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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
History of Changes

October 21, 2009
October 22, 2009
November 2004
May 2009   (final data collection date for primary outcome measure)
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 ]
Functional Ambulation Categories. Ten meter walking test. Six minutes walking test. Functional Independence Measure (task 9 shorter transfer and task 13 stairs). [ Time Frame: Baseline, after 4-5 weeks and after 10 weeks of intervention. ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01000168 on ClinicalTrials.gov Archive Site
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 ]
EU-Walking Index. Time of "Shorter transfer". Time of "Climbing stairs". Performance of climbing stairs. Heart rate registration. [ Time Frame: Baseline, after 4-5 weeks and after 10 weeks of intervention. ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Treadmill Therapy and Brain Injuries
The Effect of Treadmill Therapy With Body Weight Support on Walking and Transfer in Patients With Moderate to Severe Ambulatory Deficits After Stroke

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.

See "Brief Summary".
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
  • Cerebral Stroke
  • Hemiplegia
  • Moderate to Severe Functional Impairments
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
  • 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.
    Intervention: Other: Treadmill therapy and conventional 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.
    Intervention: Other: Treadmill therapy and conventional walking therapy.
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
May 2009
May 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT01000168
20624506 (SunHF)
No
Johan K Stanghelle, Professor MD, Sunnaas Rehabilitation Hospital, 1450 Nesoddtangen, Norway
Sunnaas Rehabilitation Hospital
University of Bergen
Principal Investigator: Liv Inger Strand, Dr. philos University of Bergen, Norway
Sunnaas Rehabilitation Hospital
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP