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

Not Applicable

Recruiting

• Conditions: Hemiparesis;Poststroke/CVA

• Registration Number: NCT06140381
• Lead Sponsor: Clinique Du Parc de Belleville

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

Study Timeline

• Status Verified: 2023-11
• Study First Submitted: 2023-11-06
• Study First Submitted QC: 2023-11-16
• Last Update Submitted: 2023-11-16
• Study First Posted: 2023-11-20
• Last Update Posted: 2023-11-20
• Study Start: 2023-12-01
• Primary Completion: 2024-06-01
• Study Completion: 2024-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
gait speed (m/s) through the 10-meter walking test.	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 Outcome Measures

Name	Time	Method
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	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
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	Fascicle length and thickness (mm) will be assessed using the ultrasound scanner.
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	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
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	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

Trial Locations

Locations (1)

Wael Maktouf; 🇫🇷 Créteil, France