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Cerebrovascular AccidentValidFURNCT06509542

Measuring the Concurrent Validity of the Upper Limb Use Ratio With Accelerometers in an Ecological Situation After Stroke.

A study testing Objective assessment of upper limb use during activities in ecological situation in people with Cerebrovascular Accident, run by University Hospital, Montpellier at 2 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this stufy is to measure the concurrent validity of the upper limb use ratio with accelerometers in an ecological situation after stroke. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cerebrovascular Accident
What is being tested?
Objective assessment of upper limb use during activities in ecological situation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
2 sitesFrance
Study dates
7 Oct 2024to 16 Jul 2025
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject with hemiparesis following stroke
  • Subject participating in ecological activities during occupational therapy sessions
  • Adult subject aged 18 or over
  • Subject informed of study participation and not objecting to participation

Who cannot join

  • Other neurological or musculoskeletal disorders limiting use of upper limbs
  • Pregnant or breast-feeding woman,
  • Failure to obtain consent,
  • Non-affiliation with a social security scheme,
  • Persons under court protection,
  • Person protected by law (under guardianship or curatorship)
  • Participant in another research project with an exclusion period still ongoing.

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • CH Paul Coste Floret

    Lamalou-les-Bains, 34240

  • CHU Montpellier

    Montpellier, 34295

Other trials in France

About this study

Official title: Measuring the Concurrent Validity of the Upper Limb Use Ratio With Accelerometers in an Ecological Situation After Stroke. ValidFUR

The purpose of this stufy is to measure the concurrent validity of the upper limb use ratio with accelerometers in an ecological situation after stroke.

Read the detailed description

The first visit will be used to present the study and potential risks to patients, obtain their consent and collect clinical data. A second visit is planned for the patients who meet the eligibility requirements, to carry out activities in ecological situation.

Being tested
Objective assessment of upper limb use during activities in ecological situation
Keywords
Learned non-use, Accelerometer, Neurorehabilitation, Stroke
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Objective assessment of upper limb use during activities in ecological situationBehavioural

    Twenty-five patients will be recorded performing three activities during their rehabilitation: getting dressed, preparing a meal, and eating a meal. The movements of their upper limbs will be tracked using wrist-worn accelerometers and video cameras.

Study groups in NCT06509542
Study groupRoleWhat they receive
Measure of FuncUseRatio using wrist-worn accelerometers and videosExperimentalThe wristbands are made from hypoallergenic silicone and weigh 27 grams. They contain three accelerometers (AX3, Axivity, Newcastle Helix, United Kingdom), recording data in the three planes of space at a sampling frequency of 50 Hz and within an acceleration range of ±8 g. The wristbands will be worn on each wrist during the activities. Two high-definition video cameras, recording at least 50 images per second, will be positioned so that the movements of the patient's upper limbs are always visible. The location of the cameras will depend on the activity and the configuration of the room in which it takes place.
Receives: Behavioral: Objective assessment of upper limb use during activities in ecological situation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Concurrent validity (Intraclass Correlation Coefficient) of FuncUseRatio, using wrist-worn accelerometers, compared with the FuncUseRatio measured by video analysis.

    FuncUseRatio is the ratio of functional use of the paretic upper arm to the non-paretic upper arm measured by two methods (actimetry and video analysis),during the same occupational therapy sessions simulating activities of daily living with hemiparetic patients.

    Measured: Baseline

Secondary outcomes (4)

  1. Number of functional movements performed with the upper limbs (FuncUse30)

    The functional movements are the movements with an amplitude greater than 30° within a spatial range of -30° to +30° around the horizontal, measured over a two-second time window (FuncUse30)

    Measured: Baseline

  2. Ratio of the acceleration vector magnitude

    The magnitude of the acceleration vector is the norm of the acceleration vector (SVM: Scalar Vector Magnitude) minus 1 for the gravitational force. The ratio between the paretic and non paretic arm is then calculated

    Measured: Baseline

  3. Activity count ratio

    The activity count is the magnitude of the acceleration vector summed per second for each arm, and converted into an activity count (0.01664g/count). The ratio between the paretic and the non-paretic arm is then calculated.

    Measured: Baseline

  4. Activity time ratio

    The activity time is the sum of the seconds of arm activity for each arm. The ratio between the paretic and the non-paretic arm is then calculated.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2024
  2. Study start7 Oct 2024
  3. Primary completion16 Jul 2025
  4. Study completion16 Jul 2025

Resources

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
Not applicable
Intervention model
Single group
Model description
While patients are in rehabilitation, upper limb movements will be recorded using wrist-worn accelerometers and video cameras, during dressing, meal preparation, and meal-taking activities.
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06509542
Sponsor's protocol ID
RECHMPL23_0428
Acronym
ValidFUR
Status last verified
Apr 2026
First submitted
13 Jul 2024
Last updated
13 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Faity G, Mottet D, Pla S, Froger J. The reserve of joint torque determines movement coordination. Sci Rep. 2021 Nov 26;11(1):23008. doi: 10.1038/s41598-021-02338-4.

