Contact information
Type
Scientific
Primary contact
Prof Eberhard Koenig
ORCID ID
Contact details
Neurologische Klinik Bad Aibling
Kolbermoorer Str. 72
Bad Aibling
83043
Germany
+49 (0)8061 903 0
EKoenig@schoen-kliniken.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
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
Acronym
Study hypothesis
Tilt table therapy with an integrated stepping device is more effective in improving the level of consciousness than traditional tilt table therapy.
Ethics approval
Local ethics committee (Ethikkommission der bayerischen Landesärztekammer), 30/05/2006, registration number: 06018
Study design
Randomised single-blind controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Persistent vegetative or minimally conscious state
Intervention
Tilt table therapy with or without an integrated stepping device for three weeks
Intervention type
Device
Phase
Not Specified
Drug names
Primary outcome measure
Level of consciousness measured by the Coma Recovery Scale - revised after three weeks of treatment and three weeks follow-up
Secondary outcome measures
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
Overall trial start date
23/06/2006
Overall trial end date
31/12/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
50
Participant exclusion criteria
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
Recruitment start date
23/06/2006
Recruitment end date
31/12/2008
Locations
Countries of recruitment
Germany
Trial participating centre
Neurologische Klinik Bad Aibling
Bad Aibling
83043
Germany
Sponsor information
Organisation
Neurologische Klinik Bad Aibling (Germany)
Sponsor details
Kolbermoorer Straße 72
Bad Aibling
83043
Germany
+49 (0)8061 903 0
EKoenig@schoen-kliniken.de
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Neurologische Klinik Bad Aibling (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26623651