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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00360997 |
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Date of registration:
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04/08/2006 |
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Primary sponsor: |
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Public title:
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Investigation of Acceptable Dose of Mobilisation and Tactile Stimulation to Enhance Upper Limb Recovery After Stroke
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Scientific title:
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Mobilisation and Tactile Stimulation to Enhance Upper Limb Recovery After Stroke: Phase I Investigation of Acceptable Dose, Efficacy and Underlying Mechanisms |
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Date of first enrolment:
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March 2006 |
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Target sample size:
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80 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00360997 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Valerie M Pomeroy, PhD |
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Address:
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Telephone:
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+44(0)20 8725 5327 |
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Email:
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v.pomeroy@sgul.ac.uk |
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Affiliation:
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Name:
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Valerie M Pomeroy, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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St George's, University of London |
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Key inclusion & exclusion criteria
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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).
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Stroke
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Intervention(s)
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Behavioral: Con UK PT + 120 minutes a day MTS
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Behavioral: Con UK PT + 30 minutes/day Mobilisation & Tactile Stimulation (MTS)
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Behavioral: Con UK PT + 60 minutes a day MTS
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Behavioral: Conventional UK physical therapy (Con UK PT)
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Primary Outcome(s)
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Efficacy: Primary outcome, Motricity Index – arm
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Secondary Outcome(s)
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Adverse events: Occurrence of upper limb pain and decrease Motricity score
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Efficacy: Action Research Arm Test (ARAT).
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Underlying mechanisms: Functional MRI for suitable London subjects
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Underlying mechanisms: Transcranial magnetic stimulation to measure evoked motor potentials in paretic upper limb for suitable London subjects.
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Secondary ID(s)
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TSA 2005/03
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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