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临床试验/NCT07827417
NCT07827417招募中不适用

Comparative Effects of Reactive Balance Training and Task-Oriented Training on Postural Stability in Patients With Diabetic Peripheral Neuropathy

Foundation University Islamabad1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2026年2月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
36
试验地点
1
主要终点
Postural stability

研究概览

简要总结

Diabetic peripheral neuropathy (DPN) is a common complication of prolonged hyperglycemia that damages peripheral nerves, leading to impaired sensory function, increased fall risk, and reduced quality of life. Balance training has shown promising effects in improving postural stability and reducing fall risk in individuals with DPN by engaging visual, vestibular, and proprioceptive systems and promoting central nervous system adaptation. This randomized controlled trial aims to compare the effects of Reactive Balance Training (RBT) and Task-Oriented Training (TOT) on postural stability in patients with DPN.

The study will be a single-blinded, two-group randomized controlled trial conducted over one year at Foundation University College of Physical Therapy. A sample of 36 participants will be recruited through convenience sampling and randomly allocated into two groups using the coin-toss method. Ethical approval will be obtained from the FUSH ERC, and written informed consent will be obtained after explaining the study procedures, risks, and benefits.

Postural stability will be assessed using the Posture Assessment Checklist, Mini-BESTest, Functional Reach Test (FRT), and Timed Up and Go (TUG). Group A will receive RBT, while Group B will receive TOT. Each session will last 30-40 minutes, including a 5-7-minute warm-up, 20-30 minutes of group-specific intervention, and a 5-minute cool-down. Participants will receive 60-second rest intervals after every three sets or 8-10 repetitions.

The intervention will continue for six weeks, with three sessions per week, totaling 18 sessions. Assessments will be conducted at baseline, at week 3, and post-intervention at week 6 using the same outcome measures.

详细描述

Diabetic peripheral neuropathy (DPN) is a common complication, resulting from prolonged high blood sugar damaging peripheral nerves. It substantially affects patients by increasing their risk of falls, impairing sensory function, and diminishing overall quality of life. Exercise programs that include balance training have demonstrated promising results in enhancing postural stability and reducing fall risk among patients with DPN .By engaging the visual, vestibular, and proprioceptive systems, balance training facilitates central nervous system adaptation, enhancing the integration of sensory inputs critical for maintaining postural control.This randomized controlled trial aims to compare the effects of Reactive Balance Training and Task-Oriented Training on Postural Stability in Patients with Diabetic Peripheral Neuropathy.The study will be a single -blinding randomized controlled trial, consisting of 2 groups and it will be conducted over a period of 1 year at Foundation University and Collage of Physical Therapy. A calculated sample of 36 subjects will be selected via convenience sampling technique followed by randomization into two groups using coin toss method. Ethical approval will be obtained from FUSH ERC. Individuals fulfilling the inclusion criteria will be selected, followed by written informed consent after explaining the study purpose. Postural stability will be assessed using Posture Assessment Checklist Form, MiniBestest, Funtional Reach test and Time Up and Go in both group.

Each group will have 30-40 minutes divided into 5-7 minutes of warm-up and 20-30 minutes of Reactive balance training or task-specific depending on the group the patient is assigned to follow by 5 minutes cool down period. With every 3 sets or 8-10 repetitions patient will take a 60 seconds break. The total intervention duration will last for 6 weeks. The total number of sessions will be 18 with 3 sessions per week. Each session will begin with a 5-7-minute warm-up consisting of marching in place, ankle pumps and circles, and anterior-posterior (AP) and medial-lateral (ML) weight shifts. This will be followed by 20-30 minutes of group-specific training, with the Reactive Balance Training group performing perturbation-based tasks involving unexpected changes in direction, timing, or surface, while the Task-Oriented Training group will perform functional, goal-directed activities with repetitive practice and progressive challenges.

Each session will conclude with a 5-minute cool-down, including slow walking and stretching of the calf, hamstrings, and hip flexors. Group A will receive reactive balance training with Protocol of 6 Weeks.

