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

NCT05415514 | Completed

• 1 other identifier: RC22_0173
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Paralysis

Outcome Measures

Primary Outcomes (1)

• proportion of usable data collected (ultrasound and elastographic images, EMG, force curves, etc.) compared to the expected usable data

  14 weeks

Secondary Outcomes (3)

• 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

Study Arms (1)

Instrumented assessment of muscle function

OTHER

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

Interventions

Instrumented assessment of muscle function OTHER

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

Instrumented assessment of muscle function

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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

CHU de Nantes

Nantes, 44000, France

Location

MeSH Terms

Conditions

Paralysis

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Thomas Lecharte

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: instrumented evaluations

Study Record Dates

• First Submitted: June 7, 2022
• First Posted: June 13, 2022
• Study Start: December 1, 2022
• Primary Completion: March 7, 2024
• Study Completion: March 7, 2024
• Last Updated: July 12, 2024

Record last verified: 2024-07

Locations

FR (1)