Clinical trial NCT00526500: Effect of Passive Gait Training on the Cortical Activity in Patients With Severe Brain Injury.
Official title: Effect of Proprioceptive Stimulation With Passive Gait Training on the Cortical Activity in Patients With Impaired Consciousness Due to Severe Brain Injury.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Craniocerebral Trauma
Traumatic Brain Injury
Subarachnoid Hemorrhage
Anoxic Brain Injury
Keywords: Severe Traumatic Brain Injury
Subarachnoid Hemorrhage
Anoxic Brain Injury
Passive Gait Training
Tilt Table With Integrated Stepping System
Electroencephalogram
Event Related Potentials
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2007-09-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: Design: Prospective controlled non-randomized study. Materials and methods: 45 patients with severe brain injury and 15 healthy volunteers will be included in this study.

The study design is illustrated below:

1. Baseline measurement of electroencephalography (EEG) and event related potentials (ERP)
2. Gait training in the tilt table with integrated stepping system(20 min).
3. Control measurement of EEG and ERP Effect parameters: se outcome measures. Statistical evaluation: All collected data will be tested with reference to normal distribution. If the data is not distributed normally, then we will use either a logarithmic transformation before we use parametric statistics, or we will use non-parametric statistics for further calculations.

Further analysis of the data will be done with the help of variance analysis with an inter-individually factor as a group (patients vs control persons) and intra-individually factors as: 1) experimental condition (before vs after training), 2) topographic distribution (anterior vs central vs posterior).

Significance level is set to 0.05 for all effect parameters.

Eligibility criteria: Inclusion Criteria:

Patient Goup:

1. Severe Brain Injury
2. Ongoing Impaired State of Consciousness (RLAS\<4)
3. Stable Vital Functions
4. Written Consent from Relatives/Legal Guardian

Control Group:

1. No History of Neurological Diseases in the Past
2. Age over 18 years
3. Written Consent -

Exclusion Criteria:

Patient and Control Goup:

1. Age older than 80 years
2. Other Neurological Diseases
3. Lack of BAEP
4. Severe Co-morbidity
5. Pregnancy
6. 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)

Primary outcomes:
measure: EEG:frequency ratios: Alpha versus delta; alpha and beta versus delta and theta; ERP: latency of P300-component.
timeFrame: immediately after the end og the training
Secondary outcomes:
measure: EEG: absolute and relative power in every frequency band; median frequency;
timeFrame: immediately after the end of the training
Other outcomes:
Locations:
city: Hammel
country: Denmark
facility: Hammel Neurorehabilitation and Research Centre
Study officials:
affiliation: Hammel Neurorehabilitation and Research Centre
name: Carsten Kock-Jensen, MD
role: STUDY_DIRECTOR
affiliation: Department of Neurology, Aarhus University
name: Johannes Jakobsen, MD, DMSc
role: STUDY_CHAIR
affiliation: Hammel Neurorehabilitation and Research Centre
name: Natallia Lapitskaya, MD, PhD-stud
role: PRINCIPAL_INVESTIGATOR
References: