Tibial Nerve Mobilization Versus Multisensory Exercises in Patients With Diabetic Foot Ulcer
Diabetic Foot
De qué trata este estudio
El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.
- Tipo de estudio
- De intervención
- Fase
- No aplica
- Rango de edad
- 55 años - 75 años
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 38 Estimado
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Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
The purpose of this study is to compare the effects of Tibial Nerve Mobilization and Multisensory Exercises on balance, quality of life, neuropathy severity and healing in patients with Diabetic Foot Ulcers. The aim is to identify the more effective intervention, which could help improve pain management, foot biomechanics, balance , mechanical loading , enhance blood circulation , nerve function, and promote physical rehabilitation outcomes for these patients. The more effective intervention may lead to a better quality of life, increased independence, and less post-operative discomfort for the patients. For healthcare providers, this could assist in optimizing rehabilitation plans, making them more cost-effective, and reducing the need for extended hospital stays or long-term care.
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
Inclusion Criteria:
- Adults aged 55-75 years
- Diagnosed cases of Type 2 Diabetes Mellitus by clinical and laboratory tests.
- Both male and female participants.
- Grade 0 and Grade 1 diabetic foot ulcers, as classified by the Wagner Ulcer Classification.
- Participants must have poor glycemic control according to HbA1c ≥ 7.5 % or Fasting Blood Glucose ≥ 130 mg/dl or Random Blood Glucose ≥ 200 mg/dl.
- Patient with healed ulcer or in last stage of healing duration \>1 to 2 weeks
- Absence of active infection.
- No cognitive impairments that would affect participation.
- Diabetes duration of less than 10 years.
- Able to perform the exercises and participate in physical therapy sessions.
- No history of amputation above the metatarsophalangeal joint.
Exclusion Criteria:
- Presence of other systemic diseases apart from diabetes, such as autoimmune diseases or rheumatoid arthritis.
- Foot ulcers that are classified as Grade 2 or higher using the Wagner Ulcer Classification.
- Recent fractures, or trauma leading to nerve injuries in the last year.
- Neurological disorders including Parkinson's disease, stroke, multiple sclerosis, or neuropathy from other causes.
- Visual impairments or cognitive disorders that could affect participation.
- History of recent vascular complications, surgical procedures for lower limbs in the last 6 months, or amputation above the metatarsophalangeal joint.
- Severe DPN with Michigan Diabetic Neuropathy Score (MDNS) above 30, or abnormal nerve conduction studies.
- Pregnancy or unwillingness to participate.
Tratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- Asignación al azar
- Enmascaramiento
- Enmascaramiento simple
Tibial Nerve Mobilization
No informado en este registro.
Behavioral: Tibial Nerve Mobilization
Multisensory Exercises
No informado en este registro.
Behavioral: Multisensory exercises
Tibial Nerve Mobilization BEHAVIORAL
Participants will receive supervised physical therapy targeting neuropathic symptoms, healing , mobility issues, quality of life associated with diabetic foot ulcers early grades. The regimen consists of 35 to 45 -minute sessions, 3 days per week, for a total duration of 4 weeks. Each session includes 15 minutes of conventional therapy, including Transcutaneous Electrical Nerve Stimulation (TENS).Pulse Duration: 150 µs and 80 Hz frequency for effective nerve stimulation and pain relief, active and passive ankle range-of-motion exercises, dosriflexion and plantar flexion, inversion eversion ,with 10 repetitions for10 minutes and foot care education which includes moisturizing and hygiene advice and foot wear guidance . This is followed by a 20-minute main intervention of tibial nerve mobilization, which utilizes a combination of remote sliders, local sliders, and tensioners (end-range neural loading) to promote neural sliding and elongation while minimizing mechanical stress.
Multisensory exercises BEHAVIORAL
Participants will receive a multisensory exercises training program alongside conventional physical therapy. The regimen consists of 35-to 45 minute sessions, 3 times per week, for a total duration of 4 weeks. Each session includes 15 minutes of conventional therapy (TENS, ankle range of motion, and foot care). Exercises include a structured warm-up, ankle flexion ,extension, inversion , eversion , short walk ,calf and hamstring stretching 10 repetitions Followed by 20 minutes of multisensory training.Visual system activities (e.g., eye tracking ,follow moving object , circular eye movements and visual-motor coordination. Somatosensory exercises (walking on varying surfaces such as flat surface , mattresses and foam rubber). Proprioception/vestibular stimulation (e.g., unipedal stances, tandem stance , tandem walking( heel to toe walk), walking variations such as backward , forward, multidirectional walking, and cognitive dual-task obstacle navigation eg. functional mobility training .
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Berg Balance Scale (BBS)
Plazo: Baseline and immediately after 4 weeks of intervention
The Berg Balance Scale (BBS) is a commonly used clinical scale for assessing static and dynamic balance in sitting and standing. It consists of 14 functional balance items that assess the ability to maintain positions and perform postural adjustments during functional movements. Each item is scored from 0 to 4, with a maximum total score of 56. Higher scores indicate better balance performance. The BBS has demonstrated high reliability and good validity for assessing balance.
Medidas secundarias
Short Form-12 Health Survey (SF-12)
Plazo: Baseline and immediately after 4 weeks of intervention
Quality of Life SF12 Questionnaire :
The SF12 questionnaire used to assess the quality of life. It is a health related quality of life questionnaire including 12 questions.It has eight main which are some up into see physical and mental health. It has a scoring range from 0 to hundred for both physical as well as mental health.
SINBAD Scoring System:
Plazo: Baseline and immediately after 4 weeks of intervention
Foot condition severity will be assessed using the SINBAD classification system, which evaluates site, ischemia, bacterial infection, area, and depth.
The SINBAD classification system will be used to assess the clinical status and severity of diabetic foot ulcer.
Toronto Clinical Neuropathy Score (TCNS)
Plazo: Baseline and immediately after 4 weeks of intervention
It is used to assess the severity of the diabetic foot neuropathy. It assess the sensory test, reflexes as well as symptoms. It scoring shows from 0 to 5 shows no diabetic peripheral neuropathy, 6 to 8 shows mild diabetic peripheral neuropathy, 9 to 11 shows moderate diabetic peripheral neuropathy and 12 to 19 shows severe diabetic peripheral neuropathy. It has a good reliability of 0.83 to 0.87. It also has a good validity of 0.713.
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (0)
El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.
No hay centros indicados. Usa el contacto oficial del estudio.
Equipo y fechas
- Patrocinador principal
- University of Lahore
- Inicio del estudio
- 2026-11 Estimado
- Finalización primaria
- 2027-05 Estimado
- Finalización del estudio
- 2027-05 Estimado
- Primera publicación
- 25 sept 2026 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
No hay un contacto central indicado. Revisa los centros y el registro oficial.
Título oficial del estudio
Tibial Nerve Mobilization Versus Multisensory Exercises in Patients With Diabetic Foot Ulcer
Consulta a Wellness Clinical Research
Tu mensaje va a WCR, incluso si otra organización realiza este estudio. WCR puede orientarte, pero podría no realizar este estudio, tener acceso a su equipo ni poder inscribirte.
Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026