Trial record 3 of 673 for:    treadmill

Treadmill Therapy and Brain Injuries

This study has been completed.
Sponsor:
Collaborator:
University of Bergen
Information provided by:
Sunnaas Rehabilitation Hospital
ClinicalTrials.gov Identifier:
NCT01000168
First received: October 21, 2009
Last updated: October 22, 2009
Last verified: October 2009
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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:
Stroke
Hemiplegia
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on September 18, 2014