Effects of an Eccentric Muscle Strengthening Protocol on Force Moment, Muscle Activation and Plantar Flexor Structure of Patients With Central Nervous System Injuries. (RenfExc)

August 14, 2024 updated by: Nantes University Hospital

Effects of an Eccentric Muscle Strengthening Protocol on Force Moment, Muscle Activation and Plantar Flexor Structure in Patients With Central Nervous System Injuries. A Randomized Controlled Trial in Post-stroke Patients and a Pilot Study in Spinal Cord Injured Patients.

Neurological disorders [such as Cerebral Vascular Accident (CVA) or Spinal Cord Injury (SCI)] are among the most costly health problems to society in industrialized countries. For those affected, they generate severe restrictions in mobility, significantly altering their quality of life.

Deterioration in motor function after stroke or BM is closely linked to the level of force produced at joint level. This is influenced by adaptations (neurological and tissue) inherent to the pathophysiology of the injury, and characterized by the presence of a spastic paresis syndrome.

A great deal of effort is devoted to motor neurorehabilitation (particularly physiotherapy) in the days and weeks following neurological injury. This so-called sub-acute rehabilitation phase is designed to have a positive impact on the patient's motor recovery (to prevent the development of spastic paresis), and to prevent future severe limitations in the long term.

Disorders observed in the chronic phase (partial recovery of strength, severe orthopedic deformities) demonstrate the limits of current therapies. In view of the results obtained in healthy subjects, eccentric training now seems to be one of the most promising physiotherapy methods for recovering muscle strength and countering neurological disorders.

However, its use in the sub-acute rehabilitation phase has never been evaluated in post-stroke or post-BM patients, either in terms of its effects on the strength developed in the strengthened muscles, or more locally on the neurological and tissue disorders found in these patients in the context of spastic paresis.

The aim of this project is to evaluate the effects of an eccentric muscle-strengthening exercise protocol on neurological patients in the sub-acute phase of their neurological impairment. The protocol will be applied to the ankle joint, given its importance for walking and the significant deficits found at this level in neurological populations.We hypothesize that the strengthening protocol will improve muscle strength at the ankle, and generate beneficial adaptations to combat the spastic paresis syndrome (improved muscle activation, increased muscle length, muscle volume, etc.).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient aged between 18 and 80 years
  • Patient with stroke< 6 months or Patient with spinal cord injury American Spinal Injury Association (ASIA) Impairment Scale C or D (incomplete motor impairment) < 6 months (second secondary criterion).
  • Patient hospitalized for primary rehabilitation in the neurological PRM department of Nantes University Hospital.
  • Patient with voluntary motricity rated between 2 and 4 on the MRC (Medical Research Council) scale

Exclusion Criteria:

History of functional surgery <3 months or intramuscular injection into plantar flexors <6 months

  • Patient with osteoarticular lesions contraindicating rehabilitation
  • Patient unlikely to adhere to protocol (severe cognitive impairment) and/or non-compliant
  • Patient with a progressive pathology contraindicating efforts (syrinx, cancer, cardiovascular instability, etc.)
  • Minors, protected adults, adults unable to give consent or pregnant women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental " EXC "
eccentric strengthening + conventional rehabilitation
Other: muscle-strengthening program
a muscle-strengthening program applied to the ankle muscles (triceps surae and dorsal flexors) in physiotherapy, as a complement to conventional rehabilitation
Active Comparator: Comparator " CONC "
concentric strengthening + conventional rehabilitation
Other: muscle-strengthening program
a muscle-strengthening program applied to the ankle muscles (triceps surae and dorsal flexors) in physiotherapy, as a complement to conventional rehabilitation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum joint force moment
Time Frame: 10 weeks after the start of the muscle-strengthening protocol
The force-generating capacity of the plantar flexors will be studied by measuring the maximum joint force moment on an isokinetic ergometer
10 weeks after the start of the muscle-strengthening protocol

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of joint force moment
Time Frame: 14 weeks after the start of the muscle-strengthening protocol
Measurement of joint force moment, performed on an isokinetic ergometer, in isometric condition
14 weeks after the start of the muscle-strengthening protocol
Measurement of joint force moment
Time Frame: 10 weeks after the start of the muscle-strengthening protocol
Measurement of joint force moment, performed on an isokinetic ergometer, in isometric condition
10 weeks after the start of the muscle-strengthening protocol

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nantes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2024

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2027

Study Registration Dates

First Submitted

October 9, 2023

First Submitted That Met QC Criteria

October 24, 2023

First Posted (Actual)

October 25, 2023

Study Record Updates

Last Update Posted (Actual)

August 16, 2024

Last Update Submitted That Met QC Criteria

August 14, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC22_0475

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Post-stroke

Clinical Trials on muscle-strengthening program

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Iran

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe