StrokeOPTISTROKENCT04747587
Non-use After Stroke: Influence of Applied Force and Precision When Reaching With the Paretic Upper Limb
A study testing Reaching Session in people with Stroke, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- Reaching Session
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 2 sitesFrance
- Study dates
- 11 May 2021to 25 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
About this study
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
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.
- Conditions
- Stroke
- Being tested
- Reaching Session
- Keywords
- Non-use, Compensation, Weakness, Optimal control
- Medical subject headings
- Stroke, Asthenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reaching SessionOther
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
| Study group | Role | What they receive |
|---|---|---|
| Patients with stroke | Experimental | Not described Receives: Other: Reaching Session |
| Controls | Experimental | Not described Receives: Other: Reaching Session |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Inclusion
Secondary outcomes (7)
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
Measured: 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
Measured: 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
Measured: 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 \& + ∞)
Measured: Inclusion
Time since stroke (acute, subacute or chronic phase)
months
Measured: Inclusion
Intensity of arm deficit
Fugl-Meyer Upper Extremity score ) (score between 0 and 66)
Measured: 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
Measured: Inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start11 May 2021
- Primary completion25 Apr 2023
- Study completion25 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jérôme Froger, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04747587
- Sponsor's protocol ID
- NIMAO/2020-1/JF-01
- Other IDs
- NCT04747587
- Acronym
- OPTISTROKE
- Status last verified
- Dec 2025
- First submitted
- 5 Feb 2021
- Last updated
- 18 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised raw datasets and code used for the analysis will be available on reasonable request.
Publications
Faity G, Mottet D, Froger J, Delorme M. Neuromechanics of Nonuse and Compensation: Implications for Rehabilitation After Stroke. Neurorehabil Neural Repair. 2026 May 4;40(8):15459683261445442. doi: 10.1177/15459683261445442. Online ahead of print.
PubMed 42080459
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04747587
- Acronym / sponsor ID
- OPTISTROKE / NIMAO/2020-1/JF-01
- Conditions
- Stroke
- Keywords
- Non-use, Compensation, Weakness, Optimal control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 11 May 2021 (actual)
- Primary completion
- 25 Apr 2023 (actual)
- Study completion
- 25 Apr 2023 (actual)
- First posted
- 10 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with stroke | Experimental | Other: Reaching Session |
| Controls | Experimental | Other: Reaching Session |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reaching SessionTwo 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 | Other | Controls, Patients with stroke |
Primary outcome
Evaluate the modifications of the proximal non-use after stroke on the paretic side according to the extent of force constraint
Time frame: Inclusion
Proximal Arm Non Use (PANU) score (%): A significant PANU (> 7.5%) indicates non-use
7 secondary outcomes
Evaluate the modifications of the proximal non-use after stroke on the paretic side according to the precision required
Time frame: Inclusion
Evaluate the modifications of the proximal non-use in the control subjects according to the constraints of force or precision
Time frame: Inclusion
Evaluate the level of neuromuscular activation during reaching
Time frame: Inclusion
Model the constraints and costs explaining non-use patient by patient, to distinguish between physiological and psycho-behavioral non-use
Time frame: Inclusion
Time since stroke (acute, subacute or chronic phase)
Time frame: Inclusion
Intensity of arm deficit
Time frame: Inclusion
height of the target
Time frame: Inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Derived from this study: PubMed 42080459Faity G, Mottet D, Froger J, Delorme M. Neuromechanics of Nonuse and Compensation: Implications for Rehabilitation After Stroke. Neurorehabil Neural Repair. 2026 May 4;40(8):15459683261445442. doi: 10.1177/15459683261445442. Online ahead of print.
- Individual participant dataSharing planned: Yes. Anonymised raw datasets and code used for the analysis will be available on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jérôme Froger principal investigator
Centre Hospitalier Universitaire de Nīmes
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reaching Session in people with Stroke, run by Centre Hospitalier Universitaire de Nīmes at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the modifications of the proximal non-use after stroke on the paretic side according to the extent of force constraint (time frame: Inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04747587, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.