Background
Objective
Methods/Design
Study design/setting
Participants
Sample size and power calculation
Randomisation and blinding
Procedures
Scales | Function/application |
---|---|
Body structure and function assessment | |
i. Modified Tardieu Scale (MTS) | |
The MTS measures spasticity [39]. Descriptively, the MTS has two measurements, the quality of muscle reaction (ordinal scale) and the angle of reaction or angle of catch (ratio). The quality of muscle is scored from 0–5; 0 implies no resistance to Passive Range of Movement (PROM) and 5 indicating joint immobile. On the other hand Angle of catch can be understood via two factors of PROM, the speed of movement and joint angle. The reporting of MTS summarily, involve the quality of muscle and angle of reaction components making it to fit into the body structure and function of the ICF absolutely. It has excellent test retest reliability (ICC = 0.86) in stroke patient [40], with good convergent validity for both elbow and ankle joints (r = 0.86 and r = 0.62 respectively) [39]. | |
ii. Medical Research Council Manual Muscle Testing (MMT) | |
MMT will be used to assess muscle strength for upper and lower extremities, attention will be paid to specific joints of both extremities. For the upper extremity attention will be focused on shoulder, elbow and wrist joints and for the lower extremity joints hip, knee and ankle will be measured. MMT is the best known and most frequently employed muscle strength grading system for manual muscle testing (MMT) [41]. It has a score range of 0–5, with 0 being the minimum and 5/5 the maximum. An excellent test-retest reliability for both right and left hip joints (ICC = 0.98 and ICC = 0.97 respectively) with osteoarthritis [42]. Its convergent validity ranges between adequate to excellent in different body parts [43]. | |
Activity assessment | |
i. Modified Rankin Scale (MRS) | |
The MRS is a hierarchical scale of 0–6 points that indicate “global disability”. It is the most prevalent functional outcome measure for stroke research. Lower scores on the scale suggest more independence and higher scores signify increased dependency. Its test-retest reliability ranged between adequate to excellent (Kappa = 0.67-0.96) [44], with an excellent convergent validity [45]. | |
ii. Modified Barthel Index (MBI) | |
The MBI assesses ten functional tasks of daily living (activities of daily living – ADL). It scores the individual based on independence in each task. Scores range from 0 and 100, with a higher score indicating greater independence. The inter-rater reliability is sufficient at the item level (kappa 0.50–0.78) and good for the overall inter-rater agreement (intraclass correlation coefficient [ICC] 0.77) [46, 47]. | |
iii. Six-minute Walk Test (6MWT) | |
6MWT is a clinically useful measure of walking ability post stroke, which incorporates the important requirements of ambulation, such as walking speed, dynamic balance, and submaximal endurance. It is performed at the individually determined fastest speed possible during walking, making it ideal for stroke survivors [48]. It measures an individual’s ability to walk for a maximum distance (meters) within 6 min. This test exhibits excellent test-retest reliability (ICC = 0.973; 95 % CI = 0.925 to 0.988), a minimal detectable change of 54.1 m, and an acceptable concurrent validity (r = 0.52 to 0.89) [48]. | |
iv. 10 Meter Walk Test (10MWT) | |
Participants’ gait speed will be measured using 10MWT [48], which will be calculated by the time required to cover a distance of 10 m. Participants will be asked to walk at their maximal speed using their regular foot wear and walking aids (for those who use aids). The test will be performed on a 14 m walkway, to avoid the effects of acceleration and deceleration, therefore the individual may accelerate 2 m before entering the 10 m distance and 2 m to decelerate afterward, this will ensure a steady velocity within the 10 m mark. 10MWT shows a high intra-observer reliability (ICC = 0.95) and validity (r = 0.79) in stroke survivors [49]. | |
v. Action Research Arm Test (ARAT) | |
The ARAT is a criterion-rated assessment of upper extremity activity limitations [50]. The ARAT includes 19 items divided into four subscales: grasp, grip, pinch, and gross movement. The items within each subtest are ranked based on a four-point ordinal scale ranging from zero to three, where three symbolises normal performance on each item. The items are ordered in a hierarchy, allowing skipping some items if the person is unable to do an earlier item normally. A score of 57 indicates normal performance. The test has a good test-retest reliability for both chronic and acute stroke, ICC = 0.963 [51], internal consistency α = 0.985 [50] and construct validity in relation to the arm section of Fugl Meyer, ICC = 0.925 [51]. | |
vi. Motor Activity Log (MAL) | |
The motor activity log (MAL) is a rating scale that evaluates how the affected hand is used to perform 30 daily activities (e.g., feeding, turning a door handle). For each activity, the patient rates how much the affected hand is used (amount of use, AOU) and how well the activity is performed (quality of movement, QOM). Ratings are usually on a scale of 0 to 5, with higher scores representing better functions. Scores on each scale are calculated as the mean of the scored items attempted with the affected arm. Its internal consistency is good, α > 0.81, with acceptable test retest reliability r > 0.91 and stability ratio >3 for the QOM and AOU, though not found to be reliable [52]. | |
Participation assessment | |
Stroke specific Quality of Life Questionnaire (SS-QOL) | |
SS-QOL is selected to assess community participation. The SS-QOL is a self-report questionnaire consisting of 49 items cutting across 12 domains of mobility, energy, upper extremity (UE) function, work/productivity, mood, self-care, social roles, family roles, vision, language, thinking, and personality specific for stroke survivors. The domains are graded individually, and a total grade is also rendered [53]. SS-QOL has a good content validity, kappa coefficient ranged from 0.75-1.00, it demonstrated multiple representations of the ICF categories and covered a broad range of the ICF components that were meaningful for the stroke subjects [54]. | |
