Ignite Creation Date:
2024-05-05 @ 4:54 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00343304
Status:
COMPLETED
Last Update Posted:
2006-06-22
First Post:
2006-06-20
Brief Title:
Pilot Study - Comparison of Upper Body Ergometer Vs Robot in Upper Extremity Motor Recovery Post-Stroke
Sponsor:
Burke Rehabilitation Hospital
Organization:
Burke Rehabilitation Hospital
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2005-04
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:
We will test whether robot driven goal directed trajectory corrected exercise enhances motor outcome in the upper limb of stroke patients better than matched motor activity on an upper body ergometer monark
Detailed Description:
Upper extremity UE weakness post-stroke occurs in 70-80 of patients By 3 months this complaint persists in 40 of patients and by 6 months this complaint persists in a similar percentage of patients 1 Greater improvement in motor functional recovery was achieved in patients with intact sensation Shoulder pain persisted in 20 of patients 2 Most of the arm recovery occurs in the initial 3 months post-stroke 234 The Copenhagen stroke study found 79 of patients with mild UE paresis achieving functional motor recovery compared to 18 of patients with severe UE paresis 4 Katrak P et al found early shoulder shrug and synergistic hand movements to be useful bedside predictors of functional motor recovery of the UE 5 The initial grade of paresis measured on admission in the hospital is the most important predictor of motor recovery after stroke with initial paralysis implying the worst prognosis for subsequent motor recovery 6 Perceptual inattention does impact upon UE action and functional recovery 7 The UE weakness and functional motor recovery lags behind lower extremity LE weakness and functional motor recovery because of the complexity of motor skills needed for daily living tasks
Due to the persistence of upper extremity weakness different rehabilitation techniques such as Constraint Induced CI 8910 and robotic 111213 therapies were developed to help with meaningful functional motor recovery in the paretic arm unilateral arm training Both of these forced-use interventions focus on the paretic arm only The main drawback of the CI therapy is that subjects need to have some degree of voluntary movement both at the wrist and the digits Bilateral arm training with rhythmic clueing BATRAC has been used in chronic stroke patients and has been found to improve functional motor performance in the paretic UE 14 The authors in a recent paper showed BATRAC inducing reorganization in contraleisonal motor networks based on functional MRI 15 Facilitation of paretic arm movement by the non-paretic arm bimanual movement is thought to be superior to individual paretic arm movement which indicates both arms to be a coordinated brain unit 16 Richards L et al in their review article 17 and Vander Lee J et al in their meta-analysis of randomized stroke trials 18 on therapeutic interventions to improve UE function found extensive practice to be the most important factor irrespective of the type of intervention instituted Early repetitive sensorimotor stimulation of the arm results in long-lasting functional motor recovery 19
The overall goal of this study is to determine whether bilateral arm training with upper body ergometer is as or more effective in upper extremity functional recovery than unilateral arm training with robot in patients with a recent ischemic and hemorrhagic stroke
Due to the persistence of upper extremity weakness different rehabilitation techniques such as Constraint Induced CI 8910 and robotic 111213 therapies were developed to help with meaningful functional motor recovery in the paretic arm unilateral arm training Both of these forced-use interventions focus on the paretic arm only The main drawback of the CI therapy is that subjects need to have some degree of voluntary movement both at the wrist and the digits Bilateral arm training with rhythmic clueing BATRAC has been used in chronic stroke patients and has been found to improve functional motor performance in the paretic UE 14 The authors in a recent paper showed BATRAC inducing reorganization in contraleisonal motor networks based on functional MRI 15 Facilitation of paretic arm movement by the non-paretic arm bimanual movement is thought to be superior to individual paretic arm movement which indicates both arms to be a coordinated brain unit 16 Richards L et al in their review article 17 and Vander Lee J et al in their meta-analysis of randomized stroke trials 18 on therapeutic interventions to improve UE function found extensive practice to be the most important factor irrespective of the type of intervention instituted Early repetitive sensorimotor stimulation of the arm results in long-lasting functional motor recovery 19
The overall goal of this study is to determine whether bilateral arm training with upper body ergometer is as or more effective in upper extremity functional recovery than unilateral arm training with robot in patients with a recent ischemic and hemorrhagic stroke
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