Lever Actuated Rehabilitation of the Arm Using Wheelchair Propulsion and Computer Gaming
Phase: NA
Conditions: Cerebrovascular Accident
Sponsor: University of California, Irvine

1 
 
 
 
 
 
Efficacy Study of the LARA Wheelchair System for Subacute Stroke Patients 
 
 
 
NCT 02830893 
 
 
 
Standard Operating Procedures 
 
 
 
February 28, 2018 
 
 
 

2 
 
 
Table of Content 
 
1. Background and Population 
2. Inclusion and Exclusion Criteria 
3. Methods 
4. Timeline of the Study 
5. Table of Clinical Testing 
6. List of Clinical Tests 
7. Daily Study Procedures 
8. Statistical Considerations 
 
 

3 
 
Background  
We will recruit 44 individuals with an acute or subacute stroke (3 days to 30 days post stroke) to 
participate in this randomized controlled trial at UCI ARU and Rancho Los Amigos National 
Rehabilitation Center. These individuals will have an acute or subacute stroke with arm/ hand 
weakness defined as a score of less than 50 (out of 66) on the arm motor scale of the Fugl-Meyer 
Assessment.  
Inclusion Criteria: 
1. History of stroke affecting the arm, at least 3 days to 30 days prior to enrollment 
2. Age 18 to 80 years of age 
3. Upper extremity weakness, defined as a score of less than 50 (out of 66) on the arm motor 
scale of the Fugl-Meyer Assessment 
Exclusion Criteria: 
1. Moderate to severe pain in the stroke-affected upper extremity (score >6 on 10-point visual 
analog pain scale), at rest or increased when attempting to use LARA 
2. Severe tone at the affected upper extremity (score >4 on the Ashworth Spasticity Scale) 
3. Severe aphasia (score of 2 or higher on the NIH stroke scale – question 9) 
4. Deficits in vision, language, attention, or other cognitive functions severe enough to interfere 
with using LARA 
5. Currently pregnant 
6. Difficulty in understanding or complying with instructions given by the experimenter 
7. Inability to perform the experimental task that will be studied 
 
Methods: 
The primary outcome measure will be the Upper Extremity Fugl-Meyer Score to assess motor 
impairment in the affected arm.  Secondary outcome measures will be Box and Blocks Test, Modified 
Ashworth Scale of Spasticity to measure spasticity of the shoulder, elbow, wrist and hand, Visual 
Analog Pain scale to assess pain, NIH Stroke Scale, mini mental state exam to assess cognitive 
function and the Borg scale to access their perceived exertion levels.  We will perform testing at three 
separate evaluations: At the initial baseline visit, 3-weeks post therapy or the day before discharge if 
sooner, and 3-month follow up.  The end point of the study will be the 3-month after baseline 
evaluation. 
After the baseline evaluation, all participants will be randomized into 2 groups:  LARA group versus 
conventional hand and arm exercise program.  Randomization will be done through a web-based 
program. 
For LARA group:  participants will be fitted for a LARA chair, they will receive a demonstration by a 
research therapist and be instructed on how to get in/out of the LARA chair, how to propel LARA in a 
straight line, turns, figure 8 if possible.  Participants will also receive training on how to perform arm 
exercises using a video gaming program.    Participants will receive 2 sessions lasting 30 mins each 
for these training exercises.  Participants will begin his/her exercise routine starting the third session.  
A research therapist will be available to assist but study participants are expected to perform exercise 
routines by themselves as much as possible.  The research therapist will record and keep a log of 
time spent assisting study participants every day. 

4 
 
If supervising therapists believe LARA participants are skilled enough to drive LARA, participants will 
begin using LARA to go to therapy appointments and move around ARU by themselves throughout 
the study. 
For control group:  participants will receive a demonstration by a research therapist and instructions 
on how to perform arm/hand exercise programs using towel and table.  Towels, tables and an 
exercise log will be provided.  Participants will receive 2 sessions lasting 30 minutes for each training.  
Participants will begin his/her exercise routine starting the third session.  A research therapist will be 
available to assist but study participants are expected to perform exercise routines by themselves as 
much as possible.  The research therapist will record and keep a log of time spent assisting study 
participants every day. 
Study participants will be compensated with a cash stipend of $100 for each evaluation.  Study 
participants will receive a maximum total of $300 from the study. 
 
 
 

5 
 
Time Line of the Study 
Visit 
# 
Week 
Evaluation 
Session # 
Evaluation 
content 
Exercise 
session # 
Training Content 
(order to be randomized) 
1 
1 
 
Screen 
 
 
2 
1 
1 
All clinical 
outcomes 
 
 
3 
1 
 
 
1 
A: LARA or B: Tabletop exercise 
program 
4 
1 
 
 
2 
A: LARA or B: Tabletop exercise 
program 
5 
1 
 
 
3 
A: LARA or B: Tabletop exercise 
program 
6 
1 
 
 
4 
A: LARA or B: Tabletop exercise 
program 
7 
1 
 
 
5 
A: LARA or B: Tabletop exercise 
program 
8 
2 
 
 
6 
A: LARA or B: Tabletop exercise 
program 
9 
2 
 
 
7 
A: LARA or B: Tabletop exercise 
program 
10 
2 
 
 
8 
A: LARA or B: Tabletop exercise 
program 
11 
2 
 
 
9 
A: LARA or B: Tabletop exercise 
program 
12 
2 
 
 
10 
A: LARA or B: Tabletop exercise 
program 
13 
3 
 
 
11 
A: LARA or B: Tabletop exercise 
program 
14 
3 
 
 
12 
A: LARA or B: Tabletop exercise 
program 
15 
3 
 
 
13 
A: LARA or B: Tabletop exercise 
program 
16 
3 
 
 
14 
A: LARA or B: Tabletop exercise 
program 
17 
3 
 
 
15 
A: LARA or B: Tabletop exercise 
program 
18 
3 
2 
All clinical 
outcomes 
 
 
19 
13 
3 
All clinical 
outcomes: 
Follow-up 
 
 

6 
 
Table of Clinical Testing 
 
Screen  
Evaluation #1 
(Baseline) 
Evaluation #2 
(Post therapy) 
Evaluation #3 
(3-month follow up) 
Consent Form  
X 
 
 
 
HIPAA wavier form 
X 
 
 
 
Photography consent 
X 
 
 
 
Medical History/ Health 
Status Questionnaire/ 
Rehab History overall 
X 
 
 
 
NIHSS 
X 
X 
X 
X 
Box and Blocks Test 
 
X 
X 
X 
Mini Mental State Exam  
 
X 
X 
X 
Modified Rankin Scale 
 
X 
X 
X 
Motor sections of Fugl-
Meyer 
X 
X 
X 
X 
Action Research Arm 
Test 
 
X 
X 
X 
Motor Activity Log 
 
X 
X 
X 
10-meter walk 
 
X 
X 
X 
Grip Strength 
 
X 
X 
X 
AROM & PROM at 
shoulder and elbow 
 
X 
X 
X 
Geriatric Depression 
Scale 
 
X 
X 
X 
Modified Ashworth 
Scale of Spasticity 
(Shoulder, Elbow, 
Wrist, Finger) 
X 
 
X 
 
X 
 
X 
 
Visual Analog of Pain 
Scale  
X 
 
X 
 
X 
 
X 
 
IMI 
X 
X 
X 
X 
Stipend 
X 
X 
X 
X 

7 
 
List of Clinical Tests 
1. Upper Extremity Fugl-Meyer Motor Score – study primary outcome measure 
2. Box and Blocks Test 
3. Motor Activity Log 
4. Action Research Arm Test 
5. Active and passive range of motion at the shoulder and elbow 
6. Modified Ashworth Spasticity Scale 
7. Visual Analog Pain Scale 
8. 10-meter walk test 
9. NIH stroke scale 
10. Mini-Mental State Examination 
11. Geriatric Depression Scale 
12. Modified Rankin Scale Score 
13. Grip Strength 
 

8 
 
 

9 
 
 
 

10 
 
 
 

11 
 
 
 

12 
 
 

13 
 
Subject ID: 
_________________________ 
Date: 
 
_________________________ 
Exam#:  
_________________________ 
Box & Blocks 
Right 
Left 
 
 
 
Box and Blocks Test 
- 
Open test box and place the divider between the two compartments 
- 
Position the box lengthwise along the edge of a standard height table with compartment with cubes on same 
side as the subject’s dominant hand 
- 
Seat the subject in a standard height chair facing the box 
- 
The examiner sits facing the subject to view blocks being transported and note discrepancies in technique 
- 
“I want to see how quickly you can pick up one block at a time with your right/left hand (point to hand), carry 
it to the other side of the box and drop it. Make sure your fingertips cross the partition. Watch me while I 
show you how.” 
- 
Examiner transports three cubes over partition 
- 
“If you pick up two blocks at a time, they will count as one. If you drop one on the floor or table after you have 
carried it across, it will still be counted, so do not waste time picking it up. If you toss the blocks without your 
fingers crossing the partition, they will not be counted. Before you start, you will have a chance to practice for 
15 seconds. Do you have any questions? Place your hands on the sides of the box. When it is time to start, I 
will say ‘READY’ and then ‘GO.’” 
- 
Perform a 15 second practice. If mistakes are made, correct them. 
- 
“This will be the actual test. The instructions are the same. Work as quickly as you can. READY… (wait 3 
seconds) GO.” 
- 
After one-minute STOP 
- 
Count the number of blocks transported and record. Subtract blocks transported more than one at a time or if 
the fingertips did not cross over 
- 
Turn the box so all the blocks are on the same side as the next hand to be tested 
- 
“Now you are to do the same thing with your left hand. First you can practice. Put your hands on the sides of 
the box as before. Pick up one block at a time with your hand and drop it on the other side of the box. READY… 
(wait 3 seconds) GO.” 
 
