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CompletedNCT00372411VA ROBOTICSUpdated Jan 13, 2014Results posted

Robotic Assisted Upper-Limb Neurorehabilitation in Stroke Patients

A Phase 2 interventional study of Robot-Assisted Therapy - MIT-MANUS System and Intensive Comparison Therapy in Stroke, sponsored by US Department of Veterans Affairs. Completed at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-01-13.

Sponsored by US Department of Veterans Affairs · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
127
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This study will compare robotic training with usual care and intensive comparison therapy to attempt to improve upper extremity function.

Read the detailed description

Primary Hypothesis: The primary hypothesis is that robotic training compared with usual care and intensive comparison therapy will lead to improved upper extremity function. Eligible patients will be randomized to one of three treatment arms: 1) usual care, 2) intensive comparison therapy, or 3) robotic training. Participants assigned to intensive comparison therapy or robot-assisted training will receive treatment for 12 weeks consisting of three one-hour sessions a week and then usual care for the remainder of follow-up. Those assigned to usual care will receive the usual stroke care as delivered at each participating medical center for 36 weeks and then will be offered, as compassionate care, their choice of either robot-assisted or intensive comparison therapy.

Secondary Hypothesis: The secondary hypotheses are that compared with usual care and intensive comparison therapy, robotic treatment will lead to improved quality of life and task performance involving proximal and distal control of the paretic arm. If the robotic arm is effective, two other secondary objects are to evaluate its early (less than 12 week) and late (36 week) effects on the primary and secondary outcomes.

Primary Outcome: The primary study outcome is the change in the Fugl-Meyer score of neurological impairment at 12 weeks relative to baseline.

Secondary Outcome: Secondary outcomes include the Stroke Impact Scale and Wolf Motor Function Test. A cost-effectiveness analysis is planned but only will be conducted if robotic training is more effective than usual care.

Study Abstract: CSP #558 will be a randomized, multi-center, outpatient phase II trial to assess the safety and efficacy of robot-assisted therapy for neurorehabilitation in stroke patients with moderate to severe upper extremity impairment.

The target sample is 158 patients: 26 usual care, 66 intensive comparison therapy and 66 robot training. This sample size will provide 90% power to detect a 5-point mean difference in the Fugl-Meyer scale between robot training and usual care and 3-point mean difference between robot training and intensive comparison therapy. There will be one interim analysis of the primary endpoint at 12 months for the purpose of sample size re-estimation using an adaptive design. The planned study duration is 33 months with 24 months of intake and nine months of follow-up.

IMPACT STATEMENT

If robotic training proves to be beneficial it will not only provide a functionally-oriented and neurophysiologically appropriate therapy, but also will make more widely available high-quality, evidence-based rehabilitative care at a time when there is a shortage of experienced therapists and a progressively growing rehabilitative need for veterans and all Americans.

02

Conditions studied

  • Stroke

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Keywords

  • Stroke
  • Rehabilitation
  • Single-blind
  • Clinical Trial
  • Randomized controlled trial
  • Upper extremity
  • Robotics
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's enrollment of 127 is above the median of 50 across 5,369 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

US Department of Veterans Affairs is the lead sponsor of 658 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • A single new focal unilateral stroke with diagnosis verified by brain imaging (MRI) or CT scan that has occurred at least 6 months prior to enrollment.
  • Age 18 years of age and older.
  • Upper extremity Fugl-Meyer score >=7 or \<=38 (max 66). (These thresholds include neither hemiplegic nor fully recovered motor function in 14 muscles of the shoulder, elbow, and wrist.)
  • Cognitive function sufficient to understand the experiments and follow instructions (Mini-Mental Status Score of 22 and higher or interview for aphasic subjects).
  • Willingness to avoid any new alternative arm rehabilitative approaches for the duration of the study.
  • Written informed consent to participate in the study.

Exclusion criteria

Exclusion Criteria:

  • A fixed contracture in the affected limb that prevents movement along the entire dynamic range required by either robot-assisted or intensive comparison therapy.
  • Joint pain that occurs within the range of motion required by the intervention protocols (intensive comparison therapy and robot-assisted therapy).
  • Enrolled in or planning to enroll in another interventional research trial that involves the upper limbs using procedures proposed to enhance or limit the function of the upper extremity (such as adjuvant rehabilitation or Botox injections) during the 36 weeks of participation.
  • Prior experience with robot-assisted therapy or intensive comparison therapy for the upper limb as described in this specific study.
  • A complicating medical condition that would prevent completion of the trial.
  • Unable to complete the nine-month study, e.g., extended planned vacation.
  • Any other known pre-existing bone diseases that might increase the risk of bone fracture or other injury from intensive comparison therapy or robot-assisted therapy.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
127 participants (actual)

