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

NCT00430703 | Completed Early Phase 1

• 1 other identifier: HNRC-AAU-06-1
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to determine whether passive gait training increases arousal, demonstrated as changes in EEG (electroencephalogram) activity. Hypotheses: 1) Passive gait training increases EEG-frequency in patients with impaired consciousness due to severe traumatic brain injury. 2\) Passive gait training increases conductivity speed of the cognitive P300-component of ERP in patients with impaired consciousness due to severe traumatic brain injury.

Conditions

Craniocerebral Trauma; Traumatic Brain Injury; "Rehabilitation"

Keywords

severe traumatic brain injury; body weight support treadmill training; Electroencephalogram; Event Related Potentials

Outcome Measures

Primary Outcomes (1)

• EEG: difference in the frequency spectrum after training.

  0-30 minutes after training end

Secondary Outcomes (5)

• EEG: absolute power i every frequency band; median frequency;

  0-30 minutes after training end

• frequency ratios: Alpha versus delta;delta and theta versus alpha and beta;

  0-30 minutes after training end

• ERP: amplitude of P300-component.

  30-60 minutes after training end

• ERP: latency of P300-component.

  30-60 minutes after training

• clinical measure: RLAS (Rancho Los Amigos Scale)

  discharge from the rehabilitation unit

Study Arms (2)

1

EXPERIMENTAL

Patients with severe traumatic brain injury

Behavioral: body weight support treadmill training

2

EXPERIMENTAL

Healthy volunteers

Behavioral: body weight support treadmill training

Interventions

body weight support treadmill training BEHAVIORAL

Gait training: Gait robot (Lokomat®, Hocoma, Switzerland) is adjusted to the patient/healthy volunteer individually with chest strap, pelvic straps, harness, leg cuffs and foot lifters. Weight is adjusted individually, so there is a minimum weight support (i.e. when one foot is standing on the treadmill the other foot lifts free from the treadmill thereby simulating normal gait). Gait speed is 1,7-2,3 km/hour (speed can be changed and adjusted that the normal step length is achieved).The duration of the training session is 20 minutes.Blood pressure and pulse are monitored.

1; 2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient group :
• severe brain injury (GCS-scale\< 8 on admission to the hospital);
• Ongoing impaired state of consciousness (RLAS-scale≤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 agreement.

You may not qualify if:

• Patient and control group:
• age older than 80 years;
• other neurological disease;
• lack of BAEP and SEP;
• severe co-morbidity;
• pregnancy;
• robotic orthosis contraindications (orthostatic circulatory problems, unstable fractures, severe osteoporosis, skin problems, joint problems, severe asymmetry (major difference in leg length over 2 cm), co-operation problems (reduced cooperation, psychotic illnesses or neurotic disturbances), body weight over 100 kg, adjustment problems (i.e. robot cannot be safely adjusted to the patient).

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus County, Denmark: collaborator

Study Sites (1)

Hammel Neurorehabilitation and Research Centre

Hammel, 8450, Denmark

Location

MeSH Terms

Conditions

Craniocerebral Trauma; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries; Brain Injuries; Brain Diseases; Central Nervous System Diseases

Study Officials

• Karsten Koch-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

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: February 1, 2007
• First Posted: February 2, 2007
• Study Start: August 1, 2006
• Primary Completion: August 1, 2008
• Study Completion: August 1, 2008
• Last Updated: November 6, 2008

Record last verified: 2008-11

Locations

DK (1)