NCT04264611

Brief Summary

The purpose of the study was to compare the effects of towel curl exercises and short foot exercises on pedobarographic parameters and balance. 91 healthy students (63 females, 28 males) with mean age of 20,65±2,41 years who attend to Muğla Sıtkı Koçman University, Faculty of Health Sciences and met the inclusion criteria and volunteered to participate included in this randomized controlled study. Participants were randomly divided into, Short Foot Exercise(n=28), Towel Curl Exercise (n=31) and Control Groups (n=32). Participant's demographic information were recorded, foot number measurement, navicular drop test, metatarsal width measurement, static and dynamic pedobarographic evaluations, and the balance evaluation were performed. Following the initial assessment, participants who included in Short Foot and Towel Curl Exercise Group performed the exercises that they were assigned to under the supervision of a physiotherapist for 4 weeks and no exercise was given to the control group. After the completion of 4 weeks all the initial assessments were repeated in all groups.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
91

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2018

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

February 7, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 11, 2020

Completed
Last Updated

February 11, 2020

Status Verified

February 1, 2020

Enrollment Period

4 months

First QC Date

February 7, 2020

Last Update Submit

February 7, 2020

Conditions

Keywords

Foot Core SystemPlantar Intrinsic Foot MusclesShort Foot ExerciseTowel Curl ExerciseMedial Longitudinal ArchPedobarography;Balance

Outcome Measures

Primary Outcomes (4)

  • Measuring navicular drop distance

    The individual was placed on a stool with the bare foot, hip, knee and ankle flexed 90 degrees with the foot in full contact with the floor and was asked to look at a fixed point opposite. In this position the navicular tubercle was determined with the erasable pen and the navicular height above the ground was marked on an index card. Then, the individual was asked to stand up without changing the position of her/his heels and while standing, the navicular tubercle was again determined and its height above the ground was marked on the index card. The distance between the navicular heights marked on the index card in the sitting and standing positions was measured with the help of the INSIZE® 1108-200 digital caliper and recorded as navicular drop distance in mm.

    3 minutes

  • Measuring metatarsal width

    Metatarsal width was recorded by measuring the extreme distance between the medial soft tissue line at the first metatarsal head level and the lateral soft tissue line at the fifth metatarsal head level. It was measured using the INSIZE® 1108-200 digital caliper for both feet while giving equal weight to both lower extremities in the sitting position at 90 degrees flexion of the hip, knee and ankle joints and giving equal weight to both lower extremities in the standing position. Metatarsal width in sitting and standing positions were recorded and the difference between them was calculated and recorded as the amount of metatarsal enlargement in mm.

    3 minutes

  • Pedobarographic evaluation

    Diagnostic Support Electronic Baropodometer and Milletrix software (DIASU®, Italy) were used for static and dynamic pedobarographic measurements to evaluate foot plantar pressure distrubution. Static measurements were made with the patient standing on a platform with pressure sensor, with two bare feet, in a loose standing position, looking at a fixed point opposite. The dynamic measurements were made after the individuals performed a trial walk on the platform once. Individuals were asked to walk self- selected speed and pattern. The average values of 4 dynamic measurements were taken for both foot and the results were recorded.

    10 minutes

  • Balance evaluation

    Static and dynamic balances of individuals on double and single legs were evaluated using SportKAT® Model 650-TS, LLC, USA. The monitor was positioned 130 cm forward and at the eye level of the subject. Individuals standing on the platform whose pressure was set to 6 PSI and they were asked to position their arms across the shoulders. The test was canceled and repeated in the event that individuals arms were distorted or they fall off the platform.

    10 minutes

Secondary Outcomes (1)

  • Foot size

    1 minute

Study Arms (3)

Short Foot Exercise Group

EXPERIMENTAL

The group that received the short foot exercise

Other: Experimental: Short Foot Exercise Group

Towel Curl Exercise Group

EXPERIMENTAL

The group that received the towel curl exercise

Other: Experimental: Towel Curl Exercise Group

Control Group

NO INTERVENTION

The group that received no exercise

Interventions

Short foot exercise which was performed under the supervision of physiotherapist for four weeks in 30 repetitions five days a week.

Short Foot Exercise Group

Towel curl exercise which was performed under the supervision of physiotherapist for four weeks in 30 repetitions five days a week.

Towel Curl Exercise Group

Eligibility Criteria

Age18 Years - 34 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Be over 18 years old
  • Sign informed consent form
  • Have not experienced towel curl exercise and short foot exercise

You may not qualify if:

  • Any sign of foot pain
  • The presence of problems affecting the foot such as diagnosed patellofemoral pain syndrome, plantar fasciitis, anterior or posterior tibialis dysfunction
  • In the last 6 months; presence of injury or surgical operation of the lower extremity
  • Lower limb length inequalities that affect gait
  • The presence of a systemic, neurological, orthopedic disease or deformity that will affect motor function, balance and gait

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lokman Hekim University

Ankara, Çankaya, 06510, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Foot InjuriesDisease

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and InjuriesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant, Physical Therapist

Study Record Dates

First Submitted

February 7, 2020

First Posted

February 11, 2020

Study Start

March 1, 2018

Primary Completion

June 30, 2018

Study Completion

August 28, 2018

Last Updated

February 11, 2020

Record last verified: 2020-02

Locations