Comparative Effects of Perturbation-Based Balance Training on Firm Surface and Rolling Board for Diabetic Neuropathy Patients
13 de mayo de 2026 actualizado por: Maryam Safdar, University of Faisalabad
The present study is designed to compare the effectiveness of perturbation-based balance training performed on two different surfaces, stable (firm surface) and unstable (rolling board), for enhancing static, dynamic, and reactive balance in individuals diagnosed with diabetic neuropathy.
This randomized clinical trial will recruit a total of 42 participants, with the sample size calculated using Epi Tool software.
A consecutive sampling technique will be implemented.
Eligible participants who fulfill the inclusion criteria will be randomly assigned into two equal groups (n = 21 each) through an online randomization method.
Participants in Group A will undergo perturbation-based balance exercises on a stable surface, whereas participants in Group B will receive similar training on a rolling board to introduce surface instability.
In addition to the primary intervention, both groups will receive contrast bath therapy as a standard baseline treatment.
Written as well as verbal informed consent will be obtained prior to participation.
The intervention protocol will span four weeks, consisting of three sessions per week on alternate days, resulting in a total of twelve treatment sessions.
The primary outcomes will focus on balance performance and fall risk.
These outcomes will be measured using the Berg Balance Scale, the Mini-Balance Evaluation Systems Test, and the Timed Up and Go test.
Screening for diabetic neuropathy will be carried out using the Michigan Neuropathy Screening Instrument.
Statistical analysis will be performed using SPSS version 23.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Descripción detallada
Diabetic peripheral neuropathy is one of the most prevalent complications associated with Type 2 Diabetes Mellitus.
It commonly presents with symptoms such as burning sensations, tingling, numbness, discomfort, and diminished sensation in the lower extremities, which significantly affect balance and functional mobility.
The present study is designed to compare the effectiveness of perturbation-based balance training performed on two different surfaces, stable (firm surface) and unstable (rolling board), for enhancing static, dynamic, and reactive balance in individuals diagnosed with diabetic neuropathy.
This randomized clinical trial will recruit a total of 42 participants, with the sample size calculated using Epi Tool software.
A consecutive sampling technique will be implemented.
Eligible participants who fulfill the inclusion criteria will be randomly assigned into two equal groups (n = 21 each) through an online randomization method.
Participants in Group A will undergo perturbation-based balance exercises on a stable surface, whereas participants in Group B will receive similar training on a rolling board to introduce surface instability.
In addition to the primary intervention, both groups will receive contrast bath therapy as a standard baseline treatment.
Written as well as verbal informed consent will be obtained prior to participation.
The intervention protocol will span four weeks, consisting of three sessions per week on alternate days, resulting in a total of twelve treatment sessions.
The primary outcomes will focus on balance performance and fall risk.
These outcomes will be measured using the Berg Balance Scale, the Mini-Balance Evaluation Systems Test, and the Timed Up and Go test.
Screening for diabetic neuropathy will be carried out using the Michigan Neuropathy Screening Instrument.
Statistical analysis will be performed using SPSS version 23.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
42
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: Maryam Safdar Dr, MS Physical Therapy (MSK)
- Número de teléfono: +92-3217978088
- Correo electrónico: maryamsafdar.DPT@tuf.edu.pk
Copia de seguridad de contactos de estudio
- Nombre: Dr Muhammad Ateeb, PhD Public Health
- Número de teléfono: +92-3357333383
- Correo electrónico: mateeb.oric@tuf.edu.pk
Ubicaciones de estudio
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Punjab Province
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Faisalābad, Punjab Province, Pakistán, 38000
- Madinah Teaching Hospital and Al Mahmood Physiotherapy Clinic, Faisalabad
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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:
- Individuals with a confirmed clinical diagnosis of Type 2 diabetes (HbA1c ≥ 6.5%) (Bolen et al., 2016).
- Participants with a diabetes duration of more than 10 years (Grewal et al., 2015).
- Participants exhibiting signs and symptoms of diabetic peripheral neuropathy (such as numbness, tingling, burning, shooting or electric shock-like pain, and glove-and-stocking distribution), confirmed using the Michigan Neuropathy Screening Instrument with scores of 6-8 (patient version) and 2.5-4 (physical assessment) (Haque et al., 2022).
- Participants aged between 40 and 75 years (Rasool et al., 2024).
- Both male and female participants will be eligible for inclusion (Haleem et al., 2024).
- Participants currently using insulin-sensitizing medications (e.g., metformin, Diamicron, insulin).
- Participants who are able to stand and walk independently (Allin et al., 2020).
- Participants with a Berg Balance Scale score ranging from 25 to 40 (Phyu et al., 2022).
