Skip to content

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

Investigating the Actual Daily-life Upper Limb Activity Profile in Relation to Observed and Perceived Function in the Chronic Phase Post Stroke

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04430153
Enrollment
60
Registered
2020-06-12
Start date
2020-10-01
Completion date
2021-05-30
Last updated
2021-06-09

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

Conditions

Stroke

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.

Interventions

OTHERClass 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.

Sponsors

Universitaire Ziekenhuizen KU Leuven
CollaboratorOTHER
Research Foundation Flanders
CollaboratorOTHER
KU Leuven
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Fugl-Meyer motor assessment - upper extremityAfter inclusionInvestigation of overall motor impairment of the affected upper limb: shoulder, arm, wrist, hand and fingers. Minimum: 0. Maximum: 66. Higher scores mean a better outcome.
Stroke Impact Scale 3.0After inclusionSelf-reported outcome, measuring the impact of a stroke on activities, participation and quality of life, using the most affected body side. Minimum: 0. Maximum: 100, for each of the 9 domains assessed. Higher scores mean a better outcome.
Hours of use of each limbAfter 3 days of sensor-based assessmentHours of use of each limb as measured with the accelerometer
Use ratioAfter 3 days of sensor-based assessmentDividing hours of use of the affected limb by the hours of use of the non-affected limb
Magnitude ratioAfter 3 days of sensor-based assessmentThe natural log of the vector magnitude of the non-dominant limb (or affected limb) divided by the vector magnitude of the dominant (or non-affected) limb The natural log of the vector magnitude of the non-dominant limb (or affected limb) divided by the vector magnitude of the dominant (or non-affected) limb Natural log of the vector magnitude of the affected divided by the non-affected limb
Bilateral magnitudeAfter 3 days of sensor-based assessmentSum of the vector magnitude from the two limbs

Secondary

MeasureTime frameDescription
Functional Ambulation Categories (FAC)After inclusionWalking ability. Minimum: 0. Maximum: 5. Higher scores mean better outcome.
International Physical Activity Questionnaire (IPAQ)After inclusionPatient-reported physical activity. 3 levels, higher levels are better.
National Institutes of Health Stroke Scale (NIHSS)After inclusionStroke severity. Minimum: 0. Maximum: 42. Higher scores mean worse outcome.
ABILHANDAfter inclusionSelf-reported measure of (bi)manual ability in everyday activities. Rasch based logit scale. Higher logit scores mean better outcome.
Motor Activity Log Amount of Use (MAL AOU) - Dutch versionAfter inclusionAmount the individual uses the paretic arm. 26 items, per item: min. 0, max. 5. Higher scores mean better outcome.
Modified Rankin Scale (mRS)After inclusionDisability. Minimum: 0. Maximum: 42. Higher scores mean worse outcome. Minimum: 0. Maximum: 6. Higher scores mean worse outcome.
Montreal Cognitive Assessment (MoCA)After inclusionCognitive impairment. Minimum: 0. Maximum: 30. Higher scores mean better outcome.
Start Cancellation Test (SCT)After inclusionUnilateral spatial neglect. Min: 0. Max: 54. Higher scores are better, scores \<44 indicate the presence of USN.
Hospital Anxiety and Depression Scale (HADS)After inclusionAnxiety and depression. Minimum: 0. Maximum: 42. Higher scores mean worse outcome.
Barthel Index (BI)After inclusionIndependence in activities of daily living. Minimum: 0. Maximum: 100. Higher scores mean better outcome.

Countries

Belgium

Outcome results

None listed

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