Hamstring ContracturesNCT05793242
Immediate and 24-hour Effects of HyperVolt, Body Tempering, and Cupping Compared to Stretching on Hamstring Flexibility
A study testing Hypervolt, Body Tempering and Dry cupping in people with Hamstring Contractures and Muscle Tightness, run by University of South Carolina at 1 site in United States.
Trial summary
The purpose of this study is to compare the effects of the HyperVolt percussive massage device, body tempering, and dry cupping to static stretching of the hamstrings of healthy adults aged 18-39 years on the active knee extension and back saver sit-and-reach test.While these modalities are frequently used in… Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Hamstring Contractures, Muscle Tightness
- What is being tested?
- Hypervolt, Body Tempering and Dry cupping
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Apr 2023to Nov 2023
- 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 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Shortened hamstring length
- Male participants will display ≤141 degrees of knee extension
- Female participants will display ≤152 degrees of knee extension
Who cannot join
- history of knee injury
- hypertension
- thrombophlebitis
- inflammation
- myositis ossificans
- osteomyelitis
Show all 18Show fewer
- open wounds
- unhealed fractures
- hematoma or hemophilia
- pregnancy
- cancer
- burns or skin grafts
- varicose veins
- synovitis
- currently taking any anticoagulation medications
- rheumatoid arthritis
- osteoporosis
- any other condition that would prevent safe participation
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of South Carolina
Columbia, South Carolina, 29208
Cathy F Arnot, DPT, 803-240-2455, arnot@mailbox.sc.edu
About this study
Official title: Immediate and 24-hour Effects of the HyperVolt Device, Body Tempering, and Cupping Compared to Static Stretching of the Hamstring Muscles to Increase Lower Extremity Range of Motion
The purpose of this study is to compare the effects of the HyperVolt percussive massage device, body tempering, and dry cupping to static stretching of the hamstrings of healthy adults aged 18-39 years on the active knee extension and back saver sit-and-reach test.While these modalities are frequently used in healthcare settings there is a paucity of research regarding effectiveness. If the effects on flexibility are comparable, patients could save time and money by performing static stretching.
Read the detailed description
Our study aims to compare the effects of the HyperVolt percussive massage device (HyperVolt), body tempering, and dry cupping compared to static stretching on flexibility and range of motion (ROM), specifically in those with active hamstring ROM limitations. Those individuals from the University of South Carolina community who are interested in becoming study participants will be identified by means of announcements made in the Seminar in Physical Therapy course which is attended by all Physical Therapy students, faculty, and staff each week. Interested individuals will be provided with Dr.Cathy Arnot's email address in order to schedule an evaluation session to determine whether or not they meet the study's inclusion and exclusion criteria. A flyer will also be posted in the Blatt PE Building with Sean Edmonds' contact information included. Interested individuals that contact Sean will be scheduled for screening by Dr.Cathy Arnot. Participants will be assigned to either the HyperVolt percussive massage device (HyperVolt) group, body tempering group, dry cupping group, or static stretching group via blocked randomization for sex and age, with at least twenty participants being placed into each group. The HyperVolt percussive massage group participants will receive a therapist-performed HyperVolt technique for a period of 5 minutes. The body tempering group participants will receive a therapist-performed body tempering technique for a period of 5 minutes. The dry cupping group participants will receive a therapist-performed dry cupping technique for a period of 5 minutes. The static stretch group participants will perform a self-facilitated stretch by looping a strap around the heel of their foot and grasping it with both hands followed by pulling the strap to raise the fully extended leg into hip flexion. The participant will then lift the leg until they reach their maximal tolerable point and then alternate between periods of resting and stretching for a total of 5 minutes. Measurements will be assessed at three time points: Immediately before the intervention, immediately after the intervention, and 24 hours after the intervention.
- Conditions
- Hamstring Contractures, Muscle Tightness
- Being tested
- Hypervolt, Body Tempering, Dry cupping, Static stretching
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HypervoltDevice
HyperVolt Percussive Massage Device: this will be performed by a physical therapist while the participant is prone. The physical therapist will apply a vibrating device to the back of the thigh with moderate pressure while continuously moving the device for 5 minutes.
Body TemperingDevice
Body Tempering:this will be performed by a physical therapist while the participant is prone. The physical therapist will apply a moderately heavy metal device to the back of the thigh while continuously moving the device for 5 minutes.
Dry cuppingDevice
Dry Cupping: This will be performed by a physical therapist while the participant is prone. The physical therapist will apply several negative pressure devices to the back of your thigh for 5 minutes.
Static stretchingOther
Participants will perform a static stretch on their lower extremity. This stretch will be performed by having the participant loop a strap around their heel and grasping it with both hands followed by pulling the strap to raise the fully extended leg into hip flexion. The participant will be instructed to lift the leg until they reach their maximal tolerable point and then to hold the position for 30 seconds. They will then lower the extremity to the table and rest for 15 seconds This self-stretch sequence will be performed for 7 cycles so that the total intervention was equal to the intervention time of the other group (5 minutes).7
| Study group | Role | What they receive |
|---|---|---|
| Static stretching | Active comparator | The static stretch group participants will perform a self-facilitated stretch by looping a strap around the heel of their foot and grasping it with both hands followed by pulling the strap to raise the fully extended leg into hip flexion. The participant will then lift the leg until they reach their maximal tolerable point and then alternate between periods of resting and stretching for a total of 5 minutes. Receives: Other: Static stretching |
| Hypervolt | Experimental | The HyperVolt percussive massage group participants will receive a therapist-performed HyperVolt technique to the hamstrings for a period of 5 minutes. Receives: Device: Hypervolt |
| Body tempering | Experimental | The body tempering group participants will receive a therapist-performed body tempering technique to the hamstrings for a period of 5 minutes. Receives: Device: Body Tempering |
| Dry cupping | Experimental | The dry cupping group participants will receive a therapist-performed dry cupping technique to the hamstrings for a period of 5 minutes. Receives: Device: Dry cupping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Active Knee Extension Test (AKE)
The Active Knee Extension (AKE) Test measures will be conducted by a pair of graders that will be blinded to the intervention applied to the study participants. Participants will have an axis of rotation labeled at the lateral aspect of the knee joint midline. The participant will be instructed to lie down on the table in the supine position. One of the test graders will assist the participant in performing and maintaining 90-degrees of hip flexion throughout this test. The participant will be instructed to extend at the knee as much as possible and told to hold the position for the second grader to measure the knee extension ROM using a goniometer. A total of 3 measurements will be conducted, with the last 2 recorded for data analysis.
Measured: Immediately after intervention
Active Knee Extension Test (AKE)
The Active Knee Extension (AKE) Test measures will be conducted by a pair of graders that will be blinded to the intervention applied to the study participants. Participants will have an axis of rotation labeled at the lateral aspect of the knee joint midline. The participant will be instructed to lie down on the table in the supine position. One of the test graders will assist the participant in performing and maintaining 90-degrees of hip flexion throughout this test. The participant will be instructed to extend at the knee as much as possible and told to hold the position for the second grader to measure the knee extension ROM using a goniometer. A total of 3 measurements will be conducted, with the last 2 recorded for data analysis.
Measured: 24 hours after the intervention
Back-Saver Sit-and-Reach Test
The Back-Saver Sit-and-ReachTest will be conducted by a pair of graders that will be blinded to the intervention group of the study participants. A box will be utilized with a ruler placed on top of the box with 9 inches protruding out towards the participant. The ruler will run parallel to the direction of forward movement by the participant. When instructed, the tested lower extremity will remain fully extended at the knee with the plantar side of the foot flat up against the wall of the box. The contralateral non-tested leg will be flexed at the knee, resulting in the plantar side of the foot flat down against the floor. The foot of the non-tested leg will be placed within 2 to 3 inches away from the fully extended tested leg and remain planted at all times during testing procedures. Participants will be instructed to reach forward as far as possible with arms fully extended, back straight, and head up.
Measured: Immediately after intervention
Back-Saver Sit-and-Reach Test
The Back-Saver Sit-and-ReachTest will be conducted by a pair of graders that will be blinded to the intervention group of the study participants. A box will be utilized with a ruler placed on top of the box with 9 inches protruding out towards the participant. The ruler will run parallel to the direction of forward movement by the participant. When instructed, the tested lower extremity will remain fully extended at the knee with the plantar side of the foot flat up against the wall of the box. The contralateral non-tested leg will be flexed at the knee, resulting in the plantar side of the foot flat down against the floor. The foot of the non-tested leg will be placed within 2 to 3 inches away from the fully extended tested leg and remain planted at all times during testing procedures. Participants will be instructed to reach forward as far as possible with arms fully extended, back straight, and head up.
