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Effects of an Eccentric Muscle Strengthening Protocol on Force Moment, Muscle Activation and Plantar Flexor Structure of Patients With Central Nervous System Injuries. (RenfExc)

Primary Purpose

Spinal Cord Injured, Post-stroke

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
muscle-strengthening program
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injured focused on measuring Neurological rehabilitation, Physiotherapy, Eccentric muscle strengthening, Strength, Spastic paresis, Stroke, Spinal cord injury

Eligibility Criteria

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

Inclusion Criteria: Patient aged between 18 and 80 years Patient with stroke< 6 months or Patient with spinal cord injury American Spinal Injury Association (ASIA) Impairment Scale C or D (incomplete motor impairment) < 6 months (second secondary criterion). Patient hospitalized for primary rehabilitation in the neurological PRM department of Nantes University Hospital. Patient with plantar flexor muscle hyperactivity: spasticity rated at least 1 on the modified Ashworth scale Patient with voluntary motricity rated at least 2 on the MRC (Medical Research Council) scale Exclusion Criteria: History of functional surgery <3 months or intramuscular injection into plantar flexors <6 months Patient with osteoarticular lesions contraindicating rehabilitation Patient unlikely to adhere to protocol (severe cognitive impairment) and/or non-compliant Patient with a progressive pathology contraindicating efforts (syrinx, cancer, cardiovascular instability, etc.) Minors, protected adults, adults unable to give consent or pregnant women.

Sites / Locations

  • Chu de Nantes

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Experimental " EXC "

Comparator " CONC "

Control " CTL "

Arm Description

eccentric strengthening + conventional rehabilitation

concentric strengthening + conventional rehabilitation

no strengthening (control, conventional rehabilitation only)

Outcomes

Primary Outcome Measures

Maximum joint force moment
The force-generating capacity of the plantar flexors will be studied by measuring the maximum joint force moment on an isokinetic ergometer

Secondary Outcome Measures

Measurement of joint force moment
Measurement of joint force moment, performed on an isokinetic ergometer, in isometric condition
Measurement of joint force moment
Measurement of joint force moment, performed on an isokinetic ergometer, in isometric condition

Full Information

First Posted
October 9, 2023
Last Updated
October 24, 2023
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06099340
Brief Title
Effects of an Eccentric Muscle Strengthening Protocol on Force Moment, Muscle Activation and Plantar Flexor Structure of Patients With Central Nervous System Injuries.
Acronym
RenfExc
Official Title
Effects of an Eccentric Muscle Strengthening Protocol on Force Moment, Muscle Activation and Plantar Flexor Structure in Patients With Central Nervous System Injuries. A Randomized Controlled Trial in Post-stroke Patients and a Pilot Study in Spinal Cord Injured Patients.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2024 (Anticipated)
Primary Completion Date
April 2027 (Anticipated)
Study Completion Date
April 2027 (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
Neurological disorders [such as Cerebral Vascular Accident (CVA) or Spinal Cord Injury (SCI)] are among the most costly health problems to society in industrialized countries. For those affected, they generate severe restrictions in mobility, significantly altering their quality of life. Deterioration in motor function after stroke or BM is closely linked to the level of force produced at joint level. This is influenced by adaptations (neurological and tissue) inherent to the pathophysiology of the injury, and characterized by the presence of a spastic paresis syndrome. A great deal of effort is devoted to motor neurorehabilitation (particularly physiotherapy) in the days and weeks following neurological injury. This so-called sub-acute rehabilitation phase is designed to have a positive impact on the patient's motor recovery (to prevent the development of spastic paresis), and to prevent future severe limitations in the long term. Disorders observed in the chronic phase (partial recovery of strength, severe orthopedic deformities) demonstrate the limits of current therapies. In view of the results obtained in healthy subjects, eccentric training now seems to be one of the most promising physiotherapy methods for recovering muscle strength and countering neurological disorders. However, its use in the sub-acute rehabilitation phase has never been evaluated in post-stroke or post-BM patients, either in terms of its effects on the strength developed in the strengthened muscles, or more locally on the neurological and tissue disorders found in these patients in the context of spastic paresis. The aim of this project is to evaluate the effects of an eccentric muscle-strengthening exercise protocol on neurological patients in the sub-acute phase of their neurological impairment. The protocol will be applied to the ankle joint, given its importance for walking and the significant deficits found at this level in neurological populations.We hypothesize that the strengthening protocol will improve muscle strength at the ankle, and generate beneficial adaptations to combat the spastic paresis syndrome (improved muscle activation, increased muscle length, muscle volume, etc.).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injured, Post-stroke
Keywords
Neurological rehabilitation, Physiotherapy, Eccentric muscle strengthening, Strength, Spastic paresis, Stroke, Spinal cord injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Prospective Randomized Open Blinded End-point
Allocation
Randomized
Enrollment
105 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental " EXC "
Arm Type
Experimental
Arm Description
eccentric strengthening + conventional rehabilitation
Arm Title
Comparator " CONC "
Arm Type
Active Comparator
Arm Description
concentric strengthening + conventional rehabilitation
Arm Title
Control " CTL "
Arm Type
No Intervention
Arm Description
no strengthening (control, conventional rehabilitation only)
Intervention Type
Other
Intervention Name(s)
muscle-strengthening program
Intervention Description
a muscle-strengthening program applied to the ankle muscles (triceps surae and dorsal flexors) in physiotherapy, as a complement to conventional rehabilitation
Primary Outcome Measure Information:
Title
Maximum joint force moment
Description
The force-generating capacity of the plantar flexors will be studied by measuring the maximum joint force moment on an isokinetic ergometer
Time Frame
10 weeks after the start of the muscle-strengthening protocol
Secondary Outcome Measure Information:
Title
Measurement of joint force moment
Description
Measurement of joint force moment, performed on an isokinetic ergometer, in isometric condition
Time Frame
14 weeks after the start of the muscle-strengthening protocol
Title
Measurement of joint force moment
Description
Measurement of joint force moment, performed on an isokinetic ergometer, in isometric condition
Time Frame
10 weeks after the start of the muscle-strengthening protocol

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 between 18 and 80 years Patient with stroke< 6 months or Patient with spinal cord injury American Spinal Injury Association (ASIA) Impairment Scale C or D (incomplete motor impairment) < 6 months (second secondary criterion). Patient hospitalized for primary rehabilitation in the neurological PRM department of Nantes University Hospital. Patient with plantar flexor muscle hyperactivity: spasticity rated at least 1 on the modified Ashworth scale Patient with voluntary motricity rated at least 2 on the MRC (Medical Research Council) scale Exclusion Criteria: History of functional surgery <3 months or intramuscular injection into plantar flexors <6 months Patient with osteoarticular lesions contraindicating rehabilitation Patient unlikely to adhere to protocol (severe cognitive impairment) and/or non-compliant Patient with a progressive pathology contraindicating efforts (syrinx, cancer, cardiovascular instability, etc.) Minors, protected adults, adults unable to give consent or pregnant women.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Raphael Gross, PU-PH
Phone
02.40.84.62.08
Email
raphael.gross@chu-nantes.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Guillaume Le Sant
Email
guillaume.le-sant@univ-nantes.fr
Facility Information:
Facility Name
Chu de Nantes
City
Nantes
ZIP/Postal Code
44400
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raphael GROSS
Phone
0240846208
Email
raphael.gross@chu-nantes.fr

12. IPD Sharing Statement

Learn more about this trial

Effects of an Eccentric Muscle Strengthening Protocol on Force Moment, Muscle Activation and Plantar Flexor Structure of Patients With Central Nervous System Injuries.

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