NCT06140381

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

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.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Clinique Du Parc de Belleville · Academic / Other
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Accepted

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

Conditions

• Hemiparesis;Poststroke/CVA

Interventions

Type	Name	Description
PROCEDURE	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
PROCEDURE	Conventional therapy	3 sessions per week of physical therapy with musculotendinous stretching and balance rehabilitation

Timeline

• Start date: 2023-12-01
• Primary completion: 2024-06-01
• Completion: 2024-10-01
• First posted: 2023-11-20
• Last updated: 2023-11-20

Locations

1 site across 1 country: France