HemophiliaNCT02389205
The Effect of Functional Activities and Balance Ability With Taping in Subjects of Hemophilia
A study testing kinesio group in people with Hemophilia, run by Tri-Service General Hospital (TSGH).
Trial summary
Background Hemophilia is a sex-linked genetic disorders. When the joint or the muscles is bleeding, it may cause haemarthrosis, synovium, cartilage tissue thickening, joint activity (Range of Motion) decreasing and other musculoskeletal and related disorder. Read more about this study
- Who is it for?
- Ages 20 to 65 years, men only
- Conditions the study is for
- Hemophilia
- What is being tested?
- kinesio group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Dec 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 20 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- subject of Hemophilia
- 20-65 years old
Who cannot join
- Any history of surgery
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Rehabilitation Department of Tri-Service General Hospital
Background Hemophilia is a sex-linked genetic disorders. When the joint or the muscles is bleeding, it may cause haemarthrosis, synovium, cartilage tissue thickening, joint activity (Range of Motion) decreasing and other musculoskeletal and related disorder. Patients will produce pain in the action, compensatory action occurs, thus causing recurrent of bleeding, and joint damage. There is high rate of ankle joint bleeding in hemophilia. The ankle articular joint disease will affect lower limbs activities, and the functional activities will impaired.
Review studies, in addition to physical therapy, Kinesio taping is a common intervention to improve other subjects' static balance, proprioception, functional ankle stability, correct poor posture.
The main intervention of this study is physical therapy and Kinesio taping, expect to improve the stability and muscular strength of lower extremities, and balance, correcting gait and lower extremity functional activities of subjects with hemophilia.
Read the detailed description
Methods:
This study is a randomized controlled trial, the subjects were randomly divided into two groups, the control group received physical therapy once a week for a period of three months; experimental group received the same physical therapy in addition to treatment, but each will be accepted Kinesio taping. Experiments group carried out before and after the relevant tests, including: muscle strength, balance, lower extremity functional activities. The participants will be followed for the duration of physical therapy , an expected average of 3 months.
- Conditions
- Hemophilia
- Being tested
- kinesio group
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kinesio groupOther
kinesio group, The kinesio Taping® Method is a definitive rehabilitative taping technique that is designed to facilitate the body's natural healing process while providing support and stability to muscles and joints without restricting the body's range of motion as well as providing extended soft tissue manipulation to prolong the benefits of manual therapy administered within the clinical setting.
The effect of intervention may affected by the varying durations and frequencies of exercise, different state of arthropathy and joint range of motion limitations of ankle , etc.
| Study group | Role | What they receive |
|---|---|---|
| control group | Placebo comparator | physical therapy |
| kinesio group | Active comparator | kinesio taping for ankle joint Receives: Other: kinesio group |
What is being measured
The primary outcome is the main question the study is designed to answer.
standing balance ability (biodex balance system)
biodex balance system
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 posted17 Mar 2015 (estimated)
- Study startApr 2015
- Primary completionNov 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HemophiliaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tri-Service General Hospital (TSGH)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chan Yuan-Chi, Tri-Service General Hospital (TSGH)
- Investigators
- Chen Liang-Cheng, Study director, Director of Rehabilitation department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02389205
- Sponsor's protocol ID
- TSGH-105-165
- Status last verified
- Mar 2015
- First submitted
- 4 Nov 2014
- Last updated
- 19 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Rodriguez-Merchan EC. Orthopaedic problems about the ankle in hemophilia. J Foot Ankle Surg. 2012 Nov-Dec;51(6):772-6. doi: 10.1053/j.jfas.2012.06.005. Epub 2012 Jul 10.
PubMed 22785085
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation Department of Tri-Service General Hospital
- ClinicalTrials.gov ID
- NCT02389205
- Acronym / sponsor ID
- TSGH-105-165
- Conditions
- Hemophilia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tri-Service General Hospital (TSGH)University, hospital or other
- Study start
- Apr 2015
- Primary completion
- Nov 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 17 Mar 2015 (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.
Background Hemophilia is a sex-linked genetic disorders. When the joint or the muscles is bleeding, it may cause haemarthrosis, synovium, cartilage tissue thickening, joint activity (Range of Motion) decreasing and other musculoskeletal and related disorder. Patients will produce pain in the action, compensatory action occurs, thus causing recurrent of bleeding, and joint damage. There is high rate of ankle joint bleeding in hemophilia. The ankle articular joint disease will affect lower limbs activities, and the functional activities will impaired.
Review studies, in addition to physical therapy, Kinesio taping is a common intervention to improve other subjects' static balance, proprioception, functional ankle stability, correct poor posture.
The main intervention of this study is physical therapy and Kinesio taping, expect to improve the stability and muscular strength of lower extremities, and balance, correcting gait and lower extremity functional activities of subjects with hemophilia.
Detailed description
Methods:
This study is a randomized controlled trial, the subjects were randomly divided into two groups, the control group received physical therapy once a week for a period of three months; experimental group received the same physical therapy in addition to treatment, but each will be accepted Kinesio taping. Experiments group carried out before and after the relevant tests, including: muscle strength, balance, lower extremity functional activities. The participants will be followed for the duration of physical therapy , an expected average of 3 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Placebo comparator | –physical therapy |
| kinesio group | Active comparator | Other: kinesio groupkinesio taping for ankle joint |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- subject of Hemophilia
- 20-65 years old
Key exclusion criteria (1 listed)
- Any history of surgery
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 |
|---|---|---|
| kinesio groupkinesio group, The kinesio Taping® Method is a definitive rehabilitative taping technique that is designed to facilitate the body's natural healing process while providing support and stability to muscles and joints without restricting the body's range of motion as well as providing extended soft tissue manipulation to prolong the benefits of manual therapy administered within the clinical setting. The effect of intervention may affected by the varying durations and frequencies of exercise, different state of arthropathy and joint range of motion limitations of ankle , etc. | Other | kinesio group |
Primary outcome
standing balance ability (biodex balance system)
Time frame: 3 months
biodex balance system
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2015.
- Results publication: PubMed 22785085Rodriguez-Merchan EC. Orthopaedic problems about the ankle in hemophilia. J Foot Ankle Surg. 2012 Nov-Dec;51(6):772-6. doi: 10.1053/j.jfas.2012.06.005. Epub 2012 Jul 10.
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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.
Chen Liang-Cheng study director
Director of Rehabilitation department
Questions about this trial
What is this clinical trial studying?
A study testing kinesio group in people with Hemophilia, run by Tri-Service General Hospital (TSGH).
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 2 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: status not confirmed, as of the sponsor's last update on 19 Mar 2015. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chan Yuan-Chi (+886287923311 ext. 17068, mmagggie@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
standing balance ability (biodex balance system) (time frame: 3 months). 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 NCT02389205, which also lists 1 linked publication.
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 19 Mar 2015.