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

2026年5月13日 更新者：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.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

42

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 巴基斯坦
    • Punjab Province
      • Faisalābad、Punjab Province、巴基斯坦、38000
        • Madinah Teaching Hospital and Al Mahmood Physiotherapy Clinic, Faisalabad

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：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.
其他：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 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.
有源比较器：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.
其他：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 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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Static and dynamic balance
大体时间：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

次要结果测量

结果测量
措施说明
大体时间
Reactive balance
大体时间：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
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University of Faisalabad

调查人员

  • 首席研究员：Dr Maryam Safdar, MS (MSK)、The University of Faisalabad

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年5月20日

初级完成 (估计的)

2026年9月20日

研究完成 (估计的)

2026年9月20日

研究注册日期

首次提交

2026年5月13日

首先提交符合 QC 标准的

2026年5月13日

首次发布 (实际的)

2026年5月20日

研究记录更新

最后更新发布 (实际的)

2026年5月20日

上次提交的符合 QC 标准的更新

2026年5月13日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • TUF/EIRB/172/26

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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