Comparative Effects of Perturbation-Based Balance Training on Firm Surface and Rolling Board for Diabetic Neuropathy Patients
13 мая 2026 г. обновлено: 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.
Обзор исследования
Статус
Еще не набирают
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.
Тип исследования
Интервенционный
Регистрация (Оцененный)
42
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Maryam Safdar Dr, MS Physical Therapy (MSK)
- Номер телефона: +92-3217978088
- Электронная почта: maryamsafdar.DPT@tuf.edu.pk
Учебное резервное копирование контактов
- Имя: Dr Muhammad Ateeb, PhD Public Health
- Номер телефона: +92-3357333383
- Электронная почта: mateeb.oric@tuf.edu.pk
Места учебы
-
-
Punjab Province
-
Faisalābad, Punjab Province, Пакистан, 38000
- Madinah Teaching Hospital and Al Mahmood Physiotherapy Clinic, Faisalabad
-
-
Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Нет
Описание
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.
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: 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.
|
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.
|
|
Активный компаратор: 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.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Static and dynamic balance
Временное ограничение: 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.
|
Baseline and Week 4
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Reactive balance
Временное ограничение: 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.
|
Baseline and Week 4
|
|
Risk of Fall
Временное ограничение: Baseline and Week 4
|
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.
|
Baseline and Week 4
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Следователи
- Главный следователь: Dr Maryam Safdar, MS (MSK), The University of Faisalabad
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Общие публикации
- 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.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Оцененный)
20 мая 2026 г.
Первичное завершение (Оцененный)
20 сентября 2026 г.
Завершение исследования (Оцененный)
20 сентября 2026 г.
Даты регистрации исследования
Первый отправленный
13 мая 2026 г.
Впервые представлено, что соответствует критериям контроля качества
13 мая 2026 г.
Первый опубликованный (Действительный)
20 мая 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
20 мая 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
13 мая 2026 г.
Последняя проверка
1 мая 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- TUF/EIRB/172/26
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
НЕТ
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .