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

Chronic Stroke Clinical Trial

— ParUse  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05581602
• Other study ID #: RECHMPL21_0512
• Status: Recruiting
• Phase: N/A
• Start date: February 13, 2023
• Est. completion date: August 20, 2025

Study information

• Verified date: January 2024
• Source: University Hospital, Montpellier
• Contact: Karima BAKHTI, PhD
• Phone: 0467336111
• Email: k-bakhti[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: August 20, 2025
• Est. primary completion date: February 20, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Stroke
• Stroke

Intervention

Device:
• Wearing 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.

Locations

Country	Name	City	State
France	University Hospital of Montpellier	Montpellier
France	Jerome FROGER	Nîmes

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Montpellier	IMT Mines Alès, Université Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 %).	7 days
Secondary	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.	7 days
Secondary	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.	7 days
Secondary	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	During intervention
Secondary	Motor deficit	Motor deficit will be measured by the Fugl-Meyer Upper Extremity (FM-UE)	During the inclusion visit or information taken in the medical file
Secondary	Dispersion of UseRatio	The dispersion of UseRatio (UseRatioDisp) over the 6 repeated measurements will be measured by the intra-patient interquartile range	6 months