NCT06041243

Brief Summary

Ankle sprains are common injuries in physically active individuals who are involved in sports such as soccer and volleyball. It is also frequently seen in sedentary individuals who are not physically active and in people who engage in recreational sports. The recurrence rate of lateral ankle sprains has been shown to be 80%. Functional Ankle Instability can be defined as recurrent ankle sprain and/or a "giving away sensation" happens after the initial sprain. Conservative treatments are recommended to prevent recurrent injuries and to return to activity after stability, since the group that usually experiences a feeling of stability consists of young people. As a treatment, sensory and cognitive notifications and exercise applications that involve progression by increasingly challenging the individual, including reducing the support surface and changing the center of gravity, are recommended. The Balance Board is a simple, cheap and applicable tool used to improve balance in treatment. In addition to improving balance, it reduces ankle sprains by up to 50%. The balance board can train the ankle unidirectionally or multiaxially. Unidirectional balance usually allows uniaxial movement based on a flat wood and a semicircle underneath. Multiaxial balance board systems are systems that allow multi-directional movement in all axes regardless of the position of the foot. It was reported that the performance gained as a result of the use of the multiaxial balance board was long-lasting and showed a rapid recovery in injuries. It has been concluded that balance training with a balance board restores the normal neuromuscular feedback loop by improving mechanoreceptor function, which contributes to the retraining of the sensorimotor system. The use of game elements in treatment is defined as gamification and is a cheap and alternative method to perform various medical procedures. The increasing interest in gamification is due to lack of compliance with traditional treatment, increase in health care costs and inequitable access to health care. Musculoskeletal disorders are one of the leading causes of physical disability worldwide and gamification can be useful in various musculoskeletal rehabilitation such as tendonitis, degenerative joint disorders, neural compressions. Games are more attractive to patients and provide therapists with a wide range of alternatives for rehabilitation, making the treatment more dynamic and attractive. The aim of our study was to investigate the effects of the exercise method on ankle stability, ankle functionality and enjoyment level of exercise in individuals with functional ankle instability.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

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

First Submitted

Initial submission to the registry

September 11, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

September 11, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 18, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2024

Completed
Last Updated

June 4, 2024

Status Verified

June 1, 2024

Enrollment Period

5 months

First QC Date

September 11, 2023

Last Update Submit

June 3, 2024

Conditions

Keywords

ankle instabilitygame-based exercisespostural balancephysical performancerecreational athletes

Outcome Measures

Primary Outcomes (1)

  • Star Excursion Balance Test

    Straight lines are drawn on the floor in anterior, posterolateral and posteromedial directions. The individual is in the middle of these directions with the leg with instability on the floor. The other leg is asked to reach in these directions. The individual is asked to reach each of these four directions three times and the average is taken.

    4 weeks

Secondary Outcomes (9)

  • Foot Lift Test

    4 weeks

  • Static Balance

    4 weeks

  • 8 Figure Jump Test

    4 weeks

  • Side Jump Test

    4 weeks

  • Short Form-12 Quality of Life Scale

    4 weeks

  • +4 more secondary outcomes

Study Arms (2)

Treatment

EXPERIMENTAL

Game-based balance exercises on BoBo Home Balance Board

Other: Game-Based Exercises

Control

NO INTERVENTION

Interventions

Exercises aimed to improve postural balance with four different games

Treatment

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Participating recreational sports and doing at least 1.5 hours of cardiovascular or resistance training per week,
  • History of one or more ankle sprains,
  • Functional Ankle Instability Definition (FABIT) score \>11,
  • Having experienced a sprain/loss of instability in the last 6 months,
  • Volunteering to attend the study.

You may not qualify if:

  • History of an active injury in both lower extremities,
  • History of surgery or fracture in both lower extremities,
  • Visual, auditory and vestibular problems,
  • Neurological and rheumatologic diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Acıbadem Mehmet Ali Aydınlar University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Ankle Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 11, 2023

First Posted

September 18, 2023

Study Start

September 11, 2023

Primary Completion

February 15, 2024

Study Completion

February 15, 2024

Last Updated

June 4, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations