Evaluation of Robot Assisted Neuro-Rehabilitation "SRT3"

Completed

Phase 1/2 Results

Update History

12 Jan '16
The description was updated.
New
After obtaining informed consent, participants will undergo 3 sessions of baseline testing using upper extremity motor assessments of the shoulder, elbow, wrist, thumb and grip. Upper extremity kinematic and strength testing will be performed with the rehabilitation robots in measurement mode. The rehabilitation robot modules include the wrist, the planar (shoulder-elbow), and alternating wrist and shoulder-elbow robot. These robotic devices are cleared for marketing as a registered medical device under U.S. FDA regulations and are listed with the FDA both as an evaluation devices and as therapy devices. Patients will be randomized to receive 12 weeks of robotic therapy sessions or 12 weeks of robot therapy combined with transition to task therapy. Study interventions will occur 3 times a week for 12 weeks. Robot therapy will consist of a progression through three robot modules: wrist, planar, and alternating wrist and shoulder-elbow robot. The progression will be sequential with four weeks of training on each robotic device. All participants will complete a motor activity log during this intervention phase. TMS is being used for physiological measurement and evaluations will be conducted with each participant at baseline, week one, week five, eight, and final. TMS will also occur during the follow-up on week twenty-four. Disability and depression questionnaires, upper extremity measures and evaluations of functional performance will be conducted during the study at baseline, and at training completion (visit 36). Patients will return twelve weeks after the end of the training period to determine whether any observed improvements persist.
Old
After obtaining informed consent, participants will undergo 3 sessions of baseline testing using upper extremity motor assessments of the shoulder, elbow, wrist, thumb and grip. Upper extremity kinematic and strength testing will be performed with the rehabilitation robots in measurement mode. The rehabilitation robot modules include the wrist, the planar (shoulder-elbow), and alternating wrist and shoulder-elbow robot. These robotic devices are cleared for marketing as a registered medical device under U.S. FDA regulations and are listed with the FDA both as an evaluation devices and as therapy devices. Patients will be randomized to receive 12 weeks of robotic therapy sessions or 12 weeks of robot therapy combined with transition to task therapy. Study interventions will occur 3 times a week for 12 weeks. Robot therapy will consist of a progression through three robot modules: wrist, planar, and alternating wrist and shoulder-elbow robot. The progression will be sequential with four weeks of training on each robotic device. All participants will complete a motor activity log during this intervention phase. TMS is being used for physiological measurement and evaluations will be conducted with each participant at baseline, week one, week five, eight, and final. TMS will also occur during the follow-up on week twenty-four. Disability and depression questionnaires, upper extremity measures and evaluations of functional performance will be conducted during the study at baseline, and at training completion (visit 36). Patients will return twelve weeks after the end of the training period to determine whether any observed improvements persist.
The eligibility criteria were updated.
New
Inclusion Criteria: - Clinically defined, unilateral, hemiparetic stroke with radiologic exclusion of other possible diagnoses - Adequate language, and cognitive function to participate in training, testing, and informed consent process - The study arm of the participant will present with moderate to severe dysfunction based on Fugl-Meyer Motor Assessment range of 7 to 38 - Stroke onset greater than 6 months for ischemic stroke and greater than 1 year for hemorrhagic stroke - Men or women over 21 years of age Exclusion Criteria: - Seizures or treatment with anticonvulsant medications within the last 10 years (This criteria does not preclude participation in the study, but does preclude participation in the TMS testing) - Treatment with any medications known to interfere with brain stimulation: any medication with central nervous system depressant activity, including, but not limited to benzodiazepines, barbiturates, and neuroleptics (This criteria does not preclude participation in the study, but does preclude participation in the TMS testing) - Serious complicating medical conditions, contractures or orthopedic problems in the study arm limiting the range of joint movement for the study positions - Visual loss such that the participant cannot see the test patterns on the monitor of the training robot computer - Botox injection to the study arm within 3 months of enrollment or during the study period - Any change in the exercise regime involving the study arm. This includes starting any new exercise or discontinuing any current exercise regimen
Old
Inclusion Criteria: - Clinically defined, unilateral, hemiparetic stroke with radiologic exclusion of other possible diagnoses - Adequate language, and cognitive function to participate in training, testing, and informed consent process - The study arm of the participant will present with moderate to severe dysfunction based on Fugl-Meyer Motor Assessment range of 7 to 38 - Stroke onset greater than 6 months for ischemic stroke and greater than 1 year for hemorrhagic stroke - Men or women over 21 years of age Exclusion Criteria: - Seizures or treatment with anticonvulsant medications within the last 10 years (This criteria does not preclude participation in the study, but does preclude participation in the TMS testing) - Treatment with any medications known to interfere with brain stimulation: any medication with central nervous system depressant activity, including, but not limited to benzodiazepines, barbiturates, and neuroleptics (This criteria does not preclude participation in the study, but does preclude participation in the TMS testing) - Serious complicating medical conditions, contractures or orthopedic problems in the study arm limiting the range of joint movement for the study positions - Visual loss such that the participant cannot see the test patterns on the monitor of the training robot computer - Botox injection to the study arm within 3 months of enrollment or during the study period - Any change in the exercise regime involving the study arm. This includes starting any new exercise or discontinuing any current exercise regimen
