Healthy VolunteersNCT03023943
The Effects of IASTM and Proprioception
A study testing Instrument Assisted Soft Tissue Mobilization in people with Healthy Volunteers, run by Youngstown State University at 1 site in United States.
Trial summary
The research design will be single group pretest-posttest design. The subject will be instructed to position the knee joint to a position previously set by the experimenter. Intervention will be 10 minutes of GT1 instrument application at anterior thigh using sweep technique. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Instrument Assisted Soft Tissue Mobilization
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2017to 31 May 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- male or female, age 18 to 65.
Who cannot join
- sensory impairments or a present contraindications to IASTM which include cancer, burn scars, kidney dysfunction, pregnancy, varicose veins, osteoporosis, body art, chronic regional pain syndrome, polyneuropathies, fractures, autoimmune disorders, diabetes, vitamin C \& D/Calcium deficiencies, rheumatoid arthritis, ankylosing spondylitis, congestive heart failure, acute inflammation, lymphedema, flu or illness with flu-like symptoms, and medications (anticoagulant, steroids, hormone replacements, NSAIDS, fluoroquinolone antibiotics, herbal supplements).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Instrument Assisted Soft Tissue Mobilization on Proprioception
The research design will be single group pretest-posttest design. The subject will be instructed to position the knee joint to a position previously set by the experimenter. Intervention will be 10 minutes of GT1 instrument application at anterior thigh using sweep technique.
- Conditions
- Healthy Volunteers
- Being tested
- Instrument Assisted Soft Tissue Mobilization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instrument Assisted Soft Tissue MobilizationOther
Also called IASTM
Intervention will be 10 minutes of GT1 instrument application at anterior thigh using sweep technique.
| Study group | Role | What they receive |
|---|---|---|
| IASTM group | Experimental | Intervention will be 10 minutes of GT1 instrument application at anterior thigh using sweep technique. Receives: Other: Instrument Assisted Soft Tissue Mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proprioception determined using the reposition error
Proprioception will be determined by measuring the reposition error of the knee joint. The subject will be instructed to position the knee joint to a position (flexion) previously set by the experimenter at 30 degree flexion. The difference will be calculated as the reposition error. The position of the knee joint will be measure using a goniometer. An alternative is to use an App (e.g. Angle Meter) on a smart phone or an iPad for accuracy.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2017 (estimated)
- Study start3 Feb 2017
- Primary completion31 May 2018
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Youngstown State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weiqing Ge, Youngstown State University
- Investigators
- Michael Hripko, Study director, Youngstown State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03023943
- Sponsor's protocol ID
- 072-2017
- Status last verified
- Jan 2020
- First submitted
- 11 Jan 2017
- Last updated
- 10 Jan 2020
- 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 10 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Instrument Assisted Soft Tissue Mobilization on Proprioception
- ClinicalTrials.gov ID
- NCT03023943
- Acronym / sponsor ID
- 072-2017
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Youngstown State UniversityUniversity, hospital or other
- Study start
- 3 Feb 2017 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 18 Jan 2017 (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.
The research design will be single group pretest-posttest design. The subject will be instructed to position the knee joint to a position previously set by the experimenter. Intervention will be 10 minutes of GT1 instrument application at anterior thigh using sweep technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IASTM group | Experimental | Other: Instrument Assisted Soft Tissue MobilizationIntervention will be 10 minutes of GT1 instrument application at anterior thigh using sweep technique. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- male or female, age 18 to 65.
Key exclusion criteria (1 listed)
- sensory impairments or a present contraindications to IASTM which include cancer, burn scars, kidney dysfunction, pregnancy, varicose veins, osteoporosis, body art, chronic regional pain syndrome, polyneuropathies, fractures, autoimmune disorders, diabetes, vitamin C \& D/Calcium deficiencies, rheumatoid arthritis, ankylosing spondylitis, congestive heart failure, acute inflammation, lymphedema, flu or illness with flu-like symptoms, and medications (anticoagulant, steroids, hormone replacements, NSAIDS, fluoroquinolone antibiotics, herbal supplements).
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 |
|---|---|---|
| Instrument Assisted Soft Tissue MobilizationAlso: IASTMIntervention will be 10 minutes of GT1 instrument application at anterior thigh using sweep technique. | Other | IASTM group |
Primary outcome
Proprioception determined using the reposition error
Time frame: 5 minutes
Proprioception will be determined by measuring the reposition error of the knee joint. The subject will be instructed to position the knee joint to a position (flexion) previously set by the experimenter at 30 degree flexion. The difference will be calculated as the reposition error. The position of the knee joint will be measure using a goniometer. An alternative is to use an App (e.g. Angle Meter) on a smart phone or an iPad for accuracy.
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 10 Jan 2020.
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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.
Michael Hripko study director
Youngstown State 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 Instrument Assisted Soft Tissue Mobilization in people with Healthy Volunteers, run by Youngstown State University at 1 site in United States.
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 1 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 10 Jan 2020. 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 United States. 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?
Proprioception determined using the reposition error (time frame: 5 minutes). 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 10 Jan 2020.