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NCT Number: NCT06099340

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

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.).

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

muscle-strengthening program

Other

a muscle-strengthening program applied to the ankle muscles (triceps surae and dorsal flexors) in physiotherapy, as a complement to conventional rehabilitation

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Guillaume Le Sant

CONTACT

[email protected]

Raphael Gross, PU-PH

CONTACT

[email protected]

02.40.84.62.08

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

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.

Acronym: RenfExc

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Oct 25, 2023
Registry last updated
Aug 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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