StrokeNCT00167089
Effects of Early Treadmill Training on Ambulatory Ability in Stroke Patients: Electromyographic and Kinematic Analyses
A study testing Treadmill Training in people with Stroke, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is to explore an alternative approach that emphasizes task specificity and treadmill training for ambulation training of these patients. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Stroke
- What is being tested?
- Treadmill Training
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 1998to Aug 2000
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- between 40 and 75 years old
- first stroke with R't side hemiplegia due to middle cerebral artery occlusion and received acute treatment at NTUH
- being willing to sign an informed consent approved by the Human Subjects Committee of the National Taiwan University Hospital
- able to ambulate independently in parallel bars and having no independent ambulation ability outside parallel bars
- Excursion criteria:
- having unstable vital sign, unconsciousness, or obvious cognitive, perception, and language impairment, and couldn't communicate with the experimenters
- having other neurological diseases, or moderate to severe neuromuscular or musculoskeletal or cardiovascular disorders, or disorders from systematic diseases other than stroke
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
School and Graduate Institute of Physical Therapy College of Medicine, National Taiwan University
Taipei, Province of China, 100
About this study
The purpose of this study is to explore an alternative approach that emphasizes task specificity and treadmill training for ambulation training of these patients.
Read the detailed description
Restoration of independent ambulatory ability is one of the most common functional goals of patients with hemiplegia after stroke. Ambulation training, therefore, is an important part of physical therapy intervention for these patients. Conventional neurologic physical therapy for ambulation training, based sorely on neurophysiology, prohibits early ambulation experience after stroke in attempt to avoid the development of abnormal gait patterns. Such an approach has been shown to be limited in helping these patients regain independent ambulatory ability.
- Conditions
- Stroke
- Being tested
- Treadmill Training
- Keywords
- Stroke, Hemiplegia, Gait, Ambulation training, Neurologic physical therapy
- Medical subject headings
- Stroke, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treadmill TrainingBehavioural
Partian body weight support treadmill training, 30 min/day * 3 days /week
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate walking speed and stride length as the representation of ambulation ability
Measured: 3 months
Secondary outcomes (1)
To investigate the the co-activation duration between the activity of hamstring and quadriceps, and tibialis anterior and gastrocnemius joints, the level of symmetry in step length and stance/swing duration ratio between the affected and unaffected legs
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startAug 1998
- Primary completionAug 2000
- Study completionAug 2000
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 National Taiwan University 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Investigators
- Pei-Fang Tang, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00167089
- Sponsor's protocol ID
- 47s1
- Status last verified
- Sep 2009
- First submitted
- 12 Sep 2005
- Last updated
- 6 Oct 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Early Treadmill Training on Ambulatory Ability in Stroke Patients: Electromyographic and Kinematic Analyses
- ClinicalTrials.gov ID
- NCT00167089
- Acronym / sponsor ID
- 47s1
- Conditions
- Stroke
- Keywords
- Stroke, Hemiplegia, Gait, Ambulation training, Neurologic physical therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Aug 1998
- Primary completion
- Aug 2000 (actual)
- Study completion
- Aug 2000 (actual)
- First posted
- 14 Sep 2005 (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 study is to explore an alternative approach that emphasizes task specificity and treadmill training for ambulation training of these patients.
Detailed description
Restoration of independent ambulatory ability is one of the most common functional goals of patients with hemiplegia after stroke. Ambulation training, therefore, is an important part of physical therapy intervention for these patients. Conventional neurologic physical therapy for ambulation training, based sorely on neurophysiology, prohibits early ambulation experience after stroke in attempt to avoid the development of abnormal gait patterns. Such an approach has been shown to be limited in helping these patients regain independent ambulatory ability.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- between 40 and 75 years old
- first stroke with R't side hemiplegia due to middle cerebral artery occlusion and received acute treatment at NTUH
- being willing to sign an informed consent approved by the Human Subjects Committee of the National Taiwan University Hospital
- able to ambulate independently in parallel bars and having no independent ambulation ability outside parallel bars
- having unstable vital sign, unconsciousness, or obvious cognitive, perception, and language impairment, and couldn't communicate with the experimenters
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 |
|---|---|---|
| Treadmill TrainingPartian body weight support treadmill training, 30 min/day * 3 days /week | Behavioural | – |
Primary outcome
To investigate walking speed and stride length as the representation of ambulation ability
Time frame: 3 months
1 secondary outcome
To investigate the the co-activation duration between the activity of hamstring and quadriceps, and tibialis anterior and gastrocnemius joints, the level of symmetry in step length and stance/swing duration ratio between the affected and unaffected legs
Time frame: 3 months
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 6 Oct 2009.
Related trials for Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
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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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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
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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.
Pei-Fang Tang, PhD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treadmill Training in people with Stroke, run by National Taiwan University 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 7 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 6 Oct 2009. 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?
To investigate walking speed and stride length as the representation of ambulation ability (time frame: 3 months). 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 6 Oct 2009.