a Surface EMG-controlled Rehabilitation Game
Cerebral Palsy, Hemiparesis; Poststroke/CVA
Not yet recruiting
Development and Efficacy of a Novel, Cost-Effective Gait Training Device Utilized at Home for Stroke Survivors
Stroke, Neurological Diseases or Conditions
RecruitingPhase 1
Psychedelic Healing: Adjunct Therapy Harnessing Opened Malleability
Stroke, Chronic Stroke
Recruiting
A Novel Wrist Wearable Sensor System to Promote Hemiparetic Upper Extremity Use in Subacute Stroke Survivors
Stroke, Stroke Sequelae
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.
Fedele Jean Michel, Investigator principal investigator
Clinique Du Parc de Belleville
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 and Conventional therapy in people with Hemiparesis;Poststroke/CVA, run by Clinique Du Parc de Belleville 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 3 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: status not confirmed, as of the sponsor's last update on 20 Nov 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact belghith kalthoum, Investigator (0649260709, belghith.kalthoum@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gait speed (m/s) through the 10-meter walking test. (time frame: initial assessment in the first week of the inclusion, intermediate assessment at 6 weeks of the inclusion, and final assessment at 12 weeks of the inclusion). 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 20 Nov 2023.