    PubMed 34836976

  • Bailey RR, Klaesner JW, Lang CE. Quantifying Real-World Upper-Limb Activity in Nondisabled Adults and Adults With Chronic Stroke. Neurorehabil Neural Repair. 2015 Nov-Dec;29(10):969-78. doi: 10.1177/1545968315583720. Epub 2015 Apr 20.

    PubMed 25896988

  • Chen S, Wolf SL, Zhang Q, Thompson PA, Winstein CJ. Minimal detectable change of the actual amount of use test and the motor activity log: the EXCITE Trial. Neurorehabil Neural Repair. 2012 Jun;26(5):507-14. doi: 10.1177/1545968311425048. Epub 2012 Jan 24.

    PubMed 22275157

  • Dusfour G, Mottet D, Muthalib M, Laffont I, Bakhti K. Comparison of wrist actimetry variables of paretic upper limb use in post stroke patients for ecological monitoring. J Neuroeng Rehabil. 2023 Apr 27;20(1):52. doi: 10.1186/s12984-023-01167-y.

    PubMed 37106460

  • Leuenberger K, Gonzenbach R, Wachter S, Luft A, Gassert R. A method to qualitatively assess arm use in stroke survivors in the home environment. Med Biol Eng Comput. 2017 Jan;55(1):141-150. doi: 10.1007/s11517-016-1496-7. Epub 2016 Apr 22.

    PubMed 27106757

  • Alt Murphy M, Willen C, Sunnerhagen KS. Kinematic variables quantifying upper-extremity performance after stroke during reaching and drinking from a glass. Neurorehabil Neural Repair. 2011 Jan;25(1):71-80. doi: 10.1177/1545968310370748. Epub 2010 Sep 9.

    PubMed 20829411

  • Noorkoiv M, Rodgers H, Price CI. Accelerometer measurement of upper extremity movement after stroke: a systematic review of clinical studies. J Neuroeng Rehabil. 2014 Oct 9;11:144. doi: 10.1186/1743-0003-11-144.

    PubMed 25297823

  • Platz T, Pinkowski C, van Wijck F, Kim IH, di Bella P, Johnson G. Reliability and validity of arm function assessment with standardized guidelines for the Fugl-Meyer Test, Action Research Arm Test and Box and Block Test: a multicentre study. Clin Rehabil. 2005 Jun;19(4):404-11. doi: 10.1191/0269215505cr832oa.

    PubMed 15929509

  • Saini V, Guada L, Yavagal DR. Global Epidemiology of Stroke and Access to Acute Ischemic Stroke Interventions. Neurology. 2021 Nov 16;97(20 Suppl 2):S6-S16. doi: 10.1212/WNL.0000000000012781.

    PubMed 34785599

  • Schambra HM, Parnandi A, Pandit NG, Uddin J, Wirtanen A, Nilsen DM. A Taxonomy of Functional Upper Extremity Motion. Front Neurol. 2019 Aug 20;10:857. doi: 10.3389/fneur.2019.00857. eCollection 2019.

    PubMed 31481922

  • Smith BA, Lang CE. Sensor Measures of Symmetry Quantify Upper Limb Movement in the Natural Environment Across the Lifespan. Arch Phys Med Rehabil. 2019 Jun;100(6):1176-1183. doi: 10.1016/j.apmr.2019.01.004. Epub 2019 Jan 29.

    PubMed 30703350

  • Sterr A, Freivogel S, Schmalohr D. Neurobehavioral aspects of recovery: assessment of the learned nonuse phenomenon in hemiparetic adolescents. Arch Phys Med Rehabil. 2002 Dec;83(12):1726-31. doi: 10.1053/apmr.2002.35660.

    PubMed 12474177

  • Stewart JC, Gordon J, Winstein CJ. Control of reach extent with the paretic and nonparetic arms after unilateral sensorimotor stroke: kinematic differences based on side of brain damage. Exp Brain Res. 2014 Jul;232(7):2407-19. doi: 10.1007/s00221-014-3938-5. Epub 2014 Apr 10.

    PubMed 24718494

  • Uswatte G, Hobbs Qadri L. A behavioral observation system for quantifying arm activity in daily life after stroke. Rehabil Psychol. 2009 Nov;54(4):398-403. doi: 10.1037/a0017501.

    PubMed 19929121

  • Uswatte G, Taub E, Morris D, Light K, Thompson PA. The Motor Activity Log-28: assessing daily use of the hemiparetic arm after stroke. Neurology. 2006 Oct 10;67(7):1189-94. doi: 10.1212/01.wnl.0000238164.90657.c2.

    PubMed 17030751

Questions about this trial

What is this clinical trial studying?

A study testing Objective assessment of upper limb use during activities in ecological situation in people with Cerebrovascular Accident, run by University Hospital, Montpellier 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 4 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 13 Apr 2026. 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?

Concurrent validity (Intraclass Correlation Coefficient) of FuncUseRatio, using wrist-worn accelerometers, compared with the FuncUseRatio measured by video analysis. (time frame: Baseline). 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 NCT06509542, which also lists 17 linked publications.

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 13 Apr 2026.

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