out-patient clinic, faculty of physical therapy, Delta university
Al Mansurah, Egypt
Location status: Recruiting
NCT Number: NCT07731035
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.
Interested in participating?
Request Info18 year–44 year
All sexes
Interventional
Not applicable
Al Mansurah, Egypt
Location status: Recruiting
Chronic ankle instability (CAI) is characterized by both mechanical and functional ankle joint instability, with various contributing factors persisting post-healing after an acute sprain. Recent studies emphasize that chronic ankle instability is a complex condition necessitating interdisciplinary research. Effective treatment requires multimodal protocols, integrating core stability training and intrinsic foot muscle exercises. Core stability enhances proximal neuromuscular control, while intrinsic exercises improve distal stability and foot function. This combined approach aims to improve lumbar and ankle proprioception, balance, and postural control, ultimately reducing recurrent injuries. Results will provide valuable insights to develop evidence-based rehabilitation programs addressing both proximal and distal factors in chronic ankle instability, enhancing understanding of sensorimotor control and rehabilitation strategies.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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
Exclusion criteria
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
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.
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.
Time frame: At baseline and after 6 weeks
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.
Time frame: At baseline and after 6 weeks
The study assesses lumbar position sense using an iPhone inclinometer. Joint repositioning methods, active and passive, evaluate this sense based on absolute error, which indicates the discrepancy between target and actual angles; lower absolute error reflects better joint position sense. The inclinometer was positioned between specific anatomical landmarks, fixed at 0°, during a 0 to 30° range of motion test. Participants held a 30° flexion posture for ten seconds before returning to the starting position, with three repetitions performed. Eye masks were used to eliminate visual cues, and average measurements were recorded after appropriate rest intervals. The proprioceptive error was determined as absolute angular error, reflecting the deviation from the reference angle.
Time frame: At baseline and after 6 weeks
Measurements of ankle proprioception were conducted using a Baseline digital inclinometer in a controlled environment with participants in a sitting position. The study assessed proprioception through active reproduction tests in both eyes open and closed conditions at specified dorsiflexion and plantar flexion angles. Participants were instructed to memorize a target angle for 10 seconds before returning to the initial position and actively or passively reproducing the angle. Deviations from the target angle, recorded as angular errors, were averaged over three trials to obtain mean values.
Time frame: At baseline and after 6 weeks
The assessment will utilize the Arabic version of the Foot and Ankle Ability Measure questionnaire. it is a patient-reported outcome tool designed to evaluate functionality in patients with leg, ankle, or foot disorders, focusing on daily living and sports-related activities. It comprises subscales for daily living (21 items) and sports (8 items), scored on a 5-point Likert scale. Final scores reflect self-reported function as a percentage, with lower scores indicating reduced functionality. it has proven reliability (Activities of Daily Living interclass correlation=0.89; Sport interclass correlation=0.87) and responsiveness in tracking patient progress, with minimal detectable changes of ±5.7 for daily living and ±12.3 points for the sport subscale.
Contact information is provided by the study sponsor or research team.
Cairo University
Other
Effect of Core Stability Training With Foot Exercises on Proprioception, Balance and Foot Function in Chronic Ankle Instability Patients
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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