- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07566442
Frenkel Exercises on Balance and Quality of Life Post Burns
Effect of Frenkel Exercises on Balance and Quality of Life in Patients With Lower Limb Burns
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Introduction: Severe burn injuries to the lower limbs result in reduced muscle strength, postural imbalance, limited walking ability, and diminished functional activities. This research aimed to study the impact of frenkel exercises on balance and quality of life, and determine the most effective treatment program for rehabilitation.
Material and methods: The primary outcome measures were balance, assessed using the Biodex Balance System, and quality of life, evaluated using a validated questionnaire. Secondary outcome measures included lower limb muscle strength, measured by a Lafayette Hand-Held Dynamometer (HHD), and functional ability, assessed using the Lower Extremity Functional Scale (LEFS). Seventy patients of both sexes with thermal burn injuries, aged 25 to 45 years, will participate in this study. The participants will be randomly selected from the Outpatient Clinic of the Faculty of Physical Therapy. They will be randomly assigned into two equal groups, 35 patients each (study group and control group). Group A (Study Group): Patients in this group will receive Frenkel exercises in addition to a traditional physiotherapy program comprising stretching, strengthening exercises and scar management, 3 times a week for 8 weeks. While, Group B (Control Group): Patients in this group will receive traditional physiotherapy program, 3 times a week for 8 weeks.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Research Ethical Committee Faculty of Physical Therapy
- Número de teléfono: 01151312322
- Correo electrónico: eth.com@pt.cu.edu.eg
Copia de seguridad de contactos de estudio
- Nombre: yasmeen hamada lotfy mohamed
- Número de teléfono: 01068963069
- Correo electrónico: yasmeen.hamada@pt.cu.edu.eg
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria
- Body mass index (BMI) between 25-30 kg/m²
- Total body surface area (TBSA) 30%-45% determined by rule of nines
- Second-degree thermal burns affecting the lower limbs
- After full wound healing
- Ability to stand and walk independently or with minimal assistance
- Ability to participate in balance training exercises
Exclusion Criteria
- Open wounds in or near the treatment area
- Chemical or electrical burns or inhalation injuries
- Musculoskeletal conditions affecting exercise or testing, or visual/hearing impairments
- Uncontrolled cardiovascular or pulmonary diseases
- Malignant conditions
- Severe behavioral or cognitive disorders
- Uncooperative patients
- Proprioception deficit or balance impairment due to other diseases
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: frenkel exercises
The program was conducted three times per week for eight weeks, with 30-minute sessions performed under visual guidance using slow, controlled, and repetitive movements to enhance coordination and balance.
Exercises progressed from supine (hip, knee, and coordination tasks) to sitting (controlled leg movements and functional transitions), and then to standing activities focusing on static balance (weight shifting, narrow base, tandem stance).
Finally, dynamic balance and gait training were introduced, including forward, sideways, and backward walking.
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The program was conducted three times per week for eight weeks, with 30-minute sessions performed under visual guidance using slow, controlled, and repetitive movements to enhance coordination and balance.
Exercises progressed from supine (hip, knee, and coordination tasks) to sitting (controlled leg movements and functional transitions), and then to standing activities focusing on static balance (weight shifting, narrow base, tandem stance).
Finally, dynamic balance and gait training were introduced, including forward, sideways, and backward walking.
Participants received a supervised traditional physiotherapy program three times per week for eight weeks. Each 45-minute session included stretching exercises for the calf and hamstring muscles, followed by range of motion (ROM) and progressive strengthening exercises for the lower limbs using free weights. Training intensity progressed from 50%-60% of 3RM in the first week to 80%-85% by weeks 7-8, with three sets of ten repetitions per exercise. Scar management included 15-20 minutes of deep friction massage, along with skin mobilization techniques. Additionally, customized pressure garments (25-40 mmHg) were used throughout the day, except during hygiene and exercise sessions, with silicone materials applied in areas requiring additional pressure. |
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Experimental: Traditional physiotherapy program
Participants received a supervised traditional physiotherapy program three times per week for eight weeks. Each 45-minute session included stretching exercises for the calf and hamstring muscles, followed by range of motion (ROM) and progressive strengthening exercises for the lower limbs using free weights. Training intensity progressed from 50%-60% of 3RM in the first week to 80%-85% by weeks 7-8, with three sets of ten repetitions per exercise. Scar management included 15-20 minutes of deep friction massage, along with skin mobilization techniques. Additionally, customized pressure garments (25-40 mmHg) were used throughout the day, except during hygiene and exercise sessions, with silicone materials applied in areas requiring additional pressure |
Participants received a supervised traditional physiotherapy program three times per week for eight weeks. Each 45-minute session included stretching exercises for the calf and hamstring muscles, followed by range of motion (ROM) and progressive strengthening exercises for the lower limbs using free weights. Training intensity progressed from 50%-60% of 3RM in the first week to 80%-85% by weeks 7-8, with three sets of ten repetitions per exercise. Scar management included 15-20 minutes of deep friction massage, along with skin mobilization techniques. Additionally, customized pressure garments (25-40 mmHg) were used throughout the day, except during hygiene and exercise sessions, with silicone materials applied in areas requiring additional pressure. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Berg Balance Scale (BBS)
Periodo de tiempo: 8 weeks
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Balance was evaluated using the 14-item BBS.
This assessment required 10 to 20 minutes for completion and measured the ability of the participant to maintain balance for set periods, both in static positions and during various functional activities.
The total score can range from 0 to 56.
The BBS assesses both static and dynamic balance components
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8 weeks
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The Short Form 36 (SF-36)
Periodo de tiempo: 8 week
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it was used to assess quality of life.
It is a widely used, validated questionnaire consisting of 36 items that evaluate eight domains: physical functioning, role limitations due to physical health, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health.
Scores for each domain are transformed to a scale ranging from 0 (worst health status) to 100 (best health status), with higher scores indicating better perceived health.
The eight domains can be further summarized into two main components: the Physical Component Summary (PCS) and the Mental Component Summary
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8 week
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Timed up and go test
Periodo de tiempo: 8 weeks
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TUG test; used to assess balance and fall risk.
Using a standard chair for the test, the patient is asked to sit on the basis of the chair and stand up and walk with regular steps a predetermined distance of 3 meters in length, then, was asked to walk at walking speed, turn around and sit on the chair again.
The passing time recorded in seconds with a stopwatch
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8 weeks
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: yasmeen hamada lotfy mohamed, Ethical Committee Faculty of Physical Therapy Cairo University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
- 12519939987
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
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