An interventional study of Hypervolt and Body Tempering in Hamstring Contractures and Muscle Tightness, sponsored by University of South Carolina. Status unknown at 1 site in United States. Open to participants aged 18 Years to 39 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-26.
Sponsored by University of South Carolina · Not applicable, Interventional, and Treatment
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.
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.
79 studies on the registry are indexed under Contracture; 18 are open to participants now.
This study's planned enrollment of 80 is above the median of 33 across 62 interventional studies indexed under Contracture.
Browse Contracture studies →University of South Carolina is the lead sponsor of 197 studies on the registry; 42 are open to participants now.
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Exclusion Criteria:
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.
Other: Static stretching
The HyperVolt percussive massage group participants will receive a therapist-performed HyperVolt technique to the hamstrings for a period of 5 minutes.
Device: Hypervolt
The body tempering group participants will receive a therapist-performed body tempering technique to the hamstrings for a period of 5 minutes.
Device: Body Tempering
The dry cupping group participants will receive a therapist-performed dry cupping technique to the hamstrings for a period of 5 minutes.
Device: Dry cupping
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 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 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.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 24 hours after the intervention
Plan to share: No
Started Apr 2023 (actual). Primary completion is estimated for Nov 2023, 7 months after the start.
Of 30 interventional studies with no phase under Contracture, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 55. This study's planned 7 months is below that.
How these figures are worked out, and which studies are left out of them.
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