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.
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 sensory/motor cortex activation prior to MTS can predict response to MTS; and, d) whether changes in sensory and/or motor cortex activation correlate with improvement.
Subjects (n=80) 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.
- Conventional UK physical therapy (Con UK PT) Behavioral
- Con UK PT + 30 minutes/day Mobilisation & Tactile Stimulation (MTS) Behavioral
- Con UK PT + 60 minutes a day MTS Behavioral
- Con UK PT + 120 minutes a day MTS Behavioral
- Allocation: Randomized
- Masking: Single Blind
- Purpose: Treatment
- Endpoint: Safety/Efficacy Study
- Intervention: Parallel Assignment
|Type||Measure||Time Frame||Safety Issue|
|Primary||Efficacy: Primary outcome, Motricity Index – arm|
|Secondary||Efficacy: Action Research Arm Test (ARAT).|
|Secondary||Adverse events: Occurrence of upper limb pain and decrease Motricity score|
|Secondary||Underlying mechanisms: Functional MRI for suitable London subjects|
|Secondary||Underlying mechanisms: Transcranial magnetic stimulation to measure evoked motor potentials in paretic upper limb for suitable London subjects.|