Treadmill Therapy and Brain Injuries
Primary Purpose
Cerebral Stroke, Hemiplegia, Moderate to Severe Functional Impairments
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Treadmill therapy and conventional walking therapy.
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Stroke focused on measuring Brain Injury, Rehabilitation, Treadmill therapy
Eligibility 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
Sites / Locations
- Department of Brain Injury, Sunnaas Rehabilitation Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Treadmill therapy
Conventional walking therapy
Arm Description
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.
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.
Outcomes
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).
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.
Full Information
NCT ID
NCT01000168
First Posted
October 21, 2009
Last Updated
October 22, 2009
Sponsor
Sunnaas Rehabilitation Hospital
Collaborators
University of Bergen
1. Study Identification
Unique Protocol Identification Number
NCT01000168
Brief Title
Treadmill Therapy and Brain Injuries
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 Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sunnaas Rehabilitation Hospital
Collaborators
University of Bergen
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
See "Brief Summary".
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Stroke, Hemiplegia, Moderate to Severe Functional Impairments
Keywords
Brain Injury, Rehabilitation, Treadmill therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treadmill therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional walking therapy
Arm Type
Active Comparator
Arm Description
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 Type
Other
Intervention Name(s)
Treadmill therapy and conventional walking therapy.
Other Intervention Name(s)
Treadmill training with body weight support (TTBWS)., Laufband Therapy, Traditional walking therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liv Inger Strand, Dr. philos
Organizational Affiliation
University of Bergen, Norway
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Brain Injury, Sunnaas Rehabilitation Hospital
City
Nesoddtangen
State/Province
Bjørnemyrveien 11
ZIP/Postal Code
1450
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
16235304
Citation
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.
Results Reference
background
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Treadmill Therapy and Brain Injuries
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