 
 

14 
 
MOTOR ACTIVITY LOG 
Task 
Use? 
AS 
HW 
If no, why? 
1. 
Turn on light switch 
 
 
 
 
2. 
Open drawer 
 
 
 
 
3. 
Remove clothing from drawer 
 
 
 
 
4. 
Pick up phone 
 
 
 
 
5. 
Wipe off counter 
 
 
 
 
6. 
Get out of car 
 
 
 
 
7. 
Open refrigerator 
 
 
 
 
8. 
Open door with doorknob 
 
 
 
 
9. 
Use TV remote 
 
 
 
 
10. 
Wash your hands 
 
 
 
 
11. 
Turn on/off water faucet 
 
 
 
 
12. 
Dry your hands 
 
 
 
 
13. 
Put on socks 
 
 
 
 
14. 
Take off socks 
 
 
 
 
15. 
Put on shoes 
 
 
 
 
16. 
Take off shoes 
 
 
 
 
17. 
Get up from chair with armrests 
 
 
 
 
18. 
Pull chair away from table 
 
 
 
 
19. 
Pull chair towards table 
 
 
 
 
20. 
Pick up glass/bottle/cup/can 
 
 
 
 
21. 
Brush your teeth 
 
 
 
 
22. 
Put makeup/lotion/cream on face 
 
 
 
 
23. 
Use key to unlock door 
 
 
 
 
24. 
Write on paper 
 
 
 
 
25. 
Carry object in hand 
 
 
 
 
26. 
Use fork or spoon 
 
 
 
 
27. 
Comb your hair 
 
 
 
 
28. 
Pick up cup by handle 
 
 
 
 
29. 
Button a shirt 
 
 
 
 
30. 
Eat half sandwich or finger food 
 
 
 
 
MEAN SCORE 
 
 
 
 
 
1. 
Did you perform this activity during the past week? Yes or No (if yes, continue) 
2. 
How much did your affected arm participate in this activity (AOU-Amount of Use)? 
0 (Never/ Not at All) 
 
5 (Always During/All the Time) 
3. 
How well did your affected arm help during this activity? (QOM – Quality of Movement) 
4. 
0 (Inability to use the affected arm for this activity) 
5 (Ability to use the affected arm just as well as before the stroke) 
Subject ID: ______________ 
Date:  __________________ 
Exam #:  ________________ 
 

15 
 
Subject ID____________________ 
 
Date_________________________ 
 
 
ACTION RESEARCH ARM TEST 
 
Grasp subscale 
 
 
 
 
 
 
Left 
 
 
Right 
Grasp and lift blocks, a cricket ball and a sharpening  
             
 
stone from one shelf of a table to another (lift over 37 cm)              
1.   Block, 10 cm (if score=3, total=18 and goto grip subscale) 
0    1    2    3  
0    1    2    3    
2.   Block, 2.5 cm (if score=0, total=0 and goto grip subscale) 
0    1    2    3   
0    1    2    3 
3.   Block, 5 cm 
 
 
 
 
 
 
0    1    2    3   
0    1    2    3 
4.   Block, 7.5 cm 
 
 
 
 
 
 
0    1    2    3    
0    1    2    3 
5.   Cricket ball 
 
 
 
 
 
 
0    1    2    3  
0    1    2    3 
6.   Sharpening stone  
 
 
 
                        0    1    2    3  
0    1    2    3 
 
 
 
 
 
 
Subtotal  
               _____/18 
 
   _____ /18 
Grip subscale 
7.   Pour water from one glass to another 
 
 
 
0    1    2    3   
0    1    2    3  
      (if score=3, total=12 and goto pinch subscale)  
 
 
8.   Displace an alloy tube (diameter 2.25 cm) from one side of the  0    1    2    3  
0    1    2    3 
      table to the other (if score=0, total=0 and goto pinch subscale) 
9.   Displace an alloy tube (diameter 1 cm) from one side of the  
0    1    2    3   
0    1    2    3 
      table to the other 
10. Put washer over a bolt                                           
 
0    1    2    3   
0    1    2    3 
 
 
 
 
 
 
Subtotal 
              _____/12 
 
     _____/12 
Pinch subscale 
Pinch and lift the ball bearing, marble from one shelf  
of a table to another (lift over 37 cm) 
11. Ball bearing of 6 mm, 3rd finger and thumb  
 
 
0    1    2    3  
0    1    2    3 
(if score=3, total=18 and goto gross movement subscale) 
12. Marble, 1st finger and thumb  
 
 
 
 
0    1    2    3    
0    1    2    3 
(if score=0, total=0 and goto gross movement subscale) 
13. Ball bearing of 6 mm, 2nd finger and thumb 
 
 
0    1    2    3   
0    1    2    3 
14. Ball bearing of 6 mm, 1st finger and thumb 
 
 
0    1    2    3  
0    1    2    3 
15. Marble, 3rd finger and thumb 
 
 
 
 
0    1    2    3  
0    1    2    3 
16. Marble, 2nd finger and thumb 
 
 
 
 
0    1    2    3  
0    1    2    3 
 
 
 
 
 
 
Subtotal 
                _____ /18  
    _____ /18 
Gross movement subscale 
17. Hand behind head (if score=3, total=9 or if score=0, total=0) 0    1    2    3  
0    1    2    3 
18. Hand on top of head 
 
 
 
 
 
0    1    2    3  
0    1    2    3 
19. Hand to mouth 
 
 
 
 
 
            0    1    2    3  
0    1    2    3   
 
                                                                                       Subtotal            _____/9 
                _____/9       
 
 
 
 
 
 
 
TOTAL 
                 ________/57 
     ________/57 
 
 

16 
 
Subject ID: _________________ 
 
Date:    ____________________ 
 
Exam#: ____________________ 
 
 
 
