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

Hemiparesis;Poststroke/CVA Clinical 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06140381
• Other study ID #: 2022-A00436-37
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: October 1, 2024

Study information

• Verified date: November 2023
• Source: Clinique Du Parc de Belleville
• Contact: belghith kalthoum, Investigator
• Phone: 0649260709
• Email: belghith.kalthoum[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hemiparesis;Poststroke/CVA
• Paresis

Intervention

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

Locations

Country	Name	City	State
France	Wael Maktouf	Créteil

Sponsors (2)

Lead Sponsor	Collaborator
Clinique Du Parc de Belleville	Henri Mondor University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	gait speed (m/s) through the 10-meter walking test.	An analysis of the walking pattern will be conducted to quantify the evolution of spatio-temporal and barometric parameters of walking and their asymmetry.	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	Biomechanical proprieties	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	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	Structural parameters	Fascicle length and thickness (mm) will be assessed using the ultrasound scanner.	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	Neuromuscular parameters	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	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	Functional parameters	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	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