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临床试验/CTRI/2024/12/078268
CTRI/2024/12/078268尚未招募3 期

Effect of vestibular exercise program with neuromuscular electrical stimulation on balance and gait recovery in post concussion combat sports athletes.

K K SHRAVAN1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年12月28日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
80
试验地点
1
主要终点
Balance,Gait

研究概览

简要总结

Aims & Objectives –

• Aim:

I. To evaluate the effectiveness of a vestibular exercise program and neuromuscular electrical stimulation on balance and gait recovery in combat sports athletes with post-concussion.

II. To evaluate the effectiveness of neuromuscular electrical stimulation combined with vestibular exercises versus placebo neuromuscular electrical stimulation combined with vestibular exercises on balance and gait recovery in post-concussion combat sports athletes.

• Objectives:

I. To evaluate the effectiveness of placebo NMES combined with vestibular exercises on balance and gait recovery in combat sports athletes with post concussion.

II. To evaluate the effectiveness of NMES combined with vestibular exercises on balance and gait recovery in combat sports athletes with post-concussion

Hypothesis –

• Null Hypothesis (H₀):

  • H01: There will be no significant effect in balance and gait recovery between athletes receiving a placebo NMES and vestibular exercises in post-concussion combat sports athletes.
  • H02: There will be no significant effect in balance and gait recovery between athletes receiving NMES combined with vestibular exercises on balance and gait recovery in combat sports athletes with post-concussion

• Alternative Hypothesis (H₁):

  • H11: There will be a significant effect in balance and gait recovery between athletes receiving a placebo NMES and vestibular exercises in post-concussion combat sports athletes.
  • H12: There will be a significant effect in balance and gait recovery between athletes receiving NMES combined with vestibular exercises on balance and gait recovery in combat sports athletes with post-concussion

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 35.00 Year(s)(—)
性别
All

入选标准

  • Athletes aged 18-35 years.
  • Diagnosed with post-concussion syndrome lasting more than 2 weeks.
  • Exhibiting balance and gait disturbances confirmed by clinical assessment.
  • Cleared for participation in exercise therapy by a healthcare professional.

排除标准

  • Athletes with pre-existing vestibular disorders unrelated to concussion.
  • Athletes with contraindications for NMES (e.g., pacemaker, skin conditions).
  • Concurrent orthopedic injuries affecting lower limbs.
  • History of neurological conditions other than concussion (e.g., stroke, multiple sclerosis).

结局指标

主要结局

Balance,Gait

时间窗: Baseline, Post Fourth week

次要结局

未报告次要终点

研究者

发起方
K K SHRAVAN
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

K K SHRAVAN

Department of Physiotherapy, Amity Institute of Health Allied Sciences

研究点 (1)

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