Range of Motion - Shoulder 
ROM 
Active 
Passive 
Active 
Passive 
Left 
Left 
Right 
Right 
 
Flexion  
 
 
 
 
 
 
Abduction  
 
 
 
 
 
Internal Rotation  
 
 
 
 
 
 
External Rotation  
 
 
 
 
 
Range of Motion - Elbow 
ROM 
Active 
Passive 
Active 
Passive 
Left 
Left 
Right 
Right 
 
Flexion  
 
 
 
 
 
Extension  
 
 
 
 
 

17 
 
RANGE OF MOTION MEASUREMENTS: 
Shoulder Flexion: 
Measurement Tool: Universal Goniometer 
Testing Position: Supine with hips and knees bent and lumbar spine flat. Arm is at the side with the 
palm in and the thumb up 
Stabilization: Body weight should stabilize scapula but manual stabilization may be required to 
prevent excessive scapular rising and tipping posteriorly 
Goniometer Axis: Lateral aspect of the center of the humeral head approximately 1" below the 
acromion process 
Stationary Arm: Parallel to midaxillary line of the trunk 
Expected ROM: 120° of pure GH flexion; 150° with GH, AC, SC, and scapulothoracic contribution; 180° if lumbar hyperextension 
permitted 
Shoulder Abduction:  
Measurement Tool: Universal Goniometer 
Testing Position: Supine with the hips and knees bent. Arm is in the anatomical position with the 
shoulder externally rotated 
Stabilization: Stabilize the thorax 
Goniometer Axis: Anterior aspect of the shoulder just inferior and lateral to the coracoid process 
Stationary Arm: Parallel to midaxillary line of the trunk 
Moving Arm: Anterior aspect of the upper arm parallel to longitudinal axis of the humerus 
Expected ROM: 90° of pure GH abduction; 150° with GH, AC, SC, and scapulothoracic contribution; 
180° if lumbar lateral flexion is allowed 
 
Shoulder Internal/External Rotation 
Measurement Tool: Universal Goniometer 
Testing Position: Supine with the shoulder and elbow abducted 90°. The forearm is midway 
between pronation/supination with the entire humerus is supported by the table. 
Stabilization: Stabilize the distal humerus through the full ROM and stabilize the thorax/scapula 
at the end ROM 
Goniometer Axis: The olecranon process of the ulna projecting through the humeral shaft toward the 
humeral head 
Stationary Arm: Parallel to the supporting surface or perpendicular to the floor 
Moving Arm: Parallel to the longitudinal axis of the ulna pointing toward the styloid process 
Expected ROM: 70° internal rotation; 90° external rotation 
 
 
Elbow Flexion: 
Measurement Tool: Universal Goniometer 
Testing Position: Supine or sitting with the arm parallel to the midline and the forearm in the 
anatomical position 
Stabilization: Examiner manually stabilizes the humerus 
Goniometer Axis: Over the lateral epicondyle of the humerus 
Stationary Arm: Parallel to the longitudinal axis of the humerus pointing towards the tip of the 
acromion 
Moving Arm: Parallel to longitudinal axis of the radius pointing toward the styloid process of the 
radius 
Expected ROM: 150° 
 
Elbow Extension: 
Measurement Tool: Universal Goniometer 
Testing Position: Supine or sitting with the arm parallel to the midline and the forearm in the 
anatomical position 
Stabilization: Examiner manually stabilizes the humerus 
Goniometer Axis: Over the lateral epicondyle of the humerus 
Stationary Arm: Parallel to the longitudinal axis of the humerus pointing towards the tip of the 
acromion 
Moving Arm: Parallel to the longitudinal axis of the radius pointing towards the styloid process of 
the radius 
Expected ROM: 0° in males; 10-15° in females is common. 
 
 

18 
 
Subject ID: 
_________________________ 
Date:  
_________________________ 
Exam#: 
_________________________ 
Modified Ashworth Scale of Spasticity 
After Katz et al, Arch PMR 73:339-347, 1992 
 
0 
No increase in muscle tone. 
1 
Slight increase in tone, manifested by a catch and release or by minimal 
resistance at the end of the range of motion when the affected part(s) is 
moved in flexion or extension. 
1+ 
Slight increase in muscle tone, manifested by a catch, followed by minimal 
resistance throughout the remainder (less than half) of the ROM, but 
affected part(s) easily moved. 
2 
More marked increase in muscle tone through most of the ROM, but 
affected part(s) easily moved. 
3 
Considerable increase in muscle tone, passive movement difficult. 
4 
Affected part(s) rigid in flexion or extension. 
 
 
For elbow, go from full flexion to full extension in 1 second with patient supine 
and arm stop a pad (per Bohannon and Smith, Phys Ther 1987). 
 
 
 
Shoulder 
Elbow 
Wrist 
Finger 
 
 
 
 

19 
 
 
 
 
 
 
 
 
 
 
 
 
No Movement:      
_____ 
 
With Movement: 
_____ 
 
 

20 
 
 
 
 
 
 
Gait velocity testing – 10m Walk 
 
Record time (to the nearest hundredth of a second) for the subject to complete the 10 meter walk. Record score 
separately for each of the two trials. 
 
