Stroke
Conditions
Keywords
upper limb, daily life activity, home-based exercise program, feedback, perceived activity
Brief summary
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.
Interventions
BEHAVIORALAdapted H-GRASP feedback program
Combination of the Home-Graded Repetitive Arm Supplementary Program with in home accelerometer-based feedback
Sponsors
Universitaire Ziekenhuizen KU Leuven
KU Leuven
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Voluntary written informed consent of the participant has been obtained prior to any screening procedures 2. First-ever unilateral, supratentorial stroke, as defined by the American Heart Association/American Stroke Association 3. Minimum six months after stroke 4. Living in the community 5. ≥18 years old 6. Good observed UL motor function but low perceived UL activity. Good observed UL motor function is defined as a score \>50/66 on the Fugl-Meyer Assessment-Upper Extremity (FMA-UE). Low perceived UL activity is defined as a score ≤75/100 on the hand subscale of the Stroke Impact Scale version 3.0 (SIS-Hand).
Exclusion criteria
1. Other neurological condition than stroke 2. Musculoskeletal disorder that affects UL use 3. No informed consent 4. Participation in an interventional Study with an investigational medicinal product (IMP) or device
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hand subscale of the Stroke Impact Scale version 3.0 (SIS-Hand) | Day 1 (enrolment) | Perceived activity of the affected UL. Minimum 0 - maximum 100; higher scores mean better outcome. |
| Activity ratio | Day 1 (enrolment) | Contribution to the activity of one upper limb (UL) versus the other: hours of activity of the affected divided by the unaffected UL |
| Safety | 45 days (post-intervention) | \# of participants with increased pain while performing exercises as measured by visual analogue scale |
| Adherence to the intervention protocol | 45 days (post-intervention) | % of participants who achieved 12 hours of average weekly exercise |
| Retention rate | 45 days (post-intervention) | % of participants who completed the intervention |
| Recruitment rate | 45 days (post-intervention) | % of individuals who were eligible and agreed to participate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Motor Activity Log - 14 Item Version Amount Of Use (MAL-14 AOU) | Day 17 (baseline), 45 days (post-intervention) | Patient-reported amount of UL use in daily life |
| Motor Activity Log - 14 Item Version Quality Of Movement (MAL-14 QOM) | Day 17 (baseline), 45 days (post-intervention) | Patient-reported quality of UL use in daily life |
| Bilateral magnitude | Day 1 (enrolment), day 17 (baseline), 45 days (post-intervention) | Intensity of the movement: sum of the vector magnitude from the two ULs |
| Visual Analogue Scale (VAS) | Day 17 (baseline), 45 days (post-intervention) | Pain intensity in the affected UL from 0 (no pain) to 10 (extreme). Minimum 0, maximum 10, higher scores mean worse outcome. |
| EuroQol Five Dimensions Five Levels Questionnaire (EQ-5D-5L) | Day 17 (baseline), 45 days (post-intervention) | Health-related quality of life. Minimum 0, maximum 100, higher scores mean better outcome. |
| Fugl-Meyer motor assessment - upper extremity (FMA-UE) | Day 1 (enrolment), day 17 (baseline), 45 days (post-intervention) | Observed motor function of the affected UL (shoulder, arm, wrist, hand, and fingers) |
| Action Research Arm Test (ARAT) | Day 17 (baseline), 45 days (post-intervention) | Grasp, grip, pinch and gross movement of the affected UL |
| Erasmus modified Nottingham Sensory Assessment (Em-NSA) | Day 17 (baseline), 45 days (post-intervention) | Sensory assessment of the UL |
| simplified modified Rankin Scale questionnaire (smRSq) | Day 17 (baseline), 45 days (post-intervention) | Global disability. Minimum 0 - maximum 5; higher scores mean worse outcome. |
| Hospital Anxiety and Depression Scale (HADS) | Day 17 (baseline), 45 days (post-intervention) | Symptoms of anxiety and depression. Minimum 0 - maximum 42; higher scores mean worse outcome. |
| Confidence in Arm and Hand Movement Scale (CAHM) | Day 17 (baseline), 45 days (post-intervention) | Perceived self-efficacy in performing tasks with the affected UL. Minimum 0 - maximum 100; higher scores mean better outcome. |
| Hours of UL activity | Day 1 (enrolment), day 17 (baseline), 45 days (post-intervention) | Sum of all seconds recorded when the activity count was nonzero and converted to hours |
| Magnitude ratio | Day 1 (enrolment), day 17 (baseline), 45 days (post-intervention) | 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. |
| Density plot | Day 1 (enrolment), day 17 (baseline), 45 days (post-intervention) | Graphical representation of accelerometry data from both ULs |
Other
| Measure | Time frame | Description |
|---|---|---|
| Demographics | Day 1 (enrolment) | Participant demography |
| Stroke event data | Day 1 (enrolment) | Disease characteristics |
| Barthel Index (BI) | Day 1 (enrolment) | Performance in activities of daily living |
| Apples Test | Day 1 (enrolment) | Visuospatial neglect |
| Montreal Cognitive Assessment (MoCA) | Day 1 (enrolment) | Cognitive function |
| Edinburgh Handedness Inventory (EHI) | Day 1 (enrolment) | Handedness |
| National Institutes of Health Stroke Scale (NIHSS) | Day 1 (enrolment) | Neurological impairments. Minimum 0, maximum 42, higher scores mean worse outcome. |
Countries
Belgium
Outcome results
None listed