Comparison of Otago and Beat it Program on Balance, Gait and QOL in Diabetic Neuropathy
4 de mayo de 2026 actualizado por: Riphah International University
Comparative Effects of Otago Exercise Program and Beat it Program on Balance, Gait and Quality of Life in Patients With Diabetic Peripheral Neuropathy
this study aims to compare the effects of Otago exercise program and BEAT IT program on balance, gait and quality of life in patients with diabetic peripheral neuropathy.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
Limited studies have been conducted to assess gait and quality of life.
Most of the studies related to the Otago exercise program conducted in the geriatric population, stroke, Parkinson's, alcoholic neuropathy, chronic inflammatory polyneuropathy, and so on, a few studies conducted on diabetes, however up to the researcher's knowledge its effect on diabetic neuropathy has not been found.
Similarly, studies related to the BEAT IT Program conducted in cancer patients and diabetes populations.
Hence there is a need for comparative study on Otago exercise program and BEAT IT program to assess balance, gait and quality of life in patients with diabetic peripheral neuropathy
Tipo de estudio
Intervencionista
Inscripción (Estimado)
32
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: Muneeb Khan, PhD
- Número de teléfono: +92336799611
- Correo electrónico: muneeb.khan@riphah.edu.pk
Ubicaciones de estudio
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Punjab Province
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Lahore, Punjab Province, Pakistán, 54500
- THQ hospital
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Contacto:
- Javeria Ghazal, MS
- Número de teléfono: +923335154664
- Correo electrónico: javeria.ghazal@riphah.edu.pk
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Investigador principal:
- Sania Hassan, MS
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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:
- physician-diagnosed type 2 diabetes, with peripheral neuropathy (defined by Michigan Neuropathy Screening Instrument questionnaire score of 5 or greater) the ability to walk independently for 20 m (97).
- Having score between 46 to 52 (out of a total of 56 points) on the BBS
Exclusion Criteria:
- fracture of the lower limb within the 6 months before the study
- diabetic ulcer, infection or partial amputation in feet
- disease or functional impairment of auditory, vestibular system
- Dementia or inability to give consistent information
- History of surgical procedure at the knee, ankle, or hip or indication of surgery throughout the intervention period malignancy, other neurological or orthopedic impairments (such as stroke, poliomyelitis, rheumatoid arthritis, prosthesis, or severe osteoarthritis), major vascular complications (venous or arterial ulcers), severe retinopathy, or severe nephropathy that causes edema or needs hemodialysis
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 |
|---|---|
|
Comparador activo: Otago program
Participants performed a combination of warm-up, strengthening, balance, and aerobic exercises at home.
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The program included: 5 Strengthening exercises and 12 balance exercises. 30-40 min, 4x/week for 8 weeks. Balance Exercises: Knee bends Backwards walking Walking and turning around Sideways walking Tandem stance (heel toe stance) Tandem walk (heel toe walk) One leg stance Heel walking Toe walk Heel toe walking backwards Sit to stand Stair walking Strength exercises: Knee extensor Knee flexor Hip adductor Ankle planter flexors (calf raises) Ankle dorsiflexors (toe raises) |
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Experimental: BEAT it program
Participants performed moderate-intensity aerobic, resistance, balance, and flexibility exercises, along with education on diabetes self-management.
The exercises were designed to be completed at home using minimal equipment or household items
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Strengthening exercises Toe spreading Ankle pump Mini wall squats Slow march in standing Knee with pillow press up Bridging Step up and down on stair 1st step Toe curls Stretching Hamstring stretch Dorsiflexors and planter flexors stretch Quads stretch Biceps stretch Triceps stretch Balance exercises Leg front and back swinging Weight shifting front and back Leg sideways Sideway alternate step Tandem stand Alternate heel toe raises Sessions were performed;
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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4 Stage Balance Test
Periodo de tiempo: 8th week
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The Four Stage Balance Test is a validated measure recommended to evaluate static balance. Four standing positions get progressively harder to maintain.
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8th week
|
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Mini BESTest
Periodo de tiempo: 8th week
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This test measures dynamic balance, functional mobility, and gait.
The Mini-BESTest, the shortened form of BESTest, contains only 14 different tasks and involves four sub-sections: anticipatory postural adjustments, postural response to external perturbations, sensory orientation, and stability in gait.
Two items of Mini-BESTest are assessed bilaterally, but only the lower score was added to the maximum score of 28 points, which results from grading based on a 3-point ordinal scale ranging from 0 (severe balance impairment) to 2 (no balance impairment) (108).
Reliability 0.98; Validity 0.65.
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8th week
|
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Functional Reach Test
Periodo de tiempo: 8th week
|
FRT is used to evaluate anticipatory balance which correlates with fall risks.
This test measures the margin of stability along with the ability to measure balance during a functional task.
Reliability 0.89; Sensitivity 76%; Specificity 34%
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8th week
|
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Functional Gait Assessment
Periodo de tiempo: 8th week
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The FGA has been validated for the assessment of balance in people with vestibular dysfunction, community-dwelling older adults, patients with stroke, and patients with Parkinson disease.
The FGA has good reliability (interrater reliability: intraclass correlation coefficient [ICC]=.74;
interrater reliability: ICC=.86 to .93) and internal consistency (Cronbach alpha=.79)
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8th week
|
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Norfolk Quality of Life-Diabetic Neuropathy (QOL-DN) questionnaire
Periodo de tiempo: 8th week
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The Norfolk Quality-of Life Diabetic Neuropathy tool (QOL-DN) has been found to be reliable across many different populations.
This comprehensive tool has demonstrated sensitivity to both small and large fiber impairment while also detecting improvements in neuropathy.
Intra class Reliability >0.9; Internal Consistency >0.6
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8th week
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Javeria Ghazal, MS, 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 (Estimado)
15 de mayo de 2026
Finalización primaria (Estimado)
30 de agosto de 2026
Finalización del estudio (Estimado)
15 de septiembre de 2026
Fechas de registro del estudio
Enviado por primera vez
23 de febrero 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
Otros números de identificación del estudio
- REC/RCR &AHS/24/0296
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
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