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临床试验/NCT05460728
NCT05460728已完成不适用

Dry Needling Effects on Spasticity and General Functioning in Patients With Traumatic Brain Injury: A Case Study

Anas Radi Hassan Alashram1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2022年4月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1
试验地点
1
主要终点
modified Ashworth Scale (MAS)

研究概览

简要总结

Thirty-six years old male with a history of TBI with compromised functionality of the right upper and lower limbs, spasticity, distributed balance, and difficulties performing independent gait has participated in the study. Berg balance scale, 6-minute walk test, modified Ashworth scale, and functional independence measure was used to assess balance, gait, spasticity, and functional intemperance, respectively.

详细描述

A 36-year-old man (height: 1.75 m, weight: 73 kg) with a 6-month history of TBI due to a motor vehicle accident resulting in right hemiplegia was admitted in March 2022 to the outpatient Neurological Physiotherapy Clinic. He was alert and oriented and had expressive aphasia. The patient had compromised functionality of the right upper and lower limbs, spasticity, distributed balance, and difficulties performing independent gait. He was right-hand dominant.

Demographic data were recorded including age, gender, occupation, and duration of disease. The outcome measures were evaluated at baseline (T0), 12 weeks from T0 (T1), and 16 weeks from T0 (4 weeks after the intervention, T2).

Spasticity assessment Spasticity for the upper and lower limbs was evaluated using the modified Ashworth Scale (MAS). The scale evaluates the resistance of a limb to a rapid passive stretch in 6 scores from 0 to 5. Score 0 indicates normal muscle tone, and 5 indicates rigid limb. The MAS for a patient with TBI has shown good reliability (ICC = 0.62-0.90).

Gait and balance assessment The primary outcome of the 6-MWT was the distance covered by the patient in 6 minutes. It was used to evaluate functional capacity in individuals with chronic disorders. The 6-MWT is a good predictor of cardiorespiratory endurance in patients with TBI. The 6-MWT for a patient with TBI has shown good reliability (ICC = 0.96-0.98) and good discriminant validity. The test was applied according to the guidelines provided by of American Thoracic Society (ATS). Two reference points were placed at 30 m from each other. Before and immediately following the test, heart rate and oxygen saturation were taken using a pulse oximeter. The patient was able to complete the 6-MWT without taking a rest break. Gait speed was demonstrated in meters per minute by dividing the total distance covered in the 6-MWT by 6 minutes.

The balance and risk of falls were evaluated using Berg Balance Scale (BBS). This scale includes 14 items requiring patients to complete tasks related to the everyday life of varying difficulty levels. The total final scores range from 0 to 56. A total score of fewer than 45 exhibits balance impairment. The BBS has excellent reliability (ICC = 0.986) in patients with TBI.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
30 Years 至 40 Years(Adult)
性别
Male
接受健康志愿者
否

入选标准

  • •Traumatic brain injury

排除标准

  • •Unstable status

研究组 & 干预措施

Dry needling

Experimental

干预措施: Dry needling (Other)

结局指标

主要结局

modified Ashworth Scale (MAS)

时间窗: Change from baseline MAS at 12-week and 16-week

Spasticity for the upper and lower limbs was evaluated using the modified Ashworth Scale (MAS) (Ghotbi, 2009). The scale evaluates the resistance of a limb to a rapid passive stretch in 6 scores from 0 to 5. Score 0 indicates normal muscle tone, and 5 indicates rigid limb (Bohannon, 1987). The MAS for a patient with TBI has shown good reliability (ICC = 0.62-0.90) (Mehrholz, 2005).

次要结局

  • Berg Balance Scale (BBS)(Change from baseline BBS at 12-week and 16-week)
  • 6-Minute Walk Teat (6-MWT)(Change from baseline 6-MWT at 12-week and 16-week)
  • Functional Independence Measure (FIM)(Change from baseline FIM at 12-week and 16-week)

研究者

发起方
Anas Radi Hassan Alashram
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Anas Radi Hassan Alashram

Associate Professor

Middle East University

研究点 (1)

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