跳至主要内容
临床试验/NCT07756073
NCT07756073尚未招募不适用

Combined Effect of Buerger's Exercises and Proprioceptive Drills on Postural Stability and Foot Perfusion in Elderly Patients With Chemotherapy-Induced Peripheral Neuropathy Randomized Controlled Trial

South Valley University0 个研究点目标入组 70 人开始时间: 2026年7月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
70
主要终点
Postural Stability Foot Perfusion

研究概览

简要总结

Chemotherapy-induced peripheral neuropathy (CIPN) is a common, dose-limiting side effect of neurotoxic chemotherapy agents, characterized by sensory loss, impaired proprioception, and muscle weakness, predominantly affecting the lower limbs. These impairments significantly contribute to postural instability and increase fall risk in elderly patients. Additionally, CIPN-associated microvascular changes can compromise peripheral circulation, further exacerbating neuromotor dysfunction and balance deficits.

While pharmacological options for CIPN are limited and often inadequate, exercise-based interventions have shown promise in mitigating functional impairments. Buerger's exercises, a vascular stimulation technique, are known to enhance peripheral blood flow, whereas proprioceptive drills can improve neuromuscular coordination and postural control. However, their combined effect on both postural stability and foot perfusion in elderly patients with CIPN has not been systematically studied.

详细描述

Aim of the Study To investigate the combined effect of Buerger's exercises and proprioceptive drills on postural stability and foot perfusion in elderly patients with chemotherapy-induced peripheral neuropathy.

  • Objectives

Primary Objectives:

  • To evaluate the effect of combined Buerger's exercises and proprioceptive drills on postural stability.
  • To assess their effect on foot perfusion.

Secondary Objectives:

• To assess changes in balance confidence, functional mobility, and fall incidence.

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
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Aged 65 years or older
  • •Diagnosed with CIPN for at least 3 months
  • •Demonstrating impaired postural stability (BBS ≤ 48 or ≥2 falls in the past year)
  • •Medically cleared for exercise
  • •Cognitively intact (MMSE ≥ 24)
  • •Willing and able to give consent

排除标准

  • •Severe peripheral arterial disease (ABI < 0.5)
  • •Severe postural hypotension or positional syncope
  • •Recent orthopedic procedures or fractures (past 6 months)
  • •Vestibular or cerebellar disorders
  • •Uncontrolled systemic diseases
  • •Cognitive impairment (MMSE < 24)
  • •Concurrent participation in another structured balance or vascular program
  • •Lower limb ulcers or active infection
  • •Severe visual impairment
  • •Intolerance to positional exercises

研究组 & 干预措施

Intervention Group

Experimental

Intervention Group (35 participants) will receive

Buerger's Exercises + Proprioceptive Drills, 3 times/week for 8 weeks:

  • Buerger's Exercises:

  • Leg elevation at 45° for 2 min until blanching

  • Dependent sitting for 3 min until hyperemia

  • Supine rest for 5 min

  • 3 cycles per session

  • Proprioceptive Drills:

  • Single-leg stance

  • Tandem stance/walking

  • Heel-to-toe walking

  • Anterior-posterior and lateral weight shifts

  • Mini-squats on foam

  • Ankle alphabet

  • Progressively increased difficulty Sessions supervised by trained physiotherapists.

干预措施: Buerger's Exercises (Combination Product)

Control Group

Active Comparator

Control Group (35 participants) will receive Standard care with educational leaflets and physical activity advice.

干预措施: Buerger's Exercises (Combination Product)

结局指标

主要结局

Postural Stability Foot Perfusion

时间窗: Week 8

.Postural Stability: Overall Stability Index (OSI) via Biodex Balance System SD Foot Perfusion: Laser Doppler Flowmetry (LDF)

Pain scale (VAS) Quality of Life Index (QLI) - SCI Version

时间窗: 8 weeks

Pain scale (VAS) The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." Quality of Life Index (QLI) - SCI Version Comprised of 4 domains: 1. Health and functioning 2. Psychological/spiritual 3. Social and economic 4. Family.

Weight Height Body mass index

时间窗: 8 weeks

Weight in kg, height in meter and body mass index in kg/m2

次要结局

  • Secondary Outcomes(8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ibrahim Abuzaid

Head of department physical therapy for cardiovascular/Respiratory disorders and Geriatrics

South Valley University

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