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Frenkel Exercises on Balance and Quality of Life Post Burns

31 de mayo de 2026 actualizado por: Yasmeen Hamada Lotfy Mohamed, Cairo University

Effect of Frenkel Exercises on Balance and Quality of Life in Patients With Lower Limb Burns

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.

Descripción general del estudio

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

Intervencionista

Inscripción (Estimado)

70

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto

Acepta Voluntarios Saludables

No

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

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿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
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.
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.

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
Berg Balance Scale (BBS)
Periodo de tiempo: 8 weeks
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
8 weeks
The Short Form 36 (SF-36)
Periodo de tiempo: 8 week
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
8 week

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Timed up and go test
Periodo de tiempo: 8 weeks
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
8 weeks

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: yasmeen hamada lotfy mohamed, Ethical Committee Faculty of Physical Therapy Cairo University

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

31 de mayo de 2026

Finalización primaria (Estimado)

8 de septiembre de 2026

Finalización del estudio (Estimado)

12 de septiembre de 2026

Fechas de registro del estudio

Enviado por primera vez

28 de abril de 2026

Primero enviado que cumplió con los criterios de control de calidad

28 de abril de 2026

Publicado por primera vez (Actual)

5 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

2 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

31 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 12519939987

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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