Neuromuscular ControlNCT04863937
Distal Thigh Compression Garment Improves Knee Control and Safety Perceptions During Single Leg Triple Hop for Distance
A study testing Distal Thigh Compression Garment, Knee Sleeve in people with Neuromuscular Control, run by Spalding University at 1 site in United States.
Trial summary
This study measured knee frontal plane projection angle (FPPA) and sports safety and performance perceptions of female athletes during a single leg triple hop for distance for 3 conditions (standard knee sleeve, no device and distal thigh compression garment (DTCG)). Read more about this study
- Who is it for?
- Ages 18 to 22 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Neuromuscular Control
- What is being tested?
- Distal Thigh Compression Garment, Knee Sleeve
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Mar 2018to 26 Mar 2019
- 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 22 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy women
- College athletes
- ≥ 18 years
Who cannot join
- Knee injury history
- Any current lower extremity injury
Trial locations and contacts
1 site in 1 country.
United States1 site
Kosair Charities College of Health and Natural Sciences
Louisville, Kentucky, 40203
About this study
This study measured knee frontal plane projection angle (FPPA) and sports safety and performance perceptions of female athletes during a single leg triple hop for distance for 3 conditions (standard knee sleeve, no device and distal thigh compression garment (DTCG)). The hypothesis was that the DTCG group would display superior dynamic knee valgus FPPA compared to the standard knee sleeve and no device groups.
Read the detailed description
Eighteen healthy college athletes participated in this prospective cohort study with a randomized device order. FPPA was measured during single leg triple hop for distance using two-dimensional biomechanical techniques to estimate dynamic knee valgus loading. A 10-cm visual analog scale survey collected data regarding subject perceived knee control, sports movement capability and overall satisfaction for each condition. Pearson correlations delineated knee valgus, safety and performance relationship perceptions (p < 0.05).
- Conditions
- Neuromuscular Control
- Being tested
- Distal Thigh Compression Garment, Knee Sleeve
- Keywords
- Dynamic Knee Stability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distal Thigh Compression Garment, Knee SleeveDevice
Randomized Comparison of Knee Sleeve, Distal Thigh Compression Garment and No Device
| Study group | Role | What they receive |
|---|---|---|
| Randomized Comparison of Knee Sleeve, Distal Thigh Compression Garment and No Device | Experimental | Randomized Comparison of Knee Sleeve, Distal Thigh Compression Garment and No Device Receives: Device: Distal Thigh Compression Garment, Knee Sleeve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frontal Plane Knee Projection Angle
Frontal plane tibio-femoral alignment at single leg triple hop completion
Measured: Immediately after the intervention
Subject Confidence in Sports Safety and Performance Perceptions
10-cm Visual Analog Confidence Scale for Sports Movement Capability and Safety Perceptions. Minimum value = 0. Maximum value = 100. Higher score equals greater confidence.
Measured: Immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start26 Mar 2018
- Primary completion26 Mar 2019
- Study completion26 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromuscular ControlStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- This study measured knee frontal plane projection angle (FPPA) and sports safety and performance perceptions of female athletes during a single leg triple hop for distance for 3 conditions (standard knee sleeve, no device and distal thigh compression garment (DTCG)).
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spalding University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Nyland, Spalding University
- Investigators
- John Nyland, Study director, Spalding University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04863937
- Sponsor's protocol ID
- REC-0118-2
- Status last verified
- Apr 2021
- First submitted
- 21 Apr 2021
- Last updated
- 29 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data collection has been completed. Information will be presented in published manuscript.
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distal Thigh Compression Garment Improves Knee Control and Safety Perceptions During Single Leg Triple Hop for Distance
- ClinicalTrials.gov ID
- NCT04863937
- Acronym / sponsor ID
- REC-0118-2
- Conditions
- Neuromuscular Control
- Keywords
- Dynamic Knee Stability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Spalding UniversityUniversity, hospital or other
- Study start
- 26 Mar 2018 (actual)
- Primary completion
- 26 Mar 2019 (actual)
- Study completion
- 26 Mar 2019 (actual)
- First posted
- 28 Apr 2021 (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.
This study measured knee frontal plane projection angle (FPPA) and sports safety and performance perceptions of female athletes during a single leg triple hop for distance for 3 conditions (standard knee sleeve, no device and distal thigh compression garment (DTCG)). The hypothesis was that the DTCG group would display superior dynamic knee valgus FPPA compared to the standard knee sleeve and no device groups.
Detailed description
Eighteen healthy college athletes participated in this prospective cohort study with a randomized device order. FPPA was measured during single leg triple hop for distance using two-dimensional biomechanical techniques to estimate dynamic knee valgus loading. A 10-cm visual analog scale survey collected data regarding subject perceived knee control, sports movement capability and overall satisfaction for each condition. Pearson correlations delineated knee valgus, safety and performance relationship perceptions (p < 0.05).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study measured knee frontal plane projection angle (FPPA) and sports safety and performance perceptions of female athletes during a single leg triple hop for distance for 3 conditions (standard knee sleeve, no device and distal thigh compression garment (DTCG)).
| Arm | Type | Receives |
|---|---|---|
| Randomized Comparison of Knee Sleeve, Distal Thigh Compression Garment and No Device | Experimental | Device: Distal Thigh Compression Garment, Knee SleeveRandomized Comparison of Knee Sleeve, Distal Thigh Compression Garment and No Device |
Who may qualify
- Ages
- 18 to 22 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy women
- College athletes
- ≥ 18 years
Key exclusion criteria (2 listed)
- Knee injury history
- Any current lower extremity injury
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 |
|---|---|---|
| Distal Thigh Compression Garment, Knee SleeveRandomized Comparison of Knee Sleeve, Distal Thigh Compression Garment and No Device | Device | Randomized Comparison of Knee Sleeve, Distal Thigh Compression Garment and No Device |
Primary outcome
Frontal Plane Knee Projection Angle
Time frame: Immediately after the intervention
Frontal plane tibio-femoral alignment at single leg triple hop completion
Subject Confidence in Sports Safety and Performance Perceptions
Time frame: Immediately after the intervention
10-cm Visual Analog Confidence Scale for Sports Movement Capability and Safety Perceptions. Minimum value = 0. Maximum value = 100. Higher score equals greater confidence.
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 Apr 2021.
- Individual participant dataSharing planned: No. Data collection has been completed. Information will be presented in published manuscript.
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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.
John Nyland study director
Spalding 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 Distal Thigh Compression Garment, Knee Sleeve in people with Neuromuscular Control, run by Spalding 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 3 inclusion and 2 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 Apr 2021. 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?
Frontal Plane Knee Projection Angle (time frame: Immediately after the intervention). The study lists 2 primary outcomes in all. 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 Apr 2021.