What do I Think I Can do and What do I Really do: the Use of the Arm in Daily Life After Stroke
- Conditions
- Stroke
- Registration Number
- NCT04430153
- Lead Sponsor
- KU Leuven
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
(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.
(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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Hours of use of each limb After 3 days of sensor-based assessment Hours of use of each limb as measured with the accelerometer
Bilateral magnitude After 3 days of sensor-based assessment Sum of the vector magnitude from the two limbs
Fugl-Meyer motor assessment - upper extremity After inclusion Investigation 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 3.0 After inclusion Self-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.Use ratio After 3 days of sensor-based assessment Dividing hours of use of the affected limb by the hours of use of the non-affected limb
Magnitude ratio After 3 days of sensor-based assessment 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
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
- Secondary Outcome Measures
Name Time Method Montreal Cognitive Assessment (MoCA) After inclusion Cognitive impairment. Minimum: 0. Maximum: 30. Higher scores mean better outcome.
Hospital Anxiety and Depression Scale (HADS) After inclusion Anxiety and depression. Minimum: 0. Maximum: 42. Higher scores mean worse outcome.
Barthel Index (BI) After inclusion Independence in activities of daily living. Minimum: 0. Maximum: 100. Higher scores mean better outcome.
Modified Rankin Scale (mRS) After inclusion Disability. Minimum: 0. Maximum: 42. Higher scores mean worse outcome. Minimum: 0. Maximum: 6. Higher scores mean worse outcome.
Functional Ambulation Categories (FAC) After inclusion Walking ability. Minimum: 0. Maximum: 5. Higher scores mean better outcome.
Start Cancellation Test (SCT) After inclusion Unilateral spatial neglect. Min: 0. Max: 54. Higher scores are better, scores \<44 indicate the presence of USN.
Motor Activity Log Amount of Use (MAL AOU) - Dutch version After inclusion Amount the individual uses the paretic arm. 26 items, per item: min. 0, max. 5. Higher scores mean better outcome.
National Institutes of Health Stroke Scale (NIHSS) After inclusion Stroke severity. Minimum: 0. Maximum: 42. Higher scores mean worse outcome.
ABILHAND After inclusion Self-reported measure of (bi)manual ability in everyday activities. Rasch based logit scale. Higher logit scores mean better outcome.
International Physical Activity Questionnaire (IPAQ) After inclusion Patient-reported physical activity. 3 levels, higher levels are better.
Trial Locations
- Locations (1)
UZ Leuven
🇧🇪Leuven, Belgium