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

Primary Purpose

Paralysis

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Instrumented assessment of muscle function
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Paralysis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CHU de NantesRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Instrumented assessment of muscle function

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

To measure the duration of the examinations
the average length of stay of included patients
the patient's opinion through a self-questionnaire of satisfaction

Full Information

First Posted
June 7, 2022
Last Updated
October 9, 2023
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05415514
Brief Title
Feasibility Study of the Instrumented Evaluation of Eccentric Strengthening in Paresis Patients
Acronym
RE PAR EX
Official Title
Feasibility Study of the Instrumented Evaluation of Eccentric Strengthening in Paresis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
September 2024 (Anticipated)
Study Completion Date
September 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paralysis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
instrumented evaluations
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Instrumented assessment of muscle function
Arm Type
Other
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Instrumented assessment of muscle function
Intervention Description
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
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
To measure the duration of the examinations
Time Frame
14 weeks
Title
the average length of stay of included patients
Time Frame
14 weeks
Title
the patient's opinion through a self-questionnaire of satisfaction
Time Frame
14 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas Lecharte
Phone
02 44 76 89 89
Email
Thomas.lecharte@chu-nantes.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Lecharte
Organizational Affiliation
Nantes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Nantes
City
Nantes
ZIP/Postal Code
44000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Lecharte
Phone
0244768989
Email
thomas.lecharte@chu-nantes.fr

12. IPD Sharing Statement

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

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