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

ISRCTN ISRCTN72853718
DOI https://doi.org/10.1186/ISRCTN72853718
Secondary identifying numbers N/A
Submission date
10/08/2006
Registration date
31/08/2006
Last edited
24/06/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Eberhard Koenig
Scientific

Neurologische Klinik Bad Aibling
Kolbermoorer Str. 72
Bad Aibling
83043
Germany

Phone +49 (0)8061 903 0
Email EKoenig@schoen-kliniken.de

Study information

Study designRandomised single-blind controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleRandomised 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
Study objectivesTilt table therapy with an integrated stepping device is more effective in improving the level of consciousness than traditional tilt table therapy.
Ethics approval(s)Local ethics committee (Ethikkommission der bayerischen Landesärztekammer), 30/05/2006, registration number: 06018
Health condition(s) or problem(s) studiedPersistent vegetative or minimally conscious state
InterventionTilt table therapy with or without an integrated stepping device for three weeks
Intervention typeDevice
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)
Primary outcome measureLevel of consciousness measured by the Coma Recovery Scale - revised after three weeks of treatment and three weeks follow-up
Secondary outcome measures1. 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 study start date23/06/2006
Completion date31/12/2008

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants50
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment23/06/2006
Date of final enrolment31/12/2008

Locations

Countries of recruitment

  • Germany

Study participating centre

Neurologische Klinik Bad Aibling
Bad Aibling
83043
Germany

Sponsor information

Neurologische Klinik Bad Aibling (Germany)
Hospital/treatment centre

Kolbermoorer Straße 72
Bad Aibling
83043
Germany

Phone +49 (0)8061 903 0
Email EKoenig@schoen-kliniken.de
Website http://www.schoen-kliniken.de
ROR logo "ROR" https://ror.org/04fr6kc62

Funders

Funder type

Hospital/treatment centre

Neurologische Klinik Bad Aibling (Germany)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/12/2015 Yes No

Editorial Notes

24/06/2016: Publication reference added.