Study arms

  • Experimental
    Arm 1

    Robot-Assisted Therapy - MIT-MANUS System

    Device: Robot-Assisted Therapy - MIT-MANUS System

  • Active comparator
    Arm 2

    Intensive Comparison Therapy

    Other: Intensive Comparison Therapy

  • Other
    Arm 3

    Usual Care

    Other: Usual Care

Interventions

  • DeviceRobot-Assisted Therapy - MIT-MANUS System

    The MIT-MANUS robot consists of four modules to train the entire upper limb: module A: shoulder-elbow; module B: anti-gravity; module C: wrist, and module D: hand-unit. Training will be given for 12 weeks and is divided into 4 consecutive blocks, with 9 training sessions per block.

  • OtherIntensive Comparison Therapy

    The intensive comparison therapy protocol being used in CSP#558 was developed and field-tested at the Burke Rehabilitation Hospital. It exposes the patient to the identical number of treatments, time, and intensity that robot treated patients will receive (12 weeks, 3 times per week). Therapy sessions can be conducted on back-to-back days if needed and on more than 3 days a week (with approval from the Study Chairman) over a treatment period of up to 14 weeks in order to complete the 36 treatment sessions. During each 1-hour session, subjects participate in therapy in four successive stages: 1) warm-up and assisted stretching; 2) active arm treatments; 3) goal-directed planar reaching, and 4) functionally based Neurodevelopment Techniques (NDT)/Bobath arm training (Bobath, 1979).

    Also known as: ICT

  • OtherUsual Care

    The usual chronic stroke care as delivered at each participating medical center

06

What researchers measure

Primary outcomes

  1. Fugl-Meyer Assessment for Motor Recovery (FM) Scale

    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.

    Time frame: 6, 12, 24 and 36 weeks minus baseline

Secondary outcomes

  1. Stroke Impact Scale

    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.

    Time frame: 6, 12, 24 and 36 weeks minus baseline

  2. Wolf Motor Function Test

    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.

    Time frame: 6, 12, 24 and 36 weeks minus baseline

  3. Change in the Numeric Rating Scale (NRS) at 12 Weeks Relative to 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).

    Time frame: 12 weeks minus baseline

  4. Change in the Modified Ashworth Scale for Spasticity at 12 Weeks Relative to 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.

    Time frame: 12 weeks minus baseline

07

Results

Posted Jan 13, 2014

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 flow — Overall Study
MilestoneRobot-assisted TherapyIntensive Comparison TherapyUsual Care
Started495028
Completed444225
Not completed583
Withdrew: Withdrawal by subject341
Withdrew: Death021
Withdrew: Lost to follow-up111
Withdrew: Adverse event110

Outcome measures

PrimaryFugl-Meyer Assessment for Motor Recovery (FM) Scale

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.

Time frame:
6, 12, 24 and 36 weeks minus baseline
Reported as:
Least squares mean · units on a scale
Fugl-Meyer Assessment for Motor Recovery (FM) Scale
units on a scaleRobot-assisted TherapyIntensive Comparison TherapyUsual Care
6 weeks minus baseline3.01 ± 0.923.19 ± 0.91-2.08 ± 1.08
12 weeks minus baseline3.87 ± 1.054.01 ± 1.06-1.06 ± 1.00
24 weeks minus baseline4.22 ± 1.052.75 ± 1.06-2.02 ± 1.14
36 weeks minus baseline5.07 ± 1.182.81 ± 1.18-0.53 ± 1.19
Statistical analysis
  • Robot-assisted Therapy vs Usual Care · ANCOVA · p = 0.08 (All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses) · Mean difference (net): 2.17 · 95% CI -0.23 to 4.58Analysis is of change at 12 weeks minus baseline adjusted for the study site as a fixed effect, the Comorbidity Disease Index, and baseline FM value.
  • Robot-assisted Therapy vs Usual Care · Mixed Models Analysis · p = 0.02 (All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.) · Mean difference (net): 2.88 · 95% CI 0.57 to 5.18Secondary analysis used longitudinal methods to assess the effect of treatment on outcomes over 36 weeks with visits at 6, 12, 24, and 36 weeks.
  • Robot-assisted Therapy vs Intensive Comparison Therapy · ANCOVA · p = 0.92 (All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses) · Mean difference (net): -0.14 · 95% CI -2.94 to 2.65Analysis is of change at 12 weeks minus baseline adjusted for the study site as a fixed effect, the Comorbidity Disease Index, and baseline FM value.
  • Robot-assisted Therapy vs Intensive Comparison Therapy · Mixed Models Analysis · p = 0.63 (All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.) · Median difference (net): -0.58 · 95% CI -2.97 to 1.81Secondary analysis used longitudinal methods to assess the effect of treatment on outcomes over 36 weeks with visits at 6, 12, 24, and 36 weeks.
SecondaryStroke Impact Scale

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.

