Ignite Creation Date:
2024-05-06 @ 3:45 AM
Last Modification Date:
2024-10-26 @ 11:38 AM
Study NCT ID:
NCT02369770
Status:
RECRUITING
Last Update Posted:
2024-02-26
First Post:
2015-02-07
Brief Title:
Sensory-Motor Rehabilitation Post Stroke
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Sensory-Motor Rehabilitation Post Stroke
Status:
RECRUITING
Status Verified Date:
2024-02
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:
None
Brief Summary:
Early after stroke patients often have significant motor impairment and sensory deficit Evidence has demonstrated heightened plasticity and significant recovery in the acute phase first months post stroke but there has been a lack of effective and practical protocols and devices for early intensive sensorimotor therapyThis research study will conduct a randomized clinical trial of an intensive motor-sensory rehabilitation on patients with acute stroke using a wearable rehabilitation robot The primary aims are to facilitate sensorimotor recovery reduce ankle impairments and improve balance and gait functions This clinical trial will be conducted on the Study and Control groups of acute stroke survivors
Detailed Description:
The study will investigate an early intensive rehabilitation in acute stroke for motor relearning reducing ankle impairments and improving balance and mobilitylocomotion functions
The acute stroke survivor will be randomly placed into two groups Subjects in the Study group will receive robot-aided motor relearning under real-time feedback stretching under intelligent control sensory stimulation and active movement training with interactive games Subjects in the Control group will receive passive movement in the middle ROM without intelligent stretching and active movement training without robotic guidance
For both groups the therapeutic training will be conducted during 5 hourly sessions including breakstransitions between tasks each week over about 3-week hospital stay Both groups will also receive the standard of care in the hospital and rehabilitation service Treatment outcome measures will be obtained through blinded assessments and evaluated before and after training involving biomechanical neuromuscular and clinical outcome measures Carry-over effects will be further evaluated 1 month after the treatment ends
Aim 1 To evaluate biomechanical and neuromuscular changes as defined by the passive and active range of motion ROM flexor-extensor muscle strength joint stiffness proprioception and reflex excitability and compare these measures between the two groups The biomechanical and neuromuscular outcome measures will be obtained through blinded assessments and evaluated before and after training using the wearable rehabilitation robot
Hypothesis 1 Robot-guided motor relearning stretching and active movement training Study group will improve the biomechanical and neuromuscular outcome measures more than those of the Control group
Aim 2 To evaluate the clinical outcome measures as defined by Fugl-Meyer score lower extremity modified Ashworth scale Berg balance scale 10 meter walk test and to compare between the Study and Control groups
Hypothesis 2 The Study group will improve the clinical outcome measures more than the Control group
The acute stroke survivor will be randomly placed into two groups Subjects in the Study group will receive robot-aided motor relearning under real-time feedback stretching under intelligent control sensory stimulation and active movement training with interactive games Subjects in the Control group will receive passive movement in the middle ROM without intelligent stretching and active movement training without robotic guidance
For both groups the therapeutic training will be conducted during 5 hourly sessions including breakstransitions between tasks each week over about 3-week hospital stay Both groups will also receive the standard of care in the hospital and rehabilitation service Treatment outcome measures will be obtained through blinded assessments and evaluated before and after training involving biomechanical neuromuscular and clinical outcome measures Carry-over effects will be further evaluated 1 month after the treatment ends
Aim 1 To evaluate biomechanical and neuromuscular changes as defined by the passive and active range of motion ROM flexor-extensor muscle strength joint stiffness proprioception and reflex excitability and compare these measures between the two groups The biomechanical and neuromuscular outcome measures will be obtained through blinded assessments and evaluated before and after training using the wearable rehabilitation robot
Hypothesis 1 Robot-guided motor relearning stretching and active movement training Study group will improve the biomechanical and neuromuscular outcome measures more than those of the Control group
Aim 2 To evaluate the clinical outcome measures as defined by Fugl-Meyer score lower extremity modified Ashworth scale Berg balance scale 10 meter walk test and to compare between the Study and Control groups
Hypothesis 2 The Study group will improve the clinical outcome measures more than the Control group
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