---
title: Effect of Passive Gait Training on the Cortical Activity in Patients With Severe Brain Injury.
nct_id: NCT00526500
overall_status: UNKNOWN
phase: EARLY_PHASE1
sponsor: University of Aarhus
study_type: INTERVENTIONAL
primary_condition: Craniocerebral Trauma
countries: Denmark
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00526500.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00526500"
ct_last_update_post_date: 2008-11-11
last_seen_at: "2026-05-12T07:19:34.485Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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.

**NCT ID:** [NCT00526500](https://clinicaltrials.gov/study/NCT00526500)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** EARLY_PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 60
- **Lead Sponsor:** University of Aarhus
- **Conditions:** Craniocerebral Trauma, Traumatic Brain Injury, Subarachnoid Hemorrhage, Anoxic Brain Injury
- **Start Date:** 2006-08
- **Completion Date:** 2009-05
- **CT.gov Last Update:** 2008-11-11

## 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

- **Minimum age:** 18 Years
- **Maximum age:** 80 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
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)
```

## Arms

- **P-T** (EXPERIMENTAL)
- **P- SAH** (EXPERIMENTAL)
- **P- A** (EXPERIMENTAL)
- **Control** (EXPERIMENTAL)

## Interventions

- **Tilt Table With Integrated Stepping System** (BEHAVIORAL) — Passive Gait Training: one session, 20 minutes, table tilted to 70-80 degrees, speed 60 steps per minute.

## Primary Outcomes

- **EEG:frequency ratios: Alpha versus delta; alpha and beta versus delta and theta; ERP: latency of P300-component.** _(time frame: immediately after the end og the training)_

## Secondary Outcomes

- **EEG: absolute and relative power in every frequency band; median frequency;** _(time frame: immediately after the end of the training)_

## Locations (1)

- Hammel Neurorehabilitation and Research Centre, Hammel, Denmark — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.hammel neurorehabilitation and research centre|hammel||denmark` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00526500.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00526500*  
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