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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2024-10-01

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.

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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

Conditions

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Hemiparesis;Poststroke/CVA

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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CTG

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

Group Type ACTIVE_COMPARATOR

Conventional therapy

Intervention Type PROCEDURE

3 sessions per week of physical therapy with musculotendinous stretching and balance rehabilitation

ETG

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

Group Type EXPERIMENTAL

Eccentric training

Intervention Type PROCEDURE

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 therapy

Intervention Type PROCEDURE

3 sessions per week of physical therapy with musculotendinous stretching and balance rehabilitation

Interventions

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Eccentric training

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

Intervention Type PROCEDURE

Conventional therapy

3 sessions per week of physical therapy with musculotendinous stretching and balance rehabilitation

Intervention Type PROCEDURE

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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes