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

Sponsor
Nantes University Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05415514
Collaborator
(none)
10
1
22

Study Details

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
  • Other: Instrumented assessment of muscle function
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
instrumented evaluationsinstrumented evaluations
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Feasibility Study of the Instrumented Evaluation of Eccentric Strengthening in Paresis Patients
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Jul 1, 2024
Anticipated Study Completion Date :
Jul 1, 2024

Arms and Interventions

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

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 [14 weeks]

Secondary Outcome Measures

  1. To measure the duration of the examinations [14 weeks]

  2. the average length of stay of included patients [14 weeks]

  3. the patient's opinion through a self-questionnaire of satisfaction [14 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

No locations specified.

Sponsors and Collaborators

  • Nantes University Hospital

Investigators

  • Principal Investigator: Thomas Lecharte, Nantes University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT05415514
Other Study ID Numbers:
  • RC22_0173
First Posted:
Jun 13, 2022
Last Update Posted:
Jun 13, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 13, 2022