- Participants willing to provide informed consent (Lepesis et al., 2023).
Exclusion Criteria:
- Patients with a confirmed diagnosis of benign paroxysmal positional vertigo (BPPV) will be excluded (Daud et al., 2021).
- Those with cognitive deficits (such as dementia or Alzheimer's disease) that may interfere with comprehension or compliance with study procedures will not be included (Hatton et al., 2019).
- Individuals presenting with foot drop or other neurological disorders (e.g., stroke, myelopathy, or cerebellar ataxia) that could affect the study findings will be excluded (Khurshid et al., 2025).
- Patients who have recently undergone surgery, sustained trauma to the feet or lower limbs, or have any foot amputation will not be eligible (Collings et al., 2023).
- Individuals diagnosed with deep vein thrombosis or orthostatic hypotension will be excluded (Khurshid et al., 2025).
- Patients with active diabetic foot ulcers or notable musculoskeletal deformities (such as scoliosis or degenerative joint disease) will be excluded (Lepesis et al., 2023).
- Individuals with neuropathy unrelated to diabetes, including cases associated with alcohol use or Charcot-Marie-Tooth disease, will not be included.
- Participants taking medications that may provoke vertigo or disturb balance (for example, aspirin) will be excluded.
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: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Group A (Perturbation Based Training on Firm Surface)
Manual perturbations will be applied in four directions: right lateral, left lateral, forward, and backward.
Training will be performed in progressive positions, starting from sitting, advancing to kneeling, and then to standing.
Contrast bath therapy will be administered for a total duration of 20 minutes.
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Manual perturbations will be applied in four directions: right lateral, left lateral, forward, and backward.
Training will be performed in progressive positions, starting from sitting, advancing to kneeling, and then to standing.
Each session will include two sets of perturbation training, 5 minutes per set and a 10-second rest interval provided between successive perturbations.
The intervention will be conducted three days per week on alternate days, with a total of 10 perturbations delivered per session.
Total treatment time will be 45 minutes.
Progression to more challenging positions will occur once the patient demonstrates adequate balance control following manual perturbations.
The total duration of the treatment program will be four weeks.
Contrast bath therapy will be administered for a total duration of 20 minutes.
The protocol will involve immersion in cold water (60-70°F) for 1 minute followed by warm water (100-105°F) for 3 minutes, repeated for five cycles.
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Comparador activo: Group B (Perturbation Based Training on Rolling Board)
Manual perturbations will be applied in multiple directions while the patient stands on a rolling board.
During the procedure, the therapist will manually perturb the rolling board to challenge the patient's balance.
Initially, the training will be conducted within parallel bars for safety and will later be progressed outside the bars as the patient's balance improves.
The total duration of the treatment program will be four weeks.
Contrast bath therapy will be administered for a total duration of 20 minutes.
|
Manual perturbations will be applied in multiple directions while the patient stands on a rolling board.
During the procedure, the therapist will manually perturb the rolling board to challenge the patient's balance.
Each session will consist of two sets of training, with each set lasting 5 minutes and a 10-second rest interval between successive perturbations.
The intervention will be performed three days per week on alternate days, with a total of 10 perturbations delivered per session.
Each treatment session will last approximately 45 minutes.
Initially, the training will be conducted within parallel bars for safety and will later be progressed outside the bars as the patient's balance improves.
The total duration of the treatment program will be four weeks.
Contrast bath therapy will be administered for a total duration of 20 minutes.
The protocol will involve immersion in cold water (60-70°F) for 1 minute followed by warm water (100-105°F) for 3 minutes, repeated for five cycles.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Static and dynamic balance
Periodo de tiempo: Baseline and Week 4
|
Static and dynamic balance will be measured using the standard Berg Balance Scale, a widely used clinical tool for assessing balance performance and fall risk.
It consists of 14 functional tasks, including sitting, standing, reaching, turning, and transferring, with each item scored on a 5-point scale from 0 to 4. Higher total scores indicate better balance ability.
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Baseline and Week 4
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Reactive balance
Periodo de tiempo: Baseline and Week 4
|
The Mini-Balance Evaluation System Test (Mini-BESTest) will be used to assess reactive balance and postural control.
It evaluates different balance systems, including anticipatory adjustments, reactive responses, sensory orientation, and dynamic gait, through functional balance tasks.
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Baseline and Week 4
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Risk of Fall
Periodo de tiempo: Baseline and Week 4
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The Timed Up and Go Test (TUG) will be used to assess functional mobility and fall risk.
In this test, participants are timed while standing up from a chair, walking 3 meters, turning, returning, and sitting down again, with longer completion times indicating greater fall risk.
