StrokeTOENCT02781077
Intensity of Task-Oriented Exercises
An observational study of Stroke, run by Mahidol University at 1 site in Thailand.
Trial summary
In an observational study, the energy consumption of stroke individuals during performing the structured, progressive task-oriented exercise program for walking rehabilitation will be measured in order to confirm the intensity demand in the range of moderate to vigorous. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Stroke
- What is being tested?
- Structured, Progressive, Task-oriented exercise program
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteThailand
- Study dates
- Jul 2016to 30 Aug 2016
- How long will I take part?
- 7 Days
- Phase
- Observational
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Stroke individuals who able to walk without physical assistance.
Who may be able to join
- Either side of both type first stroke with confirmatory diagnosis by CT Scan and MRI.
- Age above 20 years old.
- Moderate severity of stroke measured by the modified Rankin Scale (mRS- 3)
- Able to comprehend the instructions with good cognition measured by Mini-Mental State Examination (MMSE > 23).
Who cannot join
- Diagnosed with other neurological disorder such as Parkinson's disease, peripheral nerve injury.
- Serious cardiac conditions (angina and myocardial infarction during the previous month, resting heart rate of more than 120, a systolic blood pressure of more than 180 mm Hg, and a diastolic blood pressure of more than 100 mm Hg)
- Fugl Meyer Assessment score (lower extremity) less than ≤ 21
- Significant hip, knee and ankle contracture that would limit ambulation (Fugl Meyer (ROM) ≤1 in each joint).
- Orthopedic and rheumatological disorder with weight bearing pain (Fugl Meyer (pain) ≤ 1 in hip, knee and ankle joint movement).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intensity of a Task-Oriented Exercise Program for Optimizing Walking Competency in Stroke Survivors
In an observational study, the energy consumption of stroke individuals during performing the structured, progressive task-oriented exercise program for walking rehabilitation will be measured in order to confirm the intensity demand in the range of moderate to vigorous.
Read the detailed description
Community reintegration is often significantly affected in the majority of stroke individuals. To fulfill the requirements of a proper home exercise program in walking rehabilitation for stroke victims, investigators structured the task-oriented exercise program with minimal supervision. This exercise program is structured with challenging walking-related activities based on motor learning principle and Gentile's progression of the motor task. The strengthening and balance components, aerobic conditioning and walking adaptability are composed of an exercise program to optimize walking ability. There are sixty minutes last ten exercises in each three progression steps of this exercise program. For the training effect to occur, each step of exercise program is designed by increasing demand of intensity in the range from moderate to vigorous. To confirming progressive energy demand, the purpose of this study is to investigate the intensity demand of three steps task- oriented home exercise program on walking competency in individual post stroke.
- Conditions
- Stroke
- Being tested
- Structured, Progressive, Task-oriented exercise program
- Keywords
- Stroke, walking competency, Task-oriented exercise program, Exercise intensity
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured, Progressive, Task-oriented exercise programProcedure or surgery
The intervention is walking related task-oriented exercise program with three progressive steps at moderate to high intensity. Each step consists of 60 minutes last ten tasks to optimize walking function of stroke individuals.
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Oxygen Consumption (VO2rate) (ml/kg/min)
The amount of oxygen consumption of participants will be measured by using Oxycon Mobile spirometer (OM) on 3 occasions: during performing step I,II and III of exercise program with 1-2 days apart between each step.
Measured: 1 week
Secondary outcomes (3)
Heart Rate
Heart rate of participants will be measured on 3 occasions: during performing step I,II and III of exercise program with 1-2 days apart between each step
Measured: 1 week
Metabolic Equivalents (METs) [VO2max (ml.kg-1.m-1)/VO2rest(ml.kg-1.m-1)]
METs is a way to express the energy cost of activity, calculated by using the formula of VO2/VO2rest on 3 occasions:during performing step I,II and III of exercise program with 1-2 days apart between each step.
Measured: 1 week
Borg Rating of Perceived Exertion scale (RPE)
The feeling of how strenuous a given exercise to a patient related to the amount of effort exerted is rated by the categorical-ratio scale of 0 to 10 RPE on 3 occasions: during performing step I,II and III of exercise program with 1-2 days apart between each step.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2016 (estimated)
- Study startJul 2016
- Primary completion30 Aug 2016
- Study completion30 Aug 2016
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 Mahidol 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
- Target duration
- 7 Days
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thin Thin Moe, Mahidol University
- Investigators
- Thin Thin Moe, M.Med.Tech, Principal investigator, Mahidol UniversityChutima Jalayondeja, Dr.P.H. MSc, Study chair, Mahidol UniversitySopa Pichaiyongwongdee, M.Sc. B.Sc, Study director, Mahidol UniversityVimonwan Hiengkaew, PhD. MSc, Study director, Mahidol UniversityJarugool Tretriluxana, PhD. MSc, Study director, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02781077
- Sponsor's protocol ID
- 2-2016
- Acronym
- TOE
- Status last verified
- Jun 2017
- First submitted
- 16 May 2016
- Last updated
- 26 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensity of a Task-Oriented Exercise Program for Optimizing Walking Competency in Stroke Survivors
- ClinicalTrials.gov ID
- NCT02781077
- Acronym / sponsor ID
- TOE / 2-2016
- Conditions
- Stroke
- Keywords
- Stroke, walking competency, Task-oriented exercise program, Exercise intensity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- 30 Aug 2016 (actual)
- Study completion
- 30 Aug 2016 (actual)
- First posted
- 24 May 2016 (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.
In an observational study, the energy consumption of stroke individuals during performing the structured, progressive task-oriented exercise program for walking rehabilitation will be measured in order to confirm the intensity demand in the range of moderate to vigorous.
Detailed description
Community reintegration is often significantly affected in the majority of stroke individuals. To fulfill the requirements of a proper home exercise program in walking rehabilitation for stroke victims, investigators structured the task-oriented exercise program with minimal supervision. This exercise program is structured with challenging walking-related activities based on motor learning principle and Gentile's progression of the motor task. The strengthening and balance components, aerobic conditioning and walking adaptability are composed of an exercise program to optimize walking ability. There are sixty minutes last ten exercises in each three progression steps of this exercise program. For the training effect to occur, each step of exercise program is designed by increasing demand of intensity in the range from moderate to vigorous. To confirming progressive energy demand, the purpose of this study is to investigate the intensity demand of three steps task- oriented home exercise program on walking competency in individual post stroke.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 7 Days
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stroke individuals who able to walk without physical assistance.
Key inclusion criteria (4 listed)
- Either side of both type first stroke with confirmatory diagnosis by CT Scan and MRI.
- Age above 20 years old.
- Moderate severity of stroke measured by the modified Rankin Scale (mRS- 3)
- Able to comprehend the instructions with good cognition measured by Mini-Mental State Examination (MMSE > 23).
Key exclusion criteria (5 listed)
- Diagnosed with other neurological disorder such as Parkinson's disease, peripheral nerve injury.
- Serious cardiac conditions (angina and myocardial infarction during the previous month, resting heart rate of more than 120, a systolic blood pressure of more than 180 mm Hg, and a diastolic blood pressure of more than 100 mm Hg)
- Fugl Meyer Assessment score (lower extremity) less than ≤ 21
- Significant hip, knee and ankle contracture that would limit ambulation (Fugl Meyer (ROM) ≤1 in each joint).
- Orthopedic and rheumatological disorder with weight bearing pain (Fugl Meyer (pain) ≤ 1 in hip, knee and ankle joint movement).
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 |
|---|---|---|
| Structured, Progressive, Task-oriented exercise programThe intervention is walking related task-oriented exercise program with three progressive steps at moderate to high intensity. Each step consists of 60 minutes last ten tasks to optimize walking function of stroke individuals. | Procedure or surgery | – |
Primary outcome
Rate of Oxygen Consumption (VO2rate) (ml/kg/min)
Time frame: 1 week
The amount of oxygen consumption of participants will be measured by using Oxycon Mobile spirometer (OM) on 3 occasions: during performing step I,II and III of exercise program with 1-2 days apart between each step.
3 secondary outcomes
Heart Rate
Time frame: 1 week
Metabolic Equivalents (METs) [VO2max (ml.kg-1.m-1)/VO2rest(ml.kg-1.m-1)]
Time frame: 1 week
Borg Rating of Perceived Exertion scale (RPE)
Time frame: 1 week
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 26 Jun 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Stroke
Not yet recruiting
Brain-Machine Interface With Virtual Reality and Neuromuscular Electrical Stimulation for Upper Limb Rehabilitation After Stroke
Ischemic Stroke
Recruiting
Understanding and Enhancing Human Health and Movement
Spinal Cord Injury, Stroke (CVA) or Transient Ischemic Attack
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
Not yet recruitingObservational study
Integrating Wearable Monitoring and Clinical Data for Stroke Early Warning
Stroke, Ischemic Stroke
RecruitingObservational study
Stroke Hemiplegic Shoulder Pain: Ultrasound Findings and VAS (Cross-Sectional)
Hemiplegic Shoulder Pain, Stroke
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.
Thin Thin Moe, M.Med.Tech principal investigator
Mahidol University
Chutima Jalayondeja, Dr.P.H. MSc study chair
Mahidol University
Sopa Pichaiyongwongdee, M.Sc. B.Sc study director
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, run by Mahidol University at 1 site in Thailand.
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 4 inclusion and 5 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 26 Jun 2017. 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 Thailand. 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?
Rate of Oxygen Consumption (VO2rate) (ml/kg/min) (time frame: 1 week). 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 26 Jun 2017.