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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN72853718
Enrollment
50
Registered
2006-08-31
Start date
2006-06-23
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Persistent vegetative or minimally conscious state Signs and Symptoms Persistent vegetative or minimally conscious state

Interventions

Tilt table therapy with or without an integrated stepping device for three weeks

Sponsors

Neurologische Klinik Bad Aibling (Germany)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Level of consciousness measured by the Coma Recovery Scale - revised after three weeks of treatment and three weeks follow-up

Secondary

MeasureTime frame
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

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 3, 2026