Ignite Creation Date:
2024-05-05 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00372411
Status:
COMPLETED
Last Update Posted:
2014-01-13
First Post:
2006-09-05
Brief Title:
Robotic Assisted Upper-Limb Neurorehabilitation in Stroke Patients
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
CSP 558 - Robotic Assisted Upper-Limb Neurorehabilitation in Stroke Patients
Status:
COMPLETED
Status Verified Date:
2013-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VA ROBOTICS
Brief Summary:
This study will compare robotic training with usual care and intensive comparison therapy to attempt to improve upper extremity function
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None