HealthyNCT05313568
Self Stretching, Plantar Self Massage and Manual Stimulation on Balance and Reaction Time
A study testing static stretching, self massage and Manual Stimulation in people with Healthy and Stretch, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the instantaneous effects of self-stretching, plantar self-massage and manual stimulation on balance and reaction time in healthy individuals. 102 individuals meeting the inclusion criteria will be included in the study. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- What is being tested?
- static stretching, self massage and Manual Stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Jun 2021to Jun 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- being between 18 and 50 years old
- having Body Mass Index (BMI) limit to be 20-25
- having Normal range of motion of the ankle joint
- having the score of the foot is between 0 and +5 according to the foot posture index,
- having the score 3+ on ankle muscle strength
Who cannot join
- being pregnant
- having undergone surgery on the foot and ankle in the last 6 months
- history of lower extremity injury with residual symptoms in the past year
- having diseases that affect the balance such as rheumatic disease, osteoarthritis, multiple sclerosis
- being professional athlete
- presence of vestibular disease (Meniere, Vertigo etc.), diabetes, neuropathy Being in
Show all 10Show fewer
- being in the menopausal period
- having hip flexor muscle shortening
- having basal ganglia disorders such as Parkinson's disease, Huntington's disease
- having sensory problems on the sole of the foot
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University
Istanbul, Beykoz, 34815
About this study
Official title: Instant Effect of Self Stretching, Plantar Self Massage and Manual Stimulation on Balance and Reaction Time in Healthy Individuals
The aim of this study is to investigate the instantaneous effects of self-stretching, plantar self-massage and manual stimulation on balance and reaction time in healthy individuals. 102 individuals meeting the inclusion criteria will be included in the study. Individuals will be randomly divided into 3 groups: static stretching group (n=34), self-massage group (n=34) and manual stimulation group (n=34). Static stretching will be applied to all individuals (n=102). In addition to static stretching, self-massage will be applied to individuals in the self-massage group (n=34). Individuals in the manual stimulation group (n=34) will receive manual stimulation in addition to static stretching. Individuals will be evaluated in terms of static balance, dynamic balance, reaction time and foot functionality before and immediately after the applications.
- Being tested
- static stretching, self massage, Manual Stimulation
- Keywords
- Self Stretching, Self Massage, Manual Stimulation, Balance, Reaction Time, Healthy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
static stretchingOther
The stretch will be done by placing both feet on a raised platform, lowering the heel off the platform without touching the ground, and held in this position to perform a static stretch. They will perform 5 repetitions, 15 seconds of rest and 1 minute of stretching.
self massageOther
In addition to the self-stretching application, plantar self-massage will be applied. Plantar self massage will be shown to the participants by the physiotherapist with a 7 cm spiky massage ball. Then, participants will be asked to self-massage the plantar sole of the foot for 5 minutes with a 7 cm spiky massage ball.
Manual StimulationOther
In addition to the self-stretching application, manual stimulation will be applied.
Manual protocol:
- Pressure will be applied in each interdigital space and on the longitudinal arch with shear in the longitudinal direction (5 repetitions of 10 seconds each).
- Pressure with transverse shear on the metatarsal heads (5 repetitions of 5 seconds each) C) Static pressure will be applied to the first and fifth metatarsal head, center of the midfoot, and heel (5 repetitions per 10-second period each).
| Study group | Role | What they receive |
|---|---|---|
| static stretching group | Active comparator | The stretch will be done by placing both feet on a raised platform, lowering the heel off the platform without touching the ground, and held in this position to perform a static stretch. They will perform 5 repetitions, 15 seconds of rest and 1 minute of stretching. Receives: Other: static stretching |
| self massage group | Experimental | In addition to the self-stretching application, plantar self-massage will be applied. Plantar self massage will be shown to the participants by the physiotherapist with a 7 cm spiky massage ball. Then, participants will be asked to self-massage the plantar sole of the foot for 5 minutes with a 7 cm spiky massage ball. Receives: Other: static stretching; Other: self massage |
| Manual Stimulation Group | Experimental | In addition to the self-stretching application, manual stimulation will be applied.
