Plantar Intrinsic Muscles Exercises and Three-dimensional Ankle Foot Exercises Comparative Effect in DPN
Comparative Effects of Plantar Intrinsic Muscles Exercises and 3-dimensional Ankle Foot Exercises on Balance, Gait and Fall Risk in Patients With Diabetic Peripheral Neuropathy
研究概览
地位
详细说明
Diabetic Peripheral Neuropathy (DPN) is among the most common and disabling complications of diabetes mellitus, affecting up to 50% of long-term diabetic patients. Patients commonly present with symmetrical sensory loss (distal extremities), paresthesia, muscle weakness and atrophy (particularly of intrinsic foot musculature), impaired proprioception and vibration sense. Plantar intrinsic muscles exercises target the tiny, stabilizing muscles within the foot particularly, improving intrinsic support and arch integrity, whereas three-dimensional ankle foot exercises place an emphasis on multidirectional motions that increase joint mobility, neuromuscular coordination, and general lower limb strength. The aim of this study is to determine comparative effects of plantar intrinsic muscles exercises and three-dimensional ankle foot exercises on balance, gait and fall risk in patients with diabetic peripheral neuropathy.
This study will be a single-blinded randomized clinical trial. Non probability convenience sampling will be used to recruit 40 patients of either gender, aged 50-75 years, and diagnosed with Diabetic peripheral neuropathy (DPN). This study will be carried out in Dr. Faisal Masood Teaching Hospital, Sargodha. These participants will be randomly allocated to Group A and Group B through computerized table generator method. Group A will receive plantar intrinsic muscle exercises, whereas group B will receive three-dimensional ankle foot exercises. Both groups will perform their respective exercises 40 minutes, thrice a week for 8 weeks. The participants will be evaluated at the start and end of the exercise program through Michigan Neuropathy Screening Instrument (MNSI) and Tinetti Performance Oriented Mobility Assessment (POMA) to assess the effect of this intervention on balance, gait and fall risk. Data will be analyzed by SPSS version 27.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Imran Amjad, Phd
- 电话号码:033324390125
- 邮箱:imran.amjad@riphah.edu.pk
学习地点
-
-
Punjab Province
-
Sargodha、Punjab Province、巴基斯坦、40100
- 招聘中
- Dr. Faisal Masood Teaching Hospital, Sargodha
-
接触:
- Hira Jabeen
-
首席研究员:
- Amna Ahmad, MS-PT
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- The participants who scored ≥ 7 (abnormal) as per the Michigan Neuropathy Screening Instrument (MNSI)
- Able to ambulate 10 m barefoot without using a walking aid
- Patient reporting to have either fear of falling or experienced a fall in the previous 12 months
- Cognitive Function on Mini-Mental State Examination is normal (MMSE score: Above 25)
- Patients having difficulties with mobility, gait, or balance in daily life
Exclusion Criteria:
- Presence of other neurological conditions (GBS, Paraneoplastic Neuropathy, Infectious Neuropathy, others)
- Severe Retinopathy, a vascular complication of DM.
- Limited Ankle and foot ROM due to fracture or contracture.
- Presence of active plantar ulcers.
- Recent surgeries or injuries in the foot/lower limb.
- Musculoskeletal disorders affecting gait (Osteoarthritis, Rheumatoid arthritis, Muscular dystrophy, Hip dysplasia, others)
- Participation in another rehabilitation or training concurrently
学习计划
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:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器:Plantar intrinsic muscle exercises
Plantar Intrinsic Foot Exercises (PIFE), along with conventional therapy
|
Plantar Intrinsic Foot Exercises (PIFE), for 40 minutes, thrice a week for 8 weeks.
Warm-up, conventional therapy, and cool-down will be given.
|
|
实验性的:Three-Dimensional ankle foot exercises
3D Ankle-Foot Exercises (3D-AFE), along with conventional therapy
|
3D Ankle-Foot Exercises (3D-AFE), for 40 minutes, thrice a week for 8 weeks.
Warm-up, conventional therapy, and cool-down will be given.
|
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 |
|---|---|---|
|
Tinetti Performance Oriented Mobility Assessment (POMA)
大体时间:8th week
|
Changes from baseline Tinetti Performance Oriented Mobility Assessment (POMA) is clinical instrument for assessing balance and gait function in patients with neurological or musculoskeletal disorders as well as older patients.
Scores of 25-28 indicate low fall risk, 19-24 medium fall risk, and < 19 high fall risk.
|
8th week
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Michigan Neuropathy Screening Instrument (MNSI)
大体时间:8th week
|
Changes from baseline, the Michigan Neuropathy Screening Instrument (MNSI) is designed to screen for the presence of diabetic neuropathy.
