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临床试验/NCT06407596
NCT06407596已完成不适用

High-intensity Laser Therapy (HILT) or Conventional Combined Physical Therapy in the Management of Hemiplegic Shoulder Pain ; Randomized Controlled Trial

Ankara City Hospital Bilkent2 个研究点 分布在 2 个国家目标入组 42 人开始时间: 2022年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
42
试验地点
2
主要终点
arm motor ability test

研究概览

简要总结

Background: Hemiplegic shoulder pain is one of the most common complications after a stroke. There are many treatment strategies for this complication. High-intensity laser therapy (HILT) is a new treatment option, and we aimed to compare the effectiveness of conventional electrotherapy agents and HILT in this study.

Patients and methods: Participants (N = 42) were randomized into the HILT (n = 21) and TENS+US (n = 21) groups. Group 1 received 3 sessions of HILT per week for 3 weeks in addition to a therapeutic exercise program that performed 5 sessions per week for 3 weeks. Group 2 received conventional physical therapy and a therapeutic exercise program for HSP of 5 sessions per week for 3 weeks. Patients were assessed before and after treatment on the on the 6th week for radiological evaluation with ultrasonography and for clinical parameters with VAS, AMAT, MRS, and FIQ scores.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosed case of HSP,
  • First-ever unilateral stroke,
  • Visual analog scale (VAS) ≥30 mm,
  • Time since stroke ≥6 months,
  • Time since last local intervention treatment >6 months.

排除标准

  • A history of shoulder pain prior to stroke;
  • An unstable medical condition or uncontrolled systemic diseases (such as respiratory failure, congestive heart failure, liver and kidney dysfunction, or any other disorders affecting neuromuscular function);
  • Bilateral hemiplegia;
  • Cardiac pacemakers;
  • Disturbance of awareness, severe visual and cognitive impairment, Mini-Mental State Examination score: <23 points

结局指标

主要结局

arm motor ability test

时间窗: before treatment(baseline), after treatment

this scale asses the upper extremity motor function improvement and daily living activity level , between 0 is the worst score, mean is cant do/use, 5 is the best score.(between 0-5)

modified ranking scale

时间窗: before treatment(baseline), after treatment

determines the patient's addiction level and evaluates disability; the score is between 0 and 6, where 0 is complete well-being, 5 is very severe disorder and 6 is full dependency

visual analog scale

时间窗: before treatment(baseline), after treatment

pain level, between 0-10, 0 is no pain, 10 is very severe pain

functional indepandance measures

时间窗: before treatment(baseline), after treatment

functional capacity assessment scale;and despite indepandance of daily living activity 0-126, high score is better function

次要结局

  • ultrasonographic imaging(before treatment(baseline), after treatment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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