Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Change from Baseline Fugl-Meyer Assessment (FMA) at 6 weeks, and 18 weeks |
The upper-extremity subscale of the FMA will be used to assess motor impairment. FMA contains 33 items (scale 0-66). The higher summed score means the greater recovery of motor impairment. |
Baseline, 6 weeks, and 18 weeks |
|
Primary |
Change from Baseline ABILHAND Questionnaire at 6 weeks, and 18 weeks |
The ABILHAND Questionnaire will be used to evaluate the ability of the upper limb in functional activities. ABILHAND contains 23 items (scale 0-69). The higher average score means the greater recovery of the ability of the upper limb in functional activities. |
Baseline, 6 weeks, and 18 weeks |
|
Primary |
Change from Baseline Stroke Impact Scale Version 3.0 (SIS 3.0) at 6 weeks, and 18 weeks |
The SIS 3.0 is a stroke-specific health-related quality of life instrument. It consists of 59 items assessing 8 domains (i.e., strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion. memory and thinking and participation). Items are rated on a 5-point Likert scale, with lower scores indicating greater difficulty in task completion during the past week. |
Baseline, 6 weeks, and 18 weeks |
|
Secondary |
Change from Baseline Goal Attainment Scaling (GAS) at 6 weeks. |
The GAS will be used for measurement the achievement of each participant's expectation in the course of intervention. The individual intervention goals related to daily activity will be negotiated by the therapists and participants. For the goals potentially achievable and not overly ambitious, each goal will be rated on a 5-point ordinal scale with the level of attainment captured. The importance and the difficulty for each goal will be scored also based on a 3-point ordinal scale (1 to 3). The overall GAS score will be calculated by a following formula and a GAS summed score larger than 50 refers to an above-expected performance. |
Baseline and 6 weeks |
|
Secondary |
Change from Baseline Functional Independence Measure (FIM) at 6 weeks |
The FIM consists of 18 items (scale 18-126) grouped into 6 subscales measuring self-care, sphincter control, transfer, locomotion, communication, and social cognition ability. The higher summed score means the greater recovery of functional independence. |
Baseline and 6 weeks |
|
Secondary |
Change from Baseline Stroke Self Efficacy Questionnaire (SSEQ) at 6 weeks |
The SSEQ will be used to measure participants' confidence in functional performance from stroke. It consists of 13 items (scale 0-130). A higher summed score (maximum score indicates higher self- efficacy in functional performance from stroke. |
Baseline and 6 weeks |
|
Secondary |
Change from Baseline Activity level as evaluated by actigraphy at 6 weeks |
We will use the ActiGraph GX3 accelerometers (ActiGraph, Shalimar, FL, USA) to quantitatively measure the amount of use outside the laboratory settings. The accelerometer will record the number of moves each minute, and the average counts of move per minute will be calculated as the primary outcome measure. |
Baseline and 6 weeks |
|
Secondary |
Change from Baseline Possible adverse response at 6 weeks |
The vertical numerical rating scale supplemented with a faces rating scale (NRS-FRS) and a self-reported assessment will be provided to evaluate adverse effects on fatigue and pain severity, respectively. Both assessments using 11-point scale (0 = no fatigue/pain to 10 = worst possible fatigue/pain) will be applied. |
Baseline and 6 weeks |
|
Secondary |
Change from Baseline Wolf Motor Function Test (WMFT) score at 6 weeks |
The WMFT quantifies the motor functions of the upper limbs through timed and functional tasks. |
Baseline and 6 weeks |
|
Secondary |
Change from Baseline Revised Nottingham Sensory Assessment (rNSA) at 6 weeks |
The rNSA will be used to evaluate changes in sensation. The rNSA using a 3-point or 4-point scale contains 72 items (scale 0-151) and is divided into tactile sensation, proprioception, and stereognosis subscales. The higher summed score means the greater recovery of sensory impairment. |
Baseline and 6 weeks |
|
Secondary |
Change from Baseline Medical Research Council scale (MRC) at 6 weeks |
MRC will be used for measurement of muscle strength of the affected arm. MRC contains 8 items (scale 0-40). The higher summed score means the greater recovery of muscle strength of the affected arm. |
Baseline and 6 weeks |
|
Secondary |
Change from lateral pinch strength at 6 weeks |
Lateral pinch strength will be used for measurement of muscle strength of the affected hand. The higher score means the greater recovery of muscle strength on the pinch strength. |
Baseline and 6 weeks |
|
Secondary |
Change from Baseline Chedoke Arm and Hand Activity Inventory (CAHAI) score at 6 weeks |
The CAHAI quantifies the bilateral motor functions of the upper limbs through and functional tasks. |
Baseline and 6 weeks |
|