3 Oct '14
Trial name was updated.
New
Evaluation of Robot Assisted Neuro-Rehabilitation
2 May '14
A location was updated in Baltimore.
New
The overall status was removed for VA Maryland Health Care System, Baltimore.
26 Jan '13
Trial acronym was updated.
New
SRT3
25 Oct '11
The description was updated.
New
After obtaining informed consent, participants will undergo 3 sessions of baseline testing using upper extremity motor assessments of the shoulder, elbow, wrist, thumb and grip. Upper extremity kinematic and strength testing will be performed with the rehabilitation robots in measurement mode. The rehabilitation robot modules include the wrist, the planar (shoulder-elbow), and alternating wrist and shoulder-elbow robot. These robotic devices are cleared for marketing as a registered medical device under U.S. FDA regulations and are listed with the FDA both as an evaluation devices and as therapy devices. Patients will be randomized to receive 12 weeks of robotic therapy sessions or 12 weeks of robot therapy combined with transition to task therapy. Study interventions will occur 3 times a week for 12 weeks. Robot therapy will consist of a progression through three robot modules: wrist, planar, and alternating wrist and shoulder-elbow robot. The progression will be sequential with four weeks of training on each robotic device. All participants will complete a motor activity log during this intervention phase. TMS is being used for physiological measurement and evaluations will be conducted with each participant at baseline, week one, week five, eight, and final. TMS will also occur during the follow-up on week twenty-four. Disability and depression questionnaires, upper extremity measures and evaluations of functional performance will be conducted during the study at baseline, and at training completion (visit 36). Patients will return twelve weeks after the end of the training period to determine whether any observed improvements persist.
Old
After obtaining informed consent, participants will undergo 3 sessions of baseline testing using upper extremity motor assessments of the shoulder, elbow, wrist, thumb and grip. Upper extremity kinematic and strength testing will be performed with the rehabilitation robots in measurement mode. The rehabilitation robot configurations include the wrist, the planar (shoulder-elbow), and combined wrist and shoulder-elbow robot. These robotic devices are cleared for marketing as a registered medical device under U.S. FDA regulations and are listed with the FDA both as an evaluation devices and as therapy devices. Patients will be randomized to receive 12 weeks of robotic therapy sessions or 12 weeks of robot therapy combined with transition to task therapy. Study interventions will occur 3 times a week for 12 weeks. Robot therapy will consist of a progression through three robot devices: wrist, planar, and combined wrist and shoulder-elbow robot. The progression will be sequential with four weeks of training on each robotic device. All participants will complete a motor activity log during this intervention phase. TMS is being used for physiological measurement and evaluations will be conducted with each participant at baseline, and at week four, eight, twelve. TMS will also occur during the follow-up on week twenty-four. Disability and depression questionnaires, upper extremity measures and evaluations of functional performance will be conducted during the study at baseline, midpoint (visit 18) and at training completion (visit 36). Patients will return twelve weeks after the end of the training period to determine whether any observed improvements persist.
The eligibility criteria were updated.
New
Inclusion Criteria: - Clinically defined, unilateral, hemiparetic stroke with radiologic exclusion of other possible diagnoses - Adequate language, and cognitive function to participate in training, testing, and informed consent process - The study arm of the participant will present with moderate to severe dysfunction based on Fugl-Meyer Motor Assessment range of 7 to 38 - Stroke onset greater than 6 months for ischemic stroke and greater than 1 year for hemorrhagic stroke - Men or women over 21 years of age Exclusion Criteria: - Seizures or treatment with anticonvulsant medications within the last 10 years (This criteria does not preclude participation in the study, but does preclude participation in the TMS testing) - Treatment with any medications known to interfere with brain stimulation: any medication with central nervous system depressant activity, including, but not limited to benzodiazepines, barbiturates, and neuroleptics (This criteria does not preclude participation in the study, but does preclude participation in the TMS testing) - Serious complicating medical conditions, contractures or orthopedic problems in the study arm limiting the range of joint movement for the study positions - Visual loss such that the participant cannot see the test patterns on the monitor of the training robot computer - Botox injection to the study arm within 3 months of enrollment or during the study period - Any change in the exercise regime involving the study arm. This includes starting any new exercise or discontinuing any current exercise regimen
Old
Inclusion Criteria: - Clinically defined, unilateral, hemiparetic stroke with radiologic exclusion of other possible diagnoses - Adequate language, and cognitive function to participate in training, testing, and informed consent process - The study arm of the participant will present with moderate to severe dysfunction based on Fugl-Meyer Motor Assessment range of 7 to 38 - Stroke onset greater than 6 months for ischemic stroke and greater than 1 year for hemorrhagic stroke - Men or women over 21 years of age Exclusion Criteria: - Seizures or treatment with anticonvulsant medications within the last 10 years - Treatment with any medications known to interfere with brain stimulation: any medication with central nervous system depressant activity, including, but not limited to benzodiazepines, barbituates, and neuroleptics - Serious complicating medical conditions, contractures or orthopedic problems in the study arm limiting the range of joint movement for the study positions - Visual loss such that the participant cannot see the test patterns on the monitor of the training robot computer - Botox injection to the study arm within 3 months of enrollment or during the study period - Any change in the exercise regime involving the study arm. This includes starting any new exercise or discontinuing any current exercise regimen