Comparative Effects of Perturbation-Based Balance Training on Firm Surface and Rolling Board for Diabetic Neuropathy Patients

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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. 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 p
• Другое 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. 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 t

Первичные конечные точки

• Static and dynamic balance [Срок оценки: Baseline and Week 4]

Вторичные конечные точки (2)

• Reactive balance [Срок оценки: Baseline and Week 4]
• Risk of Fall [Срок оценки: Baseline and Week 4]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Пакистан · 1 центр

• Madinah Teaching Hospital and Al Mahmood Physiotherapy Clinic, Faisalabad — Faisalābad

Публикации

• 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. PMID 36601428
• 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. PMID 39145265
• 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. PMID 38057930
• 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. PMID 40016658
• 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. PMID 35386278
• 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. PMID 31320345
• 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. PMID 38887171
• 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. PMID 25721132

Идентификаторы

NCT: NCT07598513 · TUF/EIRB/172/26

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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