Investigation of Acceptable Dose of Mobilisation and Tactile Stimulation to Enhance Upper Limb Recovery After Stroke

St George's, University of London

Status

Completed

Conditions

Stroke

Treatments

Procedure: Con UK PT + Mobilisation & tactile stimulation (MTS)

Behavioral: Conventional UK physical therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT00360997

TSA 2005/03

Details and patient eligibility

About

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.

Full 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 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.

Enrollment

80 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Have suffered an infarct or haemorrhage in the anterior cerebral circulation, confirmed by neuroimaging, 8 to 84 days before recruitment
Have a paralysed or severely paretic upper limb as measured by a score of 61/100 or less on the Motricity Index Arm Section17

Exclusion criteria

Clinically important pain affecting the upper arm or shoulder when recruited to this study
Visible upper limb movement deficits attributable to pathology other than stroke
Unable to follow a 1-stage command using their non-paretic upper limb (ie severe communication or other cognitive deficits precluding ability to participate in MTS).