- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05313568
Self Stretching, Plantar Self Massage and Manual Stimulation on Balance and Reaction Time
Instant Effect of Self Stretching, Plantar Self Massage and Manual Stimulation on Balance and Reaction Time in Healthy Individuals
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Beykoz
-
Istanbul, Beykoz, Turkey, 34815
- Istanbul Medipol University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: static stretching group
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.
|
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.
|
Experimental: self massage group
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.
|
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.
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.
|
Experimental: Manual Stimulation Group
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). |
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.
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). |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
change in static balance immediately after application
|
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.
|
change in dynamic balance immediately after application
|
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.
|
change in dynamic balance immediately after application
|
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.
|
change in reaction time immediately after application
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Active-passive Limb Matching Test
Time Frame: change in proprioception immediately after application
|
It will be used to evaluate proprioception.
Same position mean better performance.
|
change in proprioception immediately after application
|
Goniometer
Time Frame: change in range of motion immediately after application
|
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.
|
change in range of motion immediately after application
|
Foot Posture Index
Time Frame: change in foot posture immediately after application
|
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.
|
change in foot posture immediately after application
|
Thomas test
Time Frame: change in hip flexor shortness immediately after application
|
It will be used to evaluate hip flexor shortness.
If the other leg raise, it is positive.
|
change in hip flexor shortness immediately after application
|
Pointed-blunt Test
Time Frame: change in sensory immediately after application
|
It will be used to evaluate presence of sensory problems. Higher scores mean worse performance. Scoring: Normal <6mm Fair 6-10mm Poor 11-15mm |
change in sensory immediately after application
|
Collaborators and Investigators
Investigators
- Principal Investigator: Miray BUDAK, PhD, Medipol University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Foot.Balance.ReactionTime.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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