Measured: 24 hours 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 posted31 Mar 2023
- Study start3 Apr 2023
- Primary completionNov 2023 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Hamstring ContracturesStudies of the same condition, open and under way.
- More trials run by University of South CarolinaThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cathy Arnot, University of South Carolina
- Investigators
- Cathy F Arnot, DPT, Study director, University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05793242
- Sponsor's protocol ID
- Pro00125174
- Status last verified
- Apr 2023
- First submitted
- 15 Mar 2023
- Last updated
- 26 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Blazevich AJ, Gill ND, Kvorning T, Kay AD, Goh AG, Hilton B, Drinkwater EJ, Behm DG. No Effect of Muscle Stretching within a Full, Dynamic Warm-up on Athletic Performance. Med Sci Sports Exerc. 2018 Jun;50(6):1258-1266. doi: 10.1249/MSS.0000000000001539.
PubMed 29300214Aguilar AJ, DiStefano LJ, Brown CN, Herman DC, Guskiewicz KM, Padua DA. A dynamic warm-up model increases quadriceps strength and hamstring flexibility. J Strength Cond Res. 2012 Apr;26(4):1130-41. doi: 10.1519/JSC.0b013e31822e58b6.
PubMed 22446678Konrad A, Glashuttner C, Reiner MM, Bernsteiner D, Tilp M. The Acute Effects of a Percussive Massage Treatment with a Hypervolt Device on Plantar Flexor Muscles' Range of Motion and Performance. J Sports Sci Med. 2020 Nov 19;19(4):690-694. eCollection 2020 Dec.
PubMed 33239942Taber CB, Colter RJ, Davis JJ, Seweje PA, Wilson DP, Foster JZ, Merrigan JJ. The Effects of Body Tempering on Force Production, Flexibility and Muscle Soreness in Collegiate Football Athletes. J Funct Morphol Kinesiol. 2022 Jan 11;7(1):9. doi: 10.3390/jfmk7010009.
PubMed 35076554Williams JG, Gard HI, Gregory JM, Gibson A, Austin J. The Effects of Cupping on Hamstring Flexibility in College Soccer Players. J Sport Rehabil. 2019 May 1;28(4):350-353. doi: 10.1123/jsr.2017-0199. Epub 2018 Dec 4.
PubMed 29364033Gunn LJ, Stewart JC, Morgan B, Metts ST, Magnuson JM, Iglowski NJ, Fritz SL, Arnot C. Instrument-assisted soft tissue mobilization and proprioceptive neuromuscular facilitation techniques improve hamstring flexibility better than static stretching alone: a randomized clinical trial. J Man Manip Ther. 2019 Feb;27(1):15-23. doi: 10.1080/10669817.2018.1475693. Epub 2018 Aug 1.
PubMed 30692839
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate and 24-hour Effects of the HyperVolt Device, Body Tempering, and Cupping Compared to Static Stretching of the Hamstring Muscles to Increase Lower Extremity Range of Motion
- ClinicalTrials.gov ID
- NCT05793242
- Acronym / sponsor ID
- Pro00125174
- Conditions
- Hamstring Contractures, Muscle Tightness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of South CarolinaUniversity, hospital or other
- Study start
- 3 Apr 2023 (actual)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 31 Mar 2023 (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.
The purpose of this study is to compare the effects of the HyperVolt percussive massage device, body tempering, and dry cupping to static stretching of the hamstrings of healthy adults aged 18-39 years on the active knee extension and back saver sit-and-reach test.While these modalities are frequently used in healthcare settings there is a paucity of research regarding effectiveness. If the effects on flexibility are comparable, patients could save time and money by performing static stretching.
