Effect of Passive Gait Training on the Cortical Activity in Patients With Severe Brain Injury.

Sponsor

University of Aarhus (Other)

Overall Status

Unknown status

CT.gov ID

NCT00526500

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

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.

Proprioceptive stimulation increases conductivity speed of the cognitive P300-component of ERP in patients with impaired consciousness due to severe brain injury.

Condition or Disease	Intervention/Treatment	Phase
Craniocerebral Trauma Traumatic Brain Injury Subarachnoid Hemorrhage Anoxic Brain Injury	Behavioral: Tilt Table With Integrated Stepping System	Early Phase 1

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:

Baseline measurement of electroencephalography (EEG) and event related potentials (ERP)
Gait training in the tilt table with integrated stepping system(20 min).
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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Aug 1, 2006

Anticipated Primary Completion Date :

May 1, 2009

Anticipated Study Completion Date :

May 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: P-T	Behavioral: Tilt Table With Integrated Stepping System Passive Gait Training: one session, 20 minutes, table tilted to 70-80 degrees, speed 60 steps per minute. Other Names: P-T:patients, traumatic brain injury P-SAH:patients, subarachnoid hemorrhage P-A:patients, anoxi Control: healthy volunteers
Experimental: P- SAH	Behavioral: Tilt Table With Integrated Stepping System Passive Gait Training: one session, 20 minutes, table tilted to 70-80 degrees, speed 60 steps per minute. Other Names: P-T:patients, traumatic brain injury P-SAH:patients, subarachnoid hemorrhage P-A:patients, anoxi Control: healthy volunteers
Experimental: P- A	Behavioral: Tilt Table With Integrated Stepping System Passive Gait Training: one session, 20 minutes, table tilted to 70-80 degrees, speed 60 steps per minute. Other Names: P-T:patients, traumatic brain injury P-SAH:patients, subarachnoid hemorrhage P-A:patients, anoxi Control: healthy volunteers
Experimental: Control	Behavioral: Tilt Table With Integrated Stepping System Passive Gait Training: one session, 20 minutes, table tilted to 70-80 degrees, speed 60 steps per minute. Other Names: P-T:patients, traumatic brain injury P-SAH:patients, subarachnoid hemorrhage P-A:patients, anoxi Control: healthy volunteers

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

EEG: absolute and relative power in every frequency band; median frequency; [immediately after the end of the training]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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 -

Exclusion Criteria:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hammel Neurorehabilitation and Research Centre	Hammel		Denmark	8450

Sponsors and Collaborators

University of Aarhus

Investigators

Study Director: Carsten Kock-Jensen, MD, Hammel Neurorehabilitation and Research Centre
Study Chair: Johannes Jakobsen, MD, DMSc, Department of Neurology, Aarhus University
Principal Investigator: Natallia Lapitskaya, MD, PhD-stud, Hammel Neurorehabilitation and Research Centre