Strengthening in Sub-acute Stroke Survivors: A Randomized Controlled Trial

Study Overview
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Brief Summary
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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
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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

Official Title
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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.

Conditions
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Hemiparesis;Poststroke/CVA

Intervention / Treatment
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* Procedure: Eccentric training
* Procedure: Conventional therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subacute hemiparesis (> 3 months) BMI between 18.5 and 25 Written consent to participate in the study. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CTG<br>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 | Procedure: Conventional therapy<br>* 3 sessions per week of physical therapy with musculotendinous stretching and balance rehabilitation<br>|
| Experimental: ETG<br>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 | Procedure: Eccentric training<br>* 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<br>Procedure: Conventional therapy<br>* 3 sessions per week of physical therapy with musculotendinous stretching and balance rehabilitation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rehabilitation, Skeletal muscle, Eccentric strengthening