Detailed description
Our study aims to compare the effects of the HyperVolt percussive massage device (HyperVolt), body tempering, and dry cupping compared to static stretching on flexibility and range of motion (ROM), specifically in those with active hamstring ROM limitations. Those individuals from the University of South Carolina community who are interested in becoming study participants will be identified by means of announcements made in the Seminar in Physical Therapy course which is attended by all Physical Therapy students, faculty, and staff each week. Interested individuals will be provided with Dr.Cathy Arnot's email address in order to schedule an evaluation session to determine whether or not they meet the study's inclusion and exclusion criteria. A flyer will also be posted in the Blatt PE Building with Sean Edmonds' contact information included. Interested individuals that contact Sean will be scheduled for screening by Dr.Cathy Arnot. Participants will be assigned to either the HyperVolt percussive massage device (HyperVolt) group, body tempering group, dry cupping group, or static stretching group via blocked randomization for sex and age, with at least twenty participants being placed into each group. The HyperVolt percussive massage group participants will receive a therapist-performed HyperVolt technique for a period of 5 minutes. The body tempering group participants will receive a therapist-performed body tempering technique for a period of 5 minutes. The dry cupping group participants will receive a therapist-performed dry cupping technique for a period of 5 minutes. The static stretch group participants will perform a self-facilitated stretch by looping a strap around the heel of their foot and grasping it with both hands followed by pulling the strap to raise the fully extended leg into hip flexion. The participant will then lift the leg until they reach their maximal tolerable point and then alternate between periods of resting and stretching for a total of 5 minutes. Measurements will be assessed at three time points: Immediately before the intervention, immediately after the intervention, and 24 hours after the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Static stretching | Active comparator | Other: Static stretchingThe static stretch group participants will perform a self-facilitated stretch by looping a strap around the heel of their foot and grasping it with both hands followed by pulling the strap to raise the fully extended leg into hip flexion. The participant will then lift the leg until they reach their maximal tolerable point and then alternate between periods of resting and stretching for a total of 5 minutes. |
| Hypervolt | Experimental | Device: HypervoltThe HyperVolt percussive massage group participants will receive a therapist-performed HyperVolt technique to the hamstrings for a period of 5 minutes. |
| Body tempering | Experimental | Device: Body TemperingThe body tempering group participants will receive a therapist-performed body tempering technique to the hamstrings for a period of 5 minutes. |
| Dry cupping | Experimental | Device: Dry cuppingThe dry cupping group participants will receive a therapist-performed dry cupping technique to the hamstrings for a period of 5 minutes. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Shortened hamstring length
- Male participants will display ≤141 degrees of knee extension
- Female participants will display ≤152 degrees of knee extension
Key exclusion criteria (18 listed)
- history of knee injury
- hypertension
- thrombophlebitis
- inflammation
- myositis ossificans
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 |
|---|---|---|
| HypervoltHyperVolt Percussive Massage Device: this will be performed by a physical therapist while the participant is prone. The physical therapist will apply a vibrating device to the back of the thigh with moderate pressure while continuously moving the device for 5 minutes. | Device | Hypervolt |
| Body TemperingBody Tempering:this will be performed by a physical therapist while the participant is prone. The physical therapist will apply a moderately heavy metal device to the back of the thigh while continuously moving the device for 5 minutes. | Device | Body tempering |
| Dry cuppingDry Cupping: This will be performed by a physical therapist while the participant is prone. The physical therapist will apply several negative pressure devices to the back of your thigh for 5 minutes. | Device | Dry cupping |
| Static stretchingParticipants will perform a static stretch on their lower extremity. This stretch will be performed by having the participant loop a strap around their heel and grasping it with both hands followed by pulling the strap to raise the fully extended leg into hip flexion. The participant will be instructed to lift the leg until they reach their maximal tolerable point and then to hold the position for 30 seconds. They will then lower the extremity to the table and rest for 15 seconds This self-stretch sequence will be performed for 7 cycles so that the total intervention was equal to the intervention time of the other group (5 minutes).7 | Other | Static stretching |
Primary outcome
Active Knee Extension Test (AKE)
Time frame: Immediately after intervention
The Active Knee Extension (AKE) Test measures will be conducted by a pair of graders that will be blinded to the intervention applied to the study participants. Participants will have an axis of rotation labeled at the lateral aspect of the knee joint midline. The participant will be instructed to lie down on the table in the supine position. One of the test graders will assist the participant in performing and maintaining 90-degrees of hip flexion throughout this test. The participant will be instructed to extend at the knee as much as possible and told to hold the position for the second grader to measure the knee extension ROM using a goniometer. A total of 3 measurements will be conducted, with the last 2 recorded for data analysis.
Active Knee Extension Test (AKE)
Time frame: 24 hours after the intervention
The Active Knee Extension (AKE) Test measures will be conducted by a pair of graders that will be blinded to the intervention applied to the study participants. Participants will have an axis of rotation labeled at the lateral aspect of the knee joint midline. The participant will be instructed to lie down on the table in the supine position. One of the test graders will assist the participant in performing and maintaining 90-degrees of hip flexion throughout this test. The participant will be instructed to extend at the knee as much as possible and told to hold the position for the second grader to measure the knee extension ROM using a goniometer. A total of 3 measurements will be conducted, with the last 2 recorded for data analysis.
