Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Change in the score of Fugl-Meyer Assessment Scale of Upper-Extremity (scale that assess the change in upper extremity motor functions) |
The Fugl-Meyer Assessment of Upper Extremity (FMA-UE) is a stroke-specific, performance-based impairment index. It measures the movement, coordination and reflex action of the shoulder, elbow, forearm, wrist and hand. The scale includes 33 items divided into 4 subscales: (A) shoulder/elbow, 18 items, (B) wrist, 5 items, (C) hand, 7 items, and (D) coordination/speed, 3 items. Each item is scored on an ordinal 3-point scale, where 2 points are assigned when the movement is performed fully, 1 point when performed partially, and 0 points when the movement cannot be performed. A total score of 66 indicates better sensorimotor function. Thus, the higher the score a patient will get after completion of the treatment program compared to the baseline score, the better the improvement in upper extremity motor functions. |
[Time Frame: Data collected at baseline, and 12 weeks after intervention commencement.] (i.e. Difference between Fugl-Meyer Assessment Scale Score of Upper-Extremity at both baseline and completion of 12 weeks of intervention) |
|
| Primary |
Change in the score of The Action Research Arm Test (test that assess the change in upper extremity functions) |
The Action Research Arm Test (ARAT) is an evaluative measure to assess specific changes in limb function among individuals with hemiplegia. It assesses a patient's ability to handle objects differing in size, weight and shape and therefore can be considered to be an arm-specific measure of activity limitation. The ARAT consists of 19 items grouped into four subscales: grasp, grip, pinch, and gross movement. The ARAT is scored on a four-level ordinal scale (0-3): 0 = cannot perform any part of the test, 1 = performs partially, 2 = take long time to complete the test, and 3 = performs the test normally. The total score on the ARAT ranges from 0 to 57, with the lowest score indicating that no movements can be performed, and the upper score indicating normal performance. Thus, the higher the score a patient will get after completion of the treatment program compared to the baseline score, the better the improvement in upper extremity motor functions. |
[Time Frame: Data collected at baseline, and 12 weeks after intervention commencement.](i.e. Difference between The Action Research Arm Test Score at both baseline and completion of 12 weeks of intervention) |
|
| Primary |
Change in the score of The Wolf Motor Function Test (test that assess the change in upper extremity motor ability) |
The Wolf Motor Function Test (WMFT) is designed to assess upper extremity motor abilities in patients with stroke through timed and functional tasks. The WMFT consists of 15 timed items (6 items involve timed functional tasks, and 9 items consist of analyzing movement quality when completing various tasks), in addition to 2 items (7&14) are measures of strength. The examiner should test the less affected upper extremity followed by the most affected side. The 15 timed items are rated on a 6-point functional ability scale (0-5), score (0) means the patient is unable to use UE being tested while score (5) means the patient is able to use it and movement appears to be normal. The total score on the WMFT ranges from 0 to 75. Lower scores are indicative of lower functioning levels. Thus, the higher the score a patient will get after completion of the treatment program compared to the baseline score, the better the improvement in upper extremity (UE) motor abilities. |
[Time Frame: Data collected at baseline, and 12 weeks after intervention commencement.](i.e. Difference between The Wolf Motor Function Test Score at both baseline and completion of 12 weeks of intervention) |
|
| Secondary |
Change in the Overall Stability Indices {percentage value (%)} for Postural Stability Test (test that assess the change in postural stability) |
The Biodex Balance System will be used to assess the change in the Overall Stability Indices of the Postural Stability Test. The test includes measurement of the following indices: overall stability index, anteroposterior index and mediolateral index which represents the patient's ability to control his postural balance stability in all directions. High values % represent less stability and the patient has difficulty in balance control. On the other hand lower values are indicative of a better balance control. |
[Time Frame: Data collected at baseline, and 12 weeks after intervention commencement.](i.e. Difference between the overall stability indices score at both baseline and completion of 12 weeks of intervention) |
|
| Secondary |
Change in the Overall Stability Index {percentage value (%)}, and Time of Control {seconds} for Limit of Stability Test (test that assess the change in balance ability) |
The Biodex Balance System will be used to assess the change in the Overall Stability Index and the Time of Control of the Limit of Stability Test. This test involves measurement of overall directional control which represented as a percentage value (%). The higher scores will indicate better balance control. The test also include measurement of total time required to complete the test (seconds), improvement in this parameter requires minimizing the time recorded to complete the test. |
[Time Frame: Data collected at baseline, and 12 weeks after intervention commencement.](i.e. Difference between the overall stability index and the time of control at both baseline and completion of 12 weeks of intervention) |
|
| Secondary |
Change in the cadence (step/minute) (which indicate the change of walking ability in patients with stroke). |
Gait Analysis Instrument will be used to assess the change in cadence (step/minute) which reflect the change of walking ability in patients with stroke after completion of the treatment program. The higher the score of cadence after completion of the treatment program compared to the baseline score, the better the improvement of gait performance. |
[Time Frame: Data collected at baseline, and 12 weeks after intervention commencement.](i.e. Difference between cadence at both baseline and completion of 12 weeks of intervention) |
|
| Secondary |
Change in the Gait Velocity (meter /second) (which indicate the change of gait function in patients with stroke). |
Gait Analysis Instrument will be used to assess the change in gait velocity (meter /second) which reflect the change of gait function in patients with stroke after completion of the treatment program. The higher the score of the gait velocity after \completion of the treatment program compared to the baseline score, the better the improvement of gait performance. |
[Time Frame: Data collected at baseline, and 12 weeks after intervention commencement.](i.e. Difference between gait velocity at both baseline and completion of 12 weeks of intervention) |
|
| Secondary |
Change in the Hand Grip Strength of the Involved Upper Extremity (pounds) (which indicate the change of the strength of the involved hand muscles in patients with stroke). |
Hand Grip Dynamometer will be used to assess the change in the strength of the hand muscles of the involved upper extremity. The higher the score of the hand grip after completion of the treatment program compared to the baseline score, the better the improvement of hand functional abilities. |
[Time Frame: Data collected at baseline, and 12 weeks after intervention commencement.](i.e. Difference between hand grip strength at both baseline and completion of 12 weeks of intervention) |
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