NCT07689747

Brief Summary

Chronic ankle instability (CAI) is associated with recurrent ankle sprains, impaired postural control, and reduced functional performance. Traditional functional performance tests are commonly used to assess athletes with CAI; however, these assessments are typically conducted under isolated motor conditions and may not adequately reflect the neurocognitive demands encountered during sports participation. The aim of this randomized crossover study is to investigate the acute effects of neurocognitively enriched testing conditions on balance and functional performance in athletes with CAI. Participants will perform functional performance tests under four different conditions: standard testing, internal focus of attention, external focus of attention, and cognitive dual-task conditions. Dynamic balance, vertical jump performance, single-leg hop performance, figure-of-8 hop performance, and dual-task cost will be assessed and compared across conditions. The findings of this study may contribute to the development of more ecologically valid assessment approaches for athletes with CAI and provide insights into the influence of attentional focus and cognitive load on functional performance.

Trial Health

77
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
3mo left

Started Jun 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress35%
Jun 2026Nov 2026

Study Start

First participant enrolled

June 8, 2026

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

June 13, 2026

Completed
25 days until next milestone

First Posted

Study publicly available on registry

July 8, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 8, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 8, 2026

Last Updated

July 8, 2026

Status Verified

July 1, 2026

Enrollment Period

4 months

First QC Date

June 13, 2026

Last Update Submit

July 5, 2026

Conditions

Keywords

Chronic Ankle Instability (CAI)Dynamic BalanceAttentional Focusdual task

Outcome Measures

Primary Outcomes (1)

  • Dynamic Balance Performance

    Dynamic balance performance assessed using the Y Balance Test under standard, internal focus of attention, external focus of attention, and cognitive dual-task conditions.

    Day 1 (during the study assessment session)

Secondary Outcomes (3)

  • Vertical Jump Performance

    Day 1 (during the study assessment session)

  • Figure-of-8 Hop Performance

    Day 1 (during the study assessment session)

  • Dual-Task Cost

    Day 1 (during the study assessment session)

Study Arms (4)

Standard Testing Condition

EXPERIMENTAL

Participants perform all functional performance tests under standard testing conditions without attentional focus instructions or additional cognitive tasks. This condition serves as the reference condition for comparison with neurocognitively enriched testing conditions.

Behavioral: Standard Testing Condition

Internal Focus of Attention Condition

EXPERIMENTAL

Participants perform all functional performance tests while receiving internal focus of attention instructions directing attention toward body movements, joint positions, and movement control.

Behavioral: Internal Focus of Attention

External Focus of Attention Condition

EXPERIMENTAL

Participants perform all functional performance tests while receiving external focus of attention instructions directing attention toward movement outcomes and environmental targets.

Behavioral: External Focus of Attention

Cognitive Dual-Task Condition

EXPERIMENTAL

Participants perform all functional performance tests while simultaneously completing a cognitive task involving backward repetition of number sequences to increase cognitive load

Behavioral: Cognitive Dual-Task Condition

Interventions

Participants perform functional performance tests under standard testing conditions without attentional focus instructions or additional cognitive tasks. This condition serves as the reference condition for comparison with neurocognitively enriched testing conditions

Standard Testing Condition

Participants perform functional performance tests while receiving internal focus of attention instructions directing attention toward body movements, joint positions, and movement control during task execution.

Internal Focus of Attention Condition

Participants perform functional performance tests while receiving external focus of attention instructions directing attention toward movement outcomes and environmental targets during task execution.

External Focus of Attention Condition

Participants perform functional performance tests while simultaneously completing a cognitive task involving backward repetition of number sequences, increasing cognitive load during motor performance.

Cognitive Dual-Task Condition

Eligibility Criteria

Age16 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Aged between 16 and 25 years.
  • Actively participating as a licensed football, basketball, or volleyball athlete.
  • History of at least one lateral ankle sprain occurring ≥12 months before study participation, associated with pain and/or swelling and resulting in at least one day of restricted physical activity.
  • History of recurrent ankle instability, defined as at least two episodes of giving way during the previous 6 months and/or recurrent ankle sprains.
  • Cumberland Ankle Instability Tool (CAIT) score ≤25.
  • Participating in regular sports training at least 3 times per week.
  • No ankle surgery within the previous 6 months.
  • Able to safely perform all functional performance tests.
  • Willing to undergo assessment of the more symptomatic ankle; in participants with bilateral chronic ankle instability, the ankle with the lower CAIT score will be evaluated.

You may not qualify if:

  • Acute ankle sprain within the previous 6 weeks accompanied by significant pain, swelling, or functional limitation.
  • History of major lower-extremity surgery (e.g., knee, hip, or ankle surgery).
  • History of neurological, vestibular, or systemic disorders that may affect balance or motor performance.
  • Visual or cognitive impairments that could interfere with test performance.
  • Lower-extremity injuries other than ankle instability within the previous 6 months that may negatively affect functional performance.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Nisantasi University

Istanbul, Sarıyer, 34453, Turkey (Türkiye)

RECRUITING

Central Study Contacts

Elif Aleyna Yazgan, Phd

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
CROSSOVER
Model Details: This study uses a randomized within-subject crossover design in which all participants are exposed to four experimental conditions: standard testing, internal focus of attention, external focus of attention, and cognitive dual-task conditions. The order of the conditions is randomized and counterbalanced using a Latin-square design to minimize potential order, learning, and carry-over effects. Each participant serves as their own control, allowing direct comparison of performance outcomes across conditions.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research assistant

Study Record Dates

First Submitted

June 13, 2026

First Posted

July 8, 2026

Study Start

June 8, 2026

Primary Completion (Estimated)

October 8, 2026

Study Completion (Estimated)

November 8, 2026

Last Updated

July 8, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be made publicly available in order to maintain participant confidentiality and comply with institutional ethical requirements.

Locations