NCT05709808

Brief Summary

this clinical trial intended to investigate the effect of applying kinesiotaping to an ankle with mild instability in the recreational runners. the authors hypothesize that kinesiotaping might improve postural stability in those patients and facilitate returning to activity

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2021

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

April 30, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 10, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 2, 2023

Completed
Last Updated

March 22, 2023

Status Verified

March 1, 2023

Enrollment Period

3 months

First QC Date

December 10, 2022

Last Update Submit

March 17, 2023

Conditions

Keywords

ankle instabilityrecreational runnerspostural stabilityKinesio-Taping

Outcome Measures

Primary Outcomes (1)

  • postural stability

    measured by the score gained on the appropriate test on biodex balance system. this test has different difficult levels from 1 - 6 with the highest numbet indicated the easiest level. the Biodex device records the number of errors the patient achieve so the higher the patient record the lower the stability score

    4 weeks

Secondary Outcomes (1)

  • star excursion test

    4 weeks

Study Arms (3)

Mixed group

EXPERIMENTAL

This taping technique is designed to guard against lateral ankle sprains. Kinesio-tape will be applied to the unstable ankle for a lateral ankle sprain. 4 strips of the tape with different stretching percentages will be applied while the ankle joint in a relaxed position. ankle exercises will be conducted for 8 weeks, 3 times/ week, each session will last for 60 minutes. A standard proprioceptive training program will be implemented three times a week. The training includes both static and dynamic balance on Wobble board with the eyes open while the last stage will be repeated with the eyes closed.

Other: Kinesio-tapingOther: exercisesOther: mixed kinesiotape plus exercises

Exercise group

ACTIVE COMPARATOR

received exercises and proprioceptive training similar as described in the experimental group

Other: exercises

Kinesio-tape group

EXPERIMENTAL

will receive Kinesio-tape only as described in the mixed group This taping technique is designed to guard against lateral ankle sprains. Kinesio-tape will be applied to the unstable ankle for a lateral ankle sprain. 4 strips of tape with different stretching percentages will be applied while the ankle joint in a relaxed position.

Other: Kinesio-taping

Interventions

kinesiotape is a method of taping used to improve support and increase proprioceptive awareness of the joint, while the exercise program was designed to improve postural stability and balance

Kinesio-tape groupMixed group

A standard proprioceptive training program will be implemented three times a week. The training includes both static and dynamic balance on Wobble board with the eyes open while the last stage will be repeated with the eyes closed.

Exercise groupMixed group

kinesiotape is a method of taping used to improve support and increase proprioceptive awareness of the joint, while the exercise program was designed to improve postural stability and balance. A standard proprioceptive training program will be implemented three times a week. The training includes both static and dynamic balance on Wobble board with the eyes open while the last stage will be repeated with the eyes closed.

Mixed group

Eligibility Criteria

Age17 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • healthy college-age males;
  • participate regularly in running activity (1-3 times /week for the last 6 months);
  • Mild ankle instability (score within 24.5-27) according to Cumberland Ankle Instability Tool (CAIT)

You may not qualify if:

  • vestibular system problems; and presence of traumatic brain injury in the last three months;
  • fracture or surgery to lower limb;
  • drugs that affect the balance or vestibular system.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Hail

Ha'il, Ha'il Region, 81451, Saudi Arabia

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
all components of the study will be concealed to the allocation process. while the participants, investigator (who collect data), and statistician will be blinded till the end of the study
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized controlled trials contain 2 groups
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

December 10, 2022

First Posted

February 2, 2023

Study Start

April 30, 2021

Primary Completion

July 30, 2021

Study Completion

September 30, 2021

Last Updated

March 22, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

all data will be kept in a safe to keep confidentiality of the patient data

Locations