 
Timed 10meter walk 
Trial #1  (# seconds) 
Trial #2 (# seconds) 
 
Was an attempt made to evaluate gait velocity testing? 
Yes or 
No 
If no, enter 999 in both of the above boxes for “# seconds” and state the reason why gait velocity 
testing could not be attempted:  
  
 
Was an attempt made to evaluate gait velocity but the subject was not able to initiate even a 
single step? 
Yes or 
No 
If yes, enter 300 in both of the above boxes for “# seconds”. 
 
Did subject use any assistive device or orthotic device (e.g., AFO, cane, or walker)? 
Yes or 
No 
If yes, state the device:   
 
 
Did study site personnel provide any physical support during gait velocity testing? 
Yes or 
No 
If yes, describe this support:  
 
 
 
 
 
 
 
1 
Property of University of California Irvine - 2015 v.3 
 
 
Subject ID  
   
Date 
 
Visit #    
  
Name of person doing exam  
 

21 
 
Subject ID:_________________________________ 
Date:______________________________________ 
Exam #:____________________________________ 
NIH Stroke Scale--Score first response.  No prompting. 
*Indicates option to score X (e.g., joint fusion/amputation); provide explanation. 
Test 
Scale Definition 
Score 
1a. Level of Consciousness--Must choose a response. 
0=Alert; keenly responsive 
1=Not alert; but arousable by minor stimulation 
2=Requires repeated or painful stimuli to attend 
3=Reflex motor, flaccid, or areflexic 
 
1b. LOC Questions--Ask pt his age & the month; must 
be correct.  Tube, dysarthria, foreign lang. barrier=1. 
0=Both correct 
1=One correct 
2=Neither correct; aphasia or stupor=2 
 
1c. LOC Commands--Ask pt to open & close eyes, 
then grip & release non-paretic hand.  Can use 
different 1-step command or pantomime 
instructions. 
0=Both correct; full credit if incomplete 2 weak 
1=One correct 
2=Neither correct 
 
2. Best Gaze--Horizontal EOM only, voluntary or 
Doll’s.  Conjugate deviation which can be 
overcome=1.  Isolated CN palsy=1. 
0=Normal 
1=Partial gaze palsy; abnl gaze in 1 or both eyes 
2=Forced deviation or total gaze paresis not overcome by Doll’s 
 
3. Visual Field--Use visual threat if nec.  If monocular, 
score per field of remaining eye.  Quadrantanopia=1. 
0=No visual loss 
1=Partial hemianopia, quadrantanopia, or extinction. 
2=Complete hemianopia 
3=Bilateral hemianopia or any blindness, incl/ctxcl 
 
4. Facial Palsy--If stuporous, check symmetry of 
grimace to pain. 
0=Normal 
1=Minor paralysis, flattened NLF, asym smile 
2=Partial paralysis (paralysis of lower face) 
3=Complete paralysis (upper & lower face) 
 
5. Motor Arm*--extend pt’s arm 90 deg (sitting) or 45 
deg (supine); watch for 10 sec.  Use pantomime or 
voice urgency but not pain.  Begin w/stronger arm.  
Circle paretic arm in score box. 
0=No drift for 10 sec 
1=Drifts before 10 sec but does not hit bed 
2=Some effort vs. gravity, can’t maintain postn 
3=No effort vs. gravity 
4=No movement (score 3 if any mvmt in extremity) 
Paretic arm 
is 
L      R 
    Other Arm*--For brainstem stroke. 
0-4, use same scale as above.  Circle L & R. 
 
6. Motor Leg*--Place leg at 30 deg (always supine); 
watch for 5 sec. 
0-4, use same scale as above 
Circle paretic leg in score box. 
L       R 
    Other Leg*--For brainstem stroke. 
0-4, use same scale as above.  Circle L & R. 
 
7. Limb Ataxia*--OU open, in good vis field.  Only 
score if o/o proportion to any weakness.  Score 0 if 
pt can’t understand or is hemiplegic.  If blind, pt to 
touch nose after extending arm. 
0=No ataxia 
1=Ataxia in 1 limb (upper ext or lower ext;; specify limb in score 
box) 
2=Ataxia in upper ext and lower ext 
 
 
8. Sensory--Use pin; only score losses related to the 
stroke.  Can assess by grimace or withdrawal if pt 
obtunded.  Score 2 only if pt clearly comprehends 
thus aphasics/stupor usually=1. 
0=Normal 
1=Mild-mod sensory loss, less sharp on affected side, pt aware of 
being touched 
2=Severe total sensory loss, unaware of touch; unresponsive=2, bilat 
sens loss(brnstem)=2 
 
9. Best Language--Describe cookie thief, name 
pictures, read sentences; can use stereognosis, 
repetition, or writing.  Score=3 only if pt mute & 
follows no 1 step commands. 
0=Normal 
1=Mild-mod aphasia 
2=Severe aphasia; great need for guessing & inference by examiner; 
lim’d info exchanged.  Examiner carries burden of 
communication. 
3=Mute, global aphasia, coma 
 
10. Dysarthria*--Have patient read from list of words; 
can rate speech w/severe aphasia.  Score=X only if 
patient intubated or has other barrier. 
0=Normal 
1=Mild-mod; pt slurs but can be understood 
2=Severe; unintelligible. Mute/anarthric=2 
 
