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

NCT06509542 | Completed

• 1 other identifier: RECHMPL23_0428
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Cerebrovascular Accident

Keywords

Learned non-use; Accelerometer; Neurorehabilitation; Stroke

Outcome Measures

Primary Outcomes (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.

  Baseline

Secondary Outcomes (4)

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

  Baseline

• Ratio of the acceleration vector magnitude

  Baseline

• Activity count ratio

  Baseline

• Activity time ratio

  Baseline

Study Arms (1)

Measure of FuncUseRatio using wrist-worn accelerometers and videos

EXPERIMENTAL

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.

Behavioral: Objective assessment of upper limb use during activities in ecological situation

Interventions

Objective assessment of upper limb use during activities in ecological situation 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.

Measure of FuncUseRatio using wrist-worn accelerometers and videos

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• Paul Coste Floret Hospital: collaborator
• Université Montpellier: collaborator

Study Sites (2)

CH Paul Coste Floret

Lamalou-les-Bains, 34240, France

Location

CHU Montpellier

Montpellier, 34295, France

Location

Related Publications (17)

• 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.

  PMID: 34836976 BACKGROUND

• 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.

  PMID: 25896988 RESULT

• 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.

  PMID: 22275157 RESULT

• 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.

  PMID: 37106460 RESULT

• 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.

  PMID: 27106757 RESULT

• 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.

  PMID: 20829411 RESULT

• 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.

  PMID: 25297823 RESULT

• 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.

  PMID: 15929509 RESULT

• 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.

  PMID: 34785599 RESULT

• 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.

  PMID: 31481922 RESULT

• 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.

  PMID: 30703350 RESULT

• 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.

  PMID: 12474177 RESULT

• 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.

  PMID: 24718494 RESULT

• 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.

  PMID: 19929121 RESULT

• 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.

  PMID: 17030751 RESULT

• 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.

  PMID: 32707987 RESULT

• 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.

  PMID: 22764084 RESULT

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 13, 2024
• First Posted: July 19, 2024
• Study Start: October 7, 2024
• Primary Completion: July 16, 2025
• Study Completion: July 16, 2025
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)