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临床试验/NCT07829172
NCT07829172已完成不适用

Immediate Effects of Reflex Locomotion Therapy According to Vojta on Postural Control Task in Older Adults: An Exploratory Randomized Assessor-Blinded Study

Marianela Alejandra Valenzuela Sandoval1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2025年6月23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
33
试验地点
1
主要终点
Change in Root Mean Square (RMS) of Center of Pressure Acceleration During Standing Balance Tasks.

研究概览

简要总结

• This exploratory randomized assessor-blinded study aimed to determine whether a single session of Reflex Locomotion Therapy according to Vojta produces immediate changes in postural control in community-dwelling older adults classified as robust or prefrail. The study focused on stabilometric variables during standing tasks, because demanding balance conditions may reveal subtle postural control changes that are not evident during quiet standing. Participants were randomly allocated to an intervention group receiving standardized Vojta therapy or to a control group receiving an educational session of equivalent duration. Postural control was assessed using force platform stabilometry during five standing conditions: eyes open, eyes closed, tandem stance, right single-leg stance, and left single-leg stance. Assessments were performed at baseline, immediately after the intervention, and 20 minutes after the intervention. Positional, dynamic, spectral and nonlinear center of pressure variables were analyzed to explore acute changes in postural sway magnitude, corrective dynamics, frequency-domain organization, and temporal regularity and complexity of postural control.

详细描述

Falls and balance impairments are major health concerns in older adults because they are associated with functional decline, loss of independence, fear of falling, and increased healthcare burden. Postural control is a key modifiable factor related to fall risk. Subtle changes in postural regulation may not be fully captured during quiet standing alone; therefore, more demanding standing tasks may provide additional information about the ability of the postural control system to adapt to reduce base of support and increased sensorimotor demands.

Reflex Locomotion Therapy according to Vojta is a non-pharmacological neurorehabilitation approach based on sustained somatosensory stimulation applied to specific body zones. This stimulation is intended to activate automatic postural and movement patterns and may influence neuromotor control mechanisms involved in postural regulation. Although Vojta therapy has been used mainly in pediatric and neurological populations, evidence regarding its effects on postural control in older adults remains limited.

This exploratory randomized assessor -blinded study examined the acute effects of a single session of Vojta therapy on stabilometric variables of standing postural control in robust and prefrail older adults. The study was designed to characterize postural response under both quiet and challenging balance conditions, with special interest in task-dependent changes that could be relevant to fall-related postural control.

Centre of pressure variables were selected to provide a multidimensional characterization of postural control. Positional variables, including root mean square displacement in the mediolateral and anteroposterior directions, were used to characterize the magnitude of postural sway. Within the dynamic dimension, root mean square acceleration was considered the primary variables of corrective postural adjustments, complemented by mean velocity as a secondary variable of sway dynamics and postural effort. Spectral variables, including mean power frequency and dominant frequency in the mediolateral and anteroposterior directions, were used to describe the frequency domain organization of postural sway across the five standing conditions. Nonlinear variables, including sample entropy and Higuchi fractal dimension, were used to explore temporal regularity, predictability, and complexity of center of pressure fluctuations. Together, these measures were intended to capture complementary aspects of postural control beyond traditional sway magnitude.

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)

盲法说明

Due to the nature of the intervention, participants and the treating therapist could not be blinded. The outcomes assessor responsible for stabilometric measurements was blinded to group allocation

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • - Community-dwelling adults aged 60 years or older
  • Residents of Santiago, Chile.
  • Classified as robust or prefrail according to the FRAIL scale: robust=0 positive criteria; prefrail= 1-2 positive criteria
  • Functional performance compatible with safe standing balance assessment, defined as a Short Physical Performance Battery (SPPB) score of 9-10 points
  • Able to stand independently and safely perform standing balance assessments
  • Sufficient cognitive ability to understand and follow simple instructions, assessed using the abbreviated Mini Mental State Examination with a cut-off score of 13 points or higher
  • Able to provide written informed consent

排除标准

  • - Neurological conditions affecting postural stability, such as stroke, Parkinson disease, multiple sclerosis, or other relevant neurological disorders.
  • Musculoskeletal disorders, chronic pain, or lower limb prosthesis affecting mobility or balance assessment
  • Permanent use of assistive devices for standing or walking
  • Vestibular disorders, including vertigo
  • Use of medications with potential effects on balance according to clinical history
  • Any medical condition preventing safe participation in the intervention or stabilometric assessment

研究组 & 干预措施

Vojta Therapy Group

Experimental

Participants assigned to this group received a standardized session of Reflex Locomotion Therapy according to Vojta. The protocol was based on the second phase of reflex rolling and was delivered by a trained physical therapist. The intervention consisted of sustained somatosensory stimulation applied to specific body zones, alternating hemibodies according to the standardized protocol.

干预措施: Reflex Locomotion Therapy according to Vojta (Other)

Educational Control Group

Active Comparator

Participants assigned to this group received an educational session of equivalent duration focused on health and well-being in later life. They did not receive physical therapy, balance exercises, or specific therapeutic stimulation during the experimental period.

干预措施: Educational Session (Behavioral)

结局指标

主要结局

Change in Root Mean Square (RMS) of Center of Pressure Acceleration During Standing Balance Tasks.

时间窗: Baselines, immediately post-intervention, and 20 minutes post-intervention

Root mean square (RMS) of center of pressure acceleration is a time domain measure derived from the acceleration of center of pressure signal recorded by force platform stabilometry during standing. It quantifies the magnitude of center of pressure acceleration asociated with corrective postural adjustments made to maintain balance. Higher values indicate greater corrective accelerations. IT is expressed in cm/s2.

次要结局

  • Change in Mean Center of Pressure Velocity During Standing Balance Tasks.(Baselines, immediately post-intervention, and 20 minutes post-intervention)
  • Change in Positional Center of Pressure Measures (RMS in the Mediolateral and Anteroposterior Directions) During Standing Balance Tasks.(Baseline, immediately post-intervention, and 20 minutes post-intervention.)
  • Change in Spectral Center of Pressure Measures (Mean Power Frequency, Dominant Frequency) During Standing Balance Tasks.(Baseline, immediately post-intervention, and 20 minutes post-intervention.)
  • Change in Nonlinear Center of Pressure Measures During Standing Balance Tasks.(Baseline, immediately post-intervention, and 20 minutes post-intervention)
  • Adverse events and Tolerability during the Experimental Session(Baseline, immediately post-intervention, and 20 minutes post-intervention.)

研究者

发起方
Marianela Alejandra Valenzuela Sandoval
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Marianela Alejandra Valenzuela Sandoval

Principal Investigator, Department of Kinesiology

Universidad Metropolitana de Ciencias de la Educacion

研究点 (1)

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