Range of MotionNCT06227312
Effect of Whole-body Vibration on the Ankle Joint, Plantar Pressure, and Running Paramethers
A study testing LADY 1 Pro, New Life Balance and exercises in people with Range of Motion and Running, run by Gdansk University of Physical Education and Sport at 1 site in Poland.
Trial summary
The main purpose of this study was the assessment of whole-body vibration warm-up, modified drop jumps, and combination of both on the range of motion of dorsiflexion in the ankle joint and running time. Read more about this study
- Who is it for?
- Ages 34 to 42 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Range of Motion, Running, Gait
- What is being tested?
- LADY 1 Pro, New Life Balance and exercises
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 sitePoland
- Study dates
- 14 Nov 2022to 22 Dec 2022
- 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 34 to 42 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy and recreationally active males
- minimum two years of running training experience
Who cannot join
- rheumatological disease
- neurological disease
- orthopaedic disease
- genetic disease
- cardiovascular system disease
- pain in lower limbs in the last year
Show all 12Show fewer
- pain in lumbar spine in the last year
- surgeries of lower limbs in the last year
- surgeries of spine in the last year
- musculoskeletal injuries in the lower limbs in the last year
- musculoskeletal injuries in the lumbar spine in the last year
- the absence during one or more training day
Trial locations and contacts
1 site in 1 country.
Poland1 site
Gdansk University of Physical Education and Sport
Gdansk, Pomeranian Voivodeship, 80-336
About this study
The main purpose of this study was the assessment of whole-body vibration warm-up, modified drop jumps, and combination of both on the range of motion of dorsiflexion in the ankle joint and running time. 16 recreationally active runners performed 4 different warm-up variants one week apart: 5 sets of 30 s calf raises on the platform but without vibration (CTRL), the same as CTRL group but with vibration with 30 s rest intervals between sets (WBV), 6 drop jumps with a 30 s rest interval between sets (DJ); last group was combination of both WBV and DJ groups (WBV+DJ). The study included muscle flexibility tests for the soleus and gastrocnemius muscles performed before the warm-up, 3 minutes after warm-up and immediately after a 3000 m run on a treadmill. The running time was measured and the run had to be completed in the shortest possible time.
Additionally, in the third week of the study there were performed static and dynamic foot measurements immediately before and after a 3000 m treadmill run. The main purpose of that gait analysis was to assess the impact of a 3km run on plantar pressure patterns and gait parameters in recreational runners.
- Conditions
- Range of Motion, Running, Gait
- Being tested
- LADY 1 Pro, New Life Balance, exercises
- Keywords
- runners, muscle flexibility, ankle, range of motion, foot arches, plantar pressure patterns, Footscan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LADY 1 Pro, New Life BalanceDevice
whole-body vibration training on the platform
exercisesOther
calf raises and modified drop jumps
| Study group | Role | What they receive |
|---|---|---|
| warm-up intervention | Experimental | Each participant performed all warm-up variants one week apart, without the possibility of repeating:
CTRL 5 sets of 30 s calf raises on the platform but without vibration with 30 s rest intervals between sets; WBV 5 sets of 30 s calf raises on the vibration platform with 30 s rest intervals between sets; DJ 6 modified drop jump with a 30 s rest interval between sets (DJ); WBV + DJ 5 sets of 30 s calf raises on the vibration platform followed by 6 drop jumps with a 30 s rest interval between sets Receives: Device: LADY 1 Pro, New Life Balance; Other: exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ankle dorsiflexion range of motion (Gastrocnemius muscle flexibility test)
The participant laid in a supine position with his knee straight and his ankle joint off the table. The researcher 1 tested the maximum dorsiflexion of the foot and controlled the position of the knee. The researcher 2 applied the AMI digital inclinometer (OPIW, Poland) to the outer edge of the foot. The The angle of dorsiflexion was measured in degrees.
Measured: 3 times - before the warm-up, 3 minutes after warm-up and immediately after a 3000 m run
Ankle dorsiflexion range of motion (Soleus muscle flexibility test)
The participant laid in a supine position with the knee bent 90 degrees. The researcher 1 performed passive maximum dorsiflexion of the foot. The researcher 2 applied the AMI digital inclinometer (OPIW, Poland) to the outer edge of the foot. The angle of dorsiflexion was measured in degrees.
