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

NCT06140381 | Unknown

• 1 other identifier: 2022-A00436-37
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemiparesis;Poststroke/CVA

Keywords

Rehabilitation; Skeletal muscle; Eccentric strengthening

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (2)

CTG

ACTIVE COMPARATOR

In conventional therapy, the treatment plan is determined based on medical opinion. After admission, each patient undergoes several multidisciplinary assessments aimed at objectively determining the care based on their needs. In this group, patients received only conventional rehabilitation. This will carry out in the same manner as a regular practice of the clinic. 3 sessions per week

Procedure: Conventional therapy

ETG

EXPERIMENTAL

In the absence of a standardized eccentric isokinetic training protocol established for hemiparetic subjects on the plantar flexor muscles, the protocol designed for this study drew inspiration from the one established by Clark and Patten. (2013) and by Harris-Love et al. (2017).This protocol allows the introduction of an eccentric stimulus for individuals who are new to this type of training and progressively advances their program to include workload levels sufficiently to stimulate muscle plasticity optimally, thereby inducing skeletal muscle adaptations. 3 sessions per week

Procedure: Eccentric training; Procedure: Conventional therapy

Interventions

Eccentric training PROCEDURE

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

ETG

Conventional therapy PROCEDURE

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

CTG; ETG

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subacute hemiparesis (\> 3 months)
• BMI between 18.5 and 25
• Written consent to participate in the study.

You may not qualify if:

• Ankle impairment
• Medical contraindication for maximal effort
• Neurodegenerative disorders
• Cardiovascular disorders
• History of epilepsy.

Sponsors & Collaborators

• Clinique Du Parc de Belleville: lead
• Henri Mondor University Hospital: collaborator

Study Sites (1)

Wael Maktouf

Créteil, 94000, France

RECRUITING

Study Officials

• Fedele Jean Michel, Investigator

  Clinique Du Parc de Belleville

  PRINCIPAL INVESTIGATOR

Central Study Contacts

belghith kalthoum, Investigator

CONTACT

0649260709; belghith.kalthoum@gmail.com

Rayan Bouserhal, Investigator

CONTACT

0171939300; resp-reeducation.belleville@orpea.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 6, 2023
• First Posted: November 20, 2023
• Study Start: December 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: October 1, 2024
• Last Updated: November 20, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)