Time frame:
6, 12, 24 and 36 weeks minus baseline
Reported as:
Least squares mean · units on a scale
Stroke Impact Scale
units on a scaleRobot-assisted TherapyIntensive Comparison TherapyUsual Care
6 weeks minus baseline5.49 ± 1.614.08 ± 1.57-3.79 ± 2.47
12 weeks minus baseline6.31 ± 1.685.77 ± 1.67-3.03 ± 2.34
24 weeks minus baseline5.58 ± 1.684.23 ± 1.69-0.26 ± 2.37
36 weeks minus baseline5.14 ± 1.894.97 ± 1.880.76 ± 2.49
Statistical analysis
  • Robot-assisted Therapy vs Usual Care · ANCOVA · p = 0.009 (All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses) · Mean difference (net): 7.64 · 95% CI 2.03 to 13.24Analysis is change at 12 weeks minus baseline, adjusted for study site as a fixed effect, Comorbidity Disease Index, and the baseline SIS value.
  • Robot-assisted Therapy vs Usual Care · Mixed Models Analysis · p = 0.04 (All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.) · Mean difference (net): 5.95 · 95% CI 0.34 to 11.56Secondary analysis used longitudinal methods to assess the effect of treatment on outcomes over 36 weeks with visits at 6, 12, 24, and 36 weeks.
  • Robot-assisted Therapy vs Intensive Comparison Therapy · ANCOVA · p = 0.81 (All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.) · Mean difference (net): 0.54 · 95% CI -3.87 to 4.94Analysis is change at 12 weeks minus baseline, adjusted for study site as a fixed effect, Comorbidity Disease Index, and the baseline SIS value.
  • Robot-assisted Therapy vs Intensive Comparison Therapy · Mixed Models Analysis · p = 0.55 (All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.) · Mean difference (net): 1.19 · 95% CI -2.74 to 5.12Secondary analysis used longitudinal methods to assess the effect of treatment on outcomes over 36 weeks with visits at 6, 12, 24, and 36 weeks.
SecondaryWolf Motor Function Test

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.

Time frame:
6, 12, 24 and 36 weeks minus baseline
Reported as:
Least squares mean · Seconds
Wolf Motor Function Test
SecondsRobot-assisted TherapyIntensive Comparison TherapyUsual Care
6 weeks minus baseline-3.98 ± 2.72-3.24 ± 2.647.38 ± 2.53
12 week minus baseline-3.96 ± 3.00-4.89 ± 3.007.54 ± 2.97
24 weeks minus baseline-5.97 ± 2.77-3.08 ± 2.748.59 ± 3.10
36 weeks minus baseline-6.23 ± 2.83-2.66 ± 2.797.30 ± 2.44
Statistical analysis
  • Robot-assisted Therapy vs Usual Care · ANCOVA · p = 0.22 (All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.) · Mean difference (net): -4.41 · 95% CI -11.52 to 2.70Analysis is change at 12 weeks minus baseline adjusted for the study site as a fixed effect, the Comorbidity Disease Index, and baseline WMFT value.
  • Robot-assisted Therapy vs Usual Care · Mixed Models Analysis · p = 0.005 (All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.) · Mean difference (net): -8.10 · 95% CI -13.61 to -2.60Secondary analysis used longitudinal methods to assess the effect of treatment on outcomes over 36 weeks with visits at 6, 12, 24, and 36 weeks.
  • Robot-assisted Therapy vs Intensive Comparison Therapy · ANCOVA · p = 0.82 (All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.) · Mean difference (net): 0.93 · 95% CI -7.03 to 8.89Analysis is change at 12 weeks minus baseline adjusted for the study site as a fixed effect, the Comorbidity Disease Index, and baseline WMFT value.
  • Robot-assisted Therapy vs Intensive Comparison Therapy · Mixed Models Analysis · p = 0.55 (All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.) · Mean difference (net): -2.13 · 95% CI -9.20 to 4.93Secondary analysis used longitudinal methods to assess the effect of treatment on outcomes over 36 weeks with visits at 6, 12, 24, and 36 weeks.
SecondaryChange in the Numeric Rating Scale (NRS) at 12 Weeks Relative to 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).

