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临床试验/NCT07709130
NCT07709130已完成不适用

Combined Rhythmic Auditory Stimulation and Dual-task Gait Training in Individuals With Chronic Stroke: a Pre-post Study With Exploratory Age-stratified Analyses

Recep Tayyip Erdogan University1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2026年1月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
46
试验地点
1
主要终点
Motor dual-task performance

研究概览

简要总结

Rhythmic auditory stimulation and dual-task gait training may improve post-stroke mobility, but evidence regarding integrated programmes and age-related differences in treatment response remains limited. The aim of the study is to evaluate changes in mobility, balance, motor dual-task performance, concern about falling, and health-related quality of life after a six-week combined programme, and to explore whether responses differed across age strata.

详细描述

This prospective single-group pre-post study included individuals with chronic stroke. Participants completed supervised rhythmic auditory stimulation and progressively intensified motor dual-task gait training three times weekly for six weeks. Outcomes included motor dual-task performance, Timed Up and Go, bilateral single-leg stance, Mini-BESTest, Falls Efficacy Scale-International, and SF-36. An independent assessor, unaware of previous scores and age-stratum allocation, conducted baseline and post-intervention assessments. Prespecified exploratory analyses compared changes across age strata.

研究设计

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

盲法说明

An independent assessor, unaware of previous scores and age-stratum allocation, conducted baseline and post-intervention assessments. Prespecified exploratory analyses compared changes across age strata.

入排标准

年龄范围
— 至 72 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age ≥45 years
  • stroke ≥6 months previously
  • ability to walk at least 10 m independently or with minimal assistance
  • sufficient hearing to follow rhythmic auditory cues

排除标准

  • advanced aphasia
  • severe neglect, cognitive impairment,
  • marked visual impairment,
  • severe spasticity (Modified Ashworth Scale score15 ≥3)
  • severe cardiopulmonary disease
  • vestibular dysfunction
  • an orthopaedic condition limiting walking
  • progressive neurological disease

结局指标

主要结局

Motor dual-task performance

时间窗: at baseline and after the six-week programme

Participants completed a 10-m walk at their comfortable speed under single-task and motor dual-task conditions. In the dual-task condition, they carried a ball while walking and were instructed to give equal attention to both tasks. Three trials were performed under each condition, and mean completion time was used in the analysis. Positive values indicated greater dual-task interference.

Functional mobility

时间窗: at baseline and after the six-week programme

Functional mobility was assessed using the Timed Up and Go test, with shorter completion times indicating better performance. One familiarization trial preceded the timed assessment.

Balance

时间窗: at baseline and after the six-week programme

Dynamic balance was assessed using the 14-item Mini-BESTest, which evaluates anticipatory postural adjustments, reactive postural control, sensory orientation, and dynamic gait. Total scores range from 0 to 28, with higher scores indicating better balance. Static balance was assessed bilaterally using the Single-Leg Stance Test. Two trials were performed on each side, and the longest duration before foot contact, stance-foot movement, or loss of balance was recorded.

次要结局

未报告次要终点

研究者

发起方
Recep Tayyip Erdogan University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Seda Karaca

Research Assistant Dr.

Recep Tayyip Erdogan University

研究点 (1)

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