跳至主要内容
临床试验/NCT05194644
NCT05194644Unknown不适用

Effects of Sensorimotor Stimulation Program With and Without Routine Physical Therapy on Balance and Cognitive Performance in Patients With Mild Traumatic Brain Injury: A Randomized Controlled Trial

University of Lahore2 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2021年11月10日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
54
试验地点
2
主要终点
Balance

研究概览

简要总结

Study design: Randomized controlled trial Settings: Physiotherapy department of Allied hospital, Faisalabad Sample size: 27 in each group Control group receive: Routine physical therapy Experimental group receive: Routine physical therapy+ Sensorimotor stimulation

详细描述

Control group: Routine physical therapy Time duration: 20 min, Rest period: 5 min and treatment will be given 5 days a week and continued for 16 weeks.

Experimental group: Routine physical therapy + Sensorimotor stimulation

Sensorimotor stimulation:

Sensory stimulation:

  1. Gustatory stimulation: Irrigation of oral cavity, brushing of teeth and tongue, gum massage, 2ml lemon juice on lateral side of tongue, Time duration will be 4 min.
  2. Tactile stimulation: For temperature sensation warm and cold water will applied on different body parts, For touch sensation wet towels and soap will be applied, For pressure sensation body parts will be massaged by lotion, Time duration will be 4 min.
  3. Olfactory stimulation: Aromatic stimuli with fragrances to which patient had been familiar e.g. coffee, tea, orange peel and perfume etc. Time duration will be 3 min.
  4. Auditory stimulation: Investigator will communicate directly to patients, familiar songs will be utilized, Time duration will be 4 min.
  5. Visual stimulation: Colored light, familiar faces, photographs of family members, moving light will be used, Time duration will be 4 min.

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 (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 38 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patient recruit from Outdoor patient department with mild traumatic brain injury having Glasgow coma scale score(13-15)
  • Normal intracranial pressure
  • Cardiopulmonary stability

排除标准

  • Preexisting disabilities
  • Suffering from severe medical disease
  • Persistent vegetative state
  • Patients with opium and drug addicted
  • Patients with deafness and delusion disorders

结局指标

主要结局

Balance

时间窗: 16th week

Balance will be measured by Berg balance scale in which (0-20)indicates high fall risk, (21-40) indicates medium fall risk and (41-56) represents low fall risk

Cognitive Performance

时间窗: 16th week

Cognitive performance will be measured by Rancho Los Amigos scale that consist of 8 levels. level I indicates no response and needs total assistance whereas level VIII represents purposeful appropriate response and needs stand by assistance,

次要结局

未报告次要终点

研究者

发起方
University of Lahore
申办方类型
Other
责任方
Principal Investigator
主要研究者

Huma Waqar

Effects of sensorimotor stimulation program with and without routine physical therapy on balance and cognitive performance in patients with mild traumatic brain injury: A randomized controlled trial

University of Lahore

研究点 (2)

Loading locations...

相似试验