Trial Outcomes & Findings for Robotic Assisted Upper-Limb Neurorehabilitation in Stroke Patients (NCT NCT00372411)

Last Updated: 2014-01-13

Results Overview

Fugl-Meyer (FM) is a standard instrument for the quantitative clinical assessment of motor impairment and function. In this study the upper extremity subsection of the FM was used. The FM assesses several impairment dimensions by using a 3 point ordinal scale: 0 = cannot perform, 1 = can perform partially and 2 = can perform fully. These measures are summed to an overall score is Scoring for upper extremity FM ranges from 0 (worst, completely plegic) to 66 (best, normal). Higher scores indicate better functioning. Outcome measure is the change in the FM score at 6, 12, 24 and 36 weeks relative to baseline.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

127 participants

Primary outcome timeframe

6, 12, 24 and 36 weeks minus baseline

Results posted on

2014-01-13

Participant Flow

Between 11-8-06 and 10-31-08, 200 were screened and 127 randomized from 4 VA medical centers: Gainesville, West Haven, Baltimore, and Seattle. Usual care enrollment was stopped after 15 months when target information was attained per protocol. Recruitment to the robot-assisted and intensive comparison groups continued for 24 months.

Participant milestones

Participant milestones
Measure	Robot-assisted Therapy Robot-Assisted Therapy uses the MIT-MANUS robot and consists of four modules, shoulder-elbow, anti-gravity, wrist, and hand-unit to train the entire upper limb. Training was given for 12 weeks and was divided into 4 consecutive blocks, with 9 training sessions per block.	Intensive Comparison Therapy Intensive comparison therapy consisted of the identical number of treatments, time, and intensity of Robot-assisted therapy (12 weeks, 3 times per week). Each 1-hour therapy session consisted of four successive stages: 1) warm-up and assisted stretching; 2) active arm treatments; 3) goal-directed planar reaching, and 4) functionally based Neurodevelopment Techniques/Bobath arm training.	Usual Care Usual Care consisted of the usual chronic stroke care as delivered at each participating medical center.
Overall Study STARTED	49	50	28
Overall Study COMPLETED	44	42	25
Overall Study NOT COMPLETED	5	8	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Robot-assisted Therapy Robot-Assisted Therapy uses the MIT-MANUS robot and consists of four modules, shoulder-elbow, anti-gravity, wrist, and hand-unit to train the entire upper limb. Training was given for 12 weeks and was divided into 4 consecutive blocks, with 9 training sessions per block.	Intensive Comparison Therapy Intensive comparison therapy consisted of the identical number of treatments, time, and intensity of Robot-assisted therapy (12 weeks, 3 times per week). Each 1-hour therapy session consisted of four successive stages: 1) warm-up and assisted stretching; 2) active arm treatments; 3) goal-directed planar reaching, and 4) functionally based Neurodevelopment Techniques/Bobath arm training.	Usual Care Usual Care consisted of the usual chronic stroke care as delivered at each participating medical center.
Overall Study Withdrawal by Subject	3	4	1
Overall Study Death	0	2	1
Overall Study Lost to Follow-up	1	1	1
Overall Study Adverse Event	1	1	0

Baseline Characteristics

Robotic Assisted Upper-Limb Neurorehabilitation in Stroke Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Robot-assisted Therapy n=49 Participants Robot-Assisted Therapy uses the MIT-MANUS robot and consists of four modules, shoulder-elbow, anti-gravity, wrist, and hand-unit to train the entire upper limb. Training was given for 12 weeks and was divided into 4 consecutive blocks, with 9 training sessions per block.	Intensive Comparison Therapy n=50 Participants Intensive comparison therapy consisted of the identical number of treatments, time, and intensity of Robot-assisted therapy (12 weeks, 3 times per week). Each 1-hour therapy session consisted of four successive stages: 1) warm-up and assisted stretching; 2) active arm treatments; 3) goal-directed planar reaching, and 4) functionally based Neurodevelopment Techniques/Bobath arm training.	Usual Care n=28 Participants Usual Care consisted of the usual chronic stroke care as delivered at each participating medical center.	Total n=127 Participants Total of all reporting groups
Age, Continuous	66 years STANDARD_DEVIATION 11 • n=5 Participants	64 years STANDARD_DEVIATION 11 • n=7 Participants	63 years STANDARD_DEVIATION 12 • n=5 Participants	65 years STANDARD_DEVIATION 11 • n=4 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants
Sex: Female, Male Male	47 Participants n=5 Participants	48 Participants n=7 Participants	27 Participants n=5 Participants	122 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	48 Participants n=5 Participants	48 Participants n=7 Participants	28 Participants n=5 Participants	124 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	10 Participants n=5 Participants	12 Participants n=7 Participants	5 Participants n=5 Participants	27 Participants n=4 Participants
Race (NIH/OMB) White	38 Participants n=5 Participants	35 Participants n=7 Participants	23 Participants n=5 Participants	96 Participants n=4 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	49 participants n=5 Participants	50 participants n=7 Participants	28 participants n=5 Participants	127 participants n=4 Participants
Index Stroke Type Hemorrhagic	7 participants n=5 Participants	6 participants n=7 Participants	6 participants n=5 Participants	19 participants n=4 Participants
Index Stroke Type Ischemic	42 participants n=5 Participants	44 participants n=7 Participants	22 participants n=5 Participants	108 participants n=4 Participants
Index Stroke Location Anterior circulation ≥1/3 of hemisphere	6 Participants n=5 Participants	14 Participants n=7 Participants	6 Participants n=5 Participants	26 Participants n=4 Participants
Index Stroke Location Anterior circulation <1/3 of hemisphere	17 Participants n=5 Participants	21 Participants n=7 Participants	10 Participants n=5 Participants	48 Participants n=4 Participants
Index Stroke Location Small deep infarct	17 Participants n=5 Participants	15 Participants n=7 Participants	6 Participants n=5 Participants	38 Participants n=4 Participants
Index Stroke Location Posterior circulation	9 Participants n=5 Participants	0 Participants n=7 Participants	6 Participants n=5 Participants	15 Participants n=4 Participants
Time from Index Stroke to Randomization	3.6 Years STANDARD_DEVIATION 4.0 • n=5 Participants	4.8 Years STANDARD_DEVIATION 4.0 • n=7 Participants	6.2 Years STANDARD_DEVIATION 5.0 • n=5 Participants	4.7 Years STANDARD_DEVIATION 4.2 • n=4 Participants
Fugl-Meyer Assessment	19.7 units on a scale STANDARD_DEVIATION 10.7 • n=5 Participants	17.3 units on a scale STANDARD_DEVIATION 8.4 • n=7 Participants	20.3 units on a scale STANDARD_DEVIATION 9.0 • n=5 Participants	18.9 units on a scale STANDARD_DEVIATION 9.5 • n=4 Participants
Comorbidity Disease Index ≤1 Domain	7 participants n=5 Participants	7 participants n=7 Participants	2 participants n=5 Participants	16 participants n=4 Participants
Comorbidity Disease Index 2 Domains	13 participants n=5 Participants	24 participants n=7 Participants	8 participants n=5 Participants	45 participants n=4 Participants
Comorbidity Disease Index ≥3 Domains	29 participants n=5 Participants	19 participants n=7 Participants	18 participants n=5 Participants	66 participants n=4 Participants

PRIMARY outcome

Timeframe: 6, 12, 24 and 36 weeks minus baseline

Population: All participants with baseline and follow-up measures were included by intention-to-treat

