Ignite Creation Date:
2024-05-05 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00360997
Status:
COMPLETED
Last Update Posted:
2018-05-16
First Post:
2006-08-04
Brief Title:
Investigation of Acceptable Dose of Mobilisation and Tactile Stimulation to Enhance Upper Limb Recovery After Stroke
Sponsor:
St Georges University of London
Organization:
St Georges University of London
Study Overview
Official Title:
Mobilisation and Tactile Stimulation to Enhance Upper Limb Recovery After Stroke Phase I Investigation of Acceptable Dose Efficacy and Underlying Mechanisms
Status:
COMPLETED
Status Verified Date:
2018-05
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:
The purpose of this study is to find which of three doses of mobilisation and tactile stimulation therapy when given in addition to conventional UK physical therapy has the most beneficial effect on enhancing motor recovery of the upper limb early after stroke
Detailed Description:
Background The scientific evidence indicates that upper limb motor recovery may be enhanced with the appropriate dose of afferent stimulation normally arising from functional activities Even if the appropriate dose was known people with severe paresis or paralysis would not be able to participate in functional training For these people mobilization and tactile stimulation MTS therapy might enhance upper limb recovery and changes in brain regions that can influence motor output
Questions In stroke patients with paralysis or severe paresis which dose of MTS therapy a produces the least adverse events b has the most beneficial effect on voluntary muscle contraction and functional ability This study will also address c whether the magnitude of sensorymotor cortex activation prior to MTS can predict response to MTS and d whether changes in sensory andor motor cortex activation correlate with improvement
Subjects n80 from two clinical centres with an anterior cerebral circulation stroke 8 to 84 days before recruitment paresis or severe paralysis and no clinically important pain affecting the upper arm or shoulder after stroke
Methods After baseline measures Day 1 subjects will be randomised to a no extra therapy or one of three doses of MTS therapy for 14 consecutive working days b 30 minutes c 60 minutes or d 120 minutes All subjects will receive the conventional therapy normally provided within each centre On Day 16 outcome measures will be made The experimental intervention MTS therapy will be individualised for each subject from a standardised schedule of techniques within treatment categories including passive movements massage specific sensory input and functional movement The measurement battery will be a efficacy Motricity Index Arm Section and the Action Research Arm Test b adverse events presence of upper limb pain and decrease in Motricity Index score and c Functional MRI London subjects T1 weighted anatomical images and T2 weighted MRI transverse echo-planar images undertaking these studies with both sensory and motor paradigms where feasible
Analysis Analysis for efficacy and adverse events will be conducted using the Chi-squared test for trend or linear regression as appropriate The results will be combined to determine the most appropriate dose of MTS Imaging data will be processed using Statistical Parametric Mapping and then analysed statistically using a least mean squares fit of the model to the data to determine regions of significant activation for each session
Questions In stroke patients with paralysis or severe paresis which dose of MTS therapy a produces the least adverse events b has the most beneficial effect on voluntary muscle contraction and functional ability This study will also address c whether the magnitude of sensorymotor cortex activation prior to MTS can predict response to MTS and d whether changes in sensory andor motor cortex activation correlate with improvement
Subjects n80 from two clinical centres with an anterior cerebral circulation stroke 8 to 84 days before recruitment paresis or severe paralysis and no clinically important pain affecting the upper arm or shoulder after stroke
Methods After baseline measures Day 1 subjects will be randomised to a no extra therapy or one of three doses of MTS therapy for 14 consecutive working days b 30 minutes c 60 minutes or d 120 minutes All subjects will receive the conventional therapy normally provided within each centre On Day 16 outcome measures will be made The experimental intervention MTS therapy will be individualised for each subject from a standardised schedule of techniques within treatment categories including passive movements massage specific sensory input and functional movement The measurement battery will be a efficacy Motricity Index Arm Section and the Action Research Arm Test b adverse events presence of upper limb pain and decrease in Motricity Index score and c Functional MRI London subjects T1 weighted anatomical images and T2 weighted MRI transverse echo-planar images undertaking these studies with both sensory and motor paradigms where feasible
Analysis Analysis for efficacy and adverse events will be conducted using the Chi-squared test for trend or linear regression as appropriate The results will be combined to determine the most appropriate dose of MTS Imaging data will be processed using Statistical Parametric Mapping and then analysed statistically using a least mean squares fit of the model to the data to determine regions of significant activation for each session
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