Comparison of Otago and Beat it Program on Balance, Gait and QOL in Diabetic Neuropathy
2026年5月4日 更新者：Riphah International University
Comparative Effects of Otago Exercise Program and Beat it Program on Balance, Gait and Quality of Life in Patients With Diabetic Peripheral Neuropathy
this study aims to compare the effects of Otago exercise program and BEAT IT program on balance, gait and quality of life in patients with diabetic peripheral neuropathy.
研究概览
详细说明
Limited studies have been conducted to assess gait and quality of life.
Most of the studies related to the Otago exercise program conducted in the geriatric population, stroke, Parkinson's, alcoholic neuropathy, chronic inflammatory polyneuropathy, and so on, a few studies conducted on diabetes, however up to the researcher's knowledge its effect on diabetic neuropathy has not been found.
Similarly, studies related to the BEAT IT Program conducted in cancer patients and diabetes populations.
Hence there is a need for comparative study on Otago exercise program and BEAT IT program to assess balance, gait and quality of life in patients with diabetic peripheral neuropathy
研究类型
介入性
注册 (估计的)
32
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
- 姓名：Muneeb Khan, PhD
- 电话号码：+92336799611
- 邮箱：muneeb.khan@riphah.edu.pk
学习地点
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Punjab Province
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Lahore、Punjab Province、巴基斯坦、54500
- THQ hospital
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接触：
- Javeria Ghazal, MS
- 电话号码：+923335154664
- 邮箱：javeria.ghazal@riphah.edu.pk
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首席研究员：
- Sania Hassan, MS
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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:
- physician-diagnosed type 2 diabetes, with peripheral neuropathy (defined by Michigan Neuropathy Screening Instrument questionnaire score of 5 or greater) the ability to walk independently for 20 m (97).
- Having score between 46 to 52 (out of a total of 56 points) on the BBS
Exclusion Criteria:
- fracture of the lower limb within the 6 months before the study
- diabetic ulcer, infection or partial amputation in feet
- disease or functional impairment of auditory, vestibular system
- Dementia or inability to give consistent information
- History of surgical procedure at the knee, ankle, or hip or indication of surgery throughout the intervention period malignancy, other neurological or orthopedic impairments (such as stroke, poliomyelitis, rheumatoid arthritis, prosthesis, or severe osteoarthritis), major vascular complications (venous or arterial ulcers), severe retinopathy, or severe nephropathy that causes edema or needs hemodialysis
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：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Otago program
Participants performed a combination of warm-up, strengthening, balance, and aerobic exercises at home.
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The program included: 5 Strengthening exercises and 12 balance exercises. 30-40 min, 4x/week for 8 weeks. Balance Exercises: Knee bends Backwards walking Walking and turning around Sideways walking Tandem stance (heel toe stance) Tandem walk (heel toe walk) One leg stance Heel walking Toe walk Heel toe walking backwards Sit to stand Stair walking Strength exercises: Knee extensor Knee flexor Hip adductor Ankle planter flexors (calf raises) Ankle dorsiflexors (toe raises) |
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实验性的：BEAT it program
Participants performed moderate-intensity aerobic, resistance, balance, and flexibility exercises, along with education on diabetes self-management.
The exercises were designed to be completed at home using minimal equipment or household items
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Strengthening exercises Toe spreading Ankle pump Mini wall squats Slow march in standing Knee with pillow press up Bridging Step up and down on stair 1st step Toe curls Stretching Hamstring stretch Dorsiflexors and planter flexors stretch Quads stretch Biceps stretch Triceps stretch Balance exercises Leg front and back swinging Weight shifting front and back Leg sideways Sideway alternate step Tandem stand Alternate heel toe raises Sessions were performed;
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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 |
|---|---|---|
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4 Stage Balance Test
大体时间：8th week
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The Four Stage Balance Test is a validated measure recommended to evaluate static balance. Four standing positions get progressively harder to maintain.
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8th week
|
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Mini BESTest
大体时间：8th week
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This test measures dynamic balance, functional mobility, and gait.
The Mini-BESTest, the shortened form of BESTest, contains only 14 different tasks and involves four sub-sections: anticipatory postural adjustments, postural response to external perturbations, sensory orientation, and stability in gait.
Two items of Mini-BESTest are assessed bilaterally, but only the lower score was added to the maximum score of 28 points, which results from grading based on a 3-point ordinal scale ranging from 0 (severe balance impairment) to 2 (no balance impairment) (108).
Reliability 0.98; Validity 0.65.
|
8th week
|
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Functional Reach Test
大体时间：8th week
|
FRT is used to evaluate anticipatory balance which correlates with fall risks.
This test measures the margin of stability along with the ability to measure balance during a functional task.
Reliability 0.89; Sensitivity 76%; Specificity 34%
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8th week
|
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Functional Gait Assessment
大体时间：8th week
|
The FGA has been validated for the assessment of balance in people with vestibular dysfunction, community-dwelling older adults, patients with stroke, and patients with Parkinson disease.
The FGA has good reliability (interrater reliability: intraclass correlation coefficient [ICC]=.74;
interrater reliability: ICC=.86 to .93) and internal consistency (Cronbach alpha=.79)
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8th week
|
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Norfolk Quality of Life-Diabetic Neuropathy (QOL-DN) questionnaire
大体时间：8th week
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The Norfolk Quality-of Life Diabetic Neuropathy tool (QOL-DN) has been found to be reliable across many different populations.
This comprehensive tool has demonstrated sensitivity to both small and large fiber impairment while also detecting improvements in neuropathy.
Intra class Reliability >0.9; Internal Consistency >0.6
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8th week
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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。
调查人员
- 首席研究员：Javeria Ghazal, MS、Riphah International University
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15日
初级完成 (估计的)
2026年8月30日
研究完成 (估计的)
2026年9月15日
研究注册日期
首次提交
2026年2月23日
首先提交符合 QC 标准的
2026年5月4日
首次发布 (实际的)
2026年5月8日
研究记录更新
最后更新发布 (实际的)
2026年5月8日
上次提交的符合 QC 标准的更新
2026年5月4日
最后验证
2026年5月1日
更多信息
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.