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Clinical Trials/NCT06140381
NCT06140381
Recruiting
N/A

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.

Clinique Du Parc de Belleville1 site in 1 country40 target enrollmentDecember 1, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Hemiparesis;Poststroke/CVA
Sponsor
Clinique Du Parc de Belleville
Enrollment
40
Locations
1
Primary Endpoint
gait speed (m/s) through the 10-meter walking test.
Status
Recruiting
Last Updated
2 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
December 1, 2023
End Date
October 1, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Clinique Du Parc de Belleville
Responsible Party
Principal Investigator
Principal Investigator

Belghith Kalthoum

Principal investigator

Clinique Du Parc de Belleville

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Neuromuscular parameters(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(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(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)
  • Biomechanical proprieties(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)

Study Sites (1)

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