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Combined Effects of Rhythmic Breathing and Balance Training on Balance and Trunk Control in Stroke Patients

4 de mayo de 2026 actualizado por: Riphah International University

Combined Effects of Rhythmic Breathing Exercises and Balance Training on Balance and Trunk Control in Patients With Stroke

The goal of this study is to evaluate the combined effects of rhythmic breathing and balance training on balance, trunk control and postural control in patients with sub-acute stroke. The main questions it aims to answer are:

  • Will there be a difference in combined effects of rhythmic breathing exercises and balance training on balance and trunk control in patients with stroke?
  • Will there be no difference in combined effects of rhythmic breathing exercises and balance training on balance and trunk control in patients with stroke? The participants will be evenly divided into two groups,
  • the experimental group will receive rhythmic breathing exercises along with balance training and conventional physical therapy
  • the control group will only receive balance training and physical therapy. Both the groups will perform their respective exercises for 60 minutes, 3 days a week for consecutive 8 weeks.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

The aim of this study is to evaluate the combined effects of rhythmic breathing and balance training on balance, trunk control and postural control in sub-acute stroke patients. It will be a single blinded randomized controlled trial. Non-probability convenience sampling will be used to recruit 50 patients aged 45-65 years from Dr. Faisal Masood Teaching Hospital Sargodha. Through the computerized generator table method of randomization, the allocated patients will be evenly divided into two groups, the experimental group undergoing Rhythmic Breathing exercises along with Balance training and conventional physical therapy and the control group only balance training and physical therapy. Both the groups will perform their respective exercises for 60 minutes 3 days a week for consecutive 8 weeks. The stroke patients will be assessed at the baseline and post intervention with outcome measuring tools. Balance will be assessed through Berg Balance Scale (BBS), trunk control will be assessed through Trunk Impairment Scale(TIS), and postural control will be assessed through Postural Assessment Scale for Stroke (PASS). Data will be analyzed in SPSS version 27.0.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

50

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

Ubicaciones de estudio

  • Pakistán
    • Punjab Province
      • Sargodha, Punjab Province, Pakistán, 40100
        • Reclutamiento
        • Dr. Faisal Masood Teaching Hospital Sargodha
        • Contacto:
          • Hira Jabeen
        • Investigador principal:
          • Anam Maqbool, MS-PT

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
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  • Age 45-65 years old
  • Either gender
  • Sub-acute stroke (3-6months)
  • The cognition level of patient according to Mini Mental Score Examination will be >24
  • The trunk control of patient based on Trunk Impairment score is 20 or less than 23
  • First-ever ischemic stroke
  • Ability to tolerate at least 60 min exercise according to berg scale scoring less than 8
  • Agree to sign the written informed consents

Exclusion Criteria:

  • • Severe visual hemianopsia

    • Acute diseases of the heart, brain, kidney and other organs
    • Sensory neuropathy such as diabetic neuropathy
    • Balance dysfunction due to other neurological disorders

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: Rhythmic breathing exercises
Otro: rhythmic breathing exercise

The protocol for Rhythmic Breathing Exercises (22) is given as:

Position: Supine with knees and hips slightly flexed, in a comfortable position Inhalation Phase: Deep inhalation with conscious outward movement of the abdomen; pause and hold for 10 seconds Exhalation Phase: Slow exhalation with conscious abdominal retraction, maintaining a slow and deep rhythm Hand Placement: One hand on the chest, one on the abdomen to monitor movement Breathing Cue: Only the hand on the abdomen should move during breathing; the chest should remain still Repetitions: 3 sets of 10 repetitions Rest Between Sets: 1 minute Total Duration: Limited to 10 minutes

Otros nombres:
  • Entrenamiento de equilibrio
  • fisioterapia convencional
Otro: Balance training
Sitting-to-Standing: Performed using a stool with 3 sets of 5 repetitions Lateral Stepping: Walk 3 meters back and forth sideways with 3 sets of 5 repetitions Forward and Backward Stepping: 5 times with right leg stepping first, 5 times with left leg stepping first with 3 sets of 5 repetitions Forward Walking: Walk 3 meters back and forth, turn right at one end and left at the other wit 3 sets of 5 repetitions Stepping Up and Down: 5 times with right leg stepping first, 5 times with left leg stepping first with 3 sets of 5 repetitions Throwing and Catching Ball: Using a soft volleyball with 3 sets of 5 repetitions
Otro: conventional physical therapy
Warm-Up: Active/passive ROM exercises for upper and lower limbs, 3 days/week for 10-15 minutes Trunk Control Exercises: Bridging, pelvic tilts, seated trunk rotations, reaching tasks with 3 sets of 5 repetitions for 3 days/week for 20 minutes Strengthening Exercises: Resistance band work for lower limb extensors, upper limb flexors with 3 sets of 5 repetitions for 3 days/week for 15-20 minutes Stretching: Hamstrings, calf, hip flexors, upper trapezius with 3 sets of 5 repetitions for 3 days/week for 10 minutes Postural Control Training: Use of Swiss ball, sitting on unstable surfaces, dual-task exercises with 3 sets of 5 repetitions for 3 days/week for 15-20 minutes Gait Training: Parallel bar walking, overground ambulation, obstacle walking 3 sets of repetitions for 3 days/week for 15-20 minutes Cool Down: Deep breathing, guided relaxation with 3 days/week for 5-10 minutes Education: Fall prevention, safe transfers, home exercise program with weekly session for 10-15 minutes
Comparador activo: Balance training and conventional physical therapy
Otro: Balance training
Sitting-to-Standing: Performed using a stool with 3 sets of 5 repetitions Lateral Stepping: Walk 3 meters back and forth sideways with 3 sets of 5 repetitions Forward and Backward Stepping: 5 times with right leg stepping first, 5 times with left leg stepping first with 3 sets of 5 repetitions Forward Walking: Walk 3 meters back and forth, turn right at one end and left at the other wit 3 sets of 5 repetitions Stepping Up and Down: 5 times with right leg stepping first, 5 times with left leg stepping first with 3 sets of 5 repetitions Throwing and Catching Ball: Using a soft volleyball with 3 sets of 5 repetitions
Otro: conventional physical therapy
Warm-Up: Active/passive ROM exercises for upper and lower limbs, 3 days/week for 10-15 minutes Trunk Control Exercises: Bridging, pelvic tilts, seated trunk rotations, reaching tasks with 3 sets of 5 repetitions for 3 days/week for 20 minutes Strengthening Exercises: Resistance band work for lower limb extensors, upper limb flexors with 3 sets of 5 repetitions for 3 days/week for 15-20 minutes Stretching: Hamstrings, calf, hip flexors, upper trapezius with 3 sets of 5 repetitions for 3 days/week for 10 minutes Postural Control Training: Use of Swiss ball, sitting on unstable surfaces, dual-task exercises with 3 sets of 5 repetitions for 3 days/week for 15-20 minutes Gait Training: Parallel bar walking, overground ambulation, obstacle walking 3 sets of repetitions for 3 days/week for 15-20 minutes Cool Down: Deep breathing, guided relaxation with 3 days/week for 5-10 minutes Education: Fall prevention, safe transfers, home exercise program with weekly session for 10-15 minutes

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Berg Balance Scale
Periodo de tiempo: Baseline and 8th week
The BBS is a 14-item measure used to assess functional mobility, static balance, and dynamic balance excluding ambulation. However, BBS scores have also been correlated with stroke patient's motor and functional performance. Scores range on an ordinal scale from zero (indicating need for assistance to minimally perform the task) to four (indicating independent performance of the task); with a maximum possible score of 56. Historically, a score below 45/56 is typically indicative of increased fall risk.
Baseline and 8th week
Trunk Impairment Scale
Periodo de tiempo: Baseline and 8th week
The original version of Trunk Impairment Scale (TIS) was developed by in 2004. It comprises 17 items (scored on a 2, 3 or 4-point ordinal scale) and evaluates static and dynamic sitting, balance and trunk coordination. The total score ranges from minimum 0 to maximum 23 points, a higher score indicating a better performance.
Baseline and 8th week
Postural Assessment Scale for Stroke
Periodo de tiempo: Baseline and 8th week
The Postural Assessment Scale for Stroke (PASS) is a scale developed specifically for stroke patients. It examines the patient's ability to maintain or change a given lying, sitting or standing posture, is easy to administer in the clinic and applicable to all patients, even those with very poor postural performance. It contains 12 items of varying difficulty for assessing ability to maintain or change a given lying, sitting, or standing posture. The items are assessed on a 4 level (0-3 point) rating scale. The score ranges from a minimum of 0 (worst performance) to a maximum of 36 (best performance).
Baseline and 8th week

Colaboradores e Investigadores

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

Patrocinador

Riphah International University

Investigadores

  • Investigador principal: Hira Jabeen, Riphah International 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 (Actual)

5 de mayo de 2026

Finalización primaria (Estimado)

5 de julio de 2026

Finalización del estudio (Estimado)

15 de julio de 2026

Fechas de registro del estudio

Enviado por primera vez

4 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

4 de mayo de 2026

Publicado por primera vez (Actual)

8 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

8 de mayo de 2026

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

4 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • REC/RCR & AHS/25/0233

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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