The first part of the screening instrument consists of 15 self-administered questions on foot sensation including pain, numbness and temperature sensitivity.
The second part of the MNSI is a brief physical examination involving 1) inspection of the feet for deformities, dry skin, hair or nail abnormalities, callous or infection, (2) semi-quantitative assessment of vibration sensation at the dorsum of the great toe, (3) grading of ankle reflexes and, (4) monofilament testing.
|
8th week
|
合作者和调查者
调查人员
- 首席研究员:Hira Jabeen、Riphah International University
- 首席研究员:Hira Jabeen, MS-PT、Riphah International University
出版物和有用的链接
一般刊物
- Willemse L, Wouters EJ, Pisters MF, Vanwanseele B. Plantar intrinsic foot muscle activation during functional exercises compared to isolated foot exercises in younger adults. Physiotherapy Theory and Practice. 2024;40(8):1656-68.
- Waheed A, Azharuddin M, Ahmad I, Noohu MM. Whole-body vibration, in addition to balance exercise, shows positive effects for strength and functional ability in patients with diabetic peripheral neuropathy: A single-blind randomized controlled trial. Journal of Diabetology. 2021;12(4):456-63.
- Alissa N, Goldstein SA, Lindsay Z, and Westlake KP. A Systematic Review of the Effect of Physical Rehabilitation on Balance in People with Diabetic Peripheral Neuropathy Who are at Risk of Falling. Clinical Interventions in Aging. 2024;19(null):1325-39.
- Jimenez-Mazuelas M, de Villar NG-P, De Casas-Albendea S, Martinez-Gimeno L, Jimenez-Gonzalez S, Angulo-Carrere M. Somatosensory and dynamic balance improvement in older adults with diabetic peripheral neuropathy through sensorimotor exercise: A multisite randomized controlled trial. Journal of Bodywork and Movement Therapies. 2024;40:2062-73.
- Vellacita G, Dewi P, editors. The Effectiveness of Diabetic Foot Exercise to Peripheral Neuropathy Symptoms and Fasting Blood Glucose in Type 2 Diabetes Patients. Proceedings of the International Conference of Health Development Covid-19 and the Role of Healthcare Workers in the Industrial Era (ICHD 2020); 2020 2020/11/25: Atlantis Press.
- Monteiro RL, Ferreira JS, Silva ÉQ, Donini A, Cruvinel-Júnior RH, Verissímo JL, et al. Feasibility and preliminary efficacy of a foot-ankle exercise program aiming to improve foot-ankle functionality and gait biomechanics in people with diabetic neuropathy: A randomized controlled trial. Sensors. 2020;20(18):5129.
- Monteiro RL, Ferreira JS, Silva ÉQ, Cruvinel-Júnior RH, Veríssimo JL, Bus SA, et al. Foot-ankle therapeutic exercise program can improve gait speed in people with diabetic neuropathy: A randomized controlled trial. Scientific reports. 2022;12(1):7561.
- Jaha GN. Effectiveness of Functional Strength Training and Balance Training on Postural Stability and Gait in Patients with Diabetic Peripheral Neuropathy to Reduce the Risk of Falls
- ark D-J, Hwang Y-I. Comparison of the intrinsic foot muscle activities between therapeutic and three-dimensional foot-ankle exercises in healthy adults: An explanatory study. International Journal of Environmental Research and Public Health. 2020;17(19):7189.
- Shin KJ, Kang JW, Sung KH, Park SH, Kim SE, Park KM, et al. Quantitative gait and postural analyses in patients with diabetic polyneuropathy. Journal of Diabetes and its Complications. 2021;35(4):107857.
- Willemse L, Wouters EJ, Pisters MF, Vanwanseele B. Effects of a 12-week intrinsic foot muscle strengthening training (STIFF) on gait in older adults: a parallel randomized controlled trial protocol. BMC Sports Science, Medicine and Rehabilitation. 2024;16(1):158.
- Lima RAdO, Piemonte GA, Nogueira CR, Nunes-Nogueira VdS. Efficacy of exercise on balance, fear of falling, and risk of falls in patients with diabetic peripheral neuropathy: a systematic review and meta-analysis. Archives of endocrinology and metabolism. 2021;65:198-211.
- rancis D, Kandaswami K, Veedu PP, Subramanian AP. Effect of exercises for strengthening the intrinsic muscles of the foot and improving ankle mobility on patients of diabetic peripheral neuropathy. Cureus. 2024;16(3).
- Pang X, Wang D, Zhang F, Guo B, Liu W. Exploring the exercise for enhancing postural control, gait, and muscle strength in older adults with diabetic peripheral neuropathy: a systematic review and meta-analysis. Frontiers in Aging. 2025;6:1507232.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- REC/RCR & AHS/25/0236
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.