Postural StabilityNCT04141384
A Study of the Effects of External Stimulations on Postural Stability
A study testing Modular Interactive Tiles System, MITS in people with Postural Stability, run by Far Eastern Memorial Hospital.
Trial summary
In view of the long-term exercise, you can maintain your health and strengthen your physical strength. It can also improve your body's balance and help maintain your body's coordination so that you can reduce the chance of falls. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Postural Stability
- What is being tested?
- Modular Interactive Tiles System, MITS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2014to 31 Jul 2015
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Stage1 Subjects were included in the condition of adults with good health and no mobility disorder. They will be considered by healthy young people over the age of 20.
- It is estimated that 12 males and 12 females will be called.
- Stage2 Forty patients with a stroke of more than six months have been admitted.
- Subjects were included as follows:
- stroke for more than 6 months;
- current stable condition;
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- able to walk independently for more than 5 meters, and if necessary, use auxiliary equipment;
- before and after the two feet Stand in a straight line for more than 10 seconds;
- can understand spoken instructions.
Who cannot join
- Stage1
- unable to stand with the feet and the walker;
- pregnant;
- within six months will affect the walking or standing surgery (such as limbs, spine or brain surgery);
- other Physical and mental state is not suitable.
- Stage2
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- unable to stand and walk with both feet;
- suffering from diabetes or other diseases combined with peripheral neuropathy, causing a poor sense of body or a neurological disease affecting lower limb movement and sensory function;
- suffering from hemophilia Patients with diseases, other blood-related diseases or severe peripheral vascular diseases;
- those who are pregnant;
- those who have been affected by walking or standing within six months (such as limb, spine or brain surgery);
- Other physical and mental states are not suitable.
About this study
Official title: Rehabilitation Section,Far Eastern Memorial Hospital Department of Industrial Management,National Taiwan University of Science and Technology
In view of the long-term exercise, you can maintain your health and strengthen your physical strength. It can also improve your body's balance and help maintain your body's coordination so that you can reduce the chance of falls.
Therefore, in the face of aging, stroke rehabilitation or balance of power caused by balance of power decline, sports injuries or falls related issues, this study will focus on "balance ability" to explore a range of impacts and relationships.
Read the detailed description
Considering the standardization comparison in the study, this study will collect data on the balance of young people under different external stimuli, and hope to understand the balance control ability by objectively collecting the physiological signals of the Center of Pressure (COP).
The change, and the use of the Berg scale as a benchmark for the assessment of balance ability, and then return to the issue of balance ability training.
Therefore, this study divides the experiment into two major stages. The first stage will focus on healthy young people, and explore how external stimuli affect balance, and then assist balance ability training to find the most appropriate adjustment of body posture control.
The second phase explores the appropriate exercise training for stroke patients, such as the use of Modular Interactive Tiles System (MITS) training, to track the effectiveness of external stimulus impact balance training.
- Conditions
- Postural Stability
- Being tested
- Modular Interactive Tiles System, MITS
- Keywords
- Modular Interactive Tiles System, MITS, Stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modular Interactive Tiles System, MITSDevice
The modular robotic brick system was developed by Danish scholar Prof. Henrik Hautop Lund in collaboration with the University of Siena in Italy to develop a new tool. The system uses the design principles of different levels of daily life activities, combined with the way of cognitive games, Lego toys can combine different game concepts, with a set of individual or multi-person activity programs with hands or feet, provide a set Modular floor tiles for stroke patients and the elderly.
| Study group | Role | What they receive |
|---|---|---|
| General rehabilitation+Modular Interactive Tiles System, MITS | Other | Subjects were randomly assigned to the experimental or control group after completing the Berg scale test before the experiment. In the experimental group, external stimulation (MITS) was added, and the training time was 65 minutes. Before the start of the experiment and after the training every 4 weeks, each group must carry out the Berg scale and balance assessment. Receives: Device: Modular Interactive Tiles System, MITS |
| General rehabilitation | No intervention | Subjects were randomly assigned to the experimental or control group after completing the Berg scale test before the experiment.In the control group, each training time was 45 minutes.Before the start of the experiment and after the training every 4 weeks, each group must carry out the Berg scale and balance assessment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Center of pressure, COP
The experiment will collect the COP signals of the participants in different situations through the force plate, and judge the external stimuli to influence the balance by measuring the results.
Measured: 50minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2019
- Study start1 May 2014
- Primary completion31 Dec 2014
- Study completion31 Jul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postural StabilityStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Stage 1-NO intervention Stage 2-To explore the possibility of enhancing the balance of stroke patients by stimulating the modular robotic brick system. Control group-General rehabilitation Study group-General rehabilitation+Modular Interactive Tiles System(MITS)
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04141384
- Sponsor's protocol ID
- 103034-F
- Status last verified
- Oct 2019
- First submitted
- 24 Oct 2019
- Last updated
- 29 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation Section,Far Eastern Memorial Hospital Department of Industrial Management,National Taiwan University of Science and Technology
- ClinicalTrials.gov ID
- NCT04141384
- Acronym / sponsor ID
- 103034-F
- Conditions
- Postural Stability
- Keywords
- Modular Interactive Tiles System, MITS, Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- 1 May 2014 (actual)
- Primary completion
- 31 Dec 2014 (actual)
- Study completion
- 31 Jul 2015 (actual)
- First posted
- 28 Oct 2019 (actual)
- 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 view of the long-term exercise, you can maintain your health and strengthen your physical strength. It can also improve your body's balance and help maintain your body's coordination so that you can reduce the chance of falls.
Therefore, in the face of aging, stroke rehabilitation or balance of power caused by balance of power decline, sports injuries or falls related issues, this study will focus on "balance ability" to explore a range of impacts and relationships.
Detailed description
Considering the standardization comparison in the study, this study will collect data on the balance of young people under different external stimuli, and hope to understand the balance control ability by objectively collecting the physiological signals of the Center of Pressure (COP).
The change, and the use of the Berg scale as a benchmark for the assessment of balance ability, and then return to the issue of balance ability training.
Therefore, this study divides the experiment into two major stages. The first stage will focus on healthy young people, and explore how external stimuli affect balance, and then assist balance ability training to find the most appropriate adjustment of body posture control.
The second phase explores the appropriate exercise training for stroke patients, such as the use of Modular Interactive Tiles System (MITS) training, to track the effectiveness of external stimulus impact balance training.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stage 1-NO intervention Stage 2-To explore the possibility of enhancing the balance of stroke patients by stimulating the modular robotic brick system. Control group-General rehabilitation Study group-General rehabilitation+Modular Interactive Tiles System(MITS)
| Arm | Type | Receives |
|---|---|---|
| General rehabilitation+Modular Interactive Tiles System, MITS | Other | Device: Modular Interactive Tiles System, MITSSubjects were randomly assigned to the experimental or control group after completing the Berg scale test before the experiment. In the experimental group, external stimulation (MITS) was added, and the training time was 65 minutes. Before the start of the experiment and after the training every 4 weeks, each group must carry out the Berg scale and balance assessment. |
| General rehabilitation | No intervention | –Subjects were randomly assigned to the experimental or control group after completing the Berg scale test before the experiment.In the control group, each training time was 45 minutes.Before the start of the experiment and after the training every 4 weeks, each group must carry out the Berg scale and balance assessment. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Stage1 Subjects were included in the condition of adults with good health and no mobility disorder. They will be considered by healthy young people over the age of 20.
- It is estimated that 12 males and 12 females will be called.
- Stage2 Forty patients with a stroke of more than six months have been admitted.
- stroke for more than 6 months;
- current stable condition;
Key exclusion criteria (12 listed)
- Stage1
- Stage2
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 |
|---|---|---|
| Modular Interactive Tiles System, MITSThe modular robotic brick system was developed by Danish scholar Prof. Henrik Hautop Lund in collaboration with the University of Siena in Italy to develop a new tool. The system uses the design principles of different levels of daily life activities, combined with the way of cognitive games, Lego toys can combine different game concepts, with a set of individual or multi-person activity programs with hands or feet, provide a set Modular floor tiles for stroke patients and the elderly. | Device | General rehabilitation+Modular Interactive Tiles System, MITS |
Primary outcome
Center of pressure, COP
Time frame: 50minute
The experiment will collect the COP signals of the participants in different situations through the force plate, and judge the external stimuli to influence the balance by measuring the results.
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 29 Oct 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Modular Interactive Tiles System, MITS in people with Postural Stability, run by Far Eastern Memorial Hospital.
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 9 inclusion and 12 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 29 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Center of pressure, COP (time frame: 50minute). 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 29 Oct 2019.