Outcome measures

Outcome measures
Measure	Robot-assisted Therapy n=47 Participants Robot-Assisted Therapy uses the MIT-MANUS robot and consists of four modules, shoulder-elbow, anti-gravity, wrist, and hand-unit to train the entire upper limb. Training was given for 12 weeks and was divided into 4 consecutive blocks, with 9 training sessions per block.	Intensive Comparison Therapy n=46 Participants Intensive comparison therapy consisted of the identical number of treatments, time, and intensity of Robot-assisted therapy (12 weeks, 3 times per week). Each 1-hour therapy session consisted of four successive stages: 1) warm-up and assisted stretching; 2) active arm treatments; 3) goal-directed planar reaching, and 4) functionally based Neurodevelopment Techniques/Bobath arm training.	Usual Care n=27 Participants Usual Care consisted of the usual chronic stroke care as delivered at each participating medical center.
Fugl-Meyer Assessment for Motor Recovery (FM) Scale 6 weeks minus baseline	3.01 units on a scale Standard Error 0.92	3.19 units on a scale Standard Error 0.91	-2.08 units on a scale Standard Error 1.08
Fugl-Meyer Assessment for Motor Recovery (FM) Scale 12 weeks minus baseline	3.87 units on a scale Standard Error 1.05	4.01 units on a scale Standard Error 1.06	-1.06 units on a scale Standard Error 1.00
Fugl-Meyer Assessment for Motor Recovery (FM) Scale 24 weeks minus baseline	4.22 units on a scale Standard Error 1.05	2.75 units on a scale Standard Error 1.06	-2.02 units on a scale Standard Error 1.14
Fugl-Meyer Assessment for Motor Recovery (FM) Scale 36 weeks minus baseline	5.07 units on a scale Standard Error 1.18	2.81 units on a scale Standard Error 1.18	-0.53 units on a scale Standard Error 1.19

SECONDARY outcome

Timeframe: 6, 12, 24 and 36 weeks minus baseline

The Stroke Impact Scale (SIS) is stroke specific, self-reported measure that evaluates function and quality of life in eight clinically relevant domains. The domains of hand function, activities of daily living, instrumental activities of daily living, mobility, and social participation were used; total score ranges from 0 to 100 with higher values indicating better functioning. Outcome is change at 6, 12, 24 and 36 weeks relative to baseline.

Outcome measures

Outcome measures
Measure	Robot-assisted Therapy n=47 Participants Robot-Assisted Therapy uses the MIT-MANUS robot and consists of four modules, shoulder-elbow, anti-gravity, wrist, and hand-unit to train the entire upper limb. Training was given for 12 weeks and was divided into 4 consecutive blocks, with 9 training sessions per block.	Intensive Comparison Therapy n=46 Participants Intensive comparison therapy consisted of the identical number of treatments, time, and intensity of Robot-assisted therapy (12 weeks, 3 times per week). Each 1-hour therapy session consisted of four successive stages: 1) warm-up and assisted stretching; 2) active arm treatments; 3) goal-directed planar reaching, and 4) functionally based Neurodevelopment Techniques/Bobath arm training.	Usual Care n=27 Participants Usual Care consisted of the usual chronic stroke care as delivered at each participating medical center.
Stroke Impact Scale 6 weeks minus baseline	5.49 units on a scale Standard Error 1.61	4.08 units on a scale Standard Error 1.57	-3.79 units on a scale Standard Error 2.47
Stroke Impact Scale 12 weeks minus baseline	6.31 units on a scale Standard Error 1.68	5.77 units on a scale Standard Error 1.67	-3.03 units on a scale Standard Error 2.34
Stroke Impact Scale 24 weeks minus baseline	5.58 units on a scale Standard Error 1.68	4.23 units on a scale Standard Error 1.69	-0.26 units on a scale Standard Error 2.37
Stroke Impact Scale 36 weeks minus baseline	5.14 units on a scale Standard Error 1.89	4.97 units on a scale Standard Error 1.88	0.76 units on a scale Standard Error 2.49

SECONDARY outcome

Timeframe: 6, 12, 24 and 36 weeks minus baseline

The Wolf Motor Function Test (WMFT) is a functionally-based test designed to provide an objective measure of both proximal (during tasks such as lifting the hand from table to box top) and distal control (grasping pencil, bringing soda can to mouth) of the paretic arm for patients after stroke or traumatic brain injury. The WMFT consists of 17 items, of which 15 measure time to perform functional tasks. The tasks are averaged to produce a score in seconds that ranges from 0 to 120 seconds, with higher scores indicating worse functioning. Outcome measure is the change in the Wolf score at 6, 12, 24 and 36 weeks relative to baseline.

