NCT05313568

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
102

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 28, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 14, 2021

Completed
6 months until next milestone

First Posted

Study publicly available on registry

April 6, 2022

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

April 6, 2022

Status Verified

March 1, 2022

Enrollment Period

10 months

First QC Date

October 14, 2021

Last Update Submit

March 29, 2022

Conditions

Keywords

Self Stretching, Self Massage, Manual Stimulation, Balance, Reaction Time, Healthy

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    change in reaction time immediately after application

Secondary Outcomes (5)

  • Active-passive Limb Matching Test

    change in proprioception immediately after application

  • Goniometer

    change in range of motion immediately after application

  • Foot Posture Index

    change in foot posture immediately after application

  • Thomas test

    change in hip flexor shortness immediately after application

  • Pointed-blunt Test

    change in sensory immediately after application

Study Arms (3)

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.

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.

Other: static stretchingOther: 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).

Other: static stretchingOther: Manual Stimulation

Interventions

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.

Manual Stimulation Groupself massage groupstatic stretching 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.

self massage 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).

Manual Stimulation Group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University

Istanbul, Beykoz, 34815, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Muscle Stretching Exercises

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Miray BUDAK, PhD

    Medipol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 14, 2021

First Posted

April 6, 2022

Study Start

June 28, 2021

Primary Completion

May 1, 2022

Study Completion

June 1, 2022

Last Updated

April 6, 2022

Record last verified: 2022-03

Locations