Table 1.
Baseline Characteristics of the Patients.*
| Characteristic | Robot-Assisted Therapy (N = 49) |
Intensive Comparison Therapy (N = 50) |
Usual Care (N = 28) |
|---|---|---|---|
| Age — yr | |||
|
| |||
| Mean | 66±11 | 64±11 | 63±12 |
|
| |||
| Range | 44–95 | 28–86 | 42–88 |
|
| |||
| Sex— no. (%) | |||
|
| |||
| Male | 47 (96) | 48 (96) | 27 (96) |
|
| |||
| Female | 2(4) | 2(4) | 1(4) |
|
| |||
| Race or ethnic group — no. (%)† | |||
|
| |||
| White | 39 (80) | 37 (74) | 23 (82) |
|
| |||
| Black | 10 (20) | 13 (26) | 5(18) |
|
| |||
| Hispanic | 1(2) | 2(4) | 0 |
|
| |||
| Other | 1(2) | 2(4) | 0 |
|
| |||
| Index stroke type — no. (%) | |||
|
| |||
| Hemorrhagic | 7(14) | 6(12) | 6(21) |
|
| |||
| Ischemic | 42 (86) | 44 (88) | 22 (79) |
|
| |||
| Index stroke location — no. (%) | |||
|
| |||
| Anterior circulation | |||
|
| |||
| ≥1/3 of hemisphere | 6(12) | 14 (28) | 6(21) |
|
| |||
| <1/3 of hemisphere | 17 (35) | 21 (42) | 10 (36) |
|
| |||
| Small deep infarct | 17(35) | 15 (30) | 6(21) |
|
| |||
| Posterior circulation | 9(18) | 0 | 6(21) |
|
| |||
| Time from index stroke to randomization — yr‡ | |||
|
| |||
| Mean | 3.6±4.0 | 4.8±4.0 | 6.2±5.0 |
|
| |||
| Range | 0.6–19.8 | 0.5–15.7 | 0.5–23.6 |
|
| |||
| Multiple strokes — no. (%) | |||
|
| |||
| Self-reported with clinical history | 11 (22) | 10 (20) | 5(18) |
|
| |||
| Identified on MRI or CT | 18 (37) | 17 (34) | 7(25) |
|
| |||
| Medical history — no. (%) | |||
|
| |||
| Musculoskeletal problem | 16 (33) | 12 (24) | 13 (46) |
|
| |||
| Diabetes | 14 (29) | 13 (26) | 9(32) |
|
| |||
| Mental health condition | 13 (27) | 12 (24) | 10 (36) |
|
| |||
| Sleep disorder | 9(18) | 12 (24) | 11 (39) |
|
| |||
| Glaucoma or cataract | 16 (33) | 10 (20) | 4(14) |
|
| |||
| Myocardial infarction | 9(18) | 8(16) | 8(29) |
|
| |||
| Congestive heart failure | 9(18) | 7(14) | 6(21) |
|
| |||
| Cancer | 8(16) | 7(14) | 5(18) |
|
| |||
| Peripheral vascular disease | 5(10) | 3(6) | 5(18) |
|
| |||
| Chronic pain syndrome | 3(6) | 4(8) | 6(21) |
|
| |||
| Angina | 2(4) | 3(6) | 3(11) |
|
| |||
| Chronic obstructive pulmonary disease | 3(6) | 3(6) | 1(4) |
|
| |||
| Comorbidity Disease Index— no. (%)§ | |||
|
| |||
| ≤1 Domain | 7(14) | 7(14) | 2(7) |
|
| |||
| 2 Domains | 13 (27) | 24 (48) | 8 (29) |
|
| |||
| ≥3 Domains | 29 (59) | 19 (38) | 18 (64) |
|
| |||
| Concomitant medication use — no. (%) | |||
|
| |||
| Lipid-lowering agent | 38 (78) | 41 (82) | 24 (86) |
|
| |||
| Aspirin or antiplatelet agent | 42 (86) | 41 (82) | 19 (68) |
|
| |||
| Antihypertensive agent | 41 (84) | 39 (78) | 21 (75) |
|
| |||
| Warfarin | 14 (29) | 13 (26) | 7(25) |
|
| |||
| Antidepressant | 19 (39) | 15 (30) | 14 (50) |
|
| |||
| Antianxiety agent | 4(8) | 9(18) | 3(11) |
|
| |||
| Prescription pain drug | 8(16) | 10 (20) | 6(21) |
|
| |||
| Baclofen | 2(4) | 6(12) | 6(21) |
|
| |||
| Tizanidine | 2(4) | 2(4) | 2(7) |
|
