Feasibility Study of the Instrumented Evaluation of Eccentric Strengthening in Paresis Patients

Paralysis Clinical Trial

— RE PAR EX  

Official title:

Feasibility Study of the Instrumented Evaluation of Eccentric Strengthening in Paresis Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05415514
• Other study ID #: RC22_0173
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: September 2024

Study information

• Verified date: October 2023
• Source: Nantes University Hospital
• Contact: Thomas Lecharte
• Phone: 02 44 76 89 89
• Email: Thomas.lecharte[@]chu-nantes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Paralysis
• Paresis

Intervention

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

Locations

Country	Name	City	State
France	CHU de Nantes	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proportion of usable data collected (ultrasound and elastographic images, EMG, force curves, etc.) compared to the expected usable data		14 weeks
Secondary	To measure the duration of the examinations		14 weeks
Secondary	the average length of stay of included patients		14 weeks
Secondary	the patient's opinion through a self-questionnaire of satisfaction		14 weeks