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ISRCTN
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ISRCTN72853718
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ClinicalTrials.gov identifier
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Public title
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Randomised controlled trial of the effect of tilt table therapy with versus without an integrated stepping device on the level of consciousness of patients in persistent vegetative or minimally conscious state
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Scientific title
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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Tilt table therapy with an integrated stepping device is more effective in improving the level of consciousness than traditional tilt table therapy.
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Lay summary
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Ethics approval
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Approval of the local ethics committee (Ethikkommission der bayerischen Landesärztekammer) on 30/05/2006 (registration number: 06018).
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Study design
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Randomised, single blind, controlled trial
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Countries of recruitment
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Germany
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Disease/condition/study domain
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Persistent vegetative or minimally conscious state
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Participants - inclusion criteria
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1. In a persistent vegetative or minimally conscious state after traumatic brain injury, intracerebral hemorrhage or ischemic stroke, or in a minimally conscious state after hypoxia
2. Aged 18 to 70 years
3. Time since injury not more than six months
4. Not yet mobilised into standing for more than 30 minutes
5. Informed consent of legal proxy
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Participants - exclusion criteria
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1. Acute severe heart or lung disease (e.g. pneumonia, heart attack during the last four weeks)
2. Cardiac pace maker
3. Severe osteoporosis
4. Contractures or severe spasticity of lower extremities
5. Pregnancy
6. Unstable fractures or decubiti on lower extremities
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Anticipated start date
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23/06/2006
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Anticipated end date
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31/12/2008
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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50
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Interventions
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Tilt table therapy with or without an integrated stepping device for three weeks
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Primary outcome measure(s)
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Level of consciousness measured by the Coma Recovery Scale - revised after three weeks of treatment and three weeks follow-up.
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Secondary outcome measure(s)
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1. Improvement in heart rate variability
2. To assess muscle tone/spasticity (modified Tardieu scale/Asworth scale)
3. To monitor reaction of blood pressure, heart rate and oxygen saturation during treatments
4. To assess Glasgow Outcome Score at discharge from hospital
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Sources of funding
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Self funded by Neurologische Klinik Bad Aibling
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Trial website
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Publications
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Contact name
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Prof
Eberhard
Koenig
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Address
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Neurologische Klinik Bad Aibling
Kolbermoorer Str. 72
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City/town
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Bad Aibling
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Zip/Postcode
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83043
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Country
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Germany
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Tel
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+49 (0) 8061 903 0
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Fax
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+49 (0) 8061 903 602
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Email
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EKoenig@schoen-kliniken.de
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Sponsor
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Neurologische Klinik Bad Aibling (Germany)
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Address
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Kolbermoorer Straße 72
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City/town
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Bad Aibling
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Zip/Postcode
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83043
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Country
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Germany
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Tel
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+49 (0) 8061 903 0
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Fax
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+49 (0) 49 8061 903 602
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Email
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EKoenig@schoen-kliniken.de
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Sponsor website:
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http://www.schoen-kliniken.de
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Date applied
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10/08/2006
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Last edited
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31/08/2006
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Date ISRCTN assigned
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31/08/2006
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