- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06608121
Upper Limb Muscle Strength Models for Patients With Motor Impairment. (MusMapS)
December 2, 2025 updated by: Pôle Saint Hélier
Study for the Development and Evaluation of Personalised Muscle Effort Generation Models for Patients With Upper Limb Motor Deficits
Upper limb motor impairments are common.
They affect quality of life and can lead to dependency.
They are mainly due to neurological conditions such as stroke, multiple sclerosis, and traumatic spinal cord injury.
However, the contractile properties of muscle, in particular the maximum force that can be generated voluntarily (MVF) depending on joint angle and motion speed, have been mainly studied and modeled in healthy people.
This study aims at developing mathematical models describing residual muscle forces in patients with motor impairments.
The knowledge could guide patients' rehabilitation and could be useful for the development of robotic assistance systems that use patients' residual capacities to control the level of assistance provided.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Rennes, France, 35043
- Fondation Saint-Hélier
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients aged between 18 and 85
- A patient who is a member or beneficiary of a social security scheme
- Patients hospitalised at the Saint-Hélier rehabilitation centre for a stroke more than 15 days old, MS or SCI
- Patients with a motor deficit ≤3/5 on the MRC (Medical Research Council) scale in both internal-external shoulder rotation and elbow flexion-extension.
- Patient with voluntary consent to participate in this study.
Exclusion Criteria:
- Spasticity >3/4 on the Aschworth scale in the shoulder abductor or elbow flexor muscles.
- Cognitive impairment that may interfere with measurements (MOCA < 20/30)
- Presence of a pressure sore > stage 2 at the ischial level
- Recent trauma to limbs or spine
- Decompensated heart disease or other unbalanced pathology which contraindicates or may hinder isokinetic testing.
- Persons deprived of their liberty by a judicial or administrative decision
- Pregnant women, women in labour or nursing mothers.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental
|
The trial is a single-center prospective interventional study.
Patients aged 18 to 85 years hospitalized in a French rehabilitation center for stroke, multiple sclerosis or traumatic tetraplegia and presenting a motor deficit ≤3/5 at the shoulder and elbow will be included.
MVF measurements will be performed using an isokinetic ergometer during a single session.
Concentric and eccentric MVF, as well as the forces generated during passive motion, will be measured in shoulder external-internal rotation and in elbow flexion-extension, in the seated position.
The demographic, anthropometric and medical data required for the study will be extracted from medical records.
Patients' residual muscle strength will be described and modeled.
Explanatory factors for model quality will be determined.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Description of the residuals of the effort generation models, defined as the difference between the actual effort values and the modelled values: o Average residual of the models (mean ± standard deviation) (Main Evaluation Criterion)
Time Frame: From enrollment to the end of the participation at maximum 7 days
|
From enrollment to the end of the participation at maximum 7 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 5, 2024
Primary Completion (Actual)
October 22, 2025
Study Completion (Actual)
October 22, 2025
Study Registration Dates
First Submitted
September 19, 2024
First Submitted That Met QC Criteria
September 19, 2024
First Posted (Actual)
September 23, 2024
Study Record Updates
Last Update Posted (Estimated)
December 3, 2025
Last Update Submitted That Met QC Criteria
December 2, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Wounds and Injuries
- Autoimmune Diseases
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Trauma, Nervous System
- Spinal Cord Diseases
- Stroke
- Multiple Sclerosis
- Spinal Cord Injuries
Other Study ID Numbers
- 2024-A01007-40
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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