Time frame:
12 weeks minus baseline
Reported as:
Least squares mean · units on a scale
Change in the Numeric Rating Scale (NRS) at 12 Weeks Relative to Baseline
units on a scaleRobot-assisted TherapyIntensive Comparison TherapyUsual Care
Change in the Numeric Rating Scale (NRS) at 12 Weeks Relative to Baseline-0.61 ± 0.290.24 ± 0.300 ± 0.38
Statistical analysis
  • Robot-assisted Therapy vs Usual Care · ANCOVA · p = 0.08 (All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.) · Mean difference (net): -0.81 · 95% CI -1.73 to 0.11Analysis of covariance at 12 weeks, adjusted for study site as a fixed effect, Comorbidity Disease Index, and the baseline value of the outcome.
  • Robot-assisted Therapy vs Intensive Comparison Therapy · ANCOVA · p = 0.03 (All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.) · Mean difference (net): -0.84 · 95% CI -1.62 to -0.06Analysis of covariance at 12 weeks, adjusted for study site as a fixed effect, Comorbidity Disease Index, and the baseline value of the outcome.
SecondaryChange in the Modified Ashworth Scale for Spasticity at 12 Weeks Relative to 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.

Time frame:
12 weeks minus baseline
Reported as:
Least squares mean · units on a scale
Change in the Modified Ashworth Scale for Spasticity at 12 Weeks Relative to Baseline
units on a scaleRobot-assisted TherapyIntensive Comparison TherapyUsual Care
Change in the Modified Ashworth Scale for Spasticity at 12 Weeks Relative to Baseline-0.07 ± 0.090.12 ± 0.09-0.04 ± 0.11
Statistical analysis
  • Robot-assisted Therapy vs Usual Care · ANCOVA · p = 0.95 (All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.) · Mean difference (net): 0.01 · 95% CI -0.25 to 0.26Analysis of covariance at 12 weeks, adjusted for study site as a fixed effect, Comorbidity Disease Index, and the baseline value of the outcome.
  • Robot-assisted Therapy vs Intensive Comparison Therapy · ANCOVA · p = 0.10 (All p-values are 2-sided with a significance level of 0.022 to adjust for multiple comparisons and interim analyses.) · Mean difference (net): -0.19 · 95% CI -0.42 to 0.04Analysis of covariance at 12 weeks, adjusted for study site as a fixed effect, Comorbidity Disease Index, and the baseline value of the outcome.

Adverse events

Collected over Adverse Events were monitored and collected over the entire participant follow-up period of 36 weeks. Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Robot-assisted Therapy—11/49 (22.4%)12/49 (24.5%)
Intensive Comparison Therapy—18/50 (36%)9/50 (18%)
Usual Care—9/28 (32.1%)0/28 (0%)
Most frequent serious events
Showing 10 of 56
Most frequent serious events
EventRobot-assisted TherapyIntensive Comparison TherapyUsual Care
Cardiac DisordersCardiac disorders1/492/503/28
InjuryInjury, poisoning and procedural complications3/494/501/28
Renal and Urinary DisordersRenal and urinary disorders1/490/502/28
Surgical and Medical ProceduresSurgical and medical procedures0/492/502/28
InfectionsInfections and infestations3/492/501/28
Gastrointestinal DisordersGastrointestinal disorders0/493/500/28
Cholecystitis acuteHepatobiliary disorders2/490/500/28
FallInjury, poisoning and procedural complications2/492/501/28
Hepatobiliary DisordersHepatobiliary disorders2/490/500/28
Nervous System DisordersNervous system disorders2/492/501/28
Most frequent other events
Most frequent other events
EventRobot-assisted TherapyIntensive Comparison TherapyUsual Care
Pain, Stiffness, or SorenessGeneral disorders10/496/500/28
FatigueGeneral disorders3/490/500/28
Cut, Scratch or IrritationGeneral disorders2/492/500/28
NumbnessGeneral disorders2/490/500/28
Swelling or BruisingGeneral disorders1/491/500/28

