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Actimetry Monitoring of the Paretic Upper Limb in Chronic Post Stroke.

Actimeric Monitoring of the Use of the Paretic Upper Limb in the Activities of Daily Living of the Post-chronic Stroke Subject in a Home Environment

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05581602
Acronym
ParUse
Enrollment
66
Registered
2022-10-14
Start date
2023-02-13
Completion date
2025-08-20
Last updated
2024-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Stroke, Non-use of the Paretic Upper Limb

Keywords

Accelerometry, Stroke, Upper limb, Functional recovery, Home environment, Rehabilitation, Real use, Non use

Brief summary

After a stroke, 80% of patients continue to have difficulty using their paretic upper limb in activities of daily living (ADL) despite post-stroke rehabilitation practices that aim to promote the use of the paretic upper limb. It is known that functional recovery depends on actual use (Use it or Loose it), but one-time measurements in the clinic do not allow quantification of the actual use of the paretic upper limb in daily life (in the person's living environment). The investigators hypothesize the feasibility of quantifying functional use of the paretic upper limb by actimetry in clinical routine.

Detailed description

After a stroke, 80% of patients continue to have difficulty using their paretic upper limb in activities of daily living (ADL) despite post-stroke rehabilitation practices that aim to promote the use of the paretic upper limb. It is known that functional recovery depends on actual use (Use it or Loose it), but one-time measurements in the clinic do not allow quantification of the actual use of the paretic upper limb in daily life (in the person's living environment). Project will monitor 30 chronic and 30 healthy subjects over one week period using two wrist worn sensors . The main objective is to objectively quantify by actimetry, over 7 days, the real functional use of the paretic upper limb in the activities of daily living of post-stroke hemiparetic subjects in chronic phase, by the functional use ratio between the two arms (UseRatio).

Interventions

DEVICEWearing bracelets (3-Axis Logging Accelerometer)

Participants will be required to wear wristbands containing an accelerometer on each wrist. The bracelets will be kept on both wrists for 7 days with permission to remove them from time to time.

Sponsors

Université Montpellier
CollaboratorOTHER
IMT Mines Alès
CollaboratorUNKNOWN
University Hospital, Montpellier
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

The first phase of this project is a bicentric cross-sectional study in 30 hemiparetic post-stroke subjects in chronic phase and 30 healthy subjects, age and gender matched. The second phase is a 6-month longitudinal study, in a subgroup of 5 post-stroke subjects.

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes

Inclusion criteria

Inclusion criteria common to all participants: * Be between 18 and 90 years old Post-stroke subjects should: * Having a stroke with motor sequelae in the upper limb * Be in the chronic phase (\>3 months post-stroke) of a stroke whatever the aetiology

Exclusion criteria

Non inclusion criteria common to all participants: * Absence of free, informed and express oral consent * No affiliation to a French social security system or beneficiary of such a system * Patient protected by law * Pregnant or breastfeeding women Not eligible for inclusion, post-stroke subjects: * Not understanding the constraints of the study * Have cognitive impairments that prevent them from understanding the study * With a known hemigligence in the medical record (omission \> 8 on bells test)

Design outcomes

Primary

MeasureTime frameDescription
FuncUseRatio7 daysThe paretic functional use score is a ratio of functional movements performed by the paretic upper limb to the sum of functional movements performed by the paretic and non-paretic upper limbs (in percentage %).

Secondary

MeasureTime frameDescription
Use7 daysMeasurement of the amount of functional movement of each upper limb, in an ecological situation during activities of daily living of post-stroke and healthy subjects.
Intensity7 daysMeasurement of the intensity of movements (functional and non-functional) of each upper limb, in an ecological situation during activities of daily living of post-stroke and healthy subjects.
ProfilDuring interventionThe activity log is presented in the form of a table. The columns represent the days of recording (Day 1 =\> Day 7), the rows represent the time slots hour by hour
Motor deficitDuring the inclusion visit or information taken in the medical fileMotor deficit will be measured by the Fugl-Meyer Upper Extremity (FM-UE)
Dispersion of UseRatio6 monthsThe dispersion of UseRatio (UseRatioDisp) over the 6 repeated measurements will be measured by the intra-patient interquartile range

Countries

France

Contacts

Primary ContactKarima BAKHTI, PhD
k-bakhti@chu-montpellier.fr0467336111

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026