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临床试验/CTRI/2025/10/096421
CTRI/2025/10/096421已完成不适用

Neurophysiological and functional responses to early antigravity training in moderate to severe head injury: A pre-post experimental study

Kle Academy of Higher Education and Research, Belagavi1 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2025年11月20日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
11
试验地点
1
主要终点
Functional mobility using mFAC

研究概览

简要总结

TBI frequently leads to severe disruptions in motor control and postural

stability, which requires structured rehabilitation interventions aimed at restoring movement function and promoting patient’s independency.

Conventional rehabilitation techniques, including head-up tilt training, have been widely used to enhance postural stability and facilitate upright tolerance in individuals recovering from TBI. Research indicates that early mobilization via head-up tilt positioning is both safe and practical in TBI patients, in early-phase neurorehabilitation.

Patients with moderate to severe TBI require necessary rehabilitation, beginning in neurocritical care units during hospitalization, continuing through inpatient rehabilitation programs, and extending to post-discharge rehabilitation services.

Tilt table mobilization is commonly introduced as an early intervention for patients with impaired consciousness following inpatient rehabilitation. The primary goals of this approach are to stimulate arousal and prevent secondary complications, such as joint contractures that are associated with prolonged immobility.

Innovative rehabilitation technologies, such as anti-gravity training systems, offer controlled body-weight support, enabling patients to move more freely with minimised stress on the musculoskeletal system. The incorporation of anti-gravity training into rehabilitation has shown notable benefits across diverse patient groups. For example, the AlterG Anti-Gravity Treadmill has been effectively used to enhance mobility, strength, and safety in individuals with neurological conditions such as TBI and stroke. The AlterG Anti-Gravity Treadmill, a specialized device that enables adjustable weight-bearing support, allowing patients to engage in progressive gait training with minimal efforts.

Dynamic body-weight support systems reduce gait and balance demands by partially unloading body weight, enabling safe and effective fall-free walking and balance training, especially for severely impaired patients. Despite its demonstrated benefits in diverse patient groups, the uses of anti-gravity postural training in the early rehabilitation of TBI remains largely unexamined. With these advancements, there remains a limitation of research specifically examining the neurophysiological and functional impacts of dynamic anti-gravity postural training in the early rehabilitation of head injury patients. Addressing this gap is crucial, as early intervention is often necessary. Therefore, a study focusing on this area is warranted to determine the efficacy of anti-gravity training modalities in enhancing neurophysiological responses, improving postural control, and functional recovery in this patient population.

The aim of this study is to evaluate the neurophysiological and functional responses to early antigravity training in moderate to severe head injury patients and objective is to evaluate changes in Orthostatic tolerance, functional mobility using mFAC, trunk control using TIS, and balance using BBS and FIST.

研究设计

研究类型
Interventional
分配方式
Na
盲法
Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patients with unstable vital signs, severe cardiopulmonary issues, fractures, contractures, and deformities, uncontrolled seizures, open wounds, severe cognitive impairment, current participation in other rehabilitation trials will be excluded.

排除标准

  • Patients with unstable vital signs, severe cardiopulmonary issues, fractures, contractures, and deformities, uncontrolled seizures, open wounds, severe cognitive impairment, current participation in other rehabilitation trials will be excluded.

结局指标

主要结局

Functional mobility using mFAC

时间窗: Baseline and 3 weeks

Trunk control using TIS

时间窗: Baseline and 3 weeks

Balance using BBS and FIST.

时间窗: Baseline and 3 weeks

次要结局

未报告次要终点

研究者

发起方
Kle Academy of Higher Education and Research, Belagavi
申办方类型
Research institution
责任方
Principal Investigator
主要研究者

Sushmitha Naik

Kle Institute of Physiotherapy

研究点 (1)

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