Baseline characteristics

Age, Continuous
Age, Continuous(years)Robot-assisted TherapyIntensive Comparison TherapyUsual CareTotal
Mean66 ± 1164 ± 1163 ± 1265 ± 11
Sex: Female, Male
Sex: Female, Male(Participants)Robot-assisted TherapyIntensive Comparison TherapyUsual CareTotal
Female2215
Male474827122
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Robot-assisted TherapyIntensive Comparison TherapyUsual CareTotal
Hispanic or Latino1203
Not Hispanic or Latino484828124
Unknown or Not Reported0000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Robot-assisted TherapyIntensive Comparison TherapyUsual CareTotal
American Indian or Alaska Native0000
Asian0101
Native Hawaiian or Other Pacific Islander0000
Black or African American1012527
White38352396
More than one race1203
Unknown or Not Reported0000
Region of Enrollment
Region of Enrollment(participants)Robot-assisted TherapyIntensive Comparison TherapyUsual CareTotal
United States495028127
Index Stroke Type
Index Stroke Type(participants)Robot-assisted TherapyIntensive Comparison TherapyUsual CareTotal
Hemorrhagic76619
Ischemic424422108
Index Stroke Location
Index Stroke Location(Participants)Robot-assisted TherapyIntensive Comparison TherapyUsual CareTotal
Anterior circulation ≥1/3 of hemisphere614626
Anterior circulation <1/3 of hemisphere17211048
Small deep infarct1715638
Posterior circulation90615
Time from Index Stroke to Randomization
Time from Index Stroke to Randomization(Years)Robot-assisted TherapyIntensive Comparison TherapyUsual CareTotal
Mean3.6 ± 4.04.8 ± 4.06.2 ± 5.04.7 ± 4.2

2 further baseline measures are reported on the registry.

08

Study locations

5 sites
  • VA Connecticut Health Care System (West Haven)
    West Haven, Connecticut 06516, United States
  • North Florida/South Georgia Veterans Health System
    Gainesville, Florida 32608, United States
  • VA Maryland Health Care System, Baltimore
    Baltimore, Maryland 21201, United States
  • Providence VA Medical Center
    Providence, Rhode Island 02908-4799, United States
  • VA Puget Sound Health Care System, Seattle
    Seattle, Washington 98108, United States
09

References and documents

Publications

  • Lo AC, Guarino P, Krebs HI, Volpe BT, Bever CT, Duncan PW, Ringer RJ, Wagner TH, Richards LG, Bravata DM, Haselkorn JK, Wittenberg GF, Federman DG, Corn BH, Maffucci AD, Peduzzi P. Multicenter randomized trial of robot-assisted rehabilitation for chronic stroke: methods and entry characteristics for VA ROBOTICS. Neurorehabil Neural Repair. 2009 Oct;23(8):775-83. doi: 10.1177/1545968309338195. Epub 2009 Jun 18. PubMed 19541917 ↗
  • Lo AC, Guarino PD, Richards LG, Haselkorn JK, Wittenberg GF, Federman DG, Ringer RJ, Wagner TH, Krebs HI, Volpe BT, Bever CT Jr, Bravata DM, Duncan PW, Corn BH, Maffucci AD, Nadeau SE, Conroy SS, Powell JM, Huang GD, Peduzzi P. Robot-assisted therapy for long-term upper-limb impairment after stroke. N Engl J Med. 2010 May 13;362(19):1772-83. doi: 10.1056/NEJMoa0911341. Epub 2010 Apr 16. Erratum In: N Engl J Med. 2011 Nov 3;365(18):1749. PubMed 20400552 ↗
  • Wagner TH, Lo AC, Peduzzi P, Bravata DM, Huang GD, Krebs HI, Ringer RJ, Federman DG, Richards LG, Haselkorn JK, Wittenberg GF, Volpe BT, Bever CT, Duncan PW, Siroka A, Guarino PD. An economic analysis of robot-assisted therapy for long-term upper-limb impairment after stroke. Stroke. 2011 Sep;42(9):2630-2. doi: 10.1161/STROKEAHA.110.606442. Epub 2011 Jul 14. PubMed 21757677 ↗
  • Wittenberg GF, Richards LG, Jones-Lush LM, Roys SR, Gullapalli RP, Yang S, Guarino PD, Lo AC. Predictors and brain connectivity changes associated with arm motor function improvement from intensive practice in chronic stroke. F1000Res. 2016 Aug 31;5:2119. doi: 10.12688/f1000research.8603.2. eCollection 2016. PubMed 28357039 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 13, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00372411
Lead sponsor
US Department of Veterans Affairs
Collaborators
Burke Medical Research Institute
Responsible party
Sponsor
First posted
Sep 7, 2006
Start date
Dec 2005
Primary completion
Jul 2009
Completion
Aug 2009
Results posted
Jan 13, 2014
Last update
Jan 13, 2014

Study contacts

Albert Lo, MD PhD
study chair · Providence VA Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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