11. Extinction & Inattention--severe vis loss + normal 
sens=0; aphasia but attending well bilat’ly=0.  Vis 
neglect or anosognosia =abnl. 
0=Normal or none detectable 
1=Inattention or extinction on DSS in any of vis, auditory, sens, 
spatial, or personal 
2=Profound in > 1 modality 
 
 
SCC 2/99 
TOTAL SCORE 

22 
 
Subject ID: 
    
Date: 
  
Exam # 
  
 
 
Mini-Mental State  Examination CMMSE) 
 
ORIENTATION - one point for each answer 
 
"What is the date today? (year)(date)(month)(day)(season)?"(5) _  
"Where are we? (state)(county)(town)(hospital)(floor)?"  (5) 
 
REGISTRATION - score 1,2,3 points according to how many are repeated on first try (Apple, 
piano, green) 
 
Name three objects: Give the patient one second to say   each. 
Ask the patient to: repeat all three after you have said them. Repeat them until the patient learns all 
three.  (3) 
 
ATTENTION AND CALCULATION - one point for each correct subtraction 
 
Ask the patient to: begin from 100 and count backwards by 7. Stop after 5 answers. (93, 86, 79, 72, 
65) or Spell   WORLD 
backwards (5) 
 
RECALL - one point for each correct answer 
 
Ask the patient to: name the three objects from above. (3) 
 
 
LANGUAGE 
 
Ask the patient to: identify and name a pencil and a watch.  (2) 
  
 
 
Ask the patient to: repeat the phrase "No ifs, ands, or buts."  (1)   
 

23 
 
Ask the patient to: "Take a paper in your right hand, fold it in half, and put it on the floor" 
(1 point for each task completed properly) (3)   
  
 
Ask the patient to: read and obey the following: (1) 
  
 
 
 
 
 
Close your eyes 
 
Ask the patient to: write a sentence. (1) 
  
 
 
 
 
 
 
Ask the patient to: copy a complex diagram of two interlocking 
pentagons. (1) 
 
 
 
 
 
 
 
 
 
 
 
 
 
TOTAL:  
/30 

24 
 
MODIFIED 
Patient Name: 
  
 
RANKIN 
Rater Name: 
  
 
SCALE (MRS) 
Date: 
  
 
 
 
Score 
Description 
 
 
0 
No symptoms at all 
 
 
1 
No significant disability despite symptoms; able to carry out all usual duties and activities 
 
 
2 
Slight disability; unable to carry out all previous activities, but able to look after own 
affairs without assistance 
 
 
3 
Moderate disability; requiring some help, but able to walk without assistance 
 
 
4 
Moderately severe disability; unable to walk without assistance and unable to attend to own 
bodily needs without assistance 
 
 
5 
Severe disability; bedridden, incontinent and requiring constant nursing care and attention 
 
 
6 
Dead 
 
 
 
TOTAL (0–6):   
 
 
References 
 
 
Rankin J. “Cerebral vascular accidents in patients over the age of 60.” 
Scott Med J 1957;2:200-15 
 
Bonita R, Beaglehole R. “Modification of Rankin Scale: Recovery of motor function after 
stroke.” 
Stroke 1988 Dec;19(12):1497-1500 
 
Van Swieten JC, Koudstaal PJ, Visser MC, Schouten HJ, van Gijn J. “Interobserver agreement 
for the assessment of handicap in stroke patients.” 
Stroke 1988;19(5):604-7 

25 
 
Subject ID: 
_________________________ 
Date:  
_________________________ 
Exam#: 
_________________________ 
Geriatric Depression Scale 
15 Question Version (“Short Form”) 
Choose the best answer for how you have felt over the past week: 
Question 
Y/N 
Score 
1. 
Are you basically satisfied with your life? 
Yes     No  
2. 
Have you dropped many of your activities and interests? 
Yes     No  
3. 
Do you feel that your life is empty? 
Yes     No  
4. 
Do you often get bored? 
Yes     No  
5. 
Are you in good spirits most of the time? 
Yes     No  
6. 
Are you afraid that something bad is going to happen to 
you? 
Yes     No  
7. 
Do you feel happy most of the time? 
Yes     No  
8. 
Do you often feel helpless? 
Yes     No  
9. 
Do you prefer to stay at home, rather than going out and 
doing new things? 
Yes     No  
10. Do you feel you have more problems with memory than 
most? 
Yes     No  
11. Do you think it is wonderful to be alive now? 
Yes     No  
12. Do you feel pretty worthless the way you are now? 
Yes     No  
13. Do you feel full of energy? 
Yes     No  
14. Do you feel that your situation is hopeless? 
Yes     No  
15. Do you think that most people are better off than you are? 
Yes     No  
Answers in bold and underlined indicate depression. Although differing sensitivities and 
specificities have been obtained across studies, for clinical purposes a score > 5 points is 
suggestive of depression and should warrant a follow-up interview. Scores > 10 are almost 
always depression. 

