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Main
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Note: This record shows only 22 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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29 June 2015 |
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Main ID: |
NCT00322192 |
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Date of registration:
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04/05/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Evaluation of Whether Functional Strength Training Can Enhance Recovery of Mobility After Stroke
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Scientific title:
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The Effects of Functional Strength Training on Weakness and Function of the Lower Limb After Stroke |
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Date of first enrolment:
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January 2004 |
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Target sample size:
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300 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00322192 |
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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: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
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Phase:
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Phase 2
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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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Email:
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Affiliation:
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St George's University London, UK |
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Name:
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Emma V Cooke, MSc |
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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 London, UK |
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Name:
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Raymond C Tallis, FMedSci |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Manchester |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
Subjects in this study will:
- be aged over 50 years.
- be between one week and three months after stroke when recruited to the study;
- have been independently mobile indoors, with or without aids, before the stroke;
- have some voluntary movement in the paretic lower limb i.e. score above 28/100 on
the lower limb section of the Motricity Index43;
- demonstrate adequate orientation and communication (be able to complete a one-stage
command using the non-paretic upper limb e.g. point at the ceiling).
In addition those who agree to participate in TMS measurement will have no
contraindications to TMS.
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: Conventional UK Physical therapy
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Behavioral: Increased intensity of UK conventional physical therapy
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Behavioral: UK conventional physical therapy plus functional strength training
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Primary Outcome(s)
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gait velocity
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Maximum torque around the knee joint
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Secondary Outcome(s)
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Lower limb kinematics during sitting down
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Transmission in the corticospinal pathways for suitable subjects who provide additional written informed consent for TMS
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Lower limb kinematics during standing up
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Lower limb kinematics during walking
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Modified Rivermead Mobility Index
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timing and pattern of muscle activation during functional activity
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EuroQuol for health related quality of life
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Secondary ID(s)
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Health Foundation 224/1960
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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