NCT07283276

Brief Summary

The purpose of the study is to investigate dynamic core stability training versus cognitive training on balance, functional performance, postural control, ankle instability scores, ankle dorsiflexion range of motion, and mental workload in chronic ankle instability

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
45

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
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2025

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 15, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

December 15, 2025

Status Verified

December 1, 2025

Enrollment Period

6 months

First QC Date

December 2, 2025

Last Update Submit

December 2, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • assessment of change of pain

    Ankle pain will be evaluated using the Arabic version of the Cumberland Ankle Instability Tool, which consists of questions that the patient must answer to reflect their condition. The scoring ranges from 0 to 30, with 0 indicating severe instability and 30 indicating normal stability. A score below 24 suggests Chronic Ankle Instability as defined by the International Ankle Consortium

    at baseline and after 2 months

  • assessment of ankle instability

    Ankle instability will be evaluated using the Arabic version of the Cumberland Ankle Instability Tool, which consists of questions that the patient must answer to reflect their condition. The scoring ranges from 0 to 30, with 0 indicating severe instability and 30 indicating normal stability. A score below 24 suggests Chronic Ankle Instability as defined by the International Ankle Consortium

    at baseline and after 2 months

Secondary Outcomes (6)

  • assessment of foot function

    at baseline and after 2 months

  • assessment of functional performance

    at baseline and after 2 months

  • assessment of postural control

    at baseline and after 2 months

  • assessment of balance

    at baseline and after 2 months

  • assessment of Dorsiflexion range of motion

    at baseline and after 2 months

  • +1 more secondary outcomes

Study Arms (3)

core stability

EXPERIMENTAL

they will receive traditional program plus functional core stability exercise

Other: strengthening exercisesOther: Balance trainingOther: Functional core trainingOther: Spinal motor control (stabilization) exercises

cognitive training

EXPERIMENTAL

they will receive traditional program plus cognitive training

Other: strengthening exercisesOther: Balance trainingOther: Cognitive training

Core stability and cognitive training

ACTIVE COMPARATOR

they will receive traditional program plus functional core training plus cognitive training

Other: strengthening exercisesOther: Balance trainingOther: Functional core trainingOther: Spinal motor control (stabilization) exercisesOther: Cognitive training

Interventions

Stretch the gastrocnemius and soleus muscles for 30 seconds with 3 repetitions. Strengthen all ankle muscles using TheraBand resistance for various movements (dorsiflexion, plantar flexion, inversion, and eversion) and combined movements for 3 sets of 10 repetitions, three sessions weekly for two months. The training program includes progression from seated to standing for stretching and single-limb for bipedal calf raises.

Core stability and cognitive trainingcognitive trainingcore stability

Challenging disc training, utilized in balance studies, begins with participants standing with slightly bent knees. The dynamic balance training comprises 9 protocols focused on tracking a moving red circular target zone using a green point cursor that represents the center of pressure. Participants shift their body weight in various directions with visual feedback on a computer screen. Over 8 weeks, participants complete 16 sessions, each lasting 20 seconds with 7 seconds of rest in between. The time spent correctly tracking the target is measured and analyzed across all protocols.

Core stability and cognitive trainingcognitive trainingcore stability

Participants will receive functional core motor control (stabilization) exercise and the traditional program (consisting of stretching protocol, strengthening of all ankle muscles, and balance activities) 3 sessions per week for 2 months.

Core stability and cognitive trainingcore stability

The training program consists of three phases: 1. \*\*Cognitive Phase (Weeks 1-2):\*\* Focuses on isolating the transversus abdominis and multifidus muscles using a biofeedback pressure device. Exercises involve isometric contractions with 10-second holds, repeated four times daily. 2. \*\*Associative Phase (Weeks 3-4):\*\* Introduces less stable exercises (e.g., quadruped and standing positions) aimed at enhancing spine neutrality. 3. \*\*Automatic Phase (Weeks 5-8):\*\* Involves dynamic movements that integrate spine control with extremity movements. Key exercises include lunges with a medicine ball, squats, and various plank variations, emphasizing co-contraction of core muscles for stability during movements.

Core stability and cognitive trainingcore stability

Balance training is combined with a cognitive task involving a backward digit span test, where participants must recall and repeat sequences of numbers in reverse order, testing working memory. This test includes three difficulty levels (3-, 4-, and 5-digit sequences) performed over 35 seconds. Participants will either recall digits while maintaining static stability or after squatting upon hearing a number, with a focus on accuracy within 5 seconds. Performance is measured by the percentage of correctly recalled digits, and error scoring will be documented via video recording for each posture task.

Core stability and cognitive trainingcognitive training

Eligibility Criteria

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

You may qualify if:

  • History of chronic lateral ankle sprain and/or recurrent sprain and/or "feelings of instability or giving way" for 6 months or more before the study, with at least 2 episodes.
  • Patients are between 18 and 30 years old. 3- Body mass index less than 30
  • \. The patient has a history of at least one significant ankle sprain with associated inflammatory symptoms and at least one day of interrupted physical activity.
  • \. Patients who have unilateral chronic ankle instability. 6. Self-reported ankle instability should be confirmed using a validated ankle instability questionnaire (greater than 24).

You may not qualify if:

  • Those with a history of spine, pelvis, and lower extremity injury, fracture, or surgery 2- Those with low back pain that require medical or surgical intervention. 3- Having a history of an acute lower extremity injury or lower extremity surgery or fracture in the 3 months before the Study 4. Participation in formal ankle rehabilitation in the 3 months before the study.
  • \. Being diagnosed with neurologic dysfunction, such as multiple sclerosis, Parkinson's disease, or head injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

out-patient clinic, faculty of physical therapy, Cairo university

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

ExerciseCognitive Training

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaNeurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Central Study Contacts

Manar Mahmoud Mohamed, Assistant lecturer

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

December 2, 2025

First Posted

December 15, 2025

Study Start

August 15, 2025

Primary Completion

February 1, 2026

Study Completion

March 1, 2026

Last Updated

December 15, 2025

Record last verified: 2025-12

Locations