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

Primary Purpose

Craniocerebral Trauma, Traumatic Brain Injury, "Rehabilitation"

Status
Completed
Phase
Early Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
body weight support treadmill training
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Craniocerebral Trauma focused on measuring severe traumatic brain injury, body weight support treadmill training, Electroencephalogram, Event Related Potentials

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Patient group :

  1. severe brain injury (GCS-scale< 8 on admission to the hospital);
  2. Ongoing impaired state of consciousness (RLAS-scale≤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 agreement.

Exclusion Criteria:

Patient and control group:

  1. age older than 80 years;
  2. other neurological disease;
  3. lack of BAEP and SEP;
  4. severe co-morbidity;
  5. pregnancy;
  6. 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).

Sites / Locations

  • Hammel Neurorehabilitation and Research Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

Patients with severe traumatic brain injury

Healthy volunteers

Outcomes

Primary Outcome Measures

EEG: difference in the frequency spectrum after training.

Secondary Outcome Measures

EEG: absolute power i every frequency band; median frequency;
frequency ratios: Alpha versus delta;delta and theta versus alpha and beta;
ERP: amplitude of P300-component.
ERP: latency of P300-component.
clinical measure: RLAS (Rancho Los Amigos Scale)

Full Information

First Posted
February 1, 2007
Last Updated
November 5, 2008
Sponsor
University of Aarhus
Collaborators
Aarhus County, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT00430703
Brief Title
Effect of Passive Gait Training on the Cortical Activity in Patients With Severe Traumatic Brain Injury.
Official Title
Effect of Massive Proprioceptive Stimulation With Passive Gait Training on the Cortical Activity in Patients With Impaired States of Consciousness After Severe Traumatic Brain Injury.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Aarhus
Collaborators
Aarhus County, Denmark

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Severe traumatic brain injury, especially after a high energy trauma, is characterised with focal lesions and diffuse axonal injury, which leads to the dysfunction in the cortico-spinal, cortico- cortical connections and reticular activation system. Formatio reticularis plays an important role in arousal. Tactile and proprioceptive stimulation with a view to improving level of consciousness in coma patients is popular in the western world despite insufficient evidence of its effectiveness. Affolter-Bobath-Coombes-concept is the most commonly used tool in the rehabilitation of brain damaged patients. This concept is based on the theory that tactile, proprioceptive and oral stimulation develops new connections in the brain and thereby stimulates consciousness and behaviour. Elliot et al shows improvement in level of consciousness due to postural changes from a lying position to a standing posture in 8 of 12 patients using Wessex Head Injury Matrix. Passive movements result in proprioceptive stimulation; the effect of which is close to that achieved by physiological voluntary activity. PET and fMRI studies show that passive movements activate several areas in the motor cortex. In order to increase afferent cortical input, passive gait training in the body weight support robotic gait orthosis could be used in patients with impaired consciousness, inability to cooperate and poor balance. This device gives the possibility to establish therapeutically correct upright body position and passive legs movement simultaneously. To our knowledge there are no studies, which illustrate the effects of passive gait training on cortical activity in patients with impaired consciousness due to severe traumatic brain injury. Our hypothesis is that passive gait training of this group of patients increases arousal, which can be shown in an increased EEG (electroencephalogram)-frequency and increased conductivity speed of the cognitive P300-component of ERP (Event Related Potentials). Comparison(s): EEG- and ERP-activity after a single training session in robotic gait orthosis in patients with severe traumatic brain injury, compared to EEG- and ERP-activity after a single training session in robotic gait orthosis in healthy persons.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Craniocerebral Trauma, Traumatic Brain Injury, "Rehabilitation"
Keywords
severe traumatic brain injury, body weight support treadmill training, Electroencephalogram, Event Related Potentials

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Patients with severe traumatic brain injury
Arm Title
2
Arm Type
Experimental
Arm Description
Healthy volunteers
Intervention Type
Behavioral
Intervention Name(s)
body weight support treadmill training
Intervention Description
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.
Primary Outcome Measure Information:
Title
EEG: difference in the frequency spectrum after training.
Time Frame
0-30 minutes after training end
Secondary Outcome Measure Information:
Title
EEG: absolute power i every frequency band; median frequency;
Time Frame
0-30 minutes after training end
Title
frequency ratios: Alpha versus delta;delta and theta versus alpha and beta;
Time Frame
0-30 minutes after training end
Title
ERP: amplitude of P300-component.
Time Frame
30-60 minutes after training end
Title
ERP: latency of P300-component.
Time Frame
30-60 minutes after training
Title
clinical measure: RLAS (Rancho Los Amigos Scale)
Time Frame
discharge from the rehabilitation unit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karsten Koch-Jensen, MD
Organizational Affiliation
Hammel Neurorehabilitation and Research Centre
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Johannes Jakobsen, MD, DMSc
Organizational Affiliation
Department of Neurology, Aarhus University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Natallia Lapitskaya, MD, PhD-stud
Organizational Affiliation
Hammel Neurorehabilitation and Research Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hammel Neurorehabilitation and Research Centre
City
Hammel
ZIP/Postal Code
8450
Country
Denmark

12. IPD Sharing Statement

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

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