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

Traumatic Brain Injury Clinical Trial

Official title:

Effect of Proprioceptive Stimulation With Passive Gait Training on the Cortical Activity in Patients With Impaired Consciousness Due to Severe Brain Injury.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00526500
• Other study ID #: HNRC-AAU-07-1
• Status: Recruiting
• Phase: Phase 0
• First received: September 6, 2007
• Last updated: November 10, 2008
• Start date: August 2006
• Est. completion date: May 2009

Study information

• Verified date: November 2008
• Source: University of Aarhus
• Contact: Natallia Lapitskaya, MD, PhD-stud
• Phone: 004587623573
• Email: neunla[@]sc.aaa.dk
• Is FDA regulated: No
• Health authority: Denmark: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anoxic Brain Injury
• Brain Injuries
• Craniocerebral Trauma
• Hemorrhage
• Hypoxia, Brain
• Subarachnoid Hemorrhage
• Traumatic Brain Injury

Intervention

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.

Locations

Country	Name	City	State
Denmark	Hammel Neurorehabilitation and Research Centre	Hammel

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	EEG: absolute and relative power in every frequency band; median frequency;		immediately after the end of the training	No