Plantar Flexor Eccentric Training in Chronic Hemiparesis

NCT06790446 | Completed

• 2 other identifiers: 2020-0612021-A01201-40
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to assess the effects of a plantar flexor eccentric training on muscle health of these muscles and teir descending command in chronic spastic hemiparesis. The effects of the strength and lower limb function will also be explored. The main question of this study is : do MG and SOL fascicle length and thickness can be modified after 2-months of eccentric training ? The experimental treatment will be compared to conventional therapy group (Gold standard). At D1, participants will be randomized into 2 groups: eccentric training versus conventional therapy for 8-weeks. Every participant will be assessed by blinded investigators at D1 and W8. In the eccentric training, patients will receive 3 sessions/week of a customized isokinetic eccentric program. in the control group, patients will follow their sessions of rehabilitation as before their inclusion.

Conditions

Hemiparesis

Keywords

Spastic myopathy; Eccentric training; Plantar flexors; Spastic cocontraction; Paresis

Outcome Measures

Primary Outcomes (1)

• MG and SOL Architectural parameters

  To quantify thickness and fascicle length (Lƒ) of soleus, then of medial gastrocnemius, participants were seated in the isokinetic ergometer: hip flexion at 45°, paretic knee extended, and the paretic ankle positioned at 80% of XV1-GAS (i.e. 80% of maximal clinical extensibility of the gastro-soleus complex). Three ultrasound images for each muscle are collected under passive conditions. Prior detection of skin landmarks allows standardization of the probe location. For collection of MG muscle images, the probe is positioned midway along the muscle body. For SOL, the probe is placed directly below the MTJ-MG.

  Day 0 ; Month 2

Secondary Outcomes (3)

• peaktorque in dorsiflexion / plantarflexion

  Day 0 ; Month 2

• MG and SOL Coefficients of agonist activation and antagonist activation

  Day 0 ; Month 2

• Ambulation speed

  Day 0 ; Month 2

Study Arms (2)

Eccentric training group (ECC)

EXPERIMENTAL

In this group, participants come three times a week during 8 weeks at the Henri Mondor University Hospital to complete their isokinetic eccentric training sessions

Other: Eccentric training group (ECC)

Conventional therapy group

ACTIVE COMPARATOR

In this group, participants continue on the routine community-based therapy carried out in private practice or at home. Quantitative and qualitative description of this rehabilitation will be collected using questionnaires at the end of the experimental phase

Other: Conventional therapy

Interventions

Eccentric training group (ECC) OTHER

The first, preparatory phase, lasts two weeks, aiming at making the participant familiar with the principles of eccentric training. Participants first experience the muscle recruitment patterns (during two sessions), then are prepared to induce protective response from the plantar flexors, conditioning these muscles for higher subsequent eccentric intensities. The aim of the second, training phase per se, which lasts six weeks, is to induce muscular and neurological adaptations through a steady increase in work intensity to stimulate muscle plasticity until the end of the program - varying volume, load and speed. Perceived exertion is quantified using Borg's scale (expected rating between 3 and 6) to ensure sufficient work intensity and prevent excessive fatigue. Musculoskeletal pain is assessed before and after each session through a Visual Analog Scale (0-10). Verbal encouragements and advising on correct exercise execution are provided by the therapist along each session.

Eccentric training group (ECC)

Conventional therapy OTHER

The participant visits a physiotherapist depending on the prescription, as in current practice

Conventional therapy group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adults with chronic hemiparesis (\> 6 months)
• XV1-GAS\<100°
• walking speed \> 0.2 m/sec
• unassisted over 10m
• stable hemiparesis with plantar flexor involvement
• written consent

You may not qualify if:

• cognitive impairment (MoCa\<26),
• orthopedic or traumatic ankle involvement,
• medical contraindication to maximal effort,
• follow-up of another research program,
• sural triceps toxin injection \< 3 months,
• adjacent neurological pathology,
• pregnant women,
• women of childbearing age who are not on effective contraception, either mechanical (IUD) or hormonal (pill),
• wearing a pacemaker or implanted defibrillator,
• persistent cardiovascular disorders following a cardiac accident,
• wearing an implanted medical device
• a history of epilepsy

Sponsors & Collaborators

• Neuroloco: lead

Study Sites (1)

Hôpitaux Universitaires Henri Mondor

Créteil, Île-de-France Region, 94010, France

Location

MeSH Terms

Conditions

Paresis

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2025
• First Posted: January 24, 2025
• Study Start: September 14, 2021
• Primary Completion: February 27, 2022
• Study Completion: February 27, 2022
• Last Updated: January 24, 2025

Record last verified: 2025-01

Locations

FR (1)