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Treadmill Therapy and Brain Injuries

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ClinicalTrials.gov Identifier: NCT01000168
Recruitment Status : Completed
First Posted : October 22, 2009
Last Update Posted : October 23, 2009
Sponsor:
Collaborator:
University of Bergen
Information provided by:
Sunnaas Rehabilitation Hospital

Brief Summary:

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 or disease Intervention/treatment
Cerebral Stroke Hemiplegia Moderate to Severe Functional Impairments Other: Treadmill therapy and conventional walking therapy.

Detailed Description:
See "Brief Summary".

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : November 2004
Primary Completion Date : May 2009
Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. 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. ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
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)
First Posted: October 22, 2009    Key Record Dates
Last Update Posted: October 23, 2009
Last Verified: October 2009

Keywords provided by Sunnaas Rehabilitation Hospital:
Brain Injury
Rehabilitation
Treadmill therapy

Additional relevant MeSH terms:
Stroke
Hemiplegia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms