Functional Inspiratory Muscle Training for Gait Recovery in Patients With Chronic Stroke

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stroke Rehabilitation; Chronic Stroke Patient
• Intervention / Treatment: Behavioral: Functional Inspiratory Muscle Training; Behavioral: Conventional Inspiratory Muscle Training

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shimaa Taha, PhD; Phone Number: +201021088610 +201021088610; Email: shimaa.taha@cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Functional Inspiratory Muscle Training Group; Participants will receive functional inspiratory muscle training combined with a standardized conventional rehabilitation program. Functional inspiratory muscle training integrates inspiratory muscle loading with functional activities and will be performed using the Threshold IMT device at 50% of maximal inspiratory pressure (MIP), 5 days per week for 8 weeks. Each session will last approximately 30 minutes (3 sets of 10-15 repetitions). Participants will also receive conventional rehabilitation including range of motion exercises, muscle tone management, strengthening and endurance training, transfer training, task-oriented activities, gait training, and activities of daily living training.	Behavioral: Functional Inspiratory Muscle Training; Functional inspiratory muscle training combines inspiratory muscle loading with functional activities to improve respiratory muscle performance, trunk stability, and functional mobility. Training will be performed at 50% of maximal inspiratory pressure using a Threshold IMT device for 30 minutes per session, 5 days per week, for 8 weeks.
Active Comparator: Conventional Inspiratory Muscle Training Group; Participants will receive conventional inspiratory muscle training combined with the same standardized conventional rehabilitation program. Inspiratory muscle training will be performed using the Threshold IMT device at 50% of maximal inspiratory pressure (MIP), 5 days per week for 8 weeks. Each session will last approximately 30 minutes (3 sets of 10-15 repetitions). The conventional rehabilitation program will include range of motion exercises, muscle tone management, strengthening and endurance training, transfer training, task-oriented activities, gait training, and activities of daily living training.	Behavioral: Conventional Inspiratory Muscle Training; Conventional inspiratory muscle training will be performed using a Threshold IMT device at 50% of maximal inspiratory pressure for 30 minutes per session, 5 days per week, for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Gait Speed	Gait speed assessed using the STEADYS gait assessment system and reported in meters per second (m/s).	Time Frame: Baseline (Day 1) and end of Week 8
Change in Cadence	Cadence assessed using the STEADYS gait assessment system and reported in steps per minute (steps/min).	Baseline (Day 1) and end of Week 8
Change in Stance Time	Stance time assessed using the STEADYS gait assessment system and reported as a percentage (%) of the gait cycle.	Baseline (Day 1) and end of Week 8
Change in Swing Time	Swing time assessed using the STEADYS gait assessment system and reported as a percentage (%) of the gait cycle.	Baseline (Day 1) and end of Week 8
Change in Double Support Time	Double support time assessed using the STEADYS gait assessment system and reported as a percentage (%) of the gait cycle.	Baseline (Day 1) and end of Week 8
Change in Stride Length	Stride length assessed using the STEADYS gait assessment system and reported in meters (m).	Baseline (Day 1) and end of Week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Functional Exercise Capacity	Functional