Outcome Measures

The following outcome measures are selected because they are relevant for stroke rehabilitation trials and are in line with the International Classification of Functioning, Disability and Health framework to facilitate interpretability of the functional

significance of treatment outcomes (Lemmens et al., 2012). The primary treatment outcomes pertain to change in sensorimotor recovery and daily activity performance.

2.5.1 Primary outcomes

1. Fugl-Meyer Assessment (FMA).

The upper-extremity subscale of the FMA will be used to assess motor impairment (Fugl-Meyer et al., 1975). There are 33 upper extremity items measuring the movements and reflexes of the shoulder/elbow/forearm, wrist, hand, and coordination/speed. Each score is on a 3-point ordinal scale (0 = cannot perform, 1 = performs partially, 2=

performs fully). The maximum score is 66, indicating optimal recovery. The subscale score of a proximal shoulder/elbow (FMA s/e: 0-42) and a distal hand/wrist (FMA h/w:

0-24) will be calculated to investigate the treatment effects on separate upper extremity

elements. The FMA has good reliability, validity, and responsiveness in stroke patients (Hsieh et al., 2009; Platz et al., 2005).

2. Medical Research Council (MRC)

The MRC will be used for measurement of muscle strength of the affected arm. The muscle strength of shoulder flexors/abductors, elbow flexors/extensors, wrist

flexors/extensors, and flexors/extensors of the metacarpophalangeal joints will be evaluated by the 6- point ordinal scale (0 = no contraction, 1 = flicker or trace

contraction, 2 = active movement with gravity eliminated, 3 = active movement against gravity, 4 = active movement against gravity and resistance and 5 = normal power) and the average MRC score will be calculated. The MRC demonstrates reliability in muscle power measurement (Gregson et al., 2000; Hsieh et al., 2011).

3.Revised Nottingham Sensory Assessment (rNSA).

The rNSA will be used to evaluate changes in sensation. Various sensory modalities will be utilized to assess the tactile sensation, proprioception, and stereognosis of

different segments of the body. Scoring of rNSA is based on a 3-point ordinal scale (0-2), with a lower score suggests greater sensory impairment. The psychometric properties have been established for patients with stroke(Lincoln et al., 1998).

4. ABILHAND Questionnaire.

The ABILHAND Questionnaire will be used to evaluate the ability of the UL in functional activities. It consists of 23 bimanual activities that measure subjectively perceived difficulty in performing some common activities in daily living, such as

buttoning, cutting nails, and opening a bottle. The scale ranges from 0 to 3 (0 = cannot perform, 1 = performs partially or with great difficulty, 2 = performs with some

difficulty, 3 = performs fully). Its reliability and construct validity has been confirmed in stroke patients(Penta et al., 2001)..

2.5.2 Secondary outcomes

5. Wolf Motor Function Test (WMFT).

The WMFT was designed to assess the effects of CIT on arm function after stroke and traumatic brain injury. There are 15 function-based and 2 strength-based tasks. For timed functional tasks, completion times from 0 to 120 seconds are averaged. For functional ability scoring, 6-point ordinal scales are used, where 0 indicates “does not attempt with the involved arm” and 5 indicates “arm does participate, movement appears to be normal.”

6. Motor Activity Log (MAL).

The MAL consists of 30 structured questions to interview how the patients rate the frequency (amount of use subscale) and quality (quality of movement subscale) of movements while using their affected arm to accomplish 30 daily activities. The score of each item ranges from 0 to 5, with a higher score indicating more frequent use or higher quality of movement. The summary score is the mean of the item scores.

7. Chedoke Arm and Hand Activity Inventory (CAHAI)

The CAHAI evaluated the ability to perform functional task with both arms and the affected arm included as much as possible, rather than the affect arm only. It included 13 functional activities. Participants were encouraged to completed all activities with both hands. Each activity was scored on a 7-point ordinal scale (1=total assistance, 2=maximal assistance, 3=moderate assistance, 4=minimal assistance, 5=supervision, 6=modified independence, 7=complete independence). The total score ranged from 13 to 91 points.

8. Functional Independence Measure (FIM).

The FIM consists of 18 items grouped into 6 subscales measuring self-care, sphincter control, transfer, locomotion, communication, and social cognition ability (Hamilton, 1987). Each item is rated from 1 (complete assistance) to 7 (complete independence), as determined by the (Hamilton et al., 1994) required level of assistance to perform the tasks, with a higher score (maximum score, 126) indicating less disability. The FIM has good inter-rater reliability, construct validity, and discriminant validity.

9. Nottingham Extended Activities of Daily Living Scale (NEADL).

The NEADL consists of 22 items scored on the basis of the requirement for help in performing the activity. There are four subscales (mobility, domestic, leisure and kitchen) and a total score. The scores range from 0 to 22, with higher scores representing better function. The psychometric properties of the NEADL have been validated in stroke patients .

10. Goal Attainment Scaling (GAS).

The GAS will be used for measurement the achievement of each participant’s expectation in the course of intervention. According to the principle of SMART (i.e.

specific, measurable, attainable, realistic and timely), the individual intervention goals related to daily activity will be negotiated by the therapists and participants. The goals will be set prior to the intervention and scored on the day before the treatment (pretest), the 3-week interim test and after 6 weeks of treatment (posttest). 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 (+2 = a much better than expected level, +1 = a somewhat better than expected level, 0 = the expected level of achievement, -1 = a

somewhat less than expected level, -2 = a much less than expected level). 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 the following formula:

, where I indicates the importance, D is the difficulty, and L is the baseline level in the baseline GAS score or the attainment level in posttest GAS score. GAS scores meet the assumption of normal distribution and represent a standardized score. A GAS score larger than 50 refers to an above-expected performance (Eftekhar et al., 2016; Turner-Stokes, 2009).

11. Stroke Impact Scale Version 3.0 (SIS 3.0).

The SIS 3.0 is a stroke-specific health-related quality of life instrument (Duncan, Bode, Lai, & Perera, 2003). 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) with a single item assessing perceived overall recovery from stroke. Items are rated on a 5-point Likert scale, with lower scores indicating greater difficulty in task completion during the past week. The SIS 3.0 has satisfactory reliability, validity, and responsiveness in stroke patients (Duncan, et al., 2003).

12. Wrist-worn accelerometers.

ActiGraph GT3X+ accelerometers were used to provide an objective measure of the amount the affected arm was used in the patient’s real-life situation. The participants wore the triaxial ActiGraph GT3X+ on each wrist for 3 consecutive days, before and after treatment. The ActiGraph accelerometers were only used in the P-IMT and D-IMT groups because of a limited number of devices. The ActiLife 6.10 software (ActiGraph, Pensacola, FL, USA) was used to process acceleration data. The raw data were integrated into 60-second epochs. The ratio of affect and nonaffect arm activity counts.

2.5.3 Possible adverse effect

Modified Ashworth Scale (MAS)

Possible adverse effect was evaluated for muscle tone. The MAS grades spasticity from 0 (no increase in muscle tone) to 5 (affected part is rigid in flexion and extension;

(Bohannon & Smith, 1987). We calculated the mean scores of the overall, proximal (shoulder and elbow), and distal (forearm, wrist, and finger) portions of UE muscle tone