| |||
| Other muscle relaxant | 4(8) | 4(8) | 4(14) |
|
| |||
| Other intervention — no. (%) | |||
|
| |||
| Exercise (≥3 times/wk for 20 min) | 19 (39) | 22 (44) | 14 (50) |
|
| |||
| Dietary management | 15 (31) | 14 (28) | 10 (36) |
|
| |||
| Therapy targeting upper limb | 12 (24) | 9(18) | 9(32) |
|
| |||
| Occupational therapy | 7(14) | 13 (26) | 2(7) |
|
| |||
| Physical therapy | 8(16) | 7(14) | 6(21) |
|
| |||
| Speech therapy | 6(12) | 5(10) | 0 |
|
| |||
| Smoking cessation | 0 | 1(2) | 2(7) |
|
| |||
| None | 12 (24) | 15 (30) | 7(25) |
|
| |||
| Upper-limb therapy — hr/wk¶ | 2.6±1.8 | 4.0±3.7 | 3.6±4.2 |
|
| |||
| Measurement of function | |||
|
| |||
| Score on Fugl-Meyer Assessment║ | 19.7±10.7 | 17.3±8.4 | 20.3±9.0 |
|
| |||
| Wolf Motor Function Test** | |||
|
| |||
| Score — sec | 66.4±37.7 | 74.1±30.4 | 74.1±29.3 |
|
| |||
| Tasks out of 15 performed within 120 sec— no. | 7.9±5.0 | 8.8±4.0 | 8.9±3.8 |
|
| |||
| Grip strength — lb | 18.6±14.1 | 16.0±11.5 | 17.8±17.5 |
|
| |||
| Score on Stroke Impact Scal†† | 49.2±14.8 | 50.5±15.1 | 48.1±14.2 |
|
| |||
| Score on pain scale‡‡ | 1.2±2.1 | 1.7±2.3 | 1.5±1.8 |
|
| |||
| Score on Modified Ashworth Scale§§ | 0.8±0.8 | 1.0±0.7 | 1.0±0.7 |
Plus–minus values are means ±SD. To convert pounds to kilograms, divide by 2.2046. CT denotes computed tomography, and MRI magnetic resonance imaging.
Race or ethnic group was self-reported, and patients could select more than one category.
P = 0.04 for all comparisons in this category. None of the other comparisons among study groups were significant.
The Comorbidity Disease Index domains include cardiac, respiratory, neurologic, musculoskeletal, general (mental or emotional problems and sleep or pain disorders), cancer, diabetes, and visual problems. The domain scores are totaled to create an overall comorbidity score (≤1, 2, or ≥3 domains).
Time includes only that for therapy targeting upper limbs.
The Fugl-Meyer Assessment measures motor and sensory impairment in the upper limbs. The scale ranges from 0 to 66, with higher scores indicating better functioning.
The Wolf Motor Function Test measures proximal and distal upper-limb motor control on 15 timed functional tasks, with an upper limit of 120 seconds per task. The tasks are averaged to produce a score that ranges from 0 to 120 seconds, with higher scores indicating worse functioning.
The Stroke Impact Scale is a self-reported measure of quality of life in the domains of hand function, activities or instrumental activities of daily living, mobility, and social participation. Scores range from 0 to 100, with higher scores indicating better functioning and greater social participation.
The numerical rating scale for pain ranges from 0 to 10, with higher scores indicating worse pain.
The Modified Ashworth Scale measures spasticity (muscle tone) on a scale of 0 to 5, with higher scores indicating more severe spasticity.