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Clinical Trials/NCT06608121
NCT06608121
Completed
N/A

Study for the Development and Evaluation of Personalised Muscle Effort Generation Models for Patients With Upper Limb Motor Deficits

Pôle Saint Hélier1 site in 1 country32 target enrollmentNovember 5, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stroke
Sponsor
Pôle Saint Hélier
Enrollment
32
Locations
1
Primary Endpoint
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)
Status
Completed
Last Updated
5 months ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
November 5, 2024
End Date
October 22, 2025
Last Updated
5 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Pôle Saint Hélier
Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

Study Sites (1)

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