Treadmill Therapy and Brain Injuries - Full Text View

Purpose

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.

Condition	Intervention
Cerebral Stroke Hemiplegia Moderate to Severe Functional Impairments	Other: Treadmill therapy and conventional walking therapy.

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment
Official Title:	The Effect of Treadmill Therapy With Body Weight Support on Walking and Transfer in Patients With Moderate to Severe Ambulatory Deficits After Stroke

Resource links provided by NLM:

MedlinePlus related topics: Rehabilitation Traumatic Brain Injury

U.S. FDA Resources

Further study details as provided by Sunnaas Rehabilitation Hospital:

Primary Outcome Measures:

Functional Ambulation Categories. Ten meter walking test. Six minutes walking test. Functional Independence Measure (task 9 shorter transfer and task 13 stairs). [ Time Frame: 0, 5 weeks and 10 weeks. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

EU-Walking Index. Time of "Shorter transfer". Time of "Climbing stairs". Performance of climbing stairs. Heart rate registration. * Temporospatial 3D gait data (a sub group analysis). ** Semistructured interview. [ Time Frame: 0, 5 and 10 weeks, * 0 and 10 weeks, **10 weeks. ] [ Designated as safety issue: No ]

Enrollment:	60
Study Start Date:	November 2004
Study Completion Date:	May 2009
Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 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.	Other: 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. Other Names: Treadmill training with body weight support (TTBWS). Laufband Therapy Traditional walking therapy
Active Comparator: 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.	Other: 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. Other Names: Treadmill training with body weight support (TTBWS). Laufband Therapy Traditional walking therapy

Detailed Description:

See "Brief Summary".

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01000168

Locations

Norway
Department of Brain Injury, Sunnaas Rehabilitation Hospital
Nesoddtangen, Bjørnemyrveien 11, Norway, 1450

Sponsors and Collaborators

Sunnaas Rehabilitation Hospital

University of Bergen

Investigators

Principal Investigator:

Liv Inger Strand, Dr. philos

University of Bergen, Norway

More Information

Publications:

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. Review.

Responsible Party:	Johan K Stanghelle, Professor MD, Sunnaas Rehabilitation Hospital, 1450 Nesoddtangen, Norway
ClinicalTrials.gov Identifier:	NCT01000168 History of Changes
Other Study ID Numbers:	20624506 (SunHF)
Study First Received:	October 21, 2009
Last Updated:	October 22, 2009
Health Authority:	Norway:National Committee for Medical and Health Research Ethics Norway: Norwegian Social Science Data Services

Keywords provided by Sunnaas Rehabilitation Hospital:

Brain Injury
Rehabilitation
Treadmill therapy

Additional relevant MeSH terms:

Hemiplegia
Stroke
Cerebral Infarction
Brain Injuries
Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Cerebrovascular Disorders

Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on May 22, 2013