Outcome measures

Outcome measures
Measure	Robot-assisted Therapy n=47 Participants Robot-Assisted Therapy uses the MIT-MANUS robot and consists of four modules, shoulder-elbow, anti-gravity, wrist, and hand-unit to train the entire upper limb. Training was given for 12 weeks and was divided into 4 consecutive blocks, with 9 training sessions per block.	Intensive Comparison Therapy n=46 Participants Intensive comparison therapy consisted of the identical number of treatments, time, and intensity of Robot-assisted therapy (12 weeks, 3 times per week). Each 1-hour therapy session consisted of four successive stages: 1) warm-up and assisted stretching; 2) active arm treatments; 3) goal-directed planar reaching, and 4) functionally based Neurodevelopment Techniques/Bobath arm training.	Usual Care n=27 Participants Usual Care consisted of the usual chronic stroke care as delivered at each participating medical center.
Wolf Motor Function Test 6 weeks minus baseline	-3.98 Seconds Standard Error 2.72	-3.24 Seconds Standard Error 2.64	7.38 Seconds Standard Error 2.53
Wolf Motor Function Test 12 week minus baseline	-3.96 Seconds Standard Error 3.00	-4.89 Seconds Standard Error 3.00	7.54 Seconds Standard Error 2.97
Wolf Motor Function Test 24 weeks minus baseline	-5.97 Seconds Standard Error 2.77	-3.08 Seconds Standard Error 2.74	8.59 Seconds Standard Error 3.10
Wolf Motor Function Test 36 weeks minus baseline	-6.23 Seconds Standard Error 2.83	-2.66 Seconds Standard Error 2.79	7.30 Seconds Standard Error 2.44

SECONDARY outcome

Timeframe: 12 weeks minus baseline

The Numeric Rating Scale (NRS) for pain is a self report scale ranging from 0 (no Pain) to 10 (pain as bad as you can imagine).

Outcome measures

Outcome measures
Measure	Robot-assisted Therapy n=47 Participants Robot-Assisted Therapy uses the MIT-MANUS robot and consists of four modules, shoulder-elbow, anti-gravity, wrist, and hand-unit to train the entire upper limb. Training was given for 12 weeks and was divided into 4 consecutive blocks, with 9 training sessions per block.	Intensive Comparison Therapy n=46 Participants Intensive comparison therapy consisted of the identical number of treatments, time, and intensity of Robot-assisted therapy (12 weeks, 3 times per week). Each 1-hour therapy session consisted of four successive stages: 1) warm-up and assisted stretching; 2) active arm treatments; 3) goal-directed planar reaching, and 4) functionally based Neurodevelopment Techniques/Bobath arm training.	Usual Care n=27 Participants Usual Care consisted of the usual chronic stroke care as delivered at each participating medical center.
Change in the Numeric Rating Scale (NRS) at 12 Weeks Relative to Baseline	-0.61 units on a scale Standard Error 0.29	0.24 units on a scale Standard Error 0.30	0 units on a scale Standard Error 0.38

SECONDARY outcome

Timeframe: 12 weeks minus baseline

The Modified Ashworth Scale for spasticity is a measurement of spasticity across 9 muscle groups. Each muscle group is scored on a 0 to 5 scale with higher scores indicating worse functioning. The total score is the average score from the 9 muscle groups and ranges from 0 to 5 with higher scores indicating worse functioning.

Outcome measures

Outcome measures
Measure	Robot-assisted Therapy n=47 Participants Robot-Assisted Therapy uses the MIT-MANUS robot and consists of four modules, shoulder-elbow, anti-gravity, wrist, and hand-unit to train the entire upper limb. Training was given for 12 weeks and was divided into 4 consecutive blocks, with 9 training sessions per block.	Intensive Comparison Therapy n=46 Participants Intensive comparison therapy consisted of the identical number of treatments, time, and intensity of Robot-assisted therapy (12 weeks, 3 times per week). Each 1-hour therapy session consisted of four successive stages: 1) warm-up and assisted stretching; 2) active arm treatments; 3) goal-directed planar reaching, and 4) functionally based Neurodevelopment Techniques/Bobath arm training.	Usual Care n=27 Participants Usual Care consisted of the usual chronic stroke care as delivered at each participating medical center.
Change in the Modified Ashworth Scale for Spasticity at 12 Weeks Relative to Baseline	-0.07 units on a scale Standard Error 0.09	0.12 units on a scale Standard Error 0.09	-0.04 units on a scale Standard Error 0.11

