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| ID | Type | Description | Link |
|---|---|---|---|
| 1153320N | Other Grant/Funding Number | Research Foundation - Flanders (FWO) |
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| Name | Class |
|---|---|
| Universitaire Ziekenhuizen KU Leuven | OTHER |
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In a recent cross-sectional study, it was shown that people with a good observed upper limb (UL) motor function but low perceived UL activity show a reduced daily-life UL activity. The investigators will now investigate the feasibility of a phone-monitored home exercise and feedback program for the UL following stroke and the preliminary effects on the perceived UL activity and actual daily-life UL activity for participants with good observed UL motor function but low perceived UL activity in the chronic phase post-stroke.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AH-GRASP feedback intervention group | Experimental | All study participants will receive the AH-GRASP feedback intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adapted H-GRASP feedback program | Behavioral | Combination of the Home-Graded Repetitive Arm Supplementary Program with in home accelerometer-based feedback |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment rate | % of individuals who were eligible and agreed to participate | 45 days (post-intervention) |
| Retention rate | % of participants who completed the intervention | 45 days (post-intervention) |
| Adherence to the intervention protocol | % of participants who achieved 12 hours of average weekly exercise | 45 days (post-intervention) |
| Safety | # of participants with increased pain while performing exercises as measured by visual analogue scale | 45 days (post-intervention) |
| Activity ratio | Contribution to the activity of one upper limb (UL) versus the other: hours of activity of the affected divided by the unaffected UL | Day 1 (enrolment) |
| Activity ratio | Contribution to the activity of one upper limb (UL) versus the other: hours of activity of the affected divided by the unaffected UL | Day 17 (baseline) |
| Activity ratio | Contribution to the activity of one upper limb (UL) versus the other: hours of activity of the affected divided by the unaffected UL | 45 days (post-intervention) |
| Hand subscale of the Stroke Impact Scale version 3.0 (SIS-Hand) |
| Measure | Description | Time Frame |
|---|---|---|
| Fugl-Meyer motor assessment - upper extremity (FMA-UE) | Observed motor function of the affected UL (shoulder, arm, wrist, hand, and fingers) | Day 1 (enrolment), day 17 (baseline), 45 days (post-intervention) |
| Action Research Arm Test (ARAT) |
| Measure | Description | Time Frame |
|---|---|---|
| Demographics | Participant demography | Day 1 (enrolment) |
| Stroke event data | Disease characteristics | Day 1 (enrolment) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Geert Verheyden, Professor | KU Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Private physiotherapy practices | Leuven | 3000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38329448 | Derived | Essers B, Veerbeek JM, Luft AR, Verheyden G. The feasibility of the adapted H-GRASP program for perceived and actual daily-life upper limb activity in the chronic phase post-stroke. Disabil Rehabil. 2024 Dec;46(24):5815-5828. doi: 10.1080/09638288.2024.2313121. Epub 2024 Feb 8. |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Perceived activity of the affected UL. Minimum 0 - maximum 100; higher scores mean better outcome. |
| Day 1 (enrolment) |
| Hand subscale of the Stroke Impact Scale version 3.0 (SIS-Hand) | Perceived activity of the affected UL. Minimum 0 - maximum 100; higher scores mean better outcome. | Day 17 (baseline) |
| Hand subscale of the Stroke Impact Scale version 3.0 (SIS-Hand) | Perceived activity of the affected UL. Minimum 0 - maximum 100; higher scores mean better outcome. | 45 days (post-intervention) |
Grasp, grip, pinch and gross movement of the affected UL
| Day 17 (baseline), 45 days (post-intervention) |
| Motor Activity Log - 14 Item Version Amount Of Use (MAL-14 AOU) | Patient-reported amount of UL use in daily life | Day 17 (baseline), 45 days (post-intervention) |
| Motor Activity Log - 14 Item Version Quality Of Movement (MAL-14 QOM) | Patient-reported quality of UL use in daily life | Day 17 (baseline), 45 days (post-intervention) |
| Erasmus modified Nottingham Sensory Assessment (Em-NSA) | Sensory assessment of the UL | Day 17 (baseline), 45 days (post-intervention) |
| simplified modified Rankin Scale questionnaire (smRSq) | Global disability. Minimum 0 - maximum 5; higher scores mean worse outcome. | Day 17 (baseline), 45 days (post-intervention) |
| Hospital Anxiety and Depression Scale (HADS) | Symptoms of anxiety and depression. Minimum 0 - maximum 42; higher scores mean worse outcome. | Day 17 (baseline), 45 days (post-intervention) |
| Confidence in Arm and Hand Movement Scale (CAHM) | Perceived self-efficacy in performing tasks with the affected UL. Minimum 0 - maximum 100; higher scores mean better outcome. | Day 17 (baseline), 45 days (post-intervention) |
| Visual Analogue Scale (VAS) | Pain intensity in the affected UL from 0 (no pain) to 10 (extreme). Minimum 0, maximum 10, higher scores mean worse outcome. | Day 17 (baseline), 45 days (post-intervention) |
| EuroQol Five Dimensions Five Levels Questionnaire (EQ-5D-5L) | Health-related quality of life. Minimum 0, maximum 100, higher scores mean better outcome. | Day 17 (baseline), 45 days (post-intervention) |
| Hours of UL activity | Sum of all seconds recorded when the activity count was nonzero and converted to hours | Day 1 (enrolment), day 17 (baseline), 45 days (post-intervention) |
| Bilateral magnitude | Intensity of the movement: sum of the vector magnitude from the two ULs | Day 1 (enrolment), day 17 (baseline), 45 days (post-intervention) |
| Magnitude ratio | Contribution to the activity of one limb versus the other: natural log of the vector magnitude of the affected UL divided by the vector magnitude of the unaffected UL, whereby values greater than and less than -7 were replaced by 7 and -7, respectively, to categorize single limb movement. | Day 1 (enrolment), day 17 (baseline), 45 days (post-intervention) |
| Density plot | Graphical representation of accelerometry data from both ULs | Day 1 (enrolment), day 17 (baseline), 45 days (post-intervention) |
| National Institutes of Health Stroke Scale (NIHSS) | Neurological impairments. Minimum 0, maximum 42, higher scores mean worse outcome. | Day 1 (enrolment) |
| Edinburgh Handedness Inventory (EHI) | Handedness | Day 1 (enrolment) |
| Montreal Cognitive Assessment (MoCA) | Cognitive function | Day 1 (enrolment) |
| Apples Test | Visuospatial neglect | Day 1 (enrolment) |
| Barthel Index (BI) | Performance in activities of daily living | Day 1 (enrolment) |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |