NCT07731035

Brief Summary

This study aims to investigate the effects of various treatments on lumbar and ankle proprioception, balance, and foot function in patients with chronic ankle instability. The objectives include assessing the combined effects of core stability training and intrinsic foot muscle exercises with conventional therapy, the impact of core stability training alone, the effects of intrinsic foot muscle exercises in conjunction with conventional treatment, and the outcomes of conventional therapy alone. Additionally, the study will compare the effectiveness of these different treatment protocols.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
1mo left

Started May 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
May 2026Sep 2026

Study Start

First participant enrolled

May 1, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 28, 2026

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Expected
Last Updated

July 28, 2026

Status Verified

July 1, 2026

Enrollment Period

3 months

First QC Date

July 23, 2026

Last Update Submit

July 23, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Assessment of balance

    The study employs the Biodex Balance System to assess dynamic control using the Limits of Stability test. This test measures the maximum angle from vertical that an individual can achieve without losing balance, with normal limits of stability parameters set at eight degrees anterior, four degrees posterior, and 16 degrees laterally. Participants perform the test, aiming to shift their weight toward blinking targets on a screen while avoiding handrail support unless necessary. Two trials per participant are conducted, with results detailing test duration and overall performance percentage, where a score of 100% indicates precise movement towards targets.

    At baseline and after 6 weeks

Secondary Outcomes (3)

  • assessment of Lumbar proprioception

    At baseline and after 6 weeks

  • assessment of Ankle proprioception:

    At baseline and after 6 weeks

  • assessment of foot function

    At baseline and after 6 weeks

Study Arms (4)

conventional physical therapy

ACTIVE COMPARATOR

Involves twenty patients who will receive conventional physical therapy treatment 18 sessions of exercises, 3 sessions per week for 6 weeks.

Other: conventional physical therapy

core stability training

EXPERIMENTAL

Involves twenty patients who will receive core stability training in addition to conventional physical therapy treatment: 18 sessions of exercises, 3 sessions per week for 6 weeks.

Other: conventional physical therapyOther: Core stability training

intrinsic foot muscle exercises

EXPERIMENTAL

Involves twenty patients who will receive intrinsic foot muscle exercises in addition to conventional physical therapy treatment: 18 sessions of exercises, 3 sessions per week for 6 weeks.

Other: conventional physical therapyOther: intrinsic foot muscle exercises

Core Stability with Foot Exercises

EXPERIMENTAL

Involves twenty patients who will receive core stability training core stability training accompanied with intrinsic foot muscle exercises in addition to conventional physical therapy treatment 18 sessions of exercises, 3 sessions per week for 6 weeks.

Other: conventional physical therapyOther: Core stability trainingOther: intrinsic foot muscle exercises

Interventions

Stretching the gastrocnemius and soleus muscle (30 s) of three repetitions, three sets of strengthening exercises of ankle musculature, using Thera Band resistance (ten repetitions in each set), and balance training exercises: First, standing on one leg with eyes open, later will be progressed to eyes closed with 60 s hold for two repetitions will be given along with balance board exercises and double-leg and single-leg stances

Core Stability with Foot Exercisesconventional physical therapycore stability trainingintrinsic foot muscle exercises

The program is structured in three phases over six weeks. The first phase (1-2 weeks) focuses on abdominal drawing-in maneuvers to activate the transverses abdominis and lumbar multifidus muscles, with participants palpating the contractions for feedback. The second phase (3-4 weeks) integrates coordinated cocontraction of both muscles alongside upper and lower limb movements in various positions such as lying, sitting, standing, and quadruped. The third phase (5-6 weeks) emphasizes core activation during functional activities, including sit-to-stand, wall squats, and lunges, incorporating three sets of ten repetitions while maintaining the final position for 10 seconds in each exercise.

Core Stability with Foot Exercisescore stability training

In this program, participants will engage in four exercises targeting the intrinsic foot muscles (IFMs): short-foot exercise, toe spread out, hallux extension, and lesser-toe extension. For the first two weeks, exercises will be done while sitting; during weeks three and four, they will shift to standing; and in weeks five and six, the exercises will be performed while standing on one leg.

Core Stability with Foot Exercisesintrinsic foot muscle exercises

Eligibility Criteria

Age18 Years - 44 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects will be selected from the outpatient clinic of Delta University hospital, Dakahlia, Egypt. 2. Both male \& female genders aged between 18 and 44 years. 3. Participants should have a history of at least one significant ankle sprain; the initial sprain must have occurred at least 12 months prior to the study enrolment and was associated with inflammatory symptoms (pain, swelling) 4. Patients having Scores on the Cumberland ankle instability tool of 24 or below 5. Participants should report at least 2 episodes of 'giving way' in the 6 months prior to the study enrolment. Episodes of giving way will be described as an incident in which the rearfoot suddenly rolled, felt weak, or lost stability; however, the individual did not sustain an ankle sprain and will have been able to continue with normal function after the incident 6. Body mass index for all groups will be ranged from 18.8-29 kg/m²

You may not qualify if:

  • history of lower extremity surgery, lower extremity fractures, and immobilization of foot or ankle for 48 hr or longer within the previous 6 months
  • Conditions other than ankle sprain that affect balance or they are receiving ankle rehabilitation at the time of screening.
  • Acute injury to the musculoskeletal structures of other joints of the lower extremity in the previous 3 months, which impacted joint integrity and function (ie, sprains, fractures) resulting in at least 1 interrupted day of desired physical activity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Al Mansurah, Egypt

RECRUITING

MeSH Terms

Conditions

Joint Instability

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Central Study Contacts

Asmaa Abdelnaser Atia Saad, physical therapist

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

July 23, 2026

First Posted

July 28, 2026

Study Start

May 1, 2026

Primary Completion

August 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

July 28, 2026

Record last verified: 2026-07

Locations