Condition category
Signs and Symptoms
Date applied
10/08/2006
Date assigned
31/08/2006
Last edited
24/06/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.schoen-kliniken.de

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

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26623651

Publication citations

Additional files

Editorial Notes

24/06/2016: Publication reference added.