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ISRCTN
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ISRCTN67543440
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ClinicalTrials.gov identifier
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Public title
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Kinematic Motion Analyses of Upper Extremity After Intensive Training with Spring-assisted Dynamic Hand Orthosis in Patient with Stroke
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Scientific title
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Effects of Spring Assisted Dynamic Hand Orthosis Training on Functions and Movement Smoothness of the Hemiparetic Upper Extremity: A randomised controlled trial
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Acronym
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SADHO
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Serial number at source
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2009-44
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Study hypothesis
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The purpose of this experiment was to evaluate the effectiveness of training using a spring assisted dynamic hand orthosis on smoothness of movement, clinical assessment score, and grip strength of the affected limb in hemiparetic patients. To determine resultant velocity and jerkiness score for movement smoothness, the Box and Block Test (BBT), Action Research Arm Test (ARAT), and Fugl-Meyer Assessment (FMA) for functions of the hemiparetic upper extremity were conducted.
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Lay summary
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Ethics approval
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Yonsei University, College of Medicine approved on the 25th of March 2010 (ref: 2009-44)
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Study design
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Randomised comparative interventional pretest-posttest control group design
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Countries of recruitment
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Korea, South
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Disease/condition/study domain
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Hemiparesis due to Stroke
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Participants - inclusion criteria
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1. 18 years or older
2. Unilateral hemiparesis more than 6 months post-stroke duration
3. No current or previous orthopedic or surgical histories affecting the hemiparetic upper extremity
4. Mini-Mental State Examination (MMSE) Korean version - score ≥ 23 (to ensure that they fully understood the study procedure)
5. Patients should have at least some active voluntary movement of the upper extremity (i.e., 10 degrees of shoulder flexion/abduction, 10 degrees of elbow flexion/extension, and 30 degrees of interphalangeal proximal joints / 20 degrees of interphalangeal distal joints of volitional finger flexion when the hand is positioned in wrist and finger extension)
6. No flaccidity of the affected limb
7. No severe contracture or spasticity of the affected wrist or hand
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Participants - exclusion criteria
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Does not match inclusion criteria
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Anticipated start date
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23/12/2009
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Anticipated end date
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15/03/2010
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use contact details to request a patient information sheet
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Target number of participants
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10
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Interventions
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Patients will undergo training activities while each wore a spring assisted dynamic hand orthosis. Training will be guided by a physiotherapist for 1 hour per day per week for 4 weeks.
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Primary outcome measure(s)
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3 clinical assessments and the measurement of grip strength. Fugl-Meyer Assessment and grip strength and Action Research Arm Test and Box and Block Test.
All outcomes were measured at baseline and after 4 weeks of training.
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Secondary outcome measure(s)
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Spatiotemporal parameters were collected using a 3-D motion analysis system and workstation software pre- and post-test (VICON MX system, Oxford Metrics, U.K.). Data collection was conducted at the Motion Analysis Research Laboratory in the Yonsei University.
All outcomes were measured at baseline and after 4 weeks of training.
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Sources of funding
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Investigator funded (South Korea) - Dissertation project
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Trial website
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Publications
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Contact name
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Dr
Young-Keun
Woo
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Address
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Department of Physical Therapy
Andong Science College
496 Kyu-ri SeoHu-Myeon
Andong City
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City/town
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Gyeongsangbuk-do
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Zip/Postcode
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760-709
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Country
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Korea, South
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Sponsor
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Yonsei University College of Medicine (South Korea)
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Address
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c/o Young-Keun Woo
Department of Physical Therapy
Andong Science College
496 Kyu-ri SeoHu-Myeon
Andong City
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City/town
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Gyeongsangbuk-do
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Zip/Postcode
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760-709
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Country
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Korea, South
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Date applied
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11/10/2010
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Last edited
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19/10/2010
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Date ISRCTN assigned
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19/10/2010
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