Manual protocol:
A) Pressure will be applied in each interdigital space and on the longitudinal arch with shear in the longitudinal direction (5 repetitions of 10 seconds each).
B) Pressure with transverse shear on the metatarsal heads (5 repetitions of 5 seconds each) C) Static pressure will be applied to the first and fifth metatarsal head, center of the midfoot, and heel (5 repetitions per 10-second period each). Receives: Other: static stretching; Other: Manual Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
One Leg Standing Test
It will be used to evaluate static balance. If the cut-off value is <10 seconds, there is a balance disorder, if it is <5 seconds, there is a risk of falling.
Measured: change in static balance immediately after application
Functional Reach Test
It will be used to evaluate dynamic balance. The distance that the person can reach is measured. Higher scores mean better performance.
Measured: change in dynamic balance immediately after application
Y Balance Test
It will be used to evaluate dynamic balance. The distance that the person can reach is measured. Higher scores mean better performance.
Measured: change in dynamic balance immediately after application
Nelson's Foot Reaction Time Test
It will be used to evaluate reaction time. The time that the person can react is measured. Higher scores mean worse performance.
Measured: change in reaction time immediately after application
Secondary outcomes (5)
Active-passive Limb Matching Test
It will be used to evaluate proprioception. Same position mean better performance.
Measured: change in proprioception immediately after application
Goniometer
It will be used to evaluate range of motion of ankle. Dorsiflexion range of motion is 20 degree. Plantar flexion range of motion is 50 degree. Eversion range of motion is 15 degree. Inversion range of motion is 35 degree. Higher score means better performance.
Measured: change in range of motion immediately after application
Foot Posture Index
It will be used to evaluate foot posture. Palpation of the talus head in the hindfoot, inclination under and over the lateral malleolus, pronation/supination of the calcaneus, ballooning in the talonavicular joint region in the forefoot, medial longitudinal arch structure, and abduction/adduction of the forefoot relative to the hindfoot are evaluated. Each of these criteria takes values between -2 and +2. 0 means the foot is in neutral position, positive values are interpreted as pronation, and negative values are interpreted as supination.
Measured: change in foot posture immediately after application
Thomas test
It will be used to evaluate hip flexor shortness. If the other leg raise, it is positive.
Measured: change in hip flexor shortness immediately after application
Pointed-blunt Test
It will be used to evaluate presence of sensory problems. Higher scores mean worse performance.
Scoring:
Normal <6mm Fair 6-10mm Poor 11-15mm
Measured: change in sensory immediately after application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start28 Jun 2021
- Primary completionMay 2022 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miray Budak, Istanbul Medipol University Hospital
- Investigators
- Miray BUDAK, PhD, Principal investigator, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05313568
- Sponsor's protocol ID
- Foot.Balance.ReactionTime.
- Status last verified
- Mar 2022
- First submitted
- 14 Oct 2021
- Last updated
- 6 Apr 2022
- 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 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Instant Effect of Self Stretching, Plantar Self Massage and Manual Stimulation on Balance and Reaction Time in Healthy Individuals
- ClinicalTrials.gov ID
- NCT05313568
- Acronym / sponsor ID
- Foot.Balance.ReactionTime.
