What do I Think I Can do and What do I Really do: the Use of the Arm in Daily Life After Stroke

NCT ID: NCT04430153

Last Updated: 2021-06-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-10-01
• Study Completion Date: 2021-05-30

Brief Summary

This study was organized to investigate the real upper limb use in persons after stroke. Persons after stroke often have problems moving their affected arm, leading to limitations in performing simple tasks. In previous research in a group of 60 patients post stroke the investigators investigated two things: they observed how patients can move their affected arm, and the investigators asked patients to indicate how they think they can use their affected arm. Surprisingly, the investigators concluded that in patients with a similar, good observed arm use there were two groups: (1) a 'match' group, reporting they can use their arm well, and (2) a 'mismatch' group, reporting they can not use their arm well. This project will further investigate this last group. The investigators will now use sensor technology to investigate the actual daily life arm use during daily life. The investigators hypothesize this daily arm use will be lower in the mismatch group than in the group with good observed and perceived ability.

Detailed Description

The investigators will perform a cross-sectional study to acquire insight into the actual daily-life UL activity profile of patients in the chronic phase post stroke. A sample of 60 community-dwelling patients more than six months after stroke will be recruited and will be investigated with both standardized clinical, patient-reported and sensor-based UL assessments. Our sample will include three groups of 20 patients with (1) both low observed and perceived function; (2) both good observed and perceived function; and (3) good observed but low perceived function, i.e. the mismatch group.

To better understand this mismatch group, it is pivotal to investigate daily arm and hand use in patients in the chronic phase after stroke as the investigators expect patients in the mismatch group to have significantly reduced arm and hand use throughout the day. After all, stroke rehabilitation interventions intend to improve patients' performance in daily life, but the objective evaluation of this aim is a challenge. Standardized assessments performed in the rehabilitation environment or patients' home do not validly reflect daily-life upper-limb use. To achieve insight into the observed upper limb function, apart from using internationally accepted observation-based assessments such as the FMA and SIS hand function, monitoring patients after stroke will also be performed using sensor-based systems.

The investigators hypothesize the mismatch group will show a comparable daily-life UL activity profile compared to patients with both low observed and perceived function. However, when compared to patients with good observed and perceived function, the mismatch group shows significantly reduced daily-life UL activity by means of sensor-based evaluation.

Conditions

Stroke

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Low match

A group with both low observed and perceived upper limb ability.

"Class 1 Medical Device" CE certified devices: ActiGraph wGT3X-BT accelerometer

Intervention Type: OTHER

Accelerometers on both patients' wrists will give insight into the daily life upper limb use.

Good match

A group with both good observed and perceived upper limb ability.

"Class 1 Medical Device" CE certified devices: ActiGraph wGT3X-BT accelerometer

Intervention Type: OTHER

Accelerometers on both patients' wrists will give insight into the daily life upper limb use.

Mismatch

A group with good observed but low perceived function.

"Class 1 Medical Device" CE certified devices: ActiGraph wGT3X-BT accelerometer

Intervention Type: OTHER

Accelerometers on both patients' wrists will give insight into the daily life upper limb use.

Interventions

"Class 1 Medical Device" CE certified devices: ActiGraph wGT3X-BT accelerometer

Accelerometers on both patients' wrists will give insight into the daily life upper limb use.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

(1) unilateral, supratentorial stroke as defined by WHO; (2) minimum 6 months after stroke, and living in the community; (3) ≥ 18 years old; and (4) informed consent.

Exclusion Criteria

(1) a musculoskeletal and/or other neurological disorder such as previous stroke, head injury, or Parkinson's disease that interfere with the protocol; and (2) severe communication or cognitive deficits.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: collaborator

Research Foundation Flanders

OTHER

Sponsor Role: collaborator

KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Prof Geert Verheyden

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Geert Verheyden

Role: PRINCIPAL_INVESTIGATOR

KU Leuven

Locations

UZ Leuven

Leuven, , Belgium

Countries

Belgium

Other Identifiers

1153320N

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

S64074

Identifier Type: -

Identifier Source: org_study_id