StrokeNCT01328301
Effect of Speed-dependent Treadmill Training in Patients With Subacute Stroke
A study testing Experimental and Speed-stable treadmill training in people with Stroke, run by The Hong Kong Polytechnic University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke
- What is being tested?
- Experimental and Speed-stable treadmill training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Dec 2008to Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Speed-dependent Treadmill Training is Effective to Improve Gait and Balance Performance in Patients With Sub-acute Stroke
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Experimental, Speed-stable treadmill training
- Keywords
- gait, hemiplegia, treadmill, physiotherapy, rehabilitation
- Medical subject headings
- Stroke, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExperimentalOther
Also called Treadmill training with increasing speed
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.
Speed-stable treadmill trainingOther
Also called Treadmill training with steady speed
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.
| Study group | Role | What they receive |
|---|---|---|
| Speed-dependent treadmill training (SDT) | Experimental | Subjects underwent short interval of walking trials with stepwise increases in the treadmill speed Receives: Other: Experimental |
| speed-stable treadmill training | Active comparator | Control subjects received gait training on the treadmill with a steady speed. Receives: Other: Speed-stable treadmill training |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in Walking speed
Measured: Change in walking speed from baseline to post-treatment, an expected average of 2 weeks
change in stride length
Measured: Change in stride length from baseline to post-treatment, an expected average of 2 weeks
change in cadence
Measured: Change in cadence from baseline to post-treatment, an expected average of 2 weeks
Secondary outcomes (1)
change in Berg's balance score
Measured: Change in Berg's balance score from baseline to post-treatment, an expected average of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2011 (estimated)
- Study startDec 2008
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Tung Wah Hospital
- Responsible party
- Principal investigator, Margaret Kit Yi Mak, The Hong Kong Polytechnic University
- Investigators
- Margaret KY Mak, PhD, Principal investigator, Department of Rehabilitation Sciences, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01328301
- Sponsor's protocol ID
- mak0001
- Status last verified
- Mar 2015
- First submitted
- 31 Mar 2011
- Last updated
- 20 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Speed-dependent Treadmill Training is Effective to Improve Gait and Balance Performance in Patients With Sub-acute Stroke
- ClinicalTrials.gov ID
- NCT01328301
- Acronym / sponsor ID
- mak0001
- Conditions
- Stroke
- Keywords
- gait, hemiplegia, treadmill, physiotherapy, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Tung Wah Hospital
- Study start
- Dec 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 4 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Speed-dependent treadmill training (SDT) | Experimental | Other: ExperimentalSubjects underwent short interval of walking trials with stepwise increases in the treadmill speed |
| speed-stable treadmill training | Active comparator | Other: Speed-stable treadmill trainingControl subjects received gait training on the treadmill with a steady speed. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExperimentalAlso: Treadmill training with increasing speedFor 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. | Other | Speed-dependent treadmill training (SDT) |
| Speed-stable treadmill trainingAlso: Treadmill training with steady speedSubjects 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. | Other | speed-stable treadmill training |
Primary outcome
change in Walking speed
Time frame: Change in walking speed from baseline to post-treatment, an expected average of 2 weeks
change in stride length
Time frame: Change in stride length from baseline to post-treatment, an expected average of 2 weeks
change in cadence
Time frame: Change in cadence from baseline to post-treatment, an expected average of 2 weeks
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2015.
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margaret KY Mak, PhD principal investigator
Department of Rehabilitation Sciences, The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental and Speed-stable treadmill training in people with Stroke, run by The Hong Kong Polytechnic University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in Walking speed (time frame: Change in walking speed from baseline to post-treatment, an expected average of 2 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2015.