Ignite Creation Date:
2024-05-06 @ 3:43 AM
Last Modification Date:
2024-10-26 @ 11:38 AM
Study NCT ID:
NCT02359253
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2015-02-04
Brief Title:
Robot Aided Rehabilitation - Intervention
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Robot-Aided Diagnosis Passive-Active Arm Motor and Sensory Rehabilitation Post Stroke Aims 23
Status:
RECRUITING
Status Verified Date:
2024-07
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:
Aim23
Brief Summary:
Sensorimotor impairments following stroke often involve complex pathological changes across multiple joints and multiple degrees of freedom of the arm and hand thereby rendering them difficult to diagnose and treat The objective of this study is to evaluate multi-joint neuromechanical impairments in the arm and hand then conduct impairment-specific treatment and determine the effects of arm versus hand training and the effects of passive stretching before active movement training
Detailed Description:
Sensorimotor impairments following stroke can lead to substantial disability involving the upper extremity These impairments often involve complex pathological changes across multiple joints and multiple degrees-of-freedom of the arm and hand thereby rendering them difficult to diagnose and treat Many potential mechanisms such as weakness motoneuronal hyperexcitability and elevated passive impedance can contribute and it is currently unclear where to focus treatment The objectives of this study are to address allocation of therapy resources between the arm and hand and to examine the benefits of combining passive stretching with active movement training
Aim 1 To compare the efficacy of training the arm versus the hand in promoting upper extremity rehabilitation
Hypothesis 1 Treating the proximal larger joints in the arm alone will lead to greater improvement than treating the distal hand alone
Aim 2 To examine the efficacy of combining passive stretching with active assistive or resistive training for the shoulder elbow wrist and hand
Hypothesis 2 Multi-joint intelligent stretching followed by active assistive or resistive movement facilitated by use of the IntelliArm arm rehabilitation robot and a Hand rehabilitation robot will improve motor control of the upper extremity more than standard movement therapy alone
Subjects will be assigned randomly with equal chance to one of four groups Groups are split into 2 conditions based on stretching and 2 conditions based on target of intervention arm or hand Half of all the subjects will be assigned to the stretching groups and the other half to the passive movement groups Half of the subjects will be assigned to the arm-training and the remaining half to hand-training groups Arm-training groups will use the IntelliArm hand-training groups will use the hand robot For those assigned to the stretching groups subjects will complete up to 30 minutes of passive stretching with the IntelliArm or the hand robot For those assigned to the passive movement condition subjects will do the robot according to their group assignment and wear it for up to 30 minutes with little to no stretching preceding the active therapy session For each group the initial about 30 minutes of stretching or relaxing will be followed by 45-60 minutes of active therapy with the IntelliArm or hand robot depending on group assignment for a total session time of 75-90 minutes
The 4 groups of subjects will be compared against each other
Aim 1 To compare the efficacy of training the arm versus the hand in promoting upper extremity rehabilitation
Hypothesis 1 Treating the proximal larger joints in the arm alone will lead to greater improvement than treating the distal hand alone
Aim 2 To examine the efficacy of combining passive stretching with active assistive or resistive training for the shoulder elbow wrist and hand
Hypothesis 2 Multi-joint intelligent stretching followed by active assistive or resistive movement facilitated by use of the IntelliArm arm rehabilitation robot and a Hand rehabilitation robot will improve motor control of the upper extremity more than standard movement therapy alone
Subjects will be assigned randomly with equal chance to one of four groups Groups are split into 2 conditions based on stretching and 2 conditions based on target of intervention arm or hand Half of all the subjects will be assigned to the stretching groups and the other half to the passive movement groups Half of the subjects will be assigned to the arm-training and the remaining half to hand-training groups Arm-training groups will use the IntelliArm hand-training groups will use the hand robot For those assigned to the stretching groups subjects will complete up to 30 minutes of passive stretching with the IntelliArm or the hand robot For those assigned to the passive movement condition subjects will do the robot according to their group assignment and wear it for up to 30 minutes with little to no stretching preceding the active therapy session For each group the initial about 30 minutes of stretching or relaxing will be followed by 45-60 minutes of active therapy with the IntelliArm or hand robot depending on group assignment for a total session time of 75-90 minutes
The 4 groups of subjects will be compared against each other
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None