- Keywords
- Self Stretching, Self Massage, Manual Stimulation, Balance, Reaction Time, Healthy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 28 Jun 2021 (actual)
- Primary completion
- May 2022 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 6 Apr 2022 (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 aim of this study is to investigate the instantaneous effects of self-stretching, plantar self-massage and manual stimulation on balance and reaction time in healthy individuals. 102 individuals meeting the inclusion criteria will be included in the study. Individuals will be randomly divided into 3 groups: static stretching group (n=34), self-massage group (n=34) and manual stimulation group (n=34). Static stretching will be applied to all individuals (n=102). In addition to static stretching, self-massage will be applied to individuals in the self-massage group (n=34). Individuals in the manual stimulation group (n=34) will receive manual stimulation in addition to static stretching. Individuals will be evaluated in terms of static balance, dynamic balance, reaction time and foot functionality before and immediately after the applications.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| static stretching group | Active comparator | Other: static stretchingThe stretch will be done by placing both feet on a raised platform, lowering the heel off the platform without touching the ground, and held in this position to perform a static stretch. They will perform 5 repetitions, 15 seconds of rest and 1 minute of stretching. |
| self massage group | Experimental | Other: static stretching, Other: self massageIn addition to the self-stretching application, plantar self-massage will be applied. Plantar self massage will be shown to the participants by the physiotherapist with a 7 cm spiky massage ball. Then, participants will be asked to self-massage the plantar sole of the foot for 5 minutes with a 7 cm spiky massage ball. |
| Manual Stimulation Group | Experimental | Other: static stretching, Other: Manual StimulationIn addition to the self-stretching application, manual stimulation will be applied. Manual protocol: A) Pressure will be applied in each interdigital space and on the longitudinal arch with shear in the longitudinal direction (5 repetitions of 10 seconds each). B) Pressure with transverse shear on the metatarsal heads (5 repetitions of 5 seconds each) C) Static pressure will be applied to the first and fifth metatarsal head, center of the midfoot, and heel (5 repetitions per 10-second period each). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- being between 18 and 50 years old
- having Body Mass Index (BMI) limit to be 20-25
- having Normal range of motion of the ankle joint
- having the score of the foot is between 0 and +5 according to the foot posture index,
- having the score 3+ on ankle muscle strength
Key exclusion criteria (10 listed)
- being pregnant
- having undergone surgery on the foot and ankle in the last 6 months
- history of lower extremity injury with residual symptoms in the past year
- having diseases that affect the balance such as rheumatic disease, osteoarthritis, multiple sclerosis
- being professional athlete
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 |
|---|---|---|
| static stretchingThe stretch will be done by placing both feet on a raised platform, lowering the heel off the platform without touching the ground, and held in this position to perform a static stretch. They will perform 5 repetitions, 15 seconds of rest and 1 minute of stretching. | Other | Manual Stimulation Group, self massage group, static stretching group |
| self massageIn addition to the self-stretching application, plantar self-massage will be applied. Plantar self massage will be shown to the participants by the physiotherapist with a 7 cm spiky massage ball. Then, participants will be asked to self-massage the plantar sole of the foot for 5 minutes with a 7 cm spiky massage ball. | Other | self massage group |
| Manual StimulationIn addition to the self-stretching application, manual stimulation will be applied. Manual protocol: A) Pressure will be applied in each interdigital space and on the longitudinal arch with shear in the longitudinal direction (5 repetitions of 10 seconds each). B) Pressure with transverse shear on the metatarsal heads (5 repetitions of 5 seconds each) C) Static pressure will be applied to the first and fifth metatarsal head, center of the midfoot, and heel (5 repetitions per 10-second period each). | Other | Manual Stimulation Group |
Primary outcome
One Leg Standing Test
Time frame: change in static balance immediately after application
It will be used to evaluate static balance. If the cut-off value is <10 seconds, there is a balance disorder, if it is <5 seconds, there is a risk of falling.
Functional Reach Test
Time frame: change in dynamic balance immediately after application
It will be used to evaluate dynamic balance. The distance that the person can reach is measured. Higher scores mean better performance.
Y Balance Test
Time frame: change in dynamic balance immediately after application
It will be used to evaluate dynamic balance. The distance that the person can reach is measured. Higher scores mean better performance.
Nelson's Foot Reaction Time Test
Time frame: change in reaction time immediately after application
It will be used to evaluate reaction time. The time that the person can react is measured. Higher scores mean worse performance.
5 secondary outcomes
Active-passive Limb Matching Test
Time frame: change in proprioception immediately after application
Goniometer
Time frame: change in range of motion immediately after application
Foot Posture Index
Time frame: change in foot posture immediately after application
Thomas test
Time frame: change in hip flexor shortness immediately after application
Pointed-blunt Test
Time frame: change in sensory immediately after application
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
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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.
Miray BUDAK, PhD principal investigator
Medipol 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 static stretching, self massage and Manual Stimulation in people with Healthy and Stretch, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
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 5 inclusion and 10 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 6 Apr 2022. 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 Turkey (Türkiye). 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?
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?
One Leg Standing Test (time frame: change in static balance immediately after application). 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?
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 6 Apr 2022.