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
Protocol serial number	N/A
Sponsor	Neurologische Klinik Bad Aibling (Germany)
Funder	Neurologische Klinik Bad Aibling (Germany)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

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

Primary study design	Interventional
Study design	Randomised single-blind controlled trial
Secondary study design	Randomised controlled trial
Study type	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
Phase	Not Specified
Drug / device / biological / vaccine name(s)
Primary outcome measure(s)	Level of consciousness measured by the Coma Recovery Scale - revised after three weeks of treatment and three weeks follow-up
Key secondary outcome measure(s)	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
Completion date	31/12/2008

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

Neurologische Klinik Bad Aibling

Bad Aibling
83043
Germany

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2015		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

24/06/2016: Publication reference added.