Ankle InjuriesNCT06343207
Percussive Therapy Reduced EMG Activity During Calf Raise in Limbs With and Without Chronic Ankle Instability
A study testing Percussive massage gun therapy in people with Ankle Injuries, run by Charles University, Czech Republic at 1 site in Czechia.
Trial summary
To examine the acute effect of percussive therapy on peak calf muscle activation during standing heel raise in subjects with and without chronic ankle instability (CAI). Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Ankle Injuries
- What is being tested?
- Percussive massage gun therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteCzechia
- Study dates
- 22 Nov 2022to 2 Feb 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- CAI group - at least two ankle luxation or ankle distortions in the last 2 years as reported by a physician.
- Healthy group - healthy
Who cannot join
- paraplegia,
- women in advanced stages of pregnancy
- feverish or acute inflammatory diseases within 7 days before the measurement
- current or healed rupture of m. gastrocnemius, m. soleus, tendo calcaneus
- purulent, fungal diseases, burns, scalds, varices
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Faculty of physical education and sport, Charles University
Prague, 16252
About this study
Official title: Percussive Therapy Reduced EMG Activity During Calf Raise in Limbs With and Without Chronic Ankle Instability: A Randomized Controlled Trial
To examine the acute effect of percussive therapy on peak calf muscle activation during standing heel raise in subjects with and without chronic ankle instability (CAI).
Read the detailed description
Total of 42 subjects in mean age of 23.5 ± 2.5 years participated in this research. From the original of 44 subjects, we had to discard 2 subjects (not finishing the measurement and extremely outlier data). The group was divided into 2 specific subcategories as follows - 21 patients with diagnosed CAI (CAI group; respectively) and the 21 of control group patients (HEALTHY group; respectively), including people who have never injured ankles, nor the ligaments and muscles group surrounding the ankle complex. The information and categorization based on the injury history to specific groups was performed by verbal questioning. The criteria for the CAI group were having had at least two ankle luxation or ankle distortions in the last 2 years as reported by a physician. The HEALTHY group was without this diagnosis. All the individuals involved in the testing underwent a medical examination by a sports physician at least once in a period of one year before testing. Subjects of both genders in both groups were then randomly divided (balanced ratio between male and female participants was kept) into 2 subgroups based on applied PT or not as follows: CAI YES (n=10), CAI NO (n=11), HEALTHY YES (n=10), HEALTHY NO (n=11). The probands were informed about the research process, which they also confirmed by signing an informed consent form according to Declaration of Helsinki. The master thesis research was approved by the ethical committee of Faculty of Physical Education and Sport, Charles University.
Data collection of Total Travelled Way (TTW) of Centre of Pressure (COP) during static postural stability tests was performed by pressure platform FootScan (RS Scan International, Belgium). Pressure sensors located in the platform sense load at frequencies up to 500 Hz. In particular, the parameter of Total Travelled Way of COP in mm (TTW) was evaluated and analyzed the postural stability tests consisted of two bilateral and one unilateral test.
First bilateral test was Close Stand with Open Eyes (OE) in duration of 30 s. Subject was asked to stand on pressure platform as close as possible without touching the feet, ankles, or knees between dominant, and nondominant lower limb. Subject was asked to relax, free both arms besides the body and to stand as stable as possible in duration 30 s, while maximally concentrating on the sticker black point, centered, and located 1,5 m in front wall in the height of the eye level (individually set up). Second test was Close Stand with closed Eyes in duration of 30 s. Besides the same body and posture position, the subject was asked to close both eyes during 30 s stand performance. Third test was unilateral stand on one lower limb, also called Flamingo test in duration of 30 s. Subject was asked to gently bend non-supportive lower limb into the air, approximately to 45° knee flexion. Eyes was open during this test. This test was performed for dominant (FLDOM) and nondominant (FLNON) lower limb separately. Dominance of the lower limb was examined and marked by verbal questioning of lateral preference of lower limb. During flamingo tests, subjects were able to choose which lower limb will be tested first. This was followed by 4 trials of Heel Rise test, which the FS recorded for 6s each. Subject was in close stand (arms free and relaxed beside the body) and by the tester command performed controlled heel rise to maximal available and comfortable height in tempo of 2 s concentric phase, 1 second stay in transfer position, and 2 s eccentric phase. Results of TTW in mm during each test were evaluated by FootScan software and assigned to individual subjects' results sheet in MS Excel (Microsoft, USA).
Data collection of calve muscle activity during static and dynamic postural stability tests was performed by surface electromyography (sEMG) by Trigno Sensors (Delsys Inc., Natick, USA) attached to the m. gastrocnemius vastus lateralis bilaterally by experienced practitioner of the laboratory. After subjects' explanation and agreement, the place of sensor application was cleaned, shaved, and again cleaned with medical cleaning cloth (Medipal, Alcohol Wipes), consequently, the sEMG sensor was attached to measurement place by original adhesive stickers from Delsys manufacturer. sEMG activity was recorded simultaneously in all tests. Sample rate of recorded signal was set at 2048 Hz with a 16-bit A/D resolution. Bandwidth of sEMG sensors was high-passed (4th-order Buterworth) at 20±5 hz and low-passed (4th-order Buterworth) at 450±5 hz for further analysis. Further sEMG data analysis was performed by EMGworks Analysis software (Delsys Inc., Natick, USA). Recorded and filtered sEMG data underwent rectification to absolute values and enveloped by window length (root mean squared; RMS) of 200 ms. For EMG activation normalization of DOM and NON lower limb individually, peak RMS muscle activity during flamingo tests (for dominant and nondominant individually) was used and applied to represent the mean RMS in percentages of sEMG activity during each test and each lower limb (%RMSmax). Using unilateral standing on one leg (Flamingo) was preferred before maximal voluntary contraction (MVC) tests of calf muscles, in order to avoid excessive muscle excitation before and during static tests and before PT application.
There was a pause (1:30min) between the 1st and 2nd measurements, during which the experimental group received triceps surae massage for 30s each. The percussive massage gun was set at 2100bpm and the pressure on the surface was 1 bar showed by the device, as indicated by the manufacturer.n During the massage the sEMG sensor were replaced for the easier access to the whole muscle group. After that it was attached to the same place as it was before. Putting it to the same spot was simplified by the fact there were visible pressure marks. The control group laid down to the same position as the experimental one and stayed like that for the same amount of time (1:30min). Afterwards they were tested once again.
- Conditions
- Ankle Injuries
- Being tested
- Percussive massage gun therapy
- Keywords
- surface electromyography, ankle injury, lower limb injury
- Medical subject headings
- Ankle Injuries, Leg Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percussive massage gun therapyDevice
Also called TheraGun
Between pre and post-test, there was a one and half minute period during which each participant were in a prone position on a medical examination bed. The experimental PT groups received a 30-second triceps surae massage on each limb, while the control group maintained the same prone position without massage. The massage gun was set to 2100bpm and 1 bar of surface pressure was indicated by the device. The massage gun movement was performed according to the manufactu'er's instructions.
| Study group | Role | What they receive |
|---|---|---|
| CAI PT | Experimental | Chronic ankle instability patient + percussive therapy intervention Receives: Device: Percussive massage gun therapy |
| CAI NOPT | No intervention | Chronic ankle instability patient + NO percussive therapy intervention (control) |
| CON PT | Experimental | Healthy subjects + percussive therapy intervention Receives: Device: Percussive massage gun therapy |
| CON NOPT | No intervention | Healthy subjects + NO percussive therapy intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percussive Therapy Reduced EMG Activity During Calf Raise in Limbs With and Without Chronic Ankle Instability.
Recorded and filtered sEMG data by Trigno Sensors (Delsys Inc., Natick, USA) underwent rectification to absolute values and enveloped by window length (root mean squared; RMS) of 200 ms (Farfan et al., 2010). For EMG activation normalization of DOM and NON lower limb individually, peak RMS muscle activity during flamingo tests (for dominant and nondominant individually) was used and applied to represent the mean RMS in percentages of sEMG activity during each test and each lower limb (%RMSmax).
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start22 Nov 2022
- Primary completion2 Feb 2023
- Study completion2 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle InjuriesStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Randomized Controlled Trial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lukáš Michal, Charles University, Czech Republic
- Investigators
- Lukas Michal, MSc., Principal investigator, Department of Pathophysiology, Charles University, Second Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06343207
- Sponsor's protocol ID
- 249637
- Status last verified
- Mar 2024
- First submitted
- 21 Mar 2024
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percussive Therapy Reduced EMG Activity During Calf Raise in Limbs With and Without Chronic Ankle Instability: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06343207
- Acronym / sponsor ID
- 249637
- Conditions
- Ankle Injuries
- Keywords
- surface electromyography, ankle injury, lower limb injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- 22 Nov 2022 (actual)
- Primary completion
- 2 Feb 2023 (actual)
- Study completion
- 2 Feb 2023 (actual)
- First posted
- 2 Apr 2024 (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.
To examine the acute effect of percussive therapy on peak calf muscle activation during standing heel raise in subjects with and without chronic ankle instability (CAI).
Detailed description
Total of 42 subjects in mean age of 23.5 ± 2.5 years participated in this research. From the original of 44 subjects, we had to discard 2 subjects (not finishing the measurement and extremely outlier data). The group was divided into 2 specific subcategories as follows - 21 patients with diagnosed CAI (CAI group; respectively) and the 21 of control group patients (HEALTHY group; respectively), including people who have never injured ankles, nor the ligaments and muscles group surrounding the ankle complex. The information and categorization based on the injury history to specific groups was performed by verbal questioning. The criteria for the CAI group were having had at least two ankle luxation or ankle distortions in the last 2 years as reported by a physician. The HEALTHY group was without this diagnosis. All the individuals involved in the testing underwent a medical examination by a sports physician at least once in a period of one year before testing. Subjects of both genders in both groups were then randomly divided (balanced ratio between male and female participants was kept) into 2 subgroups based on applied PT or not as follows: CAI YES (n=10), CAI NO (n=11), HEALTHY YES (n=10), HEALTHY NO (n=11). The probands were informed about the research process, which they also confirmed by signing an informed consent form according to Declaration of Helsinki. The master thesis research was approved by the ethical committee of Faculty of Physical Education and Sport, Charles University.
Data collection of Total Travelled Way (TTW) of Centre of Pressure (COP) during static postural stability tests was performed by pressure platform FootScan (RS Scan International, Belgium). Pressure sensors located in the platform sense load at frequencies up to 500 Hz. In particular, the parameter of Total Travelled Way of COP in mm (TTW) was evaluated and analyzed the postural stability tests consisted of two bilateral and one unilateral test.
First bilateral test was Close Stand with Open Eyes (OE) in duration of 30 s. Subject was asked to stand on pressure platform as close as possible without touching the feet, ankles, or knees between dominant, and nondominant lower limb. Subject was asked to relax, free both arms besides the body and to stand as stable as possible in duration 30 s, while maximally concentrating on the sticker black point, centered, and located 1,5 m in front wall in the height of the eye level (individually set up). Second test was Close Stand with closed Eyes in duration of 30 s. Besides the same body and posture position, the subject was asked to close both eyes during 30 s stand performance. Third test was unilateral stand on one lower limb, also called Flamingo test in duration of 30 s. Subject was asked to gently bend non-supportive lower limb into the air, approximately to 45° knee flexion. Eyes was open during this test. This test was performed for dominant (FLDOM) and nondominant (FLNON) lower limb separately. Dominance of the lower limb was examined and marked by verbal questioning of lateral preference of lower limb. During flamingo tests, subjects were able to choose which lower limb will be tested first. This was followed by 4 trials of Heel Rise test, which the FS recorded for 6s each. Subject was in close stand (arms free and relaxed beside the body) and by the tester command performed controlled heel rise to maximal available and comfortable height in tempo of 2 s concentric phase, 1 second stay in transfer position, and 2 s eccentric phase. Results of TTW in mm during each test were evaluated by FootScan software and assigned to individual subjects' results sheet in MS Excel (Microsoft, USA).
