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 design	Randomised single-blind controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet
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
Study objectives	Tilt 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) studied	Persistent vegetative or minimally conscious state
Intervention	Tilt table therapy with or without an integrated stepping device for three weeks
Intervention type	Device
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)
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 study start date	23/06/2006
Completion date	31/12/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	50
Key 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
Key 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
Date of first enrolment	23/06/2006
Date of final enrolment	31/12/2008

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"	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 share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not 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.