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| Name | Class |
|---|---|
| Burke Medical Research Institute | OTHER |
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This study will compare robotic training with usual care and intensive comparison therapy to attempt to improve upper extremity function.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Robot-Assisted Therapy - MIT-MANUS System |
|
| Arm 2 | Active Comparator | Intensive Comparison Therapy |
|
| Arm 3 | Other | Usual Care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Robot-Assisted Therapy - MIT-MANUS System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6, 12, 24 and 36 weeks minus baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Albert Lo, MD PhD | Providence VA Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Connecticut Health Care System (West Haven) | West Haven | Connecticut | 06516 | United States | ||
| North Florida/South Georgia Veterans Health System |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19541917 | Result | 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. | |
| 20400552 |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | Usual Care | Usual Care consisted of the usual chronic stroke care as delivered at each participating medical center. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | All participants with baseline and follow-up measures were included by intention-to-treat | Posted | Least Squares Mean | Standard Error | units on a scale | 6, 12, 24 and 36 weeks minus baseline |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac disorder | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain, Stiffness, or Soreness | General disorders | MedDRA (12.0) | Systematic Assessment | Only related adverse event were collected. Pain, stiffness, or soreness collected as a single type of event |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter Guarino, MPH, PhD, Director, WH-CSPCC | Dept. of Veterans Affairs, Cooperative Studies Program, West Haven, CT | 203-932-5711 | 3780 | peter.guarino@va.gov |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| Intensive Comparison Therapy | Other | 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). |
|
|
| Usual Care | Other | The usual chronic stroke care as delivered at each participating medical center |
|
| 6, 12, 24 and 36 weeks minus baseline |
| 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. | 6, 12, 24 and 36 weeks minus baseline |
| 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). | 12 weeks minus baseline |
| 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. | 12 weeks minus baseline |
| 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 |
| Result |
| 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. |
| 21757677 | Result | 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. |
| 28357039 | Derived | 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. |
| Lost to Follow-up |
|
| Adverse Event |
|
| 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. |
| BG002 | Usual Care | Usual Care consisted of the usual chronic stroke care as delivered at each participating medical center. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Index Stroke Type | Number | participants |
|
| Index Stroke Location | Number | Participants |
|
| Time from Index Stroke to Randomization | Mean | Standard Deviation | Years |
|
| Fugl-Meyer Assessment | Primary outcome baseline scores | Mean | Standard Deviation | units on a scale |
|
| Comorbidity Disease Index | 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). | Number | 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.
| OG001 | 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. |
| OG002 | Usual Care | Usual Care consisted of the usual chronic stroke care as delivered at each participating medical center. |
|
|
|
| Secondary | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | 6, 12, 24 and 36 weeks minus baseline |
|
|
|
|
| Secondary | 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. | Posted | Least Squares Mean | Standard Error | Seconds | 6, 12, 24 and 36 weeks minus baseline |
|
|
|
|
| Secondary | 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). | Posted | Least Squares Mean | Standard Error | units on a scale | 12 weeks minus baseline |
|
|
|
|
| Secondary | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | 12 weeks minus baseline |
|
|
|
|
| 11 |
| 49 |
| 12 |
| 49 |
| EG001 | 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. | 18 | 50 | 9 | 50 |
| EG002 | Usual Care | Usual Care consisted of the usual chronic stroke care as delivered at each participating medical center. | 9 | 28 | 0 | 28 |
| Cardiac failure | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Coronary artery occlusion | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Death | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Drug interaction | General disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Localised infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 12.0 | Systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Overdose | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 12.0 | Systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Renal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.0 | Systematic Assessment |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Hemiparesis | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Transient ischaemic attack | Nervous system disorders | MedDRA 12.0 | Systematic Assessment |
|
| Aggression | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 12.0 | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Neurogenic bladder | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Urinary tract obstruction | Renal and urinary disorders | MedDRA 12.0 | Systematic Assessment |
|
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 12.0 | Systematic Assessment |
|
| Respite care | Social circumstances | MedDRA 12.0 | Systematic Assessment |
|
| Cardiac pacemaker battery replacement | Surgical and medical procedures | MedDRA 12.0 | Systematic Assessment |
|
| Colon polypectomy | Surgical and medical procedures | MedDRA 12.0 | Systematic Assessment |
|
| Hernia repair | Surgical and medical procedures | MedDRA 12.0 | Systematic Assessment |
|
| Knee arthroplasty | Surgical and medical procedures | MedDRA 12.0 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Thrombosis | Vascular disorders | MedDRA 12.0 | Systematic Assessment |
|
| Cardiac Disorders | Cardiac disorders | MedDRA (12.0) | Systematic Assessment | Sum of all adverse event terms in the Cardiac Disorders System Organ Class |
