Chronic StrokeParUseNCT05581602
Actimetry Monitoring of the Paretic Upper Limb in Chronic Post Stroke.
A study testing Wearing bracelets (3-Axis Logging Accelerometer) in people with Chronic Stroke and Non-use of the Paretic Upper Limb, run by University Hospital, Montpellier at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Stroke, Non-use of the Paretic Upper Limb
- What is being tested?
- Wearing bracelets (3-Axis Logging Accelerometer)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesFrance
- Study dates
- 13 Feb 2023to 20 Sep 2025
- Phase
- Interventional
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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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:
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- 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)
Trial locations and contacts
2 sites in 1 country.
France2 sites
University Hospital of Montpellier
Montpellier, 34295
Jerome FROGER
Nîmes, 30900
About this study
Official title: 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
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.
Read the 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).
- Conditions
- Chronic Stroke, Non-use of the Paretic Upper Limb
- Being tested
- Wearing bracelets (3-Axis Logging Accelerometer)
- Keywords
- Accelerometry, Stroke, Upper limb, Functional recovery, Home environment, Rehabilitation, Real use, Non use
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearing bracelets (3-Axis Logging Accelerometer)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Hemiparetic post-stroke subjects | Experimental | Stroke patients with motor sequelae in the upper limb. Receives: Device: Wearing bracelets (3-Axis Logging Accelerometer) |
| Healthy subjects | Other | Subjects without stroke. Receives: Device: Wearing bracelets (3-Axis Logging Accelerometer) |
What is being measured
The primary outcome is the main question the study is designed to answer.
FuncUseRatio
The 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 %).
Measured: 7 days
Secondary outcomes (5)
Use
Measurement 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.
Measured: 7 days
Intensity
Measurement 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.
Measured: 7 days
Profil
The 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
Measured: During intervention
Motor deficit
Motor deficit will be measured by the Fugl-Meyer Upper Extremity (FM-UE)
Measured: During the inclusion visit or information taken in the medical file
Dispersion of UseRatio
The dispersion of UseRatio (UseRatioDisp) over the 6 repeated measurements will be measured by the intra-patient interquartile range
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2022
- Study start13 Feb 2023
- Primary completion20 Sep 2025
- Study completion20 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic StrokeStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Université Montpellier, IMT Mines Alès
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05581602
- Sponsor's protocol ID
- RECHMPL21_0512
- Acronym
- ParUse
- Status last verified
- Oct 2026
- First submitted
- 11 Oct 2022
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No