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

NCT ID: NCT06509542

Last Updated: 2024-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-07

Study Completion Date

2026-04-07

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cerebrovascular Accident

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Measure of FuncUseRatio using wrist-worn accelerometers and videos

The 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.

Group Type EXPERIMENTAL

Objective assessment of upper limb use during activities in ecological situation

Intervention Type BEHAVIORAL

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.

Interventions

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Objective assessment of upper limb use during activities in ecological situation

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Paul Coste Floret Hospital

UNKNOWN

Sponsor Role collaborator

Université Montpellier

OTHER

Sponsor Role collaborator

University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CH Paul Coste Floret

Lamalou-les-Bains, , France

Site Status RECRUITING

CHU Montpellier

Montpellier, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Karima Mrs. Bakhti, Dr

Role: CONTACT

+33 4 67 33 61 11

Facility Contacts

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Gaël LE PERF

Role: primary

04 67 55 57 29

Karima BAKHTI

Role: primary

+33 4 67 33 61 11

References

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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.

Reference Type BACKGROUND
PMID: 34836976 (View on PubMed)

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.

Reference Type RESULT
PMID: 25896988 (View on PubMed)

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.

Reference Type RESULT
PMID: 22275157 (View on PubMed)

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.

Reference Type RESULT
PMID: 37106460 (View on PubMed)

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.

Reference Type RESULT
PMID: 27106757 (View on PubMed)

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.

Reference Type RESULT
PMID: 20829411 (View on PubMed)

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.

Reference Type RESULT
PMID: 25297823 (View on PubMed)

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.

Reference Type RESULT
PMID: 15929509 (View on PubMed)

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.

Reference Type RESULT
PMID: 34785599 (View on PubMed)

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.

Reference Type RESULT
PMID: 31481922 (View on PubMed)

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.

Reference Type RESULT
PMID: 30703350 (View on PubMed)

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.

Reference Type RESULT
PMID: 12474177 (View on PubMed)

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.

Reference Type RESULT
PMID: 24718494 (View on PubMed)

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.

Reference Type RESULT
PMID: 19929121 (View on PubMed)

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.

Reference Type RESULT
PMID: 17030751 (View on PubMed)

Zhou L, Fischer E, Tunca C, Brahms CM, Ersoy C, Granacher U, Arnrich B. How We Found Our IMU: Guidelines to IMU Selection and a Comparison of Seven IMUs for Pervasive Healthcare Applications. Sensors (Basel). 2020 Jul 22;20(15):4090. doi: 10.3390/s20154090.

Reference Type RESULT
PMID: 32707987 (View on PubMed)

Zou GY. Sample size formulas for estimating intraclass correlation coefficients with precision and assurance. Stat Med. 2012 Dec 20;31(29):3972-81. doi: 10.1002/sim.5466. Epub 2012 Jul 4.

Reference Type RESULT
PMID: 22764084 (View on PubMed)

Other Identifiers

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RECHMPL23_0428

Identifier Type: -

Identifier Source: org_study_id

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