Body Weight Supported Treadmill Training vs. Overground Walking Training in Persons With Chronic Stroke
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|ClinicalTrials.gov Identifier: NCT01180738|
Recruitment Status : Completed
First Posted : August 12, 2010
Last Update Posted : January 30, 2013
|Condition or disease||Intervention/treatment||Phase|
|Stroke Difficulty Walking||Behavioral: Body weight supported treadmill training Behavioral: Overground walking training||Phase 1 Phase 2|
Body weight supported treadmill training (BWSTT) and overground walking training (OWT) are two interventions commonly applied for enhancing gait and balance in patients with chronic stroke. BWSTT and OWT are often used by clinicians separately or in tandem. While various aspects of the two interventions have been investigated in the past, limited research has been conducted to compare the effects of the two interventions in patients with chronic stroke.
Longer training durations may not always be feasible due to limited reimbursement options, lack of clinic accessibility, or transportation restrictions for patients with chronic deficits following stroke. A short burst of training consisting of a ''booster''-like protocol may provide a convenient option for some patients with chronic stroke to improve necessary functional skills in a short period of time.
The primary purpose of this pilot study is to compare walking speed immediately and 3-months after a short-burst of body-weight support treadmill training (BWSTT) or overground walking training (OWT) for adults with chronic stroke. Twenty participants with chronic stroke will be recruited and screened to determine eligibility for the study. Participants will be randomly assigned to either BWSTT or OWT for 30 minutes, 5 days per week for 2 weeks. Outcome measures will include assessments of gait speed, endurance, walking pattern, fear of falling, balance confidence, anxiety, and activity and participation in daily life. Outcomes will be tested prior to (pre-test) and immediately after (post-test) the assigned intervention and again 3-months after completing the intervention (retention).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Comparison of Short Bursts of Body Weight Supported Treadmill Training vs. Overground Walking Training in Persons With Chronic Stroke|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||December 2011|
|Active Comparator: Body weight supported treadmill training||
Behavioral: Body weight supported treadmill training
Training will include 10 sessions over a 2 week period, each session with 30 minutes of walking on a treadmill using a body weight support system.
|Active Comparator: Overground walking training||
Behavioral: Overground walking training
Training will include 10 sessions over a 2 week period, each session with 30 minutes of walking overground.
- Gait speed: measured with the comfortable 10-meter walk test [ Time Frame: The outcome measure will be assessed at pre-test (within 1-week before beginning the intervention), post-test (within 1-week after completing the 2-week intervention period) and at retention (3-months following completion of the intervention). ]
- Gait endurance: measured with the 6-minute walk test; Fear of falling: measured with the Fear of Falling questionnaire and Falls Efficacy Scale-International [ Time Frame: The outcome measures will be assessed at pre-test (within 1-week before beginning the intervention), post-test (within 1-week after completing the 2-week intervention period) and at retention (3-months following completion of the intervention). ]
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): NCT01180738
|United States, Indiana|
|University of Indianapolis, Krannert School of Physical Therapy|
|Indianapolis, Indiana, United States, 46227|
|Principal Investigator:||Stephanie A Combs, PT, PhD, NCS||University of Indianapolis, Krannert School of Physical Therapy, Indianapolis, IN|
|Principal Investigator:||Arlene A Schmid, OTR, PhD||Co-Investigator, Roudebush VA Medical Center, Indianapolis, IN|