Effect Of Thoracic Mobility Versus Lumbopelvic Stabilization Exercises On Patients With Chronic Ankle Instability

August 27, 2023 updated by: Yeditepe University

Effect Of Thoracic Mobility Versus Lumbopelvic Stabilization Exercises On Lower Extremity Flexibility, Dynamic Balance And Proprioception In Patients With Chronic Ankle Instability

The aim of the study is to investigate the effectiveness of thoracic mobility versus lumbopelvic stabilization exercises combined with ankle strengthening exercises with resistive band on patients with chronic ankle instability in terms of lower extremity flexibility, proprioception and dynamic balance.The participants were divided into two group as Thoracic Mobility group (n=15) and Lumbopelvic Stability group (n=15). In addition their exercise programs (2 times/wk, 8 wk duration), both groups were given home exercise ankle strengthening exercises.(3 sets/ 10 reps, 3 times/wk.)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The aim of the study is to investigate the effectiveness of thoracic mobility versus lumbopelvic stabilization exercises combined with ankle strengthening exercises with resistive band on patients with chronic ankle instability in terms of lower extremity flexibility, proprioception and dynamic balance. The study were conducted in Noi Physio Pilates Studio in Istanbul between November 2022 - January 2023 during 8 weeks. 30 volunteers with chronic ankle instability were included according to Cumberland Ankle Instability Tool (CAIT). The cut off value for the CAIT test was determined as 27. Participants who received 27 or less than this value were included in the study. All participants were right dominant. Lower extremity flexibility was assessed with Active Straight Leg Raise Test, proprioception (hip, knee, ankle) was assessed with Joint Position Sense Test using electronic goniometer. Determined angles for joints; hip flexion angle as 75°, knee flexion angle as 50° and ankle dorsiflexion as 10° plantarflexion as 40°.Y Balance Test (anterior, posterolateral, posteromedial) was used for evaluating dynamic balance. 30 participants were divided into two groups as thoracic mobility and lumbopelvic stability group. Both groups were given ankle strengthening exercises (dorsiflexion, plantarflexion, inversion and eversion) with resistive band. Home exercises were performed 3 days a week for a total of 3 sets of 10 repetitions. Thoracic mobility group was given; thoracic extension on foam roller, sidelying thoracic rotation, quadruped thoracic rotation, squat with extension and rotation. Lumbopelvic stabilization group was prescribed; bridge with alternate leg, single leg bridge, four point kneeling with arm and leg extension, side plank on front arm with knee flexed (right, left), sitting on a Swiss Ball and hip flexion.Sessions took approximately 50 minutes and exercise program was planned twice a week for 8 weeks, 16 sessions total. Both groups were given ankle strengthening exercises (dorsiflexion, plantarflexion, inversion and eversion) with resistive band. Home exercises were performed 3 days a week for a total of 3 sets of 10 repetitions.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Ataşehir
      • Istanbul, Ataşehir, Turkey
        • Noi Physio Pilates Studio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Being older than 18 years
  • Having at least two previous lateral ankle sprain of same ankle.
  • At least one episode of "giving way" wtihin previous 6 months.
  • Having persistent symptoms during functional activities and being free of.
  • Symptoms from any previous lower limb injuries.
  • No other lower extremity injuries.

Exclusion Criteria:

  • Having any systemic illness (eg. Rheumatoid arthritis, DM).
  • Any surgery history related to fractures or disorders.
  • Getting steroid injection or physiotherapy intervention previous 6 months.
  • Being a pregnant and existence of tumor.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Thoracic Mobility Group
Thoracic Mobility Exercises Ankle Strengthening Home Exercises with resistive band
Procedure: Thoracic Mobility Rehabilitation
Thoracic mobility exercises: Thoracic extension on foam roller, Sidelying thoracic rotation, Quadruped thoracic rotation, Squat with extension and rotation ( 10 reps x 3 set - 2 times x wk - 8 wk)
Procedure: Ankle Strengthening Home Exercises
Ankle Strengthening exercises with resistive band (dorsiflexion, plantarflexion, inversion, eversion) (10 reps x 3 set - 3 times/wk)
Experimental: Lumbopelvic Stability Group
Lumbopelvic stabilization exercises Ankle Strengthening Home Exercises with resistive band
Procedure: Ankle Strengthening Home Exercises
Ankle Strengthening exercises with resistive band (dorsiflexion, plantarflexion, inversion, eversion) (10 reps x 3 set - 3 times/wk)
Procedure: Lumbopelvic Stability Rehabilitation
Lumbopelvic Stabilization Exercises : Bridge with alternate leg, Single leg bridge, Four point kneeling with arm and leg extension, Side plank on front arm with knee flexed (right, left), Sitting on a Swiss Ball and hip flexion (10 reps x 3 set - 2times/wk - 8 wk)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cumberland Ankle Instability Tool (CAIT)
Time Frame: 8 weeks
CAIT is questionnaire' has 9 items with scores ranging from 0 to 30, with lower scores indicating worse stability
8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Active Straight Leg Raise Test
Time Frame: 8 weeks
It is used for evaluation of lower extremity flexibility.
8 weeks
Y Balance Test
Time Frame: 8 weeks
Dynamic balance test for right and left leg including three directions (anterior, posterolateral, posteromedial)
8 weeks
Joint Position Sense Test
Time Frame: 8 weeks
It is a test for measuring proprioception of joints. (Hip, knee, ankle)
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yeditepe University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ecem Nur TAKINDI, MSc, Yeditepe University, Institute of Health Science, Sports Physiotherapy Department
  • Study Director: Elif Tuğçe ÇİL, PhD, Yeditepe University, Institute of Health Science, Sports Physiotherapy Department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 15, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 30, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 31, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 31, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ecemnur

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Participants were included to study accorcing to Informed Consent Form (ICF). Datas and informations were recorded.

IPD Sharing Time Frame

8 week

IPD Sharing Access Criteria

Informed consent form was used for gathering demographic information from participants. Cumberland Ankle Instability Tool (CAIT) was used for assesing chronic ankle instability. Cut off value was determined as ≤27 points.

IPD Sharing Supporting Information Type

  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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