NCT04599985

Brief Summary

The ankle joint sustains injuries particularly in athletics/sports activities at a high rate, resulting in loss of static \& dynamic balance, neuromuscular control, and diminished lower extremity's function. This study aimed to compare the effectiveness of two balance-training protocols on balance, proprioception, range of motion (ROM), and pain in male athletes with chronic ankle instability (CAI). Both the balance training protocols were proven to be equally effective in improving the static \& dynamic balance, proprioception, ROM, and pain in athletes with CAI.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

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 10, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 19, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 21, 2019

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 23, 2020

Completed
Last Updated

October 23, 2020

Status Verified

October 1, 2020

Enrollment Period

3 months

First QC Date

October 12, 2020

Last Update Submit

October 18, 2020

Conditions

Outcome Measures

Primary Outcomes (5)

  • Static Balance

    Static balance assessed by single-leg stance time test with eyes open and closed. It measures the time (in sec) taken by an individual to uphold their base of support with minimal movement while standing on single leg.

    4-weeks

  • Proprioception

    Assessed by foot position sense. Foot position sense recorded by placing the ankle joint of non-affected side in some degrees of either dorsiflexion or plantarflexion, and asking athlete to match the position with the affected ankle with eyes closed. Angle of difference in the position of ankles was noted in degrees.

    4-weeks

  • Pain intensity,

    assessed by Visual Analog Scale (VAS). A 10-cm horizontal line marked with 0 (no pain) and 10 (worst pain) on its either end.

    4-weeks

  • Ankle Range of motion

    Assessed by hand held half-circle goniometer marked with 0 and 180 degree at either end. It has two arm named as stable arm which is fixed in line with the axis of the non-movable arm and movable arm of goniometer is fixed with the movable arm of the body. It is measured in degree.

    4-weeks

  • Dynamic balance

    The dynamic balance assessed by Star Excursion Balance Test (SEB test) where an individual was asked to stand barefooted on the affected leg and attempt to reach farthest in all 8-directions one by one with the swing leg and return to the starting position while maintaining the balance on the stance leg. Either falling of swing leg or the deviation of stance-leg from its fixed place while attempting to reach farthest in a particular direction and reaching to its starting position considered as a foul to the test and discarded the reading until correct reach performed.

    4-weeks

Study Arms (2)

Star excursion balance training (SEBT)

EXPERIMENTAL

Received star excursion balance training (SEBT) program. Performed 3-trials in all 8 directions of the SEBT grid.

Other: star excursion balance training (SEBT)

Simplified star excursion balance training (SSEBT)

ACTIVE COMPARATOR

Received simplified star excursion balance training (SSEBT) program. Performed 3-trials in all 3 directions of SSEBT grid.

Other: Simplified star excursion balance training (SSEBT)

Interventions

The SEBT is aimed to be maintained the single limb stance on one leg while reaching farthest possible with the swing leg. An individual can reach farthest with the swing leg while maintaining the balance on the stance leg

Star excursion balance training (SEBT)

It is one of the training protocols, in a simplified way, with respect to star excursion balance test. It consists a series of reaching tasks for the lower limbs in three-directions i.e., anteromedial, medial and posteromedial.

Simplified star excursion balance training (SSEBT)

Eligibility Criteria

Age18 Years - 24 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsYoung adult athletes with chronic ankle instability
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Self-reported case of unilateral CAI with grade I \& II verified on CT/MRI by orthopedic surgeon;
  • Aged between 18-25 years;
  • Onset between 2 to 6 months;
  • Exhibited enough strength and flexibility of lower extremity, available ankle ROM, and coordination to execute SEBT and SSEBT.

You may not qualify if:

  • Self-reported case of bilateral CAI;
  • Grade III ankle sprain;
  • No past injuries to the lower extremity including ankle sprain within 2-months prior to the commencement of the study;
  • Exhibited any neurological, vestibular, and visual disorder;
  • Showed muscle tightness, muscle weakness and joint stiffness of lower extremity;
  • History of fracture to the ankle; and
  • Showed non-cooperation for the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rehabilitation Research Chair

Riyadh, 11433, Saudi Arabia

Location

Study Officials

  • AMIR IQBAL, MPT-Ortho

    Rehabilitation Research Chair, CAMS, King Saud University, Riyadh, Saudi Arabia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two-arm, parallel groups randomized comparative Trial.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 12, 2020

First Posted

October 23, 2020

Study Start

March 10, 2019

Primary Completion

June 19, 2019

Study Completion

October 21, 2019

Last Updated

October 23, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations