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

• ClinicalTrials.gov Identifier: NCT05415514
• Recruitment Status: Not yet recruiting
• First Posted: June 13, 2022
• Last Update Posted: June 13, 2022
• Sponsor: Nantes University Hospital
• Information provided by (Responsible Party): Nantes University Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Paralysis	Other: Instrumented assessment of muscle function	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: instrumented evaluations
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Feasibility Study of the Instrumented Evaluation of Eccentric Strengthening in Paresis Patients
• Estimated Study Start Date: September 2022
• Estimated Primary Completion Date: July 2024
• Estimated Study Completion Date: July 2024

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. To measure the duration of the examinations [ Time Frame: 14 weeks ]
2. the average length of stay of included patients [ Time Frame: 14 weeks ]
3. the patient's opinion through a self-questionnaire of satisfaction [ Time Frame: 14 weeks ]

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Contacts

Contact: Thomas Lecharte; 02 44 76 89 89; Thomas.lecharte@chu-nantes.fr

Sponsors and Collaborators

Nantes University Hospital

Investigators

• Principal Investigator: Thomas Lecharte; Nantes University Hospital

More Information

• Responsible Party: Nantes University Hospital
• ClinicalTrials.gov Identifier: NCT05415514
• Other Study ID Numbers: RC22_0173
• First Posted: June 13, 2022
• Last Update Posted: June 13, 2022
• Last Verified: June 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Paralysis; Paresis; Neurologic Manifestations; Nervous System Diseases