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Baseline and Week 4
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Dr Maryam Safdar, MS (MSK), The University of Faisalabad
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Akbari NJ, Naimi SS. The effect of exercise therapy on balance in patients with diabetic peripheral neuropathy: a systematic review. J Diabetes Metab Disord. 2022 Jul 4;21(2):1861-1871. doi: 10.1007/s40200-022-01077-1. eCollection 2022 Dec.
- Phyu SN, Wanpen S, Chatchawan U. Responsiveness of the Mini-Balance Evaluation System Test in Type 2 Diabetic Patients with Peripheral Neuropathy. J Multidiscip Healthc. 2022 Dec 29;15:3015-3028. doi: 10.2147/JMDH.S392058. eCollection 2022.
- Nugraha MHS. Balance Problems in the Elderly with Diabetes Mellitus: A Literature Review. J Midlife Health. 2024 Apr-Jun;15(2):55-61. doi: 10.4103/jmh.jmh_29_23. Epub 2024 Jul 5.
- Lepesis V, Paton J, Rickard A, Latour JM, Marsden J. Effects of foot and ankle mobilisations combined with home stretches in people with diabetic peripheral neuropathy: a proof-of-concept RCT. J Foot Ankle Res. 2023 Dec 6;16(1):88. doi: 10.1186/s13047-023-00690-4.
- Khurshid S, Saeed A, Kashif M, Nasreen A, Riaz H. Effects of multisystem exercises on balance, postural stability, mobility, walking speed, and pain in patients with diabetic peripheral neuropathy: a randomized controlled trial. BMC Neurosci. 2025 Feb 27;26(1):16. doi: 10.1186/s12868-024-00924-6.
- Jiang X, Deng F, Rui S, Ma Y, Wang M, Deng B, Wang H, Du C, Chen B, Yang X, Boey J, Armstrong DG, Deng W, Duan X. The Evaluation of Gait and Balance for Patients with Early Diabetic Peripheral Neuropathy: A Cross-Sectional Study. Risk Manag Healthc Policy. 2022 Mar 30;15:543-552. doi: 10.2147/RMHP.S361698. eCollection 2022.
- Hatton AL, Gane EM, Maharaj JN, Burns J, Paton J, Kerr G, Rome K. Textured shoe insoles to improve balance performance in adults with diabetic peripheral neuropathy: study protocol for a randomised controlled trial. BMJ Open. 2019 Jul 17;9(7):e026240. doi: 10.1136/bmjopen-2018-026240.
- Haleem F, Saeed A, Kundi M, Jalal A, Bilal M, Jalal M. Combined effects of strength and balance training versus aerobic training on balance, neuropathy symptoms and quality of life in patients with diabetic peripheral neuropathy. Physiother Res Int. 2024 Jul;29(3):e2103. doi: 10.1002/pri.2103.
- Grewal GS, Schwenk M, Lee-Eng J, Parvaneh S, Bharara M, Menzies RA, Talal TK, Armstrong DG, Najafi B. Sensor-Based Interactive Balance Training with Visual Joint Movement Feedback for Improving Postural Stability in Diabetics with Peripheral Neuropathy: A Randomized Controlled Trial. Gerontology. 2015;61(6):567-74. doi: 10.1159/000371846. Epub 2015 Feb 19.
- Collings R, Freeman J, Latour JM, Hosking J, Paton J. Insoles to ease plantar pressure in people with diabetes and peripheral neuropathy: a feasibility randomised controlled trial with an embedded qualitative study. Pilot Feasibility Stud. 2023 Feb 3;9(1):20. doi: 10.1186/s40814-023-01252-y.
- Allin LJ, Brolinson PG, Beach BM, Kim S, Nussbaum MA, Roberto KA, Madigan ML. Perturbation-based balance training targeting both slip- and trip-induced falls among older adults: a randomized controlled trial. BMC Geriatr. 2020 Jun 12;20(1):205. doi: 10.1186/s12877-020-01605-9.
- Daud SAH, Rahman MU, Arsh A, Junaid M. Effect of balance training with Biodex Balance System to improve balance in patients with diabetic neuropathy: A quasi experimental study. Pak J Med Sci. 2021 Mar-Apr;37(2):389-392. doi: 10.12669/pjms.37.2.2336.
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)
20 de mayo de 2026
Finalización primaria (Estimado)
20 de septiembre de 2026
Finalización del estudio (Estimado)
20 de septiembre de 2026
Fechas de registro del estudio
Enviado por primera vez
13 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
13 de mayo de 2026
Publicado por primera vez (Actual)
20 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
20 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
13 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
- TUF/EIRB/172/26
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. .