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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Stroke

Intervention / Treatment
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* Other: Class 1 Medical Device CE certified devices: ActiGraph wGT3X-BT accelerometer


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Low match<br>A group with both low observed and perceived upper limb ability. | Other: Class 1 Medical Device CE certified devices: ActiGraph wGT3X-BT accelerometer<br>* Accelerometers on both patients' wrists will give insight into the daily life upper limb use.<br>|
| Good match<br>A group with both good observed and perceived upper limb ability. | Other: Class 1 Medical Device CE certified devices: ActiGraph wGT3X-BT accelerometer<br>* Accelerometers on both patients' wrists will give insight into the daily life upper limb use.<br>|
| Mismatch<br>A group with good observed but low perceived function. | Other: Class 1 Medical Device CE certified devices: ActiGraph wGT3X-BT accelerometer<br>* Accelerometers on both patients' wrists will give insight into the daily life upper limb use.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer motor assessment - upper extremity | 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. | After inclusion | 
| Stroke Impact Scale 3.0 | 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. | After inclusion | 
| Hours of use of each limb | Hours of use of each limb as measured with the accelerometer | After 3 days of sensor-based assessment | 
| Use ratio | Dividing hours of use of the affected limb by the hours of use of the non-affected limb | After 3 days of sensor-based assessment | 
| Magnitude ratio | 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 | After 3 days of sensor-based assessment | 
| Bilateral magnitude | Sum of the vector magnitude from the two limbs | After 3 days of sensor-based assessment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| National Institutes of Health Stroke Scale (NIHSS) | Stroke severity. Minimum: 0. Maximum: 42. Higher scores mean worse outcome. | After inclusion | 
| Modified Rankin Scale (mRS) | Disability. Minimum: 0. Maximum: 42. Higher scores mean worse outcome. Minimum: 0. Maximum: 6. Higher scores mean worse outcome. | After inclusion | 
| Montreal Cognitive Assessment (MoCA) | Cognitive impairment. Minimum: 0. Maximum: 30. Higher scores mean better outcome. | After inclusion | 
| Start Cancellation Test (SCT) | Unilateral spatial neglect. Min: 0. Max: 54. Higher scores are better, scores <44 indicate the presence of USN. | After inclusion | 
| Hospital Anxiety and Depression Scale (HADS) | Anxiety and depression. Minimum: 0. Maximum: 42. Higher scores mean worse outcome. | After inclusion | 
| Barthel Index (BI) | Independence in activities of daily living. Minimum: 0. Maximum: 100. Higher scores mean better outcome. | After inclusion | 
| Functional Ambulation Categories (FAC) | Walking ability. Minimum: 0. Maximum: 5. Higher scores mean better outcome. | After inclusion | 
| International Physical Activity Questionnaire (IPAQ) | Patient-reported physical activity. 3 levels, higher levels are better. | After inclusion | 
| Motor Activity Log Amount of Use (MAL AOU) - Dutch version | Amount the individual uses the paretic arm. 26 items, per item: min. 0, max. 5. Higher scores mean better outcome. | After inclusion | 
| ABILHAND | Self-reported measure of (bi)manual ability in everyday activities. Rasch based logit scale. Higher logit scores mean better outcome. | After inclusion |