Effect of Functional Inspiratory Muscle Training on Spatiotemporal Gait Parameters in Patients With Chronic Stroke

Cairo University0 个研究点目标入组 60 人开始时间: 2026年8月1日最近更新: 2026年7月27日

适应症

试验速览

阶段: 不适用
状态: 尚未招募
发起方: Cairo University
入组人数: 60
主要终点: Change in Gait Speed

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

The purpose of this randomized controlled trial is to evaluate the effect of functional inspiratory muscle training (F-IMT) on spatiotemporal gait parameters in patients with chronic stroke. Sixty participants with chronic stroke will be randomly assigned to either a functional inspiratory muscle training group or a conventional inspiratory muscle training group. Both groups will receive the same conventional rehabilitation program for 8 weeks. The primary outcome is spatiotemporal gait parameters measured using the STEADYS gait assessment system. Secondary outcomes include exercise capacity assessed by the Six-Minute Walk Test (6MWT) and health-related quality of life assessed using the EuroQol Five-Dimension (EQ-5D) questionnaire.

详细描述

Stroke is a leading cause of long-term disability worldwide and is frequently associated with persistent impairments in walking ability. Patients with chronic stroke commonly demonstrate reduced gait speed, shorter stride length, impaired gait symmetry, prolonged double-support time, and decreased functional mobility. These gait abnormalities are associated with impaired trunk control, respiratory muscle weakness, reduced exercise tolerance, and diminished quality of life. Although conventional rehabilitation improves motor function, many patients continue to experience limitations in walking performance.

Inspiratory muscle training (IMT) has been shown to improve inspiratory muscle strength, pulmonary function, exercise capacity, and trunk stability in individuals with neurological disorders. Functional inspiratory muscle training (F-IMT) integrates inspiratory muscle training with functional rehabilitation exercises, allowing simultaneous activation of respiratory and postural muscles during task-oriented activities. This integrated approach may enhance motor control and walking performance beyond conventional IMT alone.

This study is a prospective, single-center, randomized controlled trial involving 60 participants with chronic stroke. Eligible participants will be randomly allocated in a 1:1 ratio to one of two intervention groups. The intervention group will receive functional inspiratory muscle training using a Threshold IMT device integrated with functional rehabilitation exercises at an intensity of 50% of maximal inspiratory pressure (MIP), five sessions per week for 8 weeks. The control group will receive conventional inspiratory muscle training using the same device, training intensity, frequency, and duration without integration into functional activities. Both groups will receive an identical standardized conventional rehabilitation program throughout the intervention period.

The primary outcome will be changes in spatiotemporal gait parameters measured using the STEADYS gait assessment system, including gait speed, cadence, stance time, swing time, double-support time, and stride length. Secondary outcomes will include functional exercise capacity measured using the Six-Minute Walk Test (6MWT) and health-related quality of life measured using the EuroQol Five-Dimension (EQ-5D) questionnaire. Outcome assessments will be performed at baseline and after completion of the 8-week intervention.

The findings of this trial will provide evidence regarding the effectiveness of functional inspiratory muscle training as an adjunct to conventional rehabilitation for improving gait performance, exercise capacity, and quality of life in individuals with chronic stroke.

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: 55 Years 至 65 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Patients aged between 55 and 65 years.
•Both male and female participants.
•Chronic stroke patients (>6 months after stroke onset), including ischemic or hemorrhagic stroke confirmed by neuroimaging.
•Moderate gait impairment with gait speed ranging from 0.4 to 0.8 m/s.
•Ability to understand instructions and communicate sufficiently to participate in the study procedures.
•Breathing spontaneously without ventilatory support.
•No thoracic or abdominal surgery within the previous 6 months.
•No facial palsy, or mild facial palsy without limitation of labial occlusion.
•Ability to walk independently for at least 10 meters with or without an assistive device.
•Willingness to participate and provide written informed consent.

排除标准

•Unstable cardiovascular disease (e.g., recent myocardial infarction, uncontrolled hypertension, decompensated heart failure).
•Uncontrolled metabolic disease or poorly controlled diabetes mellitus.
•Severe pulmonary disease or respiratory impairment (e.g., severe COPD, hypoxemia, chronic cough, or sputum retention).
•Active malignancy.
•Presence of nasal feeding tube, tracheostomy tube, or any condition preventing implementation of the study procedures.
•Severe musculoskeletal disorders affecting gait performance (e.g., lower limb fracture, severe osteoarthritis, or amputation).
•Significant cognitive or communication impairment preventing reliable participation.
•Severe spasticity (Modified Ashworth Scale >3) or fixed contractures.
•Other neurological disorders affecting gait (e.g., Parkinson's disease, multiple sclerosis, spinal cord injury).
•Severe obesity (BMI ≥35 kg/m²) that may interfere with gait assessment or exercise performance.
•Previous participation in inspiratory muscle training programs.

结局指标

主要结局

Change in Gait Speed

时间窗: Time Frame: Baseline (Day 1) and end of Week 8

Gait speed assessed using the STEADYS gait assessment system and reported in meters per second (m/s).

Change in Cadence