Stroke, CardiovascularNCT03194282
Effects of the Insole on Balance Capacity in Chronic Stroke
A study testing insole in people with Stroke, Cardiovascular, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
Trial summary
Poor balance capacity is one of clinical symptoms of stroke patient. The reason of loss balance capacity is motor impairment, as well as a diminished capacity to voluntarily shift body weight or to with stand external pertubations. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Stroke, Cardiovascular
- What is being tested?
- insole
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteTaiwan
- Study dates
- 27 Jul 2017to 25 Jun 2018
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A history of unilateral chronic stroke occurrence over 6 months prior to the study
- Ability to understand verbal instructions.
- Ability to walk 5 meters independently without the need of ankle-foot orthosis.
Who cannot join
- A diagnosis of other neurological or musculoskeletal disorders that could affect postural balance.
Trial locations and contacts
1 site in 1 country.
About this study
Poor balance capacity is one of clinical symptoms of stroke patient. The reason of loss balance capacity is motor impairment, as well as a diminished capacity to voluntarily shift body weight or to with stand external pertubations. Postural movement patterns include three discrete control strategies: hip, knee, and ankle strategy. The ankle rocker is an important factor to maintain balance during standing and the ankle strategy restores the center of mass (CoM) to a position of stability through body movement. As a result, effective control of foot motion and ankle stability may decrease postural sway and the risk of fall in chronic stroke.The purpose of this study is to investigate the effects of the insole on balance capacity in chronic stroke.
Read the detailed description
An important determinant of activities of daily living performance is standing balance. Therefore, poor balance, or postural stability, is significant predictors the risk of fall. After a fall, the patient can experience psychological, physical, social, economic, and sometimes fatal effects. The injuries can reduce the patient's mobility as well as independence and influence quality of life.Patients with chronic stroke wearing functional insoles and sham insoles to challenge balance tests.
- Conditions
- Stroke, Cardiovascular
- Being tested
- insole
- Keywords
- stroke, balance, insole
- Medical subject headings
- Myocardial Infarction, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
insoleOther
The subjects are randomly assigned to assess balance capacity either with or without insole.
| Study group | Role | What they receive |
|---|---|---|
| chronic stroke patient with insole | Experimental | Poor balance capacity is one of clinical symptoms of stroke patient.Poor balance, or postural stability, is significant predictors the risk of fall. Receives: Other: insole |
| chronic stroke patient without insole | Sham comparator | Poor balance capacity is one of clinical symptoms of stroke patient.Poor balance, or postural stability, is significant predictors the risk of fall. Receives: Other: insole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Berg balance scale from pre to post-intervention.
The Berg Balance Scale (BBS) was developed to measure balance among older people with impairment in balance function by assessing the performance of functional tasks.
Measured: up to 30 minutes.
Change in Functional Reach Test(FRT) from pre to post-intervention.
The Functional Reach Test (FRT) is a quick screen for determining risk for falls.
Measured: up to 10 minutes.
Change in Timed Up and Go (TUG) Test from pre to post-intervention.
Timed Up and Go (TUG) Test was developed to assess mobility.
Measured: up to 10 minutes.
Secondary outcomes (1)
Change in Center of pressure (CoP) from pre to post-intervention.
The center of pressure (CoP) measures derived from the foot pressure mat and force plate of Biodex Balance system.
Measured: up to 30 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2017
- Study start27 Jul 2017
- Primary completion1 Jun 2018
- Study completion25 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Stroke, CardiovascularStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- YENTING LIU, Master, Study chair, Wang Fang Hospital, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03194282
- Sponsor's protocol ID
- N201705003
- Status last verified
- May 2018
- First submitted
- 31 May 2017
- Last updated
- 13 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Christovao TC, Neto HP, Grecco LA, Ferreira LA, Franco de Moura RC, Eliege de Souza M, Franco de Oliveira LV, Oliveira CS. Effect of different insoles on postural balance: a systematic review. J Phys Ther Sci. 2013 Oct;25(10):1353-6. doi: 10.1589/jpts.25.1353. Epub 2013 Nov 20.
PubMed 24259792Chen TH, Chou LW, Tsai MW, Lo MJ, Kao MJ. Effectiveness of a heel cup with an arch support insole on the standing balance of the elderly. Clin Interv Aging. 2014 Feb 20;9:351-6. doi: 10.2147/CIA.S56268. eCollection 2014.
PubMed 24600215Rougier PR, Genthon N. Dynamical assessment of weight-bearing asymmetry during upright quiet stance in humans. Gait Posture. 2009 Apr;29(3):437-43. doi: 10.1016/j.gaitpost.2008.11.001. Epub 2008 Dec 12.
PubMed 19070493Liu YT, Tsai HT, Hsu CY, Lin YN. Effects of orthopedic insoles on postural balance in patients with chronic stroke: A randomized crossover study. Gait Posture. 2021 Jun;87:75-80. doi: 10.1016/j.gaitpost.2021.04.014. Epub 2021 Apr 20.
PubMed 33894465
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Insole on Balance Capacity in Chronic Stroke
- ClinicalTrials.gov ID
- NCT03194282
- Acronym / sponsor ID
- N201705003
- Conditions
- Stroke, Cardiovascular
- Keywords
- stroke, balance, insole
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- 27 Jul 2017 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 25 Jun 2018 (actual)
- First posted
- 21 Jun 2017 (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.
Poor balance capacity is one of clinical symptoms of stroke patient. The reason of loss balance capacity is motor impairment, as well as a diminished capacity to voluntarily shift body weight or to with stand external pertubations. Postural movement patterns include three discrete control strategies: hip, knee, and ankle strategy. The ankle rocker is an important factor to maintain balance during standing and the ankle strategy restores the center of mass (CoM) to a position of stability through body movement. As a result, effective control of foot motion and ankle stability may decrease postural sway and the risk of fall in chronic stroke.The purpose of this study is to investigate the effects of the insole on balance capacity in chronic stroke.
Detailed description
An important determinant of activities of daily living performance is standing balance. Therefore, poor balance, or postural stability, is significant predictors the risk of fall. After a fall, the patient can experience psychological, physical, social, economic, and sometimes fatal effects. The injuries can reduce the patient's mobility as well as independence and influence quality of life.Patients with chronic stroke wearing functional insoles and sham insoles to challenge balance tests.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| chronic stroke patient with insole | Experimental | Other: insolePoor balance capacity is one of clinical symptoms of stroke patient.Poor balance, or postural stability, is significant predictors the risk of fall. |
| chronic stroke patient without insole | Sham comparator | Other: insolePoor balance capacity is one of clinical symptoms of stroke patient.Poor balance, or postural stability, is significant predictors the risk of fall. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- A history of unilateral chronic stroke occurrence over 6 months prior to the study
- Ability to understand verbal instructions.
- Ability to walk 5 meters independently without the need of ankle-foot orthosis.
Key exclusion criteria (1 listed)
- A diagnosis of other neurological or musculoskeletal disorders that could affect postural balance.
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 |
|---|---|---|
| insoleThe subjects are randomly assigned to assess balance capacity either with or without insole. | Other | chronic stroke patient with insole, chronic stroke patient without insole |
Primary outcome
Change in Berg balance scale from pre to post-intervention.
Time frame: up to 30 minutes.
The Berg Balance Scale (BBS) was developed to measure balance among older people with impairment in balance function by assessing the performance of functional tasks.
Change in Functional Reach Test(FRT) from pre to post-intervention.
Time frame: up to 10 minutes.
The Functional Reach Test (FRT) is a quick screen for determining risk for falls.
Change in Timed Up and Go (TUG) Test from pre to post-intervention.
Time frame: up to 10 minutes.
Timed Up and Go (TUG) Test was developed to assess mobility.
1 secondary outcome
Change in Center of pressure (CoP) from pre to post-intervention.
Time frame: up to 30 minutes.
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 13 Mar 2019.
- Background: PubMed 24259792Christovao TC, Neto HP, Grecco LA, Ferreira LA, Franco de Moura RC, Eliege de Souza M, Franco de Oliveira LV, Oliveira CS. Effect of different insoles on postural balance: a systematic review. J Phys Ther Sci. 2013 Oct;25(10):1353-6. doi: 10.1589/jpts.25.1353. Epub 2013 Nov 20.
- Background: PubMed 24600215Chen TH, Chou LW, Tsai MW, Lo MJ, Kao MJ. Effectiveness of a heel cup with an arch support insole on the standing balance of the elderly. Clin Interv Aging. 2014 Feb 20;9:351-6. doi: 10.2147/CIA.S56268. eCollection 2014.
- Background: PubMed 19070493Rougier PR, Genthon N. Dynamical assessment of weight-bearing asymmetry during upright quiet stance in humans. Gait Posture. 2009 Apr;29(3):437-43. doi: 10.1016/j.gaitpost.2008.11.001. Epub 2008 Dec 12.
- Derived from this study: PubMed 33894465Liu YT, Tsai HT, Hsu CY, Lin YN. Effects of orthopedic insoles on postural balance in patients with chronic stroke: A randomized crossover study. Gait Posture. 2021 Jun;87:75-80. doi: 10.1016/j.gaitpost.2021.04.014. Epub 2021 Apr 20.
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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.
YENTING LIU, Master study chair
Wang Fang Hospital, Taipei 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 insole in people with Stroke, Cardiovascular, run by Taipei Medical University WanFang 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 3 inclusion and 1 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 13 Mar 2019. 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. Some participants in this study may receive a placebo. 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?
Change in Berg balance scale from pre to post-intervention. (time frame: up to 30 minutes.). The study lists 3 primary outcomes in all. 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 NCT03194282, which also lists 4 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 13 Mar 2019.