NCT00526500

Brief Summary

The aim of this study is to determine effect of proprioceptive stimulation with passive gait training on the cortical activity in patients with severe brain injury, demonstrated as changes in EEG (electroencephalogram)and ERP (Event Related Potentials). Hypotheses: 1) Proprioceptive stimulation increases EEG-frequency in patients with impaired consciousness due to severe brain injury. 2\) Proprioceptive stimulation increases conductivity speed of the cognitive P300-component of ERP in patients with impaired consciousness due to severe brain injury.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Aug 2006

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 6, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 10, 2007

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

November 11, 2008

Status Verified

November 1, 2008

Enrollment Period

2.8 years

First QC Date

September 6, 2007

Last Update Submit

November 10, 2008

Conditions

Craniocerebral TraumaTraumatic Brain InjurySubarachnoid HemorrhageAnoxic Brain Injury

Keywords

Severe Traumatic Brain InjurySubarachnoid HemorrhageAnoxic Brain InjuryPassive Gait TrainingTilt Table With Integrated Stepping SystemElectroencephalogramEvent Related Potentials

Outcome Measures

Primary Outcomes (1)

  • EEG:frequency ratios: Alpha versus delta; alpha and beta versus delta and theta; ERP: latency of P300-component.

    immediately after the end og the training

Secondary Outcomes (1)

  • EEG: absolute and relative power in every frequency band; median frequency;

    immediately after the end of the training

Study Arms (4)

P-T

EXPERIMENTAL
Behavioral: Tilt Table With Integrated Stepping System

P- SAH

EXPERIMENTAL
Behavioral: Tilt Table With Integrated Stepping System

P- A

EXPERIMENTAL
Behavioral: Tilt Table With Integrated Stepping System

Control

EXPERIMENTAL
Behavioral: Tilt Table With Integrated Stepping System

Interventions

Tilt Table With Integrated Stepping SystemBEHAVIORAL

Passive Gait Training: one session, 20 minutes, table tilted to 70-80 degrees, speed 60 steps per minute.

Also known as: P-T:patients, traumatic brain injury, P-SAH:patients, subarachnoid hemorrhage, P-A:patients, anoxi, Control: healthy volunteers
ControlP- AP- SAHP-T

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient Goup:
  • Severe Brain Injury
  • Ongoing Impaired State of Consciousness (RLAS\<4)
  • Stable Vital Functions
  • Written Consent from Relatives/Legal Guardian
  • Control Group:
  • No History of Neurological Diseases in the Past
  • Age over 18 years
  • Written Consent -

You may not qualify if:

  • Patient and Control Goup:
  • Age older than 80 years
  • Other Neurological Diseases
  • Lack of BAEP
  • Severe Co-morbidity
  • Pregnancy
  • Tilt table contraindications: orthostatic circulatory problems, unstable fractures, severe osteoporosis, sken problems, joint problems, severe asymmetry (major difference in leg length over 2 cm), co-operation problems (psychotic illnesses or neurotic disturbances), adjustment problems (i.e. integrated stepping system cannot be safely adjusted to the patient)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hammel Neurorehabilitation and Research Centre

Hammel, 8450, Denmark

RECRUITING

MeSH Terms

Conditions

Craniocerebral TraumaBrain Injuries, TraumaticSubarachnoid HemorrhageHypoxia-Ischemia, Brain

Condition Hierarchy (Ancestors)

Trauma, Nervous SystemNervous System DiseasesWounds and InjuriesBrain InjuriesBrain DiseasesCentral Nervous System DiseasesIntracranial HemorrhagesCerebrovascular DisordersVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsBrain IschemiaHypoxia, BrainHypoxiaSigns and Symptoms, RespiratorySigns and Symptoms

Study Officials

  • Carsten Kock-Jensen, MD

    Hammel Neurorehabilitation and Research Centre

    STUDY DIRECTOR

  • Johannes Jakobsen, MD, DMSc

    Department of Neurology, Aarhus University

    STUDY CHAIR

  • Natallia Lapitskaya, MD, PhD-stud

    Hammel Neurorehabilitation and Research Centre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Natallia Lapitskaya, MD, PhD-stud

CONTACT

004587623573neunla@sc.aaa.dk

Lena Bjorn, secretary

CONTACT

0045 8762 3562neuleb@sc.aaa.dk

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 6, 2007

First Posted

September 10, 2007

Study Start

August 1, 2006

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

November 11, 2008

Record last verified: 2008-11

Locations

DK(1)