Adverse Events

Robot-assisted Therapy

Serious events: 11 serious events

Other events: 12 other events

Deaths: 0 deaths

Intensive Comparison Therapy

Serious events: 18 serious events

Other events: 9 other events

Deaths: 0 deaths

Usual Care

Serious events: 9 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Robot-assisted Therapy n=49 participants at risk Robot-Assisted Therapy uses the MIT-MANUS robot and consists of four modules, shoulder-elbow, anti-gravity, wrist, and hand-unit to train the entire upper limb. Training was given for 12 weeks and was divided into 4 consecutive blocks, with 9 training sessions per block.	Intensive Comparison Therapy n=50 participants at risk Intensive comparison therapy consisted of the identical number of treatments, time, and intensity of Robot-assisted therapy (12 weeks, 3 times per week). Each 1-hour therapy session consisted of four successive stages: 1) warm-up and assisted stretching; 2) active arm treatments; 3) goal-directed planar reaching, and 4) functionally based Neurodevelopment Techniques/Bobath arm training.	Usual Care n=28 participants at risk Usual Care consisted of the usual chronic stroke care as delivered at each participating medical center.
General disorders Pain, Stiffness, or Soreness	20.4% 10/49 • Number of events 23 • Adverse Events were monitored and collected over the entire participant follow-up period of 36 weeks Site personnel inquired about adverse and serious adverse events at each study contact.	12.0% 6/50 • Number of events 7 • Adverse Events were monitored and collected over the entire participant follow-up period of 36 weeks Site personnel inquired about adverse and serious adverse events at each study contact.	0.00% 0/28 • Adverse Events were monitored and collected over the entire participant follow-up period of 36 weeks Site personnel inquired about adverse and serious adverse events at each study contact.
General disorders Fatigue	6.1% 3/49 • Number of events 6 • Adverse Events were monitored and collected over the entire participant follow-up period of 36 weeks Site personnel inquired about adverse and serious adverse events at each study contact.	0.00% 0/50 • Adverse Events were monitored and collected over the entire participant follow-up period of 36 weeks Site personnel inquired about adverse and serious adverse events at each study contact.	0.00% 0/28 • Adverse Events were monitored and collected over the entire participant follow-up period of 36 weeks Site personnel inquired about adverse and serious adverse events at each study contact.
General disorders Swelling or Bruising	2.0% 1/49 • Number of events 1 • Adverse Events were monitored and collected over the entire participant follow-up period of 36 weeks Site personnel inquired about adverse and serious adverse events at each study contact.	2.0% 1/50 • Number of events 3 • Adverse Events were monitored and collected over the entire participant follow-up period of 36 weeks Site personnel inquired about adverse and serious adverse events at each study contact.	0.00% 0/28 • Adverse Events were monitored and collected over the entire participant follow-up period of 36 weeks Site personnel inquired about adverse and serious adverse events at each study contact.
General disorders Cut, Scratch or Irritation	4.1% 2/49 • Number of events 2 • Adverse Events were monitored and collected over the entire participant follow-up period of 36 weeks Site personnel inquired about adverse and serious adverse events at each study contact.	4.0% 2/50 • Number of events 2 • Adverse Events were monitored and collected over the entire participant follow-up period of 36 weeks Site personnel inquired about adverse and serious adverse events at each study contact.	0.00% 0/28 • Adverse Events were monitored and collected over the entire participant follow-up period of 36 weeks Site personnel inquired about adverse and serious adverse events at each study contact.
General disorders Numbness	4.1% 2/49 • Number of events 2 • Adverse Events were monitored and collected over the entire participant follow-up period of 36 weeks Site personnel inquired about adverse and serious adverse events at each study contact.	0.00% 0/50 • Adverse Events were monitored and collected over the entire participant follow-up period of 36 weeks Site personnel inquired about adverse and serious adverse events at each study contact.	0.00% 0/28 • Adverse Events were monitored and collected over the entire participant follow-up period of 36 weeks Site personnel inquired about adverse and serious adverse events at each study contact.

Additional Information

Peter Guarino, MPH, PhD, Director, WH-CSPCC

Dept. of Veterans Affairs, Cooperative Studies Program, West Haven, CT

Phone: 203-932-5711

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place