In Weeks 1-2 - Familiarization: Warm-up (5-7 min), followed by lean-and-release (forward/backward), gentle AP pelvic perturbations, predictable reactive stepping, and elastic-band perturbations in AP/lateral directions. Cool-down (5 min). Dosage: 3 × 10 perturbations, 60-s rest.

In Weeks 3-4 - Adaptation: Multidirectional lean-and-release, eyes-closed perturbations, foam-surface perturbations, foam + elastic-band perturbations, and eyes-closed elastic perturbations. Dosage: 3 × 10 trials, 60-s rest.

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
Single (Participant)

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Both gender
  • Adults aged 40 years and above diagnosed with type 2 diabetes mellitus.
  • Diagnosed cases diabetic peripheral neuropathy.
  • Able to stand and walk independently
  • Balance or postural stability, as indicated by clinical tests (e.g., mini-bestest score below -normative values/21 or less or history of falls/near-falls).
  • Functional reach test with scores 6-10 inches
  • Time up and go up to 14 seconds

排除标准

  • History of neurological disorders other than DPN (e.g., stroke, Parkinson's disease, multiple sclerosis).
  • Musculoskeletal disorders affecting lower limb function (e.g., grade 4 osteoarthritis, recent fractures).
  • Uncontrolled cardiovascular conditions (e.g., unstable angina, recent myocardial infarction).
  • Vestibular impairments affecting balance independently of DPN.
  • Diabetic complications that contraindicate exercise (e.g., active foot ulcers, severe retinopathy).

研究组 & 干预措施

Group A- REACTIVE BALANCE TRAINING

Experimental

Participants will receive reactive balance training focused on improving rapid postural responses to unexpected balance disturbances through controlled external perturbations during standing and walking, emphasizing ankle, hip, and stepping strategies with progressive difficulty.

干预措施: Reactive Balance Training (Procedure)

TASK ORIENTED TRAINING

Experimental

Participants will receive task-oriented training consisting of functional, goal-directed activities such as sit-to-stand, reaching, stepping, walking with direction changes, obstacle negotiation, and weight-shifting, with gradual progression in task complexity

干预措施: TASK ORIENTED TRAINING (Procedure)

结局指标

主要结局

Postural stability

时间窗: 6 weeks

Postural stability during Reactive Balance will be assessed using MiniBestest test in both groups. The test has a maximum score of 28 points from 14 items that are each scored from 0-2. "0" indicates the lowest level of function and "2" the highest level of function. If a subject must use an assistive device for an item, score that item one category lower. If a subject requires physical assistance to perform an item, score "0" for that item. For Item 3 (stand on one leg) and Item 6 (compensatory stepping-lateral) only include the score for one side (the worse score). For Item 3 (stand on one leg) select the best time of the 2 trials \[from a given side\] for the score. For Item 14 (timed up \& go with dual task) if a person's gait slows greater than 10% between the TUG without and with a dual task then the score should be decreased by a point.

Functional Postural stability

时间窗: 6 weeks

Functional postural stability will assess using Functional Reach Test. Use to measure ability to maintain stability while reaching forward and controlling the center of mass. * If the reach distance exceeds 25.40 cm, it is considered a negative test and a low risk of falling. * If the reach distance is within the range of 15.24-25.40 cm, the risk of falling is twice as high during the next six months. * If the reach distance is less than 15.24 cm, there is a four times greater risk of falling during the next six months.

Dynamic Postural Stability

时间窗: 6 weeks

Dynamic Postural Stability will be assess using TIME UP \& GO. A TUG time of ≤10.7 seconds indicates better functional mobility and lower fall risk, whereas a time of \>10.7 seconds indicates poorer functional mobility and increased fall risk in individuals with diabetic peripheral neuropathy. Posture Assessment Checklist will be use as well in order to check the anterior, posterior and lateral view of posture for ruling out any kind of deformity

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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