Clinical trial NCT06140381: Strengthening in Sub-acute Stroke Survivors: A Randomized Controlled Trial
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hemiparesis;Poststroke/CVA
Keywords: Rehabilitation
Skeletal muscle
Eccentric strengthening
Lead sponsor: Clinique Du Parc de Belleville
Sponsor class: OTHER
Collaborators: name: Henri Mondor University Hospital
First posted: 2023-11-20
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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. 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

Eligibility criteria: 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.

Primary outcomes:
measure: gait speed (m/s) through the 10-meter walking test.
timeFrame: 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:
measure: Biomechanical proprieties
timeFrame: 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
measure: Structural parameters
timeFrame: 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
measure: Neuromuscular parameters
timeFrame: 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
measure: Functional parameters
timeFrame: 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
Other outcomes:
Locations:
city: Créteil
country: France
facility: Wael Maktouf
Study officials:
affiliation: Clinique Du Parc de Belleville
name: Fedele Jean Michel, Investigator
role: PRINCIPAL_INVESTIGATOR
References: