Ankle Sprain 2Nd DegreePhase 4NCT03808454
The Effect of Proprioception of Platelet Rich Plasma for Patients With Ankle Sprain
A Phase 4 study testing PRP, Rehabilitation and PRP+Rehabilitation in people with Ankle Sprain 2Nd Degree and Ankle Sprain 3Rd Degree, run by National Defense Medical Center, Taiwan at 1 site in Taiwan.
Trial summary
Ankle sprain is a fairly common sports medicine clinic. In Taiwan at least 150,000 to 200,000 people will suffer from ankle sprains every years. Clinicians have been looking for ways to shorten treatment time and reduce discomfort. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ankle Sprain 2Nd Degree, Ankle Sprain 3Rd Degree
- What is being tested?
- PRP, Rehabilitation and PRP+Rehabilitation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Oct 2019to 31 Dec 2024
- Phase
- Phase 4
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ankle sprain within one months
- Gr II or Gr III ankle sprain (anterior talus fibular ligament)by sonogram proved
- MMSE≥23
- could cooperate the examination of the test
Who cannot join
- Hemianopsia or hemineglect any brain lesion such as cerebrum of cerebellum involved movement
- cancer victim
- pregnant If needed PRP treatment
- Liver cirrhosis
- Platelet < 150000/UL
- Sepsis, Leukemia
- use anti-coagulation agents
- under hemodialysis
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Tri-service General Hospital
Taipei, 115
Department of Rehabilitation
About this study
Ankle sprain is a fairly common sports medicine clinic. In Taiwan at least 150,000 to 200,000 people will suffer from ankle sprains every years. Clinicians have been looking for ways to shorten treatment time and reduce discomfort. Platelet Rich Plasma(PRP) is an endogenous therapeutic technology that involved in regenerative medicine due to its potential to stimulate and accelerate tissue healing. PRP can release lots of growth factors like platelet-derived growth factor (PDGF),transforming Growth Factor Beta(TGF-β), vascular endothelial growth factor(VEGF),Epidermal growth factor(EGF) and insulin-like growth factor (IGF). Its use had been based on the theory that increased autologous platelets, that then yield high concentrations of growth factors and other proteins, will lead to increased healing of tendon and soft tissue on a cellular level. In addition, there is no objective evaluation after treatment, so that patients can not provide effective and accurate quantitative feedback. In this study, the investigators divided patients into three groups, respectively, general rehabilitation therapy, autologous PRP injection therapy, autologous PRP injection combined with general rehabilitation therapy.
Read the detailed description
The investigators divided patients into three groups, respectively, general rehabilitation therapy, autologous PRP injection therapy, autologous PRP injection combined with general rehabilitation therapy randomly. The investigators also use the new ankle proprioception evaluation system and evaluation of clinical function after treatment. It is expected to establish another feasible and rapid treatment method for ankle sprain. Combined with high accuracy ankle body defect evaluation method, it is helpful to design proper treatment and rehabilitation strategy in the future so as to improve the rehabilitation of limbs Coordination and control capabilities.
- Conditions
- Ankle Sprain 2Nd Degree, Ankle Sprain 3Rd Degree
- Being tested
- PRP, Rehabilitation, PRP+Rehabilitation
- Keywords
- Platelet rich plasma, proprioception, ankle sprain
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRPDrug
The investigators draw 10cc of blood and concentrate the blood to get the platelet rich plasma
RehabilitationOther
strengthening ex, posture training,...
PRP+RehabilitationCombination product
combine PRP and Rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| Platelet rich plasma (PRP) | Experimental | PRP injection only Receives: Drug: PRP |
| PRP+Rehabilitation | Experimental | PRP injection combined with rehabilitation Receives: Combination Product: PRP+Rehabilitation |
| Rehabilitation | Active comparator | Rehabilitation treatment only Receives: Other: Rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean of the distance of ankle movement by the force plate system
The proprioception could be evaluated by the parameter of mean of the distance of ankle movement by the force plate system
Measured: 10 min
standard error
evaluated by the parameter of standard error of the distance of ankle movement by the force plate system
Measured: 10 min
coefficient of variance
evaluated by the parameter of coefficient of variance of the distance of ankle movement by the force plate system
Measured: 10 min
Secondary outcomes (3)
Time Up and Go(TUG)
walking ability
Measured: 15 sec
Visual analogues scale (VAS )
pain level
Measured: 5 sec
AOFAS Ankle-Hindfoot score
function of ankle and foot
Measured: 10 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2019
- Study start1 Oct 2019
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (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 Ankle Sprain 2Nd DegreeStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Defense Medical Center, Taiwan
- Sponsor type
- University, hospital or other
- Collaborators
- Tri-Service General Hospital (TSGH)
- Responsible party
- Principal investigator, Shang-Lin Chiang, National Defense Medical Center, Taiwan
- Investigators
- Shang-Lin Chiang, PhD, Study director, Department of rehabiliation,TSGH, Taipei, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03808454
- Sponsor's protocol ID
- Tri-Service General Hospital
- Status last verified
- Sep 2023
- First submitted
- 1 Jan 2019
- Last updated
- 2 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators don't want to share IPD until the investigators publish it.
Publications
L. Laver, M. R. Carmont, M. O. McConkey, E. Palmanovich, E. Yaacobi, G. Mann, et al.,
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Proprioception of Platelet Rich Plasma for Patients With Ankle Sprain
- ClinicalTrials.gov ID
- NCT03808454
- Acronym / sponsor ID
- Tri-Service General Hospital
- Conditions
- Ankle Sprain 2Nd Degree, Ankle Sprain 3Rd Degree
- Keywords
- Platelet rich plasma, proprioception, ankle sprain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Defense Medical Center, TaiwanUniversity, hospital or other
- Collaborators
- Tri-Service General Hospital (TSGH)
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 17 Jan 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.
Ankle sprain is a fairly common sports medicine clinic. In Taiwan at least 150,000 to 200,000 people will suffer from ankle sprains every years. Clinicians have been looking for ways to shorten treatment time and reduce discomfort. Platelet Rich Plasma(PRP) is an endogenous therapeutic technology that involved in regenerative medicine due to its potential to stimulate and accelerate tissue healing. PRP can release lots of growth factors like platelet-derived growth factor (PDGF),transforming Growth Factor Beta(TGF-β), vascular endothelial growth factor(VEGF),Epidermal growth factor(EGF) and insulin-like growth factor (IGF). Its use had been based on the theory that increased autologous platelets, that then yield high concentrations of growth factors and other proteins, will lead to increased healing of tendon and soft tissue on a cellular level. In addition, there is no objective evaluation after treatment, so that patients can not provide effective and accurate quantitative feedback. In this study, the investigators divided patients into three groups, respectively, general rehabilitation therapy, autologous PRP injection therapy, autologous PRP injection combined with general rehabilitation therapy.
Detailed description
The investigators divided patients into three groups, respectively, general rehabilitation therapy, autologous PRP injection therapy, autologous PRP injection combined with general rehabilitation therapy randomly. The investigators also use the new ankle proprioception evaluation system and evaluation of clinical function after treatment. It is expected to establish another feasible and rapid treatment method for ankle sprain. Combined with high accuracy ankle body defect evaluation method, it is helpful to design proper treatment and rehabilitation strategy in the future so as to improve the rehabilitation of limbs Coordination and control capabilities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Platelet rich plasma (PRP) | Experimental | Drug: PRPPRP injection only |
| PRP+Rehabilitation | Experimental | Combination Product: PRP+RehabilitationPRP injection combined with rehabilitation |
| Rehabilitation | Active comparator | Other: RehabilitationRehabilitation treatment only |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ankle sprain within one months
- Gr II or Gr III ankle sprain (anterior talus fibular ligament)by sonogram proved
- MMSE≥23
- could cooperate the examination of the test
Key exclusion criteria (8 listed)
- Hemianopsia or hemineglect any brain lesion such as cerebrum of cerebellum involved movement
- cancer victim
- pregnant If needed PRP treatment
- Liver cirrhosis
- Platelet < 150000/UL
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 |
|---|---|---|
| PRPThe investigators draw 10cc of blood and concentrate the blood to get the platelet rich plasma | Drug | Platelet rich plasma (PRP) |
| Rehabilitationstrengthening ex, posture training,... | Other | Rehabilitation |
| PRP+Rehabilitationcombine PRP and Rehabilitation | Combination product | PRP+Rehabilitation |
Primary outcome
mean of the distance of ankle movement by the force plate system
Time frame: 10 min
The proprioception could be evaluated by the parameter of mean of the distance of ankle movement by the force plate system
standard error
Time frame: 10 min
evaluated by the parameter of standard error of the distance of ankle movement by the force plate system
coefficient of variance
Time frame: 10 min
evaluated by the parameter of coefficient of variance of the distance of ankle movement by the force plate system
3 secondary outcomes
Time Up and Go(TUG)
Time frame: 15 sec
Visual analogues scale (VAS )
Time frame: 5 sec
AOFAS Ankle-Hindfoot score
Time frame: 10 min
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2023.
- Results publicationL. Laver, M. R. Carmont, M. O. McConkey, E. Palmanovich, E. Yaacobi, G. Mann, et al.,
- Individual participant dataSharing planned: No. The investigators don't want to share IPD until the investigators publish it.
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.
Shang-Lin Chiang, PhD study director
Department of rehabiliation,TSGH, Taipei, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PRP, Rehabilitation and PRP+Rehabilitation in people with Ankle Sprain 2Nd Degree and Ankle Sprain 3Rd Degree, run by National Defense Medical Center, Taiwan 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 4 inclusion and 8 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 2 Oct 2023. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Shang-Lin Chiang, PhD (8860287923311 ext. 12677, andyyy520@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mean of the distance of ankle movement by the force plate system (time frame: 10 min). 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 NCT03808454, 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 2 Oct 2023.