|
| Gastrointestinal Disorders | Gastrointestinal disorders | MedDRA (12.0) | Systematic Assessment | Sum of all adverse event terms in the Gastrointestinal Disorders System Organ Class |
|
| General Disorders | General disorders | MedDRA (12.0) | Systematic Assessment | Sum of all adverse event terms in the General Disorders System Organ Class |
|
| Hepatobiliary Disorders | Hepatobiliary disorders | MedDRA (12.0) | Systematic Assessment | Sum of all adverse event terms in the Hepatobiliary Disorders System Organ Class |
|
| Infections | Infections and infestations | MedDRA (12.0) | Systematic Assessment | Sum of all adverse event terms in the Infections and Infestations System Organ Class |
|
| Injury | Injury, poisoning and procedural complications | MedDRA (12.0) | Systematic Assessment | Sum of all adverse event terms in the Injury, Poisoning and Procedural Complications System Organ Class |
|
| Neoplasms | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (12.0) | Systematic Assessment | Sum of all adverse event terms in the Neoplasms System Organ Class |
|
| Nervous System Disorders | Nervous system disorders | MedDRA (12.0) | Systematic Assessment | Sum of all adverse event terms in the Nervous System Disorders System Organ Class |
|
| Psychiatric Disorders | Psychiatric disorders | MedDRA (12.0) | Systematic Assessment | Sum of all adverse event terms in the Psychiatric Disorders System Organ Class |
|
| Renal and Urinary Disorders | Renal and urinary disorders | MedDRA (12.0) | Systematic Assessment | Sum of all adverse event terms in the Renal and Urinary Disorders System Organ Class |
|
| Respiratory Disorders | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Systematic Assessment | Sum of all adverse event terms in the Respiratory Disorders System Organ Class |
|
| Social Circumstances | Social circumstances | MedDRA (12.0) | Systematic Assessment | Sum of all adverse event terms in the Social Circumstances System Organ Class |
|
| Surgical and Medical Procedures | Surgical and medical procedures | MedDRA (12.0) | Systematic Assessment | Sum of all adverse event terms in the Surgical and Medical Procedures System Organ Class |
|
| Vascular Disorders | Vascular disorders | MedDRA (12.0) | Systematic Assessment | Sum of all adverse event terms in the Vascular Disorders System Organ Class |
|
|
| Fatigue | General disorders | MedDRA (12.0) | Systematic Assessment | Fatigue related to study therapy. |
|
| Swelling or Bruising | General disorders | MedDRA (12.0) | Systematic Assessment | Swelling or Bruising collected as one event related to study therapy. |
|
| Cut, Scratch or Irritation | General disorders | MedDRA (12.0) | Systematic Assessment | Cut, Scratch or Irritation related to study therapy collected as one event type. |
|
| Numbness | General disorders | MedDRA (12.0) | Systematic Assessment | Numbness related to study therapy. |
|
Not provided
Not provided
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
|
| 24 weeks minus baseline |
|
| 36 weeks minus baseline |
|
| Because randomization to usual care was stopped after 15 months as specified by the protocol comparisons of robot-assisted therapy with usual care included only patients who were recruited during this period. | Mixed Models Analysis | Secondary analysis used longitudinal methods to assess the effect of treatment on outcomes over 36 weeks with visits at 6, 12, 24, and 36 weeks. | 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 | 2-Sided | 95 | 0.34 | 11.56 | No | Superiority or Other |
| Comparisons between robot-assisted therapy and intensive comparison therapy included all patients who underwent randomization and were evaluated. | ANCOVA | Analysis is change at 12 weeks minus baseline, adjusted for study site as a fixed effect, Comorbidity Disease Index, and the baseline SIS value. | 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 | 2-Sided | 95 | -3.87 | 4.94 | No | Superiority or Other |
| Comparisons between robot-assisted therapy and intensive comparison therapy included all patients who underwent randomization and were evaluated. | Mixed Models Analysis | Secondary analysis used longitudinal methods to assess the effect of treatment on outcomes over 36 weeks with visits at 6, 12, 24, and 36 weeks. | 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 | 2-Sided | 95 | -2.74 | 5.12 | No | Superiority or Other |
|
| 24 weeks minus baseline |
|
| 36 weeks minus baseline |
|
| Because randomization to usual care was stopped after 15 months as specified by the protocol comparisons of robot-assisted therapy with usual care included only patients who were recruited during this period. | Mixed Models Analysis | Secondary analysis used longitudinal methods to assess the effect of treatment on outcomes over 36 weeks with visits at 6, 12, 24, and 36 weeks. | 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 | 2-Sided | 95 | -13.61 | -2.60 | No | Superiority or Other |
| Comparisons between robot-assisted therapy and intensive comparison therapy included all patients who underwent randomization and were evaluated. | ANCOVA | Analysis is change at 12 weeks minus baseline adjusted for the study site as a fixed effect, the Comorbidity Disease Index, and baseline WMFT value. | 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 | 2-Sided | 95 | -7.03 | 8.89 | No | Superiority or Other |
| Comparisons between robot-assisted therapy and intensive comparison therapy included all patients who underwent randomization and were evaluated. | Mixed Models Analysis | Secondary analysis used longitudinal methods to assess the effect of treatment on outcomes over 36 weeks with visits at 6, 12, 24, and 36 weeks. | 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 | 2-Sided | 95 | -9.20 | 4.93 | No | Superiority or Other |
| Comparisons between robot-assisted therapy and intensive comparison therapy included all patients who underwent randomization and were evaluated. | ANCOVA | Analysis of covariance at 12 weeks, adjusted for study site as a fixed effect, Comorbidity Disease Index, and the baseline value of the outcome. | 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 | 2-Sided | 95 | -1.62 | -0.06 | No | Superiority or Other |
| Comparisons between robot-assisted therapy and intensive comparison therapy included all patients who underwent randomization and were evaluated. | ANCOVA | Analysis of covariance at 12 weeks, adjusted for study site as a fixed effect, Comorbidity Disease Index, and the baseline value of the outcome. | 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 | 2-Sided | 95 | -0.42 | 0.04 | No | Superiority or Other |