Non-use After Stroke: Influence of Applied Force and Precision When Reaching With the Paretic Upper Limb (OPTISTROKE)

Non-use après Accident Vasculaire cérébral : Influence de la Force et de la précision du Geste à Fournir Lors Des Mouvements du Membre supérieur parétique

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Other: Reaching Session

• Study Type: Observational
• Enrollment (Actual): 53

Contacts and Locations

Study Locations

• France
  • Montpellier, France
    • CHU de Montpellier
  • Nîmes, France
    • CHU de Nîmes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The target population corresponds to hemiparetic patients after stroke. The control population corresponds to subjects without neurological disorder. The two groups will be matched on age (18-44, 45-64, 65-79, +80) and sex.

Description

Inclusion Criteria:

Inclusion criteria specific to the stroke group:

• 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

Inclusion criteria specific to the control group:

• Subject who has never had a stroke
• Subject without motor or orthopedic impairment of the upper limbs and in particular of the shoulder

General inclusion criteria:

• Subject who has given free and informed consent.
• Subject who signed the consent form.
• Subject affiliated or beneficiary of a health insurance plan.

Exclusion criteria:

• Pregnant, parturient or breastfeeding subject.
• The subject is participating in a category 1 interventional study, or is in a period of exclusion determined by a previous study
• 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Controls	Other: Reaching Session; 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
Patients with stroke	Other: Reaching Session; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the modifications of the proximal non-use after stroke on the paretic side according to the precision required	PANU score (%): Physiological non-use considered as a decrease in PANU due to to the increase in the size of the target; A psychological non-use considered as absence of decrease in PANU, regardless of the condition	Inclusion
Evaluate the modifications of the proximal non-use in the control subjects according to the constraints of force or precision	PANU score (%) of force and precision	Inclusion
Evaluate the level of neuromuscular activation during reaching	% Voluntary Maximum Contraction (VMC) of anterior and intermediate part of the deltoid, biceps brachii and pectoralis major	Inclusion
Model the constraints and costs explaining non-use patient by patient, to distinguish between physiological and psycho-behavioral non-use	Weight-over-force ratio of the arm (Ratio between 0 & + ∞)	Inclusion
Time since stroke (acute, subacute or chronic phase)	months	Inclusion
Intensity of arm deficit	Fugl-Meyer Upper Extremity score ) (score between 0 and 66)	Inclusion
height of the target	Evaluate changes in the proximal non-use after stroke on the paretic side according to the height of the target to be reached with PANU score (%) : A significant PANU (> 7.5%) indicates non-use	Inclusion

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2021
• Primary Completion (Actual): April 25, 2023
• Study Completion (Actual): April 25, 2023

Study Registration Dates

• First Submitted: February 5, 2021
• First Submitted That Met QC Criteria: February 5, 2021
• First Posted (Actual): February 10, 2021

Study Record Updates

• Last Update Posted (Estimate): May 4, 2023
• Last Update Submitted That Met QC Criteria: May 3, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Weakness; Compensation; Non-use; Optimal control
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: NIMAO/2020-1/JF-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymised raw datasets and code used for the analysis will be available on reasonable request.
• IPD Sharing Supporting Information Type: ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No