- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07731035
Effect of Core Stability Training With Foot Exercises in Chronic Ankle Instability Patients
Effect of Core Stability Training With Foot Exercises on Proprioception, Balance and Foot Function in Chronic Ankle Instability Patients
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Asmaa Abdelnaser Atia Saad, physical therapist
- Numéro de téléphone: 01024728414
- E-mail: asmaa.naser56@gmail.com
Lieux d'étude
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Al Mansurah, Egypte
- Recrutement
- out-patient clinic, faculty of physical therapy, Delta university
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Contact:
- Asmaa Abdelnaser Atia Saad, physical therapist
- Numéro de téléphone: 01024728414
- E-mail: asmaa.naser56@gmail.com
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
La description
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:
- 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Comparateur actif: conventional physical therapy
Involves twenty patients who will receive conventional physical therapy treatment 18 sessions of exercises, 3 sessions per week for 6 weeks.
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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
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Expérimental: core stability training
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.
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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.
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Expérimental: intrinsic foot muscle exercises
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.
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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
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.
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Expérimental: Core Stability with Foot Exercises
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.
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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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Assessment of balance
Délai: At baseline and after 6 weeks
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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.
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At baseline and after 6 weeks
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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assessment of Lumbar proprioception
Délai: At baseline and after 6 weeks
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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.
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At baseline and after 6 weeks
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assessment of Ankle proprioception:
Délai: At baseline and after 6 weeks
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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.
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At baseline and after 6 weeks
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assessment of foot function
Délai: At baseline and after 6 weeks
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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.
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At baseline and after 6 weeks
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Collaborateurs et enquêteurs
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Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Asmaa_Msc
Informations sur les médicaments et les dispositifs, documents d'étude
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