Back-Saver Sit-and-Reach Test
Time frame: Immediately after intervention
The Back-Saver Sit-and-ReachTest will be conducted by a pair of graders that will be blinded to the intervention group of the study participants. A box will be utilized with a ruler placed on top of the box with 9 inches protruding out towards the participant. The ruler will run parallel to the direction of forward movement by the participant. When instructed, the tested lower extremity will remain fully extended at the knee with the plantar side of the foot flat up against the wall of the box. The contralateral non-tested leg will be flexed at the knee, resulting in the plantar side of the foot flat down against the floor. The foot of the non-tested leg will be placed within 2 to 3 inches away from the fully extended tested leg and remain planted at all times during testing procedures. Participants will be instructed to reach forward as far as possible with arms fully extended, back straight, and head up.
Back-Saver Sit-and-Reach Test
Time frame: 24 hours after the intervention
The Back-Saver Sit-and-ReachTest will be conducted by a pair of graders that will be blinded to the intervention group of the study participants. A box will be utilized with a ruler placed on top of the box with 9 inches protruding out towards the participant. The ruler will run parallel to the direction of forward movement by the participant. When instructed, the tested lower extremity will remain fully extended at the knee with the plantar side of the foot flat up against the wall of the box. The contralateral non-tested leg will be flexed at the knee, resulting in the plantar side of the foot flat down against the floor. The foot of the non-tested leg will be placed within 2 to 3 inches away from the fully extended tested leg and remain planted at all times during testing procedures. Participants will be instructed to reach forward as far as possible with arms fully extended, back straight, and head up.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
- Results publication: PubMed 29300214Blazevich AJ, Gill ND, Kvorning T, Kay AD, Goh AG, Hilton B, Drinkwater EJ, Behm DG. No Effect of Muscle Stretching within a Full, Dynamic Warm-up on Athletic Performance. Med Sci Sports Exerc. 2018 Jun;50(6):1258-1266. doi: 10.1249/MSS.0000000000001539.
- Results publication: PubMed 22446678Aguilar AJ, DiStefano LJ, Brown CN, Herman DC, Guskiewicz KM, Padua DA. A dynamic warm-up model increases quadriceps strength and hamstring flexibility. J Strength Cond Res. 2012 Apr;26(4):1130-41. doi: 10.1519/JSC.0b013e31822e58b6.
- Results publication: PubMed 33239942Konrad A, Glashuttner C, Reiner MM, Bernsteiner D, Tilp M. The Acute Effects of a Percussive Massage Treatment with a Hypervolt Device on Plantar Flexor Muscles' Range of Motion and Performance. J Sports Sci Med. 2020 Nov 19;19(4):690-694. eCollection 2020 Dec.
- Results publication: PubMed 35076554Taber CB, Colter RJ, Davis JJ, Seweje PA, Wilson DP, Foster JZ, Merrigan JJ. The Effects of Body Tempering on Force Production, Flexibility and Muscle Soreness in Collegiate Football Athletes. J Funct Morphol Kinesiol. 2022 Jan 11;7(1):9. doi: 10.3390/jfmk7010009.
- Results publication: PubMed 29364033Williams JG, Gard HI, Gregory JM, Gibson A, Austin J. The Effects of Cupping on Hamstring Flexibility in College Soccer Players. J Sport Rehabil. 2019 May 1;28(4):350-353. doi: 10.1123/jsr.2017-0199. Epub 2018 Dec 4.
- Results publication: PubMed 30692839Gunn LJ, Stewart JC, Morgan B, Metts ST, Magnuson JM, Iglowski NJ, Fritz SL, Arnot C. Instrument-assisted soft tissue mobilization and proprioceptive neuromuscular facilitation techniques improve hamstring flexibility better than static stretching alone: a randomized clinical trial. J Man Manip Ther. 2019 Feb;27(1):15-23. doi: 10.1080/10669817.2018.1475693. Epub 2018 Aug 1.
- Individual participant dataSharing planned: No
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.
Cathy F Arnot, DPT study director
University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypervolt, Body Tempering and Dry cupping in people with Hamstring Contractures and Muscle Tightness, run by University of South Carolina 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 18 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 26 Apr 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cathy F Arnot, DPT (8032402455, arnot@mailbox.sc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Active Knee Extension Test (AKE) (time frame: Immediately after intervention). The study lists 4 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 NCT05793242, which also lists 6 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 26 Apr 2023.