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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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TCTR |
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Last refreshed on:
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29 April 2024 |
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Main ID: |
TCTR20150128001 |
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Date of registration:
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28/01/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Effects of multi-sensory stimulation therapy on cognitive impairment in adult patients with traumatic brain injury
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Scientific title:
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Effects of Snoezelen® multi-sensory stimulation therapy on cognitive impairment in adult patients with traumatic braininjury; A randomized controlled trial |
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Date of first enrolment:
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01/02/2015 |
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Target sample size:
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40 |
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Recruitment status: |
Pending (Not yet recruiting) |
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URL:
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https://www.thaiclinicaltrials.org/show/TCTR20150128001 |
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Study type:
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Interventional |
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Study design:
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Randomized
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Phase:
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N/A
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Contacts
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Name:
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Phichamon
Khanittanuphong |
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Address:
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Orthopaedic Surgery and Physical Medicine Department, Faculty of Medicine, Prince of Songkla Univers
90110
Songkhla
Thailand |
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Telephone:
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0819592698 |
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Email:
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dearpicha@yahoo.com |
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Affiliation:
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Faculty Of Medicine, Prince of Songkla University |
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Name:
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Phichamon
Khanittanuphong |
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Address:
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Orthopaedic Surgery and Physical Medicine Department, Faculty of Medicine, Prince of Songkla Univers
90110
Songkhla
Thailand |
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Telephone:
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0819592698 |
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Email:
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dearpicha@yahoo.com |
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Affiliation:
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Faculty Of Medicine, Prince of Songkla University |
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Key inclusion & exclusion criteria
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Inclusion criteria: - Patients are diagnosed as traumatic brain injuries by CT scan or MRI
- Score of MMSE ‐Thai 2002 are equal or less than 17 in case of primary school education and equal or less than 22 in case of above primary school education
- Stable medical condition
- Eligible patients for Snoezelen® multisensory stimulation therapy
- Mobility by walking or wheelchair
- Duration of 1-12 months after brain injuries
Exclusion criteria: - Penetrating brain injuries
- Diagnosed as psychiatric or other neurological disorders
- History of seizure
- Illiterate patients
Age minimum:
18 Years
Age maximum:
0 N/A (No limit)
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Traumatic brain injuries in adult patients
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Intervention(s)
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Snoezelen® multisensory stimulation is a therapeutic room that includes various sensory stimulation such as light, color, sound, odor and touch. All sensations are orderly applied to brain-injured patients for brain recovery. Patients also receive conventional physical and occupational therapy.,Patients receive only conventional physical and occupational therapy.
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Experimental Device,Active Comparator Other
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Snoezelen® multisensory stimulation therapy,Conventional therapy
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Primary Outcome(s)
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Mini Mental Status Examination - Thai version Baseline, immediate and 4-week post interventions Questionnaire
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Secondary Outcome(s)
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Rancho los Amigos Scale Baseline, immediate and 4-week post interventions Clinical Observation and grading by physician,modified Barthel Index Baseline, immediate and 4-week post interventions Questionnaire, assessed by physician
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Source(s) of Monetary Support
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Research fund, Faculty of Medicine, Prince of Songkla University
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Ethics review
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Status: Submitted, approved
Approval date:
Contact:
medpsu.ec@gmail.com
Human Research Ethics Committee, Faculty of Medicine, Prince of Songkla University
0-7445-1157 Ext.
medpsu.ec@gmail.com
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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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31/12/2015 |
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URL:
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