Clinical trial NCT04430153: What do I Think I Can do and What do I Really do: the Use of the Arm in Daily Life After Stroke
Official title: Investigating the Actual Daily-life Upper Limb Activity Profile in Relation to Observed and Perceived Function in the Chronic Phase Post Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: Universitaire Ziekenhuizen KU Leuven
name: Research Foundation Flanders
First posted: 2020-06-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Sixty patients with chronic stroke (\>6 months post stroke) will be recruited

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.

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.

Primary outcomes:
measure: Fugl-Meyer motor assessment - upper extremity
timeFrame: After inclusion
measure: Stroke Impact Scale 3.0
timeFrame: After inclusion
measure: Hours of use of each limb
timeFrame: After 3 days of sensor-based assessment
measure: Use ratio
timeFrame: After 3 days of sensor-based assessment
measure: Magnitude ratio
timeFrame: After 3 days of sensor-based assessment
measure: Bilateral magnitude
timeFrame: After 3 days of sensor-based assessment
Secondary outcomes:
measure: National Institutes of Health Stroke Scale (NIHSS)
timeFrame: After inclusion
measure: Modified Rankin Scale (mRS)
timeFrame: After inclusion
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: After inclusion
measure: Start Cancellation Test (SCT)
timeFrame: After inclusion
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: After inclusion
measure: Barthel Index (BI)
timeFrame: After inclusion
measure: Functional Ambulation Categories (FAC)
timeFrame: After inclusion
measure: International Physical Activity Questionnaire (IPAQ)
timeFrame: After inclusion
measure: Motor Activity Log Amount of Use (MAL AOU) - Dutch version
timeFrame: After inclusion
measure: ABILHAND
timeFrame: After inclusion
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
affiliation: KU Leuven
name: Geert Verheyden
role: PRINCIPAL_INVESTIGATOR
References: