NCT07078916

Brief Summary

This study aims to evaluate the effect of one-leg balance activity (OLBA) combined with visual feedback using BlazePod™ as a dual motor-cognitive rehabilitation task in basketball players with Chronic Ankle Instability (CAI). The intervention will be compared to OLBA alone as a motor task. Outcomes measured include dynamic balance, sense of instability, response time, athletic performance, and self-reported physical function. This study will help improve rehabilitation strategies for athletes suffering from ankle instability.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet 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

First Submitted

Initial submission to the registry

July 14, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 22, 2025

Completed
10 days until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

July 22, 2025

Status Verified

July 1, 2025

Enrollment Period

6 months

First QC Date

July 14, 2025

Last Update Submit

July 14, 2025

Conditions

Keywords

Ankle Injuries [MeSH]Ankle SprainChronic Ankle InstabilityBasketball PlayersBalance Rehabilitation [MeSH]Motor Skills [MeSH]Cognitive Training [MeSH]Visual FeedbackBlazePodDual-task TrainingDynamic BalanceMotor-Cognitive TrainingReaction Time

Outcome Measures

Primary Outcomes (4)

  • Dynamic balance

    Dynamic balance will be assessed using the Y-Balance Test, a reliable and valid tool for measuring postural control in three directions: anterior, posteromedial, and posterolateral. The participant will be asked to stand on the injured leg, then using another leg to reach the maximal point along the line in the three different directions, the directions named concerning the contact leg. The length of the line is normalized by the length of the patient's limb which is measured from ASIS to the medial malleolus. The goal of this test is to reach maximum excursion in every direction without shifting weight to or coming to rest on this foot of the reaching limb and then return the reaching limb to the beginning position in the center. Three trials in each direction to be familiarized. Actual trials will be 3 trials and best score will be calculated, The test will be conducted at baseline and after 4 weeks of intervention.

    At baseline and after 4 weeks of intervention

  • Sense of instability

    Sense of ankle instability will be assessed using the Cumberland Ankle Instability Tool (CAIT), Consist of 32 points with a score less than 24 indicating CAI according to the International Ankle Consortium. The tool will be used in the Arabic version. The participants will be asked to choose the most suitable answer, with lower scores indicating greater perceived instability.

    The CAIT will be administered at baseline and after 4 weeks of intervention.

  • Response time.

    Response time will be measured through the BlazePod™ application, BlazePod™ is a method of motor learning assessment and cognitive motor training. BlazePod™ sensors are reactive lights that turn off or deactivate with contact, They are controlled via smartphone applications using Bluetooth low energy technology and allow for full customization of 10 colored lights which record time variables from activation until deactivation. In this scenario, pods will activate automatically and randomly with a timer and deactivate with the impact of the foot touching the top. Lower response time means better motor learning and is calculated automatically through the BlazePod application.

    Assessment will be conducted at baseline and after 4 weeks of intervention

  • Self-reported physical function

    Self-reported physical function will be assessed using the Sport subscale of the Foot and Ankle Ability Measure (FAAM), a validated tool for evaluating functional limitations related to sports activities in individuals with foot and ankle disorders. The Sport subscale consists of 8 items, he response to each item on the Sports subscale is scored from 4 to 0, with 4 being "no difficulty" and 0 being "unable to do", scores on each item are added together to get the item score total, the highest potential score of the questioner is 32, The item score total is divided by the highest potential score. This value is multiplied by 100 to get a percentage, A higher score represents a higher level of physical function. with higher scores indicating better function. FAAM sport subscale will be used in Arabic version.

    The questionnaire will be administered at baseline and after 4 weeks of intervention.

Study Arms (2)

Motor-Cognitive Training Group (OLBA + BlazePod™)

EXPERIMENTAL

Participants in this group will perform one-leg balance activities combined with visual feedback using BlazePod™

Behavioral: Motor-Cognitive Training Group (OLBA + BlazePod™)

Motor Training Group (OLBA Only)

ACTIVE COMPARATOR

Participants in this group will perform one-leg balance activities without any visual feedback.

Behavioral: Motor Training Group (OLBA Only)

Interventions

Arm 1 participant will receive the One-leg-balance activity using visual feedback BlazePod technology as a dual motor-cognitive task training.

Motor-Cognitive Training Group (OLBA + BlazePod™)

Arm 2 participant will receive a the One-leg-balance activity as a single motor task.

Motor Training Group (OLBA Only)

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Young adult basketball athletes aged between (18 - 30) years.
  • A history of unilateral one or more significant ankle inversion injury occurred at least 1 year before participation in the study.
  • Interruption of physical activity or cessation from training for at least 24 hours following injury.
  • Report episodes of giving way and sense of instability of the affected ankle.
  • Two episodes of giving way or/ recurrent inversion injury should be reported by the patient before study enrollment at least two times in the last 6 months.
  • Cumberland Ankle Instability Tool (CAIT) patient scores \< 24.

You may not qualify if:

  • A history of previous surgery or fracture to musculoskeletal structure (bone, joint, etc.) in the limb of the affected ankle.
  • Acute lower limb sprain in the last 3 months before enrollment in the study resulting in interruption of physical activity for 1 day.
  • Any disorder or disease that could affect the balance as vestibular disorders, eye injury, and so on.
  • Any athlete who participates in any formal or informal rehabilitation.
  • If they received NSAID 2 weeks before enrollment in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aman physical therapy center

Alexandria, 21532, Egypt

Location

MeSH Terms

Conditions

Ankle Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Study Officials

  • nasr awad abdelkader, Ph.D. in Physical Therapy

    Assistant Professor of Physical Therapy for Musculoskeletal Disorders and its Surgeries, Faculty of Physical Therapy, Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

moaid mohamed elzarka, Bachelor of Physiotherapy

CONTACT

afaf mohamed tahoon, Ph.D. in Physical Therapy

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Double-blind parallel design randomized control study with allocation ratio 1:1
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of Physical Therapy for Musculoskeletal Disorders and its Surgeries, Faculty of Physical Therapy, kafrelsheikh University

Study Record Dates

First Submitted

July 14, 2025

First Posted

July 22, 2025

Study Start

August 1, 2025

Primary Completion

February 1, 2026

Study Completion

April 1, 2026

Last Updated

July 22, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations