Effect of Speed-dependent Treadmill Training in Patients With Subacute Stroke
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Experimental
Speed-stable treadmill training
Sponsored by

About this trial
This is an interventional treatment trial for Stroke focused on measuring gait, hemiplegia, treadmill, physiotherapy, rehabilitation
Eligibility Criteria
Inclusion Criteria:
- first episode of stroke
- within 1 month of stroke onset
- hemiparesis resulting from unilateral ischemic stroke
- Ashworth score of 0 or 1 indicating no spasticity or slight spasticity over the affected lower limb respectively
- mini-mental status examination score of ≥ 23
- the ability to walk on level ground without physical assistance and to walk on a treadmill with a minimum speed of 22.2 cm/s for 30s
Exclusion Criteria:
- neurological diseases other than stroke,
- active cardiovascular disease (i.e. American Heart Association class C or above),
- lower limb fractures
- total hip replacement
- active rheumatoid arthritis that affected their gait performance
- Patients who required assistance to ambulate before the stroke were also excluded
Sites / Locations
- Margaret Mak
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Speed-dependent treadmill training (SDT)
speed-stable treadmill training
Arm Description
Subjects underwent short interval of walking trials with stepwise increases in the treadmill speed
Control subjects received gait training on the treadmill with a steady speed.
Outcomes
Primary Outcome Measures
change in Walking speed
change in stride length
change in cadence
Secondary Outcome Measures
change in Berg's balance score
Full Information
NCT ID
NCT01328301
First Posted
March 31, 2011
Last Updated
March 18, 2015
Sponsor
The Hong Kong Polytechnic University
Collaborators
Tung Wah Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01328301
Brief Title
Effect of Speed-dependent Treadmill Training in Patients With Subacute Stroke
Official Title
Speed-dependent Treadmill Training is Effective to Improve Gait and Balance Performance in Patients With Sub-acute Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University
Collaborators
Tung Wah Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study aimed to explore whether speed-dependent treadmill training is more effective at improving walking and balance performance than speed-stable treadmill training in patients with subacute stroke. Twenty-six patients with stroke completed 2 weeks of treadmill training. Results showed that speed-dependent treadmill training is more effective at improving walking speed and step length than speed-stable treadmill training in patients with subacute stroke.
Detailed Description
Objectives: To compare the effects of speed-dependent treadmill training (SDT) on gait and balance performance in patients with sub-acute stroke. Design: Double-blinded randomized controlled trial. Subjects: Twenty-six patients with sub-acute stroke were randomly assigned to SDT (n=13) and control (n=13) groups. Methods: Subjects in the SDT group underwent short interval of walking trials with stepwise increases in the treadmill speed, following the principles of sprint training. Control subjects received gait training on the treadmill with a steady speed (SST). Gait speed, stride length, cadence, and Berg's balance score (BBS) were recorded and analysed before and after the 10 training sessions. Results: Results of two-way repeated measures ANOVA showed significant group x time interactions for gait speed and stride length (p < 0.05). Within each subject group, there were improvements in all gait parameters and BBS (all p < 0.001) after the training program. In addition, the SDT group showed significantly larger percentage increases in gait speed (by 72.8%) and stride length (by 29.2%) than the control subjects (p < 0.02). Conclusions: SDT in patients with sub-acute stroke resulted in larger gains in gait speed and stride length compared with SST. The positive findings provide evidence for clinical practice of SDT in enhancing gait function after stroke.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
gait, hemiplegia, treadmill, physiotherapy, rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Speed-dependent treadmill training (SDT)
Arm Type
Experimental
Arm Description
Subjects underwent short interval of walking trials with stepwise increases in the treadmill speed
Arm Title
speed-stable treadmill training
Arm Type
Active Comparator
Arm Description
Control subjects received gait training on the treadmill with a steady speed.
Intervention Type
Other
Intervention Name(s)
Experimental
Other Intervention Name(s)
Treadmill training with increasing speed
Intervention Description
For SDT training, subjects received short intervals of locomotion training with a treadmill. After walking for 30s, the subjects were given two minutes of rest. If they completed the first walking trial safely and without stumbling, the belt speed was increased by 10% on the next trial. However, if a subject failed to complete the first trial, the belt speed was decreased by 10% on the next trial. The speed of the treadmill was adjusted in each subsequent trial according to the same principle. Subjects usually completed 7-8 walking trials in one session. The belt speed was increased by a maximum of five increments within one training session.
Intervention Type
Other
Intervention Name(s)
Speed-stable treadmill training
Other Intervention Name(s)
Treadmill training with steady speed
Intervention Description
Subjects in the control group walked on the treadmill with the belt speed adjusted according to their fastest over-ground gait speed. There was no adjustment of the belt speed throughout the 30-minute steady-speed treadmill training session.
Primary Outcome Measure Information:
Title
change in Walking speed
Time Frame
Change in walking speed from baseline to post-treatment, an expected average of 2 weeks
Title
change in stride length
Time Frame
Change in stride length from baseline to post-treatment, an expected average of 2 weeks
Title
change in cadence
Time Frame
Change in cadence from baseline to post-treatment, an expected average of 2 weeks
Secondary Outcome Measure Information:
Title
change in Berg's balance score
Time Frame
Change in Berg's balance score from baseline to post-treatment, an expected average of 2 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
first episode of stroke
within 1 month of stroke onset
hemiparesis resulting from unilateral ischemic stroke
Ashworth score of 0 or 1 indicating no spasticity or slight spasticity over the affected lower limb respectively
mini-mental status examination score of ≥ 23
the ability to walk on level ground without physical assistance and to walk on a treadmill with a minimum speed of 22.2 cm/s for 30s
Exclusion Criteria:
neurological diseases other than stroke,
active cardiovascular disease (i.e. American Heart Association class C or above),
lower limb fractures
total hip replacement
active rheumatoid arthritis that affected their gait performance
Patients who required assistance to ambulate before the stroke were also excluded
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margaret KY Mak, PhD
Organizational Affiliation
Department of Rehabilitation Sciences, The Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Margaret Mak
City
Hong Kong
State/Province
Hong Kong
Country
China
12. IPD Sharing Statement
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Effect of Speed-dependent Treadmill Training in Patients With Subacute Stroke
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