Feasibility Study of the Instrumented Evaluation of Eccentric Strengthening in Paresis Patients (RE PAR EX)

he aim of the "RE PAR EX" research is to evaluate the feasibility of the instrumented examination of the effects of eccentric muscle strengthening in paralytic patients. This project is part of the research axis of the movement analysis laboratory.

Following a stroke or spinal cord injury, patients develop a spastic paresis syndrome, which is characterized by the appearance of paresis, musculo-tendinous retractions and muscular hyperactivities.

If the traditional treatments proposed (stretching, motor work) show limits, the use of eccentric muscle strengthening in paresis patients has been developing for about ten years, with results superior to the usual treatments. The results of the studies evaluating it are focused on clinical evaluations and do not make it possible to identify the precise origin of the observed responses.

A pathophysiological understanding of the therapeutic effects of eccentric strengthening would be possible through instrumented examination of muscle structure and function, combining dynamometry, ultrasound, elastrography and electromyography (EMG). However, the feasibility of this quantified instrumental examination in paretic patients during a strengthening protocol has not been evaluated.

The feasibility of a quantified instrumented examination in this setting is the aim of this research, a necessary prerequisite for a larger interventional study to evaluate the biomechanical and neurophysiological effects of eccentric muscle strengthening in paretic patients.

Study Overview

• Status: Recruiting
• Conditions: Paralysis
• Intervention / Treatment: Other: Instrumented assessment of muscle function

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Thomas Lecharte; Phone Number: 02 44 76 89 89; Email: Thomas.lecharte@chu-nantes.fr

Study Locations

• France
  • Nantes, France, 44000
    • Recruiting
    • CHU de Nantes
    • Contact: Thomas Lecharte; Phone Number: 0244768989; Email: thomas.lecharte@chu-nantes.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient aged 18 to 80 years;
• Validation by the medical team of an eccentric strengthening protocol:

presence of a paresis of the studied muscle considered as functionally (triceps surae rated at 2 or more on the MRC scale), more or less associated with HAM and muscl retraction;

• Patient with a traumatic or ischemic spinal cord injury of grade Asia Impairment Scale (AIS) C or D (incomplete motor impairment) < 6 months or stroke < 6 months;
• Patient is competent to consent (Boston Diagnostic Aphasia Examination [BDAE] score greater than or equal to 2);
• Patient hospitalized in the neurological PRM service of the Nantes University Hospital.

Exclusion Criteria:

• History of functional surgery < 3 months ;
• Patient with osteoarticular lesions considered as a contraindication to to rehabilitation;
• Patient who is unlikely to adhere to the study program and/or not compliant compliant in the judgment of the investigator or refusing to participate in the study;
• Patients with a progressive pathology that contraindicates major muscular efforts (syrinx, cancer, etc.) (syrinx, cancer, cardiovascular instability...);
• Patients who are minors, protected adults, adults unable to express their consent or pregnant woman.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Instrumented assessment of muscle function; During the instrumented evaluations, the investigators will evaluate the possibility of measuring the passive and active function of the muscle using: - an isokinetic dynamometer, an ultrasound and elastography device, an electrical stimulation of the calf nerve	Other: Instrumented assessment of muscle function; During the instrumented evaluations, we will evaluate the possibility of measuring the passive and active function of the muscle using: - an isokinetic dynamometer, an ultrasound and elastography device, an electrical stimulation of the calf nerve

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
proportion of usable data collected (ultrasound and elastographic images, EMG, force curves, etc.) compared to the expected usable data	14 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
To measure the duration of the examinations	14 weeks
the average length of stay of included patients	14 weeks
the patient's opinion through a self-questionnaire of satisfaction	14 weeks

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Investigators: Principal Investigator: Thomas Lecharte, Nantes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: June 7, 2022
• First Submitted That Met QC Criteria: June 10, 2022
• First Posted (Actual): June 13, 2022

Study Record Updates

• Last Update Posted (Actual): October 11, 2023
• Last Update Submitted That Met QC Criteria: October 9, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Paralysis; Paresis
• Other Study ID Numbers: RC22_0173

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No