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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
研究概览
简要总结
The aim of this study is to determine the 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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
Randomized for RCT
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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