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

Stroke Clinical Trial

— OPTISTROKE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04747587
• Other study ID #: NIMAO/2020-1/JF-01
• Status: Completed
• Start date: May 11, 2021
• Est. completion date: April 25, 2023

Study information

• Verified date: May 2023
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: April 25, 2023
• Est. primary completion date: April 25, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

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

Locations

Country	Name	City	State
France	CHU de Montpellier	Montpellier
France	CHU de Nîmes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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 & + 8)	Inclusion
Secondary	Time since stroke (acute, subacute or chronic phase)	months	Inclusion
Secondary	Intensity of arm deficit	Fugl-Meyer Upper Extremity score ) (score between 0 and 66)	Inclusion
Secondary	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