Data collection of calve muscle activity during static and dynamic postural stability tests was performed by surface electromyography (sEMG) by Trigno Sensors (Delsys Inc., Natick, USA) attached to the m. gastrocnemius vastus lateralis bilaterally by experienced practitioner of the laboratory. After subjects' explanation and agreement, the place of sensor application was cleaned, shaved, and again cleaned with medical cleaning cloth (Medipal, Alcohol Wipes), consequently, the sEMG sensor was attached to measurement place by original adhesive stickers from Delsys manufacturer. sEMG activity was recorded simultaneously in all tests. Sample rate of recorded signal was set at 2048 Hz with a 16-bit A/D resolution. Bandwidth of sEMG sensors was high-passed (4th-order Buterworth) at 20±5 hz and low-passed (4th-order Buterworth) at 450±5 hz for further analysis. Further sEMG data analysis was performed by EMGworks Analysis software (Delsys Inc., Natick, USA). Recorded and filtered sEMG data underwent rectification to absolute values and enveloped by window length (root mean squared; RMS) of 200 ms. For EMG activation normalization of DOM and NON lower limb individually, peak RMS muscle activity during flamingo tests (for dominant and nondominant individually) was used and applied to represent the mean RMS in percentages of sEMG activity during each test and each lower limb (%RMSmax). Using unilateral standing on one leg (Flamingo) was preferred before maximal voluntary contraction (MVC) tests of calf muscles, in order to avoid excessive muscle excitation before and during static tests and before PT application.
There was a pause (1:30min) between the 1st and 2nd measurements, during which the experimental group received triceps surae massage for 30s each. The percussive massage gun was set at 2100bpm and the pressure on the surface was 1 bar showed by the device, as indicated by the manufacturer.n During the massage the sEMG sensor were replaced for the easier access to the whole muscle group. After that it was attached to the same place as it was before. Putting it to the same spot was simplified by the fact there were visible pressure marks. The control group laid down to the same position as the experimental one and stayed like that for the same amount of time (1:30min). Afterwards they were tested once again.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
- Model description
- A Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| CAI PT | Experimental | Device: Percussive massage gun therapyChronic ankle instability patient + percussive therapy intervention |
| CAI NOPT | No intervention | –Chronic ankle instability patient + NO percussive therapy intervention (control) |
| CON PT | Experimental | Device: Percussive massage gun therapyHealthy subjects + percussive therapy intervention |
| CON NOPT | No intervention | –Healthy subjects + NO percussive therapy intervention |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- CAI group - at least two ankle luxation or ankle distortions in the last 2 years as reported by a physician.
- Healthy group - healthy
Key exclusion criteria (5 listed)
- paraplegia,
- women in advanced stages of pregnancy
- feverish or acute inflammatory diseases within 7 days before the measurement
- current or healed rupture of m. gastrocnemius, m. soleus, tendo calcaneus
- purulent, fungal diseases, burns, scalds, varices
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 |
|---|---|---|
| Percussive massage gun therapyAlso: TheraGunBetween pre and post-test, there was a one and half minute period during which each participant were in a prone position on a medical examination bed. The experimental PT groups received a 30-second triceps surae massage on each limb, while the control group maintained the same prone position without massage. The massage gun was set to 2100bpm and 1 bar of surface pressure was indicated by the device. The massage gun movement was performed according to the manufactu'er's instructions. | Device | CAI PT, CON PT |
Primary outcome
Percussive Therapy Reduced EMG Activity During Calf Raise in Limbs With and Without Chronic Ankle Instability.
Time frame: 1 week
Recorded and filtered sEMG data by Trigno Sensors (Delsys Inc., Natick, USA) underwent rectification to absolute values and enveloped by window length (root mean squared; RMS) of 200 ms (Farfan et al., 2010). For EMG activation normalization of DOM and NON lower limb individually, peak RMS muscle activity during flamingo tests (for dominant and nondominant individually) was used and applied to represent the mean RMS in percentages of sEMG activity during each test and each lower limb (%RMSmax).
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 2 Apr 2024.
- Individual participant dataSharing planned: No
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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.
Lukas Michal, MSc. principal investigator
Department of Pathophysiology, Charles University, Second Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percussive massage gun therapy in people with Ankle Injuries, run by Charles University, Czech Republic at 1 site in Czechia.
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 2 inclusion and 5 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 2 Apr 2024. 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 Czechia. 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?
Percussive Therapy Reduced EMG Activity During Calf Raise in Limbs With and Without Chronic Ankle Instability. (time frame: 1 week). 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 2 Apr 2024.