26 
 
Subject ID: 
_________________________ 
Date:  
_________________________ 
Exam#: 
_________________________ 
Power Grasp Test 
 
Trial 1 
Trial 2 
Trial 3 
Average 
Grasp (kg) Right 
 
 
 
 
Grasp (kg) Left 
 
 
 
 
 
Grasp 
- Displays grip force in pounds (0-200) and kilograms (0-90). 
- Isometric; accommodates variable size hands, adjusts to five grip 
positions (1 ⅜” to 3 ⅜”). 
- Set adjustable handle to the desired spacing. 
- Rotate the peak hold needle counter-clockwise to 0. 
- The patient should be seated with shoulder adducted and neutrally rotated, 
elbow flexed at 90 degrees, and the forearm in neutral position and wrist 
between 0-30 degrees dorsiflexion and 0-15 degrees ulnar deviation. 
- Let the patient comfortably arrange the instrument in hand. Lightly hold around 
the readout dial to prevent inadvertent dropping 
- Have the patient squeeze with maximum strength. 
- 3 trials with 2-3 min. rest period between trials. 
- The average of the three trials is recorded. 
- Compare the other hand and the normative data. Scores within 2 standard 
deviations of the mean are considered within normal limits. 
 
 

27 
 
Subject ID: 
_________________________ 
Date:  
_________________________ 
Exam#: 
_________________________ 
Pinch Strength Test 
Test 
Trial 1 
Trial 2 
Trial 3 
Average 
Lateral Pinch (kg) 
Right 
 
 
 
 
Lateral Pinch (kg) 
Left 
 
 
 
 
 
Pinch 
- Measures key (Lateral Pinch) strength. 
-Measures in pounds (0-45) or kilograms (0-20). 
-ASHT recommends the following test position: patient should be seated, 
shoulders adducted and neutrally rotated, elbow flexed at 90 degrees, forearm 
and wrist in neutral position. 
-Key or lateral pinch: pad of thumb and lateral surface of index finger 
 
 

28 
 
Daily Procedures:  
1. 
Stroke patients admitted to ARU. 
2. 
Screen will be done upon admission (within 1-2 days). 
3. 
Baseline evaluation will be performed within 1-3 days after the screening visit.  
The therapist will see patients in a separate room right outside ARU.   
4. 
Randomization occurs after baseline evaluation – same day if possible.  We will 
use the web-based formula to randomize patients from both study sites. 
5. 
Study participants will be assigned to groups the day after randomization and 
begin their assigned intervention. 
6. 
We will measure patient’s heart rate and blood pressure in sitting position before 
and after each training session and record the data in the vital signs log. 
7. 
For LARA group:  participants will be fitted for LARA chair, will receive a 
demonstration by a research therapist and will be instructed on how to get in/out of 
LARA chair, how to propel LARA in a straight line, turns, figure 8 if possible (please see 
below for more details).  Participants will receive 2 sessions lasting 30 minutes each for 
these trainings.  If time permits, participants will perform video games using LARA in the 
common area at ARU.  Instruction for all these trainings will be played through a pre-
programmed computer.  All data will be recorded to the same computer.  Starting the 
third session, a research therapist will be available to assist but study participants are 
expected to perform exercise routines by themselves as much as possible.  The 
research therapist will record and keep a log of time spent assisting study participants 
every day.   
Study participants will perform the following exercise routines for 15 minutes, 5 days a 
week: 
a. Spin LARA with unimpaired arm (wheel on impaired side is locked) for 30 sec. 
b. Spin LARA with impaired arm (wheel on unimpaired side is locked) for 30 sec. 
c. Go straight (put these two skills to use) for 2 mins. 
d. Turn test unconstrained (turn towards the impaired side) for 30 sec. 
e. Turn test unconstrained (turn towards the unimpaired side) for 30 sec. 
f. Functional Task (Figure 8 track) for 2 mins. 
Study participants will then play the video games:  balloon and rocket driving for another 
15 minutes, 5 days a week. 
8. 
For control group:  participants will receive a demonstration by a research 
therapist and will be instructed on how to perform arm/hand exercises using towel and 
table (please see appendix A for details).  Towels, tables and an exercise logs will be 
provided.  Participants will receive 2 sessions lasting 30 minutes each for these 
trainings.  Starting the third session, a research therapist will be available to assist but 
study participants are expected to perform exercise routines by themselves as much as 

29 
 
possible.  The research therapist will record and keep a log of time spent assisting study 
participants every day.   
 
9. 
If supervising therapists at ARU and research therapist believe LARA participants 
are skilled enough to drive LARA, participants will begin using LARA to go to therapy 
appointments and move around ARU by themselves. 
10. 
3 clinical evaluations:  baseline, 3-week post therapy or the day before discharge 
if sooner, 3-month follow up.  All clinical evaluations must be completed within 2 days of 
scheduled dates. 
11. 
3-month follow up is 3 months after baseline evaluation. 
 
 

30 
 
Statistical Considerations 
Data will be analyzed using modified intention-to-treat analysis. That is, all participants will be 
included in the analysis if data from the last follow-up assessment is available, regardless of 
treatment they receive or deviations from protocol. For missing data, we will carry forward the 
last available value. The effect of treatment on each outcome measure will be assessed using a 
repeated-measures ANOVA. Follow up analysis will be done using t-tests with Bonferroni 
corrections, or Wilcoxon rank sum tests if the distributions fail the Lilliefors test for normality. We 
hypothesize that the participants in the LARA therapy group will have significantly greater 
reductions in motor impairment measured by FM score than participants in the conventional 
therapy group. We expect this will be due to the increased dose of therapy LARA provides, and 
we will include total arm activity (as measured by the wrist-mounted actigraphy) and baseline 
function as covariates in the analysis. We will compare changes in MAL score, ARAT score, 
range of motion at the shoulder and elbow, Visual Analog Pain scores, Ashworth Spasticity, and 
10 min walk scores using student’s t-test or Wilcoxon rank sum tests for non-parametric data. 
We expect improvements in functional use of the impaired limb (MAL and ARAT) and range of 
motion but expect no significant differences in pain, spasticity, wheelchair odometer reading, or 
walking speed. All analyses will be reviewed by our statistical consultant. 
 

31 
 
Appendix A 
Part 1: Arm Strengthening Exercises with Tabletop 
Support 
 
These exercises for the joints of the arm can help strengthen weak arm muscles, improve 
range of motion, and minimize stiffness and pain. 
 
Instructions 
 
• Use the muscles of your weak arm as much as possible. 
• Use the stronger arm to help guide the weaker arm only as needed. 
• Move slowly. 
• The movements should not cause pain, but you may feel your muscles stretch. 
• Repeat each exercise ten times. 
• Perform exercises  
times per day. 
 
 
Exercises 
 
(1) 
Shoulder and Elbow Flexion/Extension 
 
1. Place towel on the table 
2. Place weaker arm on top of towel. 
3. Using the strength of your shoulder and elbow, stretch your arm out in front of you 
4. Try to keep arm as straight as possible. 
5. Using the strength of your weaker arm, bend your elbow. 
6. Pull arm back towards you. 

32 
 
 
(2) 
Shoulder Abduction/Adduction 
 
 
1. Using the strength of your shoulder, slide arm out away from you. 
2. Try to keep elbow straight and move only at the shoulder. 
3. Slide arm in and around toward the opposite side of your body. 
4. Try to keep elbow straight and move only at the shoulder. 
 
 
(3) 
Shoulder Internal/External Rotation 
 
1. Bend arm at elbow and tuck elbow in at your side. 
2. Pull your arm in, toward your body. 
3. Now slide hand out away from your body. 
4. Keep elbow tucked in as much as possible. (You may need to use stronger hand to hold 
the weaker elbow in during this movement). 

33 
 
(4) 
Forearm Supination/Pronation 
 
1. Place weaker elbow on the table. 
2. Allow weaker forearm to rest in the palm of the stronger hand. 
3. Using the strength of your weaker arm, turn palm toward you. 
4. Keep hands in the same position. 
5. Using the strength of your weaker arm, turn your palm away from you. 
 
 
(5) 
Wrist Flexion/Extension 
 
1. Hold weaker arm behind the wrist with your stronger hand, and lift the weaker arm slightly 
off the table. This will help your weaker hand to move without rubbing on the table. 
2. Using the strength of your weaker arm, bend wrist forward. 
3. Using the strength of your weaker arm, bend wrist backward. 

34 
 
(6) 
Finger and Thumb Flexion/Extension 
 
 
1. Hold weaker arm behind the wrist with your stronger hand, and lift the weaker arm slightly 
off the table. This will help your weaker hand to move without rubbing on the table. 
2. Using the strength of your weaker hand, close fingers into a fist. 
3. Using the strength of your weaker hand, open all of your fingers and straighten thumb. 

35 
 
Part 2: Weight Bearing Exercises for the Arm 
These exercises can help maintain range of movement and minimize stiffness and pain in the 
arm joints. 
Instructions 
 
• Move slowly and carefully. Stretches should not cause pain. 
• Hold each position for at least 20 to 60 seconds. 
• Perform exercises five times. 
• If unable to stand easily, do only the first exercise 
 
(1) 
Sitting Weight Bearing - Elbow/Wrist/Finger Extension 
 
 
1. Place two stable chairs (of the same height) next to each other. 
2. Place weaker hand on the seat next to you, as close to your body as possible. 
3. Try to open weaker hand and place palm flat. 
4. If unable to open hand, try placing only the heel of hand on the chair. 
5. Use stronger hand to help straighten weaker elbow by placing hand behind elbow and 
pulling forward. Keep weaker arm as straight as possible. 
6. Push down through the heel. 
7. Hold position for 20-60 seconds. 
8. To increase the stretch if desired, keep weaker hand on chair with elbow straight while 
stronger arm reaches forward and up. 
9. Hold position for 20-60 seconds. 

36 
 
 
(2) 
Standing Weight Bearing - Elbow/Wrist/Finger Extension 
 
 
1. Stand facing a table. Place weaker hand on top of table, as close to your body as possible. 
2. Try to open weaker hand and place palm flat. 
3. If unable to open hand, try placing only the heel of hand on the table. 
4. Use stronger hand to help straighten weaker elbow by placing hand behind elbow and pulling 
forward. 
5. Keep weaker arm as straight as possible and push down through the heel of hand. 
6. Hold position for 20-60 seconds. 
7. To increase stretch if desired, keep weaker hand on chair and elbow straight while stronger 
arm reaches forward and up. 
8. Hold position for 20-60 seconds.