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

NCT06099340 | Not Yet Recruiting

• 1 other identifier: RC22_0475
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.).

Conditions

Spinal Cord Injured; Post-stroke

Keywords

Neurological rehabilitation; Physiotherapy; Eccentric muscle strengthening; Strength; Spastic paresis; Stroke; Spinal cord injury

Outcome Measures

Primary Outcomes (1)

• Maximum joint force moment

  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 Outcomes (2)

• Measurement of joint force moment

  14 weeks after the start of the muscle-strengthening protocol

• Measurement of joint force moment

  10 weeks after the start of the muscle-strengthening protocol

Study Arms (2)

Experimental " EXC "

EXPERIMENTAL

eccentric strengthening + conventional rehabilitation

Other: muscle-strengthening program

Comparator " CONC "

ACTIVE COMPARATOR

concentric strengthening + conventional rehabilitation

Other: muscle-strengthening program

Interventions

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

Comparator " CONC "; Experimental " EXC "

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Chu de Nantes

Nantes, 44400, France

Location

MeSH Terms

Conditions

Stroke; Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Spinal Cord Diseases; Trauma, Nervous System; Wounds and Injuries

Central Study Contacts

Raphael Gross, PU-PH

CONTACT

02.40.84.62.08; raphael.gross@chu-nantes.fr

Guillaume Le Sant

CONTACT

guillaume.le-sant@univ-nantes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Prospective Randomized Open Blinded End-point
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2023
• First Posted: October 25, 2023
• Study Start: September 1, 2024
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: August 16, 2024

Record last verified: 2024-08

Locations

FR (1)