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

Stroke Clinical Trial

Official title:

Mobilisation and Tactile Stimulation to Enhance Upper Limb Recovery After Stroke: Phase I Investigation of Acceptable Dose, Efficacy and Underlying Mechanisms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00360997
• Other study ID #: TSA 2005/03
• Status: Completed
• Phase: N/A
• Start date: March 2006
• Est. completion date: December 2008

Study information

• Verified date: May 2018
• Source: St George's, University of London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• Conventional UK physical therapy

Procedure:
• Con UK PT + Mobilisation & tactile stimulation (MTS)
Con UK PT + Mobilisation & Tactile Stimulation (MTS) which is further randomised to 30, 60 or 120 mins/day

Locations

Country	Name	City	State
United Kingdom	St Thomas' Foundation Hospital NHS Trust	London
United Kingdom	North Staffordshire Combined Healthcare NHS Trust	Stoke-on-Trent	Staffordshire

Sponsors (1)

Lead Sponsor	Collaborator
St George's, University of London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	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.