Ischemic Cerebrovascular AccidentNCT01934374
Long-Term Effects of Task-Oriented Lower Extremity Strengthening Training
A study testing Task-Oriented Lower Extremity Strengthening Training in people with Ischemic Cerebrovascular Accident, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Task-oriented exercises combined with strengthening have been shown effective in improving walking functions in patients with chronic stroke. However, similar approaches of therapeutic exercises have not been applied to subacute stroke with long-term follow-up, using outcome measures across the three levels of… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ischemic Cerebrovascular Accident
- What is being tested?
- Task-Oriented Lower Extremity Strengthening Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2009to Aug 2012
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- in the subacute stage of stroke (within 20 to 30 days post-onset) and stable medical condition;
- presence of residual gait impairment;
- being able to walk 5 m with or without assistive device independently;
- the paretic lower leg being able to perform at least 10 degrees of active ankle dorsiflexion from the resting position;
- no apparent spasticity in affected leg to interfere the affected limb movement (Modified Ashworth Scale < 2)
Who cannot join
- claustrophobia and indwelling metals or implanted devices incompatible with fMRI testing;
- serious cardiac conditions (e.g. unstable angina serious cardiac arrhythmias, heart failure, hypertrophic cardiomyopathy, severe aortic stenosis, pulmonary embolus, or infarction);
- symptoms or history of other neurological or orthopedic problems which would affect their lower limb function;
- severe cognitive, perceptual, or communication problems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long-Term Effects of Task-Oriented Lower Extremity Strengthening Training on Functional Connectivity of the Brain, Motor Functions, Physical Activity Level, and Quality of Life in Patients With Subacute Stroke
Task-oriented exercises combined with strengthening have been shown effective in improving walking functions in patients with chronic stroke. However, similar approaches of therapeutic exercises have not been applied to subacute stroke with long-term follow-up, using outcome measures across the three levels of functioning (body functions/structure, activities, and participation) of the International Classification of Functioning, Disability, and
Health (ICF) model. Therefore, this study will be conducted to fulfill three purposes:
- To investigate the long-term effects of a four-week task-oriented lower extremity strengthening training (TOLEST) program in patients with subacute stroke;
- To investigate the interrelationships among functional connectivity of the brain, lower extremity motor functions, physical activity level, and quality of life in patients with stroke who have received this four-week TOLEST program in the subacute phase of stroke; and
- To identify prognostic factors for recovery in functional connectivity of the brain, lower extremity motor functions, physical activity level, and quality of life in patients with stroke who have received this four-week TOLEST program in the subacute phase of stroke.
Read the detailed description
We conducted a meta-analysis to examine the effects of task-oriented approach in patients with sub-acute stroke and a preliminary study of an assessor-blind randomized controlled trial with a total of 3 patients with sub-acute stroke (experimental group: E1; control group: C1 and C2). The participants were randomly assigned to the experimental group or the control group. All participants received 4 weeks of exercise training, which were 4 sessions per week and 60 minutes for each session. The experimental group received task-oriented circuit training to improve lower extremity motor functions. The control group received stretch exercises and upper extremity activities in sitting posture. Both groups received clinical asessments on lower extremity motor functions (primary outcomes), the structural integrity of the CST using diffusion spectrum imaging, and the cortical activation patterns of the SMC using functional magnetic resonance imaging(secondary outcomes) at baseline, post-training (week 4), and 1 month follow-up (week 8). Because of the small number of subjects, we also included one subject (E2) who received the same training programs as experimental group in our pilot study as one subject of the training group result. Training effects were descriptively analyzed for individual subjects.
The meta-analysis results showed that task-oriented training led to significantly greater improvement than other training on 6-minute walking distance (mean difference = 82.49 meter; 95% confidence interval: 27.59-137.38) and comfortable gait speed (standardized mean difference = 0.27; 95% confidence interval: 0.03-0.52) in patients with subacute stroke. Our preliminary results showed that the experimental group achieved meaningful improvements in most of the primary outcomes but not for the control group. In addition, different brain reorganization patterns were observed in the two groups.
The results of meta-analysis provide relevant clinical evidence for the effects of task-oriented training on lower extremity motor functions, and this preliminary study provides the pilot result for the effects of task-oriented circuit training on lower extremity motor functions, brain structural and functional plasticity in patients with sub-acute stroke.
- Conditions
- Ischemic Cerebrovascular Accident
- Being tested
- Task-Oriented Lower Extremity Strengthening Training
- Keywords
- task-oriented training, long-term effects, plasticity
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Task-Oriented Lower Extremity Strengthening TrainingBehavioural
On the 30th day post stroke (D30), the experimental group will start to receive the TOLEST program for four weeks, one hour per session and three sessions per week. The TOLEST focuses on using task-specific circuit training combined with strengthening of bilateral lower limbs.
The control group will receive equal-dose exercises starting on D30, with the emphasis on stretching and non-functional movements of the affected lower extremity.
| Study group | Role | What they receive |
|---|---|---|
| Stroke | Experimental | On the 30th day post stroke (D30), the exjperimental group will start to receive the task-oriented lower extremity strengthening training (TOLEST) program for four weeks, one hour per session and three sessions per week. The TOLEST focuses on using task-specific circuit training combined with strengthening of bilateral lower limbs. Receives: Behavioral: Task-Oriented Lower Extremity Strengthening Training |
| Control | No intervention | The control group will receive equal-dose exercises starting on D30, with the emphasis on stretching and non-functional movements of the affected lower extremity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
10-meter walk test
Measured: up to 4 weeks, change from baseline to 4 weeks
Secondary outcomes (1)
Functional MRI (fMRI), diffusion spectrum imaging (DSI)
Measured: up to 4 weeks, change from baseline to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2013 (estimated)
- Study startMar 2009
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Cerebrovascular AccidentStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pei-Fang Tang, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01934374
- Sponsor's protocol ID
- 200812148R
- Status last verified
- Aug 2013
- First submitted
- 8 Aug 2013
- Last updated
- 4 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Effects of Task-Oriented Lower Extremity Strengthening Training on Functional Connectivity of the Brain, Motor Functions, Physical Activity Level, and Quality of Life in Patients With Subacute Stroke
- ClinicalTrials.gov ID
- NCT01934374
- Acronym / sponsor ID
- 200812148R
- Conditions
- Ischemic Cerebrovascular Accident
- Keywords
- task-oriented training, long-term effects, plasticity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 4 Sep 2013 (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.
Task-oriented exercises combined with strengthening have been shown effective in improving walking functions in patients with chronic stroke. However, similar approaches of therapeutic exercises have not been applied to subacute stroke with long-term follow-up, using outcome measures across the three levels of functioning (body functions/structure, activities, and participation) of the International Classification of Functioning, Disability, and
Health (ICF) model. Therefore, this study will be conducted to fulfill three purposes:
- To investigate the long-term effects of a four-week task-oriented lower extremity strengthening training (TOLEST) program in patients with subacute stroke;
- To investigate the interrelationships among functional connectivity of the brain, lower extremity motor functions, physical activity level, and quality of life in patients with stroke who have received this four-week TOLEST program in the subacute phase of stroke; and
- To identify prognostic factors for recovery in functional connectivity of the brain, lower extremity motor functions, physical activity level, and quality of life in patients with stroke who have received this four-week TOLEST program in the subacute phase of stroke.
Detailed description
We conducted a meta-analysis to examine the effects of task-oriented approach in patients with sub-acute stroke and a preliminary study of an assessor-blind randomized controlled trial with a total of 3 patients with sub-acute stroke (experimental group: E1; control group: C1 and C2). The participants were randomly assigned to the experimental group or the control group. All participants received 4 weeks of exercise training, which were 4 sessions per week and 60 minutes for each session. The experimental group received task-oriented circuit training to improve lower extremity motor functions. The control group received stretch exercises and upper extremity activities in sitting posture. Both groups received clinical asessments on lower extremity motor functions (primary outcomes), the structural integrity of the CST using diffusion spectrum imaging, and the cortical activation patterns of the SMC using functional magnetic resonance imaging(secondary outcomes) at baseline, post-training (week 4), and 1 month follow-up (week 8). Because of the small number of subjects, we also included one subject (E2) who received the same training programs as experimental group in our pilot study as one subject of the training group result. Training effects were descriptively analyzed for individual subjects.
The meta-analysis results showed that task-oriented training led to significantly greater improvement than other training on 6-minute walking distance (mean difference = 82.49 meter; 95% confidence interval: 27.59-137.38) and comfortable gait speed (standardized mean difference = 0.27; 95% confidence interval: 0.03-0.52) in patients with subacute stroke. Our preliminary results showed that the experimental group achieved meaningful improvements in most of the primary outcomes but not for the control group. In addition, different brain reorganization patterns were observed in the two groups.
The results of meta-analysis provide relevant clinical evidence for the effects of task-oriented training on lower extremity motor functions, and this preliminary study provides the pilot result for the effects of task-oriented circuit training on lower extremity motor functions, brain structural and functional plasticity in patients with sub-acute stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stroke | Experimental | Behavioral: Task-Oriented Lower Extremity Strengthening TrainingOn the 30th day post stroke (D30), the exjperimental group will start to receive the task-oriented lower extremity strengthening training (TOLEST) program for four weeks, one hour per session and three sessions per week. The TOLEST focuses on using task-specific circuit training combined with strengthening of bilateral lower limbs. |
| Control | No intervention | –The control group will receive equal-dose exercises starting on D30, with the emphasis on stretching and non-functional movements of the affected lower extremity. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- in the subacute stage of stroke (within 20 to 30 days post-onset) and stable medical condition;
- presence of residual gait impairment;
- being able to walk 5 m with or without assistive device independently;
- the paretic lower leg being able to perform at least 10 degrees of active ankle dorsiflexion from the resting position;
- no apparent spasticity in affected leg to interfere the affected limb movement (Modified Ashworth Scale < 2)
Key exclusion criteria (4 listed)
- claustrophobia and indwelling metals or implanted devices incompatible with fMRI testing;
- serious cardiac conditions (e.g. unstable angina serious cardiac arrhythmias, heart failure, hypertrophic cardiomyopathy, severe aortic stenosis, pulmonary embolus, or infarction);
- symptoms or history of other neurological or orthopedic problems which would affect their lower limb function;
- severe cognitive, perceptual, or communication problems
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 |
|---|---|---|
| Task-Oriented Lower Extremity Strengthening TrainingOn the 30th day post stroke (D30), the experimental group will start to receive the TOLEST program for four weeks, one hour per session and three sessions per week. The TOLEST focuses on using task-specific circuit training combined with strengthening of bilateral lower limbs. The control group will receive equal-dose exercises starting on D30, with the emphasis on stretching and non-functional movements of the affected lower extremity. | Behavioural | Stroke |
Primary outcome
10-meter walk test
Time frame: up to 4 weeks, change from baseline to 4 weeks
1 secondary outcome
Functional MRI (fMRI), diffusion spectrum imaging (DSI)
Time frame: up to 4 weeks, change from baseline to 4 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 4 Sep 2013.
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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 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 Task-Oriented Lower Extremity Strengthening Training in people with Ischemic Cerebrovascular Accident, 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 5 inclusion and 4 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 4 Sep 2013. 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?
10-meter walk test (time frame: up to 4 weeks, change from baseline to 4 weeks). 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 4 Sep 2013.