NCT06608121

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Nov 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 23, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

November 5, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 22, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 22, 2025

Completed
Last Updated

December 3, 2025

Status Verified

December 1, 2025

Enrollment Period

12 months

First QC Date

September 19, 2024

Last Update Submit

December 2, 2025

Conditions

Keywords

muscle strengthmodelingupper limbmotor impairment

Outcome Measures

Primary Outcomes (1)

  • 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)

    From enrollment to the end of the participation at maximum 7 days

Study Arms (1)

Experimental

EXPERIMENTAL
Other: Upper limb isokinetic forces measurements

Interventions

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.

Experimental

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondation Saint-Hélier

Rennes, 35043, France

Location

Related Publications (1)

  • Tomezzoli A, Cassard B, Leblong E, Hayter J, Anne C, Bodet L, Pontonnier C. Are Isokinetic Torque-Angle Models Derived from Healthy Subjects Applicable to Patients with Upper-Limb Neurological Motor Impairment? Ann Biomed Eng. 2026 Feb 22. doi: 10.1007/s10439-026-04041-9. Online ahead of print.

MeSH Terms

Conditions

StrokeMultiple SclerosisSpinal Cord Injuries

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesSpinal Cord DiseasesTrauma, Nervous SystemWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2024

First Posted

September 23, 2024

Study Start

November 5, 2024

Primary Completion

October 22, 2025

Study Completion

October 22, 2025

Last Updated

December 3, 2025

Record last verified: 2025-12

Locations