StrokeNCT02619110
The Effect of Backward Walking Treadmill Training on Balance in Patient With Chronic Stroke
A study testing backward walking treadmill training and conventional physical therapy in people with Stroke, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
The purpose of this research was to discuss the effect of backward walking treadmill training on balance ability, speed of walking and cardiopulmonary fitness in patients with chronic stroke. Read more about this study
- Who is it for?
- Ages 60 to 65 years
- Conditions the study is for
- Stroke
- What is being tested?
- backward walking treadmill training and conventional physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- Feb 2014to Dec 2014
- 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 60 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- This experiment recruited subjects with chronic stroke more than six months, whose level of Brunnstrom stage was beyond IV and who were able to walk more than eleven meters with or without assistive devices
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Purpose of This Study Was to Discuss on the Effects of Backward Walking Treadmill Training on Balance Ability, Speed of Walking and Cardiopulmonary Fitness for Patient With Chronic Stroke
The purpose of this research was to discuss the effect of backward walking treadmill training on balance ability, speed of walking and cardiopulmonary fitness in patients with chronic stroke.
Read the detailed description
Walking training is a good method and strategy to improve postural stability, balance, gait symmetry, and increase walking ability. Generally, there are many walking training theories and methods for patients with chronic stroke and treadmill walking training is applied in recent years. Previous studies showed that patients with stroke improve the walking abilities and speed after the walking treadmill training. However, most studies have demonstrated that forward walking treadmill training improved balance and walking ability in patients with stroke, but fewer studies have investigated the effects on backward walking treadmill training. However, no studies to date have investigated the effects of backward walking treadmill training for patients with chronic stroke.
- Conditions
- Stroke
- Being tested
- backward walking treadmill training, conventional physical therapy
- Keywords
- Chronic Stroke, cardiopulmonary, Berg Balance Scale (BBS)
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
backward walking treadmill trainingOther
subjects accepted 30 minutes backward walking treadmill training. a week for four weeks.
conventional physical therapyOther
subjects accepted 30 minutes traditional physical therapy three times a week for four weeks
| Study group | Role | What they receive |
|---|---|---|
| backward walking treadmill training | Other | The intervention group not only received four weeks of conventional physical therapy but also accepted additional four weeks of backward walking treadmill training at the same time Receives: Other: backward walking treadmill training; Other: conventional physical therapy |
| conventional physical therapy | Other | The conventional physical therapy training focused on strengthening, postural control, functional mobility and forward gait training program but excluded backward walking training Receives: Other: conventional physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of Berg Balance Scale (BBS)
Measured: Baseline, week 4.
Secondary outcomes (1)
The change of pulmonary function test (PFT): forced vital capacity (FVC) and Forced expiratory volume in one second (FEV1)
Measured: Baseline, week 4.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2015 (estimated)
- Study startFeb 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lan Y Guo, Ph.D, Study chair, Department of Sports Medicine, College of Medicine, Kaohsiung Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02619110
- Sponsor's protocol ID
- KMUH-IRB-20130288
- Status last verified
- Feb 2015
- First submitted
- 17 Nov 2015
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mathers CD, Loncar D. Projections of global mortality and burden of disease from 2002 to 2030. PLoS medicine 3(11):e442, 2006. Mendis S. Stroke disability and rehabilitation of stroke: World Health Organization perspective. International journal of stroke : official journal of the International Stroke Society 8(1):3-4, 2013 Chen CY, Huang YB, Tzu-Chi Lee C. Epidemiology and disease burden of ischemic stroke in Taiwan. The International journal of neuroscience 123(10):724-731, 2013 Bonita R, Beaglehole R. Recovery of motor function after stroke. Stroke; a journal of cerebral circulation 19(12):1497-1500, 1988 Niam S, Cheung W, Sullivan PE, Kent S, Gu X. Balance and physical impairments after stroke. Archives of physical medicine and rehabilitation 80(10):1227-1233, 1999
Chang KW, Lin CM, Yen CW, Yang CC, Tanaka T, Guo LY. The Effect of Walking Backward on a Treadmill on Balance, Speed of Walking and Cardiopulmonary Fitness for Patients with Chronic Stroke: A Pilot Study. Int J Environ Res Public Health. 2021 Mar 1;18(5):2376. doi: 10.3390/ijerph18052376.
