Treadmill Therapy and Brain Injuries

NCT ID: NCT01000168

Last Updated: 2009-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2009-05-31

Brief Summary

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Introduction.

* There is a demand for evidence whether treadmill therapy is more efficient than traditional walking training as an intervention for patients with hemiplegia after cerebral stroke.

Design.

* A randomized controlled trial.

Material.

* Stroke patients with moderate to severe functional deficits referred to inpatient medical rehabilitation.

Method.

* Comparing a treatment group receiving treadmill training with body weight support with a treatment group receiving conventional walking training.

Study aim:

* Investigate whether treadmill therapy is more effective than traditional functional training in restoring walking and transfer in patients with moderate to severe ambulatory deficits after stroke.

Detailed Description

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See "Brief Summary".

Conditions

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Cerebral Stroke Hemiplegia Moderate to Severe Functional Impairments

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Treadmill therapy

Patients assigned to the "Treadmill therapy group" received daily 30 minutes specific walking training on "treadmill with body weight support" alternatively overground, and 30 minutes functional training, treated by a physiotherapist.

Group Type EXPERIMENTAL

Treadmill therapy and conventional walking therapy.

Intervention Type OTHER

The experimental group received 30 sessions of treadmill therapy with body weight support for a time period of 10 weeks.

The conventional group received traditional walking therapy for the same time period.

Conventional walking therapy

Patients assigned to the comparative conventional walking therapy group received daily 30 minutes specific traditional walking training overground and 30 minutes functional training, treated by a physiotherapist.

Group Type ACTIVE_COMPARATOR

Treadmill therapy and conventional walking therapy.

Intervention Type OTHER

The experimental group received 30 sessions of treadmill therapy with body weight support for a time period of 10 weeks.

The conventional group received traditional walking therapy for the same time period.

Interventions

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Treadmill therapy and conventional walking therapy.

The experimental group received 30 sessions of treadmill therapy with body weight support for a time period of 10 weeks.

The conventional group received traditional walking therapy for the same time period.

Intervention Type OTHER

Other Intervention Names

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Treadmill training with body weight support (TTBWS). Laufband Therapy Traditional walking therapy

Eligibility Criteria

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Inclusion Criteria

* Cerebral stoke
* Hemiplegia
* Primary rehabilitation
* Medical stable
* Wheelchair user
* Dependent of assistance for walking
* Dependent of maximum one person for transfer
* No physical impairments that could prevent walking ability from being restored
* Able to participate in the training modalities

Exclusion Criteria

* Medical unstable
* Orthopaedic or other impairments preventing relearning walking
* Cognitive impairments that prevents understanding the study information
* Cognitive or psychological impairments that prevents study collaboration
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Bergen

OTHER

Sponsor Role collaborator

Sunnaas Rehabilitation Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sunnaas Rehabilitation Hospital, 1450 Nesoddtangen, Norway

Principal Investigators

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Liv Inger Strand, Dr. philos

Role: PRINCIPAL_INVESTIGATOR

University of Bergen, Norway

Locations

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Department of Brain Injury, Sunnaas Rehabilitation Hospital

Nesoddtangen, Bjørnemyrveien 11, Norway

Site Status

Countries

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Norway

References

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Moseley AM, Stark A, Cameron ID, Pollock A. Treadmill training and body weight support for walking after stroke. Cochrane Database Syst Rev. 2005 Oct 19;(4):CD002840. doi: 10.1002/14651858.CD002840.pub2.

Reference Type BACKGROUND
PMID: 16235304 (View on PubMed)

Other Identifiers

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20624506 (SunHF)

Identifier Type: -

Identifier Source: org_study_id

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