Measured: 3 times - before the warm-up, 3 minutes after warm-up and immediately after a 3000 m run
Static foot analysis (FootScan platform)
In static measurement participants stood barefoot on the Footscan platform at a designated point, assuming a relaxed and natural position, remaining still and looking straight ahead with their arms by their sides. Static paramethers include the pressure of the parts of each foot (impulse - Ns/cm).
Measured: 2 times - immediately before and after 3000 m run
Dynamic foot analysis (FootScan platform) 1
During dynamic measurement participants were asked to walk barefoot in a relaxed manner at a self-selected comfort speed, and not to look at the ground. Dynamic parametrers include foot pressure (impulse - Ns/cm).
Measured: 2 times - immediately before and after 3000 m run
Dynamic foot analysis (FootScan platform) 2
During dynamic measurement participants were asked to walk barefoot in a relaxed manner at a self-selected comfort speed, and not to look at the ground. Dynamic parametrers include gait speed (m/s).
Measured: 2 times - immediately before and after 3000 m run
Dynamic foot analysis (FootScan platform) 3
During dynamic measurement participants were asked to walk barefoot in a relaxed manner at a self-selected comfort speed, and not to look at the ground. Dynamic parametrers include walking time (s).
Measured: 2 times - immediately before and after 3000 m run
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start14 Nov 2022
- Primary completion22 Dec 2022
- Study completion22 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Range of MotionStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The participants engaged in four experimental sessions within 4 weeks. These sessions were conducted in a randomized sequence, with a one-week gap between each session. During each session, every participant performed one of the following tasks: 5 sets of 30 s calf raises on the platform but without vibration (CTRL); 5 sets of 30 s calf raises on the vibration platform with 30 s rest intervals between sets (WBV); 6 drop jump with a 30 s rest interval between sets (DJ); 5 sets of 30 s calf raises on the vibration platform followed by 6 drop jumps with a 30 s rest interval between sets (WBV + DJ).
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gdansk University of Physical Education and Sport
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paulina W Ewertowska, PhD, Study chair, Gdansk University of Physical Education and Sport
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06227312
- Sponsor's protocol ID
- AWFiS/2023_6_PE
- Status last verified
- Oct 2023
- First submitted
- 18 Oct 2023
- Last updated
- 26 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Whole-body Vibration on the Ankle Joint, Plantar Pressure, and Running Paramethers
- ClinicalTrials.gov ID
- NCT06227312
- Acronym / sponsor ID
- AWFiS/2023_6_PE
- Conditions
- Range of Motion, Running, Gait
- Keywords
- runners, muscle flexibility, ankle, range of motion, foot arches, plantar pressure patterns, Footscan
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Gdansk University of Physical Education and SportUniversity, hospital or other
- Study start
- 14 Nov 2022 (actual)
- Primary completion
- 22 Dec 2022 (actual)
- Study completion
- 22 Dec 2022 (actual)
- First posted
- 26 Jan 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.
The main purpose of this study was the assessment of whole-body vibration warm-up, modified drop jumps, and combination of both on the range of motion of dorsiflexion in the ankle joint and running time. 16 recreationally active runners performed 4 different warm-up variants one week apart: 5 sets of 30 s calf raises on the platform but without vibration (CTRL), the same as CTRL group but with vibration with 30 s rest intervals between sets (WBV), 6 drop jumps with a 30 s rest interval between sets (DJ); last group was combination of both WBV and DJ groups (WBV+DJ). The study included muscle flexibility tests for the soleus and gastrocnemius muscles performed before the warm-up, 3 minutes after warm-up and immediately after a 3000 m run on a treadmill. The running time was measured and the run had to be completed in the shortest possible time.
Additionally, in the third week of the study there were performed static and dynamic foot measurements immediately before and after a 3000 m treadmill run. The main purpose of that gait analysis was to assess the impact of a 3km run on plantar pressure patterns and gait parameters in recreational runners.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The participants engaged in four experimental sessions within 4 weeks. These sessions were conducted in a randomized sequence, with a one-week gap between each session. During each session, every participant performed one of the following tasks: 5 sets of 30 s calf raises on the platform but without vibration (CTRL); 5 sets of 30 s calf raises on the vibration platform with 30 s rest intervals between sets (WBV); 6 drop jump with a 30 s rest interval between sets (DJ); 5 sets of 30 s calf raises on the vibration platform followed by 6 drop jumps with a 30 s rest interval between sets (WBV + DJ).
| Arm | Type | Receives |
|---|---|---|
| warm-up intervention | Experimental | Device: LADY 1 Pro, New Life Balance, Other: exercisesEach participant performed all warm-up variants one week apart, without the possibility of repeating: CTRL 5 sets of 30 s calf raises on the platform but without vibration with 30 s rest intervals between sets; WBV 5 sets of 30 s calf raises on the vibration platform with 30 s rest intervals between sets; DJ 6 modified drop jump with a 30 s rest interval between sets (DJ); WBV + DJ 5 sets of 30 s calf raises on the vibration platform followed by 6 drop jumps with a 30 s rest interval between sets |
Who may qualify
- Ages
- 34 to 42 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- healthy and recreationally active males
- minimum two years of running training experience
Key exclusion criteria (12 listed)
- rheumatological disease
- neurological disease
- orthopaedic disease
- genetic disease
- cardiovascular system disease
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 |
|---|---|---|
| LADY 1 Pro, New Life Balancewhole-body vibration training on the platform | Device | warm-up intervention |
| exercisescalf raises and modified drop jumps | Other | warm-up intervention |
Primary outcome
Ankle dorsiflexion range of motion (Gastrocnemius muscle flexibility test)
Time frame: 3 times - before the warm-up, 3 minutes after warm-up and immediately after a 3000 m run
The participant laid in a supine position with his knee straight and his ankle joint off the table. The researcher 1 tested the maximum dorsiflexion of the foot and controlled the position of the knee. The researcher 2 applied the AMI digital inclinometer (OPIW, Poland) to the outer edge of the foot. The The angle of dorsiflexion was measured in degrees.
Ankle dorsiflexion range of motion (Soleus muscle flexibility test)
Time frame: 3 times - before the warm-up, 3 minutes after warm-up and immediately after a 3000 m run
The participant laid in a supine position with the knee bent 90 degrees. The researcher 1 performed passive maximum dorsiflexion of the foot. The researcher 2 applied the AMI digital inclinometer (OPIW, Poland) to the outer edge of the foot. The angle of dorsiflexion was measured in degrees.
Static foot analysis (FootScan platform)
Time frame: 2 times - immediately before and after 3000 m run
In static measurement participants stood barefoot on the Footscan platform at a designated point, assuming a relaxed and natural position, remaining still and looking straight ahead with their arms by their sides. Static paramethers include the pressure of the parts of each foot (impulse - Ns/cm).
Dynamic foot analysis (FootScan platform) 1
Time frame: 2 times - immediately before and after 3000 m run
During dynamic measurement participants were asked to walk barefoot in a relaxed manner at a self-selected comfort speed, and not to look at the ground. Dynamic parametrers include foot pressure (impulse - Ns/cm).
Dynamic foot analysis (FootScan platform) 2
Time frame: 2 times - immediately before and after 3000 m run
During dynamic measurement participants were asked to walk barefoot in a relaxed manner at a self-selected comfort speed, and not to look at the ground. Dynamic parametrers include gait speed (m/s).
Dynamic foot analysis (FootScan platform) 3
Time frame: 2 times - immediately before and after 3000 m run
During dynamic measurement participants were asked to walk barefoot in a relaxed manner at a self-selected comfort speed, and not to look at the ground. Dynamic parametrers include walking time (s).
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 26 Jan 2024.
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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.
Paulina W Ewertowska, PhD study chair
Gdansk University of Physical Education and Sport
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LADY 1 Pro, New Life Balance and exercises in people with Range of Motion and Running, run by Gdansk University of Physical Education and Sport at 1 site in Poland.
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 12 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 26 Jan 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 Poland. 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?
Ankle dorsiflexion range of motion (Gastrocnemius muscle flexibility test) (time frame: 3 times - before the warm-up, 3 minutes after warm-up and immediately after a 3000 m run). The study lists 6 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 26 Jan 2024.