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
2 other identifiers
interventional
53
1 country
2
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable stroke
Started May 2021
Typical duration for not_applicable stroke
2 active sites
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
CompletedFirst Posted
Study publicly available on registry
February 10, 2021
CompletedStudy Start
First participant enrolled
May 11, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 25, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 25, 2023
CompletedDecember 18, 2025
December 1, 2025
2 years
February 5, 2021
December 11, 2025
Conditions
Keywords
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
EXPERIMENTALControls
EXPERIMENTALInterventions
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
Eligibility Criteria
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
CHU de Nîmes
Nîmes, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jérôme Froger
Centre Hospitalier Universitaire de Nīmes
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
- Shared Documents
- ANALYTIC CODE
Anonymised raw datasets and code used for the analysis will be available on reasonable request.