Acceptability | |
To assess acceptability participants will complete a purpose-designed questionnaire [55]. The tool is a six-item scale adapted from the original treatment acceptability questionnaire, it is a seven point scale, with lower score indicating lower acceptability. Possible score on the scale ranged from 6–42. Participants in all the intervention groups and the control will be asked to provide information specific to their treatment. The test has not been tested for reliability and validity. |
Intervention groups
Stations/description | Prescribed tasks |
---|---|
Workstation 1 | |
Tasks for warm-up specific for upper extremity | |
Active flexion- extension of shoulder, elbow and wrist joints | |
Abduction-adduction of shoulder joint | |
Upper extremity weight bearing on physiotherapy ball | |
Push-ups on physiotherapy ball or using chair arm rest | |
Workstation 2 | |
Tasks for warm-up specific for lower extremity | |
Stretching the lower extremity (flexion/extension of the limb in supine or sitting position) | |
Marching on spot | |
Shuttle walking | |
Jogging on spot | |
Workstation 3 | |
Tasks to achieve reaching, gripping and transferring light objects | |
Sitting with arm supported on high plinth at 90° shoulder flexion | |
Active protraction to push small objects (light ball) off edge of plinth to target the wall | |
Sitting same way to push weighted object (a heavier ball) | |
Active horizontal abduction and adduction to reach object (cup) on the wall | |
Use of protracted shoulder to open a door with patient standing three feet away from the door | |
Wrist flexion/extension in gravity counter balance (provide a target to aim for) | |
Radial and ulnar deviation (in gravity counter balance) with a target to push (cup) | |
Picking light objects from table to the wall and back | |
Workstation 4 | |
Tasks to achieve lower extremity flexibility and function | |
Timed shuttle walk/Initiation of minimal Shuttle jogging (50 % of time allotted for this station) | |
Sit to stand from high chair with arm rest (placing affected leg behind the intact) | |
Stationary bike riding | |
Squatting activity using the wall bars | |
Workstation 5 | |
Task to achieve upper extremity strength/control | |
Active shoulder flexion, extension and abduction with weight of varying sizes (dumbbells) | |
Active shoulder flexion, extension and abduction with resistant band to reach for a target on the wall (cup) | |
Active shoulder abduction with weights of varying sizes (dumbbells), to reach for a target on the wall | |
Active elbow flexion/extension with resistance band. Also substitute with varying weights | |
Active wrist flexion/extension, ulna/radial deviations with resistance band. Can be substituted later with weights of varying sizes | |
Finger to nose movement | |
Rapid hand alternating movements | |
Workstation 5 | |
Task to achieve upper extremity strength/control | |
Active shoulder flexion, extension and abduction with weight of varying sizes (dumbbells) | |
Active shoulder flexion, extension and abduction with resistant band to reach for a target on the wall (cup) | |
Active shoulder abduction with weights of varying sizes (dumbbells), to reach for a target on the wall | |
Active elbow flexion/extension with resistance band. Also substitute with varying weights | |
Active wrist flexion/extension, ulna/radial deviations with resistance band. Can be substituted later with weights of varying sizes | |
Finger to nose movement | |
Rapid hand alternating movements | |
Workstation 6 | |
Task to achieve balance/coordination while walking | |
Sit to stand from lower chair without arm rest (affected leg behind a distant placed intact leg) | |
Standing on foam eye closed (safety is key in this activity) | |
Carrying object while on shuttle walking (a tray with cup of water) | |
Walk up and down stairs (patient walk backward while coming down stairs) | |
Sudden stops and turns while walking | |
Obstacle crossing while walking | |
Figure 8 walking | |
Workstation seven | |
Task to achieve improved grip, precision and dexterity with upper extremity | |
Draw a line on the white board | |
Rolling a dumbbell forwards and backwards on a flat surface (table) | |
Open and close a window | |
Take lids off bottles | |
Bring object from table to mouth, vary size and weight of objects | |
Pour water from jug to cup | |
Mix water with spoon of various sizes | |
Take money in and out of a purse | |
Fold paper and place in an envelop | |
Trace pattern of different figures on white board | |
Workstation 8 | |
Task to achieve lower extremity strength/control of gait | |
Walking different step length of parallel line | |
Obstacle crossing while walking with a tray of cups filled with water | |
Walking backward and side ways | |
Heel lift in standing without and with carrying an object | |
Walk on toes short distance forward and backward | |
Workstation 9 | |
Task to achieve advanced motor task with upper extremity | |
Rolling pin pushing forward and backward | |
Reach, grasp and move objects to and from different heights | |
Wipe over windows | |
Wash, wring and peg clothing on lining rope | |
Paint sketched objects on cardboard paper | |
Use key boards to type | |
Cut customised foams using knifes of varying sizes | |
Put-on common clothing and foot wears | |
Workstation 10 | |
Tasks to achieve improved outdoor activities with lower extremity | |
Walking while picking objects from the floor | |
Walking through closely packed obstacles | |
Walking through tight space | |
Jumping on foam eyes closed | |
Walking on joined foams | |
Reverse walking on straight line | |
Treadmill walking/jogging | |
Speed stair climbing | |
Outdoor walking | |
NOTE: | |
1. Tasks within stations are not necessarily convenient and possible for all participants, choice is therefore individualized | |
2. Tasks in stations vary because it is not necessary for participants to undergo all activities and also to allow room for wide range of opportunities and choices | |
3. Progression might be based on activities not initially possible within stations or based on modifications considered necessary by physiotherapist | |
4. Tasks are performed as structured in the model based on durations allotted for each group |