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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07655973
Foot Intensive Rehabilitation With Perturbation Based Training in Ankle Sprain Patients
Foot Intensive Rehabilitation With & Without Perturbation Based Training in Patients With Ankle Sprain
To determine the foot-intensive rehabilitation with and without perturbation-based training on pain reduction, range of motion improvement, balance enhancement, and functional instability in patients recovering from ankle sprains NULL HYPOTHESIS There will be no significant difference in the effectiveness of foot-intensive rehabilitation with perturbation-based training compared to foot-intensive rehabilitation alone in reducing pain, improving range of motion, enhancing balance, or reducing functional instability among patients recovering from ankle sprains.
ALTERNATE HYPOTHESIS There will be a significant difference in pain reduction, range of motion improvement, balance enhancement, and reduction in functional instability between patients undergoing foot- intensive rehabilitation with perturbation-based training compared to those undergoing foot-intensive rehabilitation.
Study Design:
It will be a Randomized Clinical Trial
Study Population:
Ankle Sprain Both groups will undergo the assigned interventions for the duration of 6 weeks under the supervision of trained physical therapists or healthcare professionals. The interventions will aim to address pain reduction, range of motion improvement, balance enhancement, and reduction in functional instability among participants recovering from ankle sprains.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Group A: Foot-Intensive Rehabilitation with Perturbation-Based Training
Foot-Intensive Rehabilitation:
Participants in Group A will undergo a structured rehabilitation program focused on addressing ankle sprains and improving foot-specific impairments. This program will typically include:
- Therapeutic Exercises: Range of motion exercises, strengthening exercises for foot and ankle muscles, proprioceptive training, and flexibility exercises tailored to individual needs.
- Manual Therapy: Hands-on techniques performed by a physical therapist or trained personnel to address soft tissue restrictions, joint mobilization, and mayofascial release.
- Modalities: Use of modalities like ice, heat, ultrasound, or electrical stimulation for pain relief and enhancing tissue healing.
- Functional Training: Specific drills and activities mimicking daily tasks or sports- related movements to improve functional capacity.
Perturbation-Based Training: In addition to the foot-intensive rehabilitation program, participants will undergo perturbation-based training sessions:
- Balance Challenges: Engaging in exercises on unstable surfaces (e.g., balance boards, foam pads) or using devices inducing controlled instability to challenge balance and neuro- muscular control.
- Dynamic Movements: Performing controlled perturbations or sudden movements to elicit adaptive responses and improve reactive balance strategies.
- Progression: Gradual progression of difficulty and complexity in perturbation-based exercises based on individual tolerance and improvement.
Group B: Foot-Intensive Rehabilitation without Perturbation-Based Training
Foot-Intensive Rehabilitation:
Participants in Group B will receive the same structured rehabilitation program focusing on foot- intensive exercises as in Group A. This program includes similar components such as therapeutic exercises, manual therapy, modalities, and functional training targeting ankle sprain recovery and foot-specific impairments.
Both groups will undergo the assigned interventions for the duration of 6 weeks under the supervision of trained physical therapists or healthcare professionals
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Punjab Province
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Lahore, Punjab Province, Pakistán, 54000
- Pakistan sports board
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
• Gender: male /female
- Participants aged 18 to 35 years old.
- Diagnosis of an ankle sprain (within 4 weeks of injury).
- No prior history of severe ankle fractures or surgeries(Hoch et al., 2023)
Exclusion Criteria:
- Presence of severe or complex ankle fractures requiring surgical intervention.
- Conditions other than ankle sprain like neuropathy that affect balance or cutaneous sensation.
- Neurological disorders impacting balance or proprioception.
- Pregnancy or planning to become pregnant during the study period(Hoch et al., 2023)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Foot-Intensive Rehabilitation
Foot-Intensive Rehabilitation: Participants in Group A will undergo a structured rehabilitation program focused on addressing ankle sprains and improving foot-specific impairments |
Foot-Intensive Rehabilitation This program will typically include:
|
|
Experimental: Foot-Intensive Rehabilitation + Perturbation-Based Training
In addition to the foot-intensive rehabilitation program, participants will undergo perturbation-based training sessions
|
In addition to the foot-intensive rehabilitation program, participants in experimental group will undergo perturbation-based training sessions:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Numeric pain rate scale (NPRS)
Periodo de tiempo: 6 weeks (Baseline, 3rd week, 6th week)
|
Patient level of pain will be assessed using this scale.
This scale ranges from 0 to 10. 0 indicates "no pain" and 10 indicates "worst pain" (Riley et al., 2019)
|
6 weeks (Baseline, 3rd week, 6th week)
|
|
Range of Motion (ROM) Measurement
Periodo de tiempo: 6 weeks (Baseline, 3rd week, 6th week)
|
Goniometer: To measure dorsiflexion, plantarflexion, inversion, and eversion of the ankle joint(Rome & Cowieson, 1996).
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6 weeks (Baseline, 3rd week, 6th week)
|
|
Balance Assessment:
Periodo de tiempo: 6 weeks (Baseline, 3rd week, 6th week)
|
Star Excursion Balance Test (SEBT): Measures reach distances in multiple directions to assess dynamic balance and reach symmetry.(Coughlan
et al., 2012)
|
6 weeks (Baseline, 3rd week, 6th week)
|
|
Functional Instability Measurement
Periodo de tiempo: 6 weeks (Baseline, 3rd week, 6th week)
|
Cumberland Ankle Instability Tool (CAIT): A questionnaire to assess the severity of functional ankle instability.(ALEXANDRE
et al., 2024)
|
6 weeks (Baseline, 3rd week, 6th week)
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Sana Akram, MSOMPT, University of Lahore
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- UOL/IREB/25/15/03/10
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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