NCT04747587

Brief Summary

After a stroke, 80% of patients have an upper limb deficit, limiting activity. Some develop a non-use: they can, but do not, use their paretic limb. Non-use is a general phenomenon applied to all situations where the patient applies unnecessary compensation. Several rehabilitation techniques are effective to counter non-use, but there is insufficient knowledge to choose the most suitable technique. Optimal control theory could help guide these choices. It assumes that the chosen coordination satisfies the constraints of the task (force, amplitude, tolerance) while reducing the cost of the movement. This study will assess non-use by anticipating the sensitivity to the constraints of force and precision deduced from the logic of optimal control. The study authors expect to observe a weakness effect: in a reaching task (i.e. when the person has to touch an object placed in front of them), lightening the paretic arm makes it possible to reduce non-use, and a precision effect: in a reaching task, non-use increases with the required spatial precision.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
Completed

Started May 2021

Typical duration for not_applicable stroke

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 5, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 10, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

May 11, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2023

Completed
Last Updated

December 18, 2025

Status Verified

December 1, 2025

Enrollment Period

2 years

First QC Date

February 5, 2021

Last Update Submit

December 11, 2025

Conditions

Keywords

Non-useCompensationWeaknessOptimal control

Outcome Measures

Primary Outcomes (1)

  • Evaluate the modifications of the proximal non-use after stroke on the paretic side according to the extent of force constraint

    Proximal Arm Non Use (PANU) score (%): A significant PANU (\> 7.5%) indicates non-use

    Inclusion

Secondary Outcomes (7)

  • Evaluate the modifications of the proximal non-use after stroke on the paretic side according to the precision required

    Inclusion

  • Evaluate the modifications of the proximal non-use in the control subjects according to the constraints of force or precision

    Inclusion

  • Evaluate the level of neuromuscular activation during reaching

    Inclusion

  • Model the constraints and costs explaining non-use patient by patient, to distinguish between physiological and psycho-behavioral non-use

    Inclusion

  • Time since stroke (acute, subacute or chronic phase)

    Inclusion

  • +2 more secondary outcomes

Study Arms (2)

Patients with stroke

EXPERIMENTAL
Other: Reaching Session

Controls

EXPERIMENTAL
Other: Reaching Session

Interventions

Two x 45 minutes sessions of reaching tasks. Patients in the stroke group will perform the task with the paretic arm using a weight reduction system, allowing movement in the horizontal plane. Subjects in the control group will perform the task with the randomly selected arm weighted at 80% of their maximum voluntary shoulder torque

ControlsPatients with stroke

Eligibility Criteria

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

You may qualify if:

  • Patient having had a 1st stroke
  • Patient whose stroke occurred more than a month ago.
  • Patient having had a supratentorial stroke
  • Patient able to touch the opposite knee with the paretic arm
  • Subject who has never had a stroke
  • Subject without motor or orthopedic impairment of the upper limbs and in particular of the shoulder
  • Subject who has given free and informed consent.
  • Subject who signed the consent form.
  • Subject affiliated or beneficiary of a health insurance plan.

You may not qualify if:

  • Pregnant, parturient or breastfeeding subject.
  • The subject refuses to sign the consent
  • It is impossible to give the subject informed information
  • The patient is under safeguard of justice or state guardianship
  • Patient with cognitive disorders incompatible with a good understanding of the use of the device
  • Patient with other neurological or osteoarticular history that may limit the performance of the task - criterion left to the deiscretion of the investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU de Montpellier

Montpellier, France

Location

CHU de Nîmes

Nîmes, France

Location

MeSH Terms

Conditions

StrokeAsthenia

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jérôme Froger

    Centre Hospitalier Universitaire de Nīmes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2021

First Posted

February 10, 2021

Study Start

May 11, 2021

Primary Completion

April 25, 2023

Study Completion

April 25, 2023

Last Updated

December 18, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

Anonymised raw datasets and code used for the analysis will be available on reasonable request.

Shared Documents
ANALYTIC CODE

Locations