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
Scientific
Neurologische Klinik Bad Aibling
Kolbermoorer Str. 72
Bad Aibling
83043
Germany
Phone | +49 (0)8061 903 0 |
---|---|
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
83043
Germany
Sponsor information
Neurologische Klinik Bad Aibling (Germany)
Hospital/treatment centre
Hospital/treatment centre
Kolbermoorer Straße 72
Bad Aibling
83043
Germany
Phone | +49 (0)8061 903 0 |
---|---|
EKoenig@schoen-kliniken.de | |
Website | http://www.schoen-kliniken.de |
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.