PubMed 33804374
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Purpose of This Study Was to Discuss on the Effects of Backward Walking Treadmill Training on Balance Ability, Speed of Walking and Cardiopulmonary Fitness for Patient With Chronic Stroke
- ClinicalTrials.gov ID
- NCT02619110
- Acronym / sponsor ID
- KMUH-IRB-20130288
- Conditions
- Stroke
- Keywords
- Chronic Stroke, cardiopulmonary, Berg Balance Scale (BBS)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 2 Dec 2015 (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.
The purpose of this research was to discuss the effect of backward walking treadmill training on balance ability, speed of walking and cardiopulmonary fitness in patients with chronic stroke.
Detailed description
Walking training is a good method and strategy to improve postural stability, balance, gait symmetry, and increase walking ability. Generally, there are many walking training theories and methods for patients with chronic stroke and treadmill walking training is applied in recent years. Previous studies showed that patients with stroke improve the walking abilities and speed after the walking treadmill training. However, most studies have demonstrated that forward walking treadmill training improved balance and walking ability in patients with stroke, but fewer studies have investigated the effects on backward walking treadmill training. However, no studies to date have investigated the effects of backward walking treadmill training for patients with chronic stroke.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| backward walking treadmill training | Other | Other: backward walking treadmill training, Other: conventional physical therapyThe intervention group not only received four weeks of conventional physical therapy but also accepted additional four weeks of backward walking treadmill training at the same time |
| conventional physical therapy | Other | Other: conventional physical therapyThe conventional physical therapy training focused on strengthening, postural control, functional mobility and forward gait training program but excluded backward walking training |
Who may qualify
- Ages
- 60 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- This experiment recruited subjects with chronic stroke more than six months, whose level of Brunnstrom stage was beyond IV and who were able to walk more than eleven meters with or without assistive devices
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| backward walking treadmill trainingsubjects accepted 30 minutes backward walking treadmill training. a week for four weeks. | Other | backward walking treadmill training |
| conventional physical therapysubjects accepted 30 minutes traditional physical therapy three times a week for four weeks | Other | backward walking treadmill training, conventional physical therapy |
Primary outcome
The change of Berg Balance Scale (BBS)
Time frame: Baseline, week 4.
1 secondary outcome
The change of pulmonary function test (PFT): forced vital capacity (FVC) and Forced expiratory volume in one second (FEV1)
Time frame: Baseline, week 4.
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 2 Dec 2015.
- Results publicationMathers CD, Loncar D. Projections of global mortality and burden of disease from 2002 to 2030. PLoS medicine 3(11):e442, 2006. Mendis S. Stroke disability and rehabilitation of stroke: World Health Organization perspective. International journal of stroke : official journal of the International Stroke Society 8(1):3-4, 2013 Chen CY, Huang YB, Tzu-Chi Lee C. Epidemiology and disease burden of ischemic stroke in Taiwan. The International journal of neuroscience 123(10):724-731, 2013 Bonita R, Beaglehole R. Recovery of motor function after stroke. Stroke; a journal of cerebral circulation 19(12):1497-1500, 1988 Niam S, Cheung W, Sullivan PE, Kent S, Gu X. Balance and physical impairments after stroke. Archives of physical medicine and rehabilitation 80(10):1227-1233, 1999
- Derived from this study: PubMed 33804374Chang KW, Lin CM, Yen CW, Yang CC, Tanaka T, Guo LY. The Effect of Walking Backward on a Treadmill on Balance, Speed of Walking and Cardiopulmonary Fitness for Patients with Chronic Stroke: A Pilot Study. Int J Environ Res Public Health. 2021 Mar 1;18(5):2376. doi: 10.3390/ijerph18052376.
Related trials for Stroke
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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.
Lan Y Guo, Ph.D study chair
Department of Sports Medicine, College of Medicine, Kaohsiung Medical 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 backward walking treadmill training and conventional physical therapy in people with Stroke, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
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 1 inclusion and 0 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 2 Dec 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 Taiwan. 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?
The change of Berg Balance Scale (BBS) (time frame: Baseline, week 4.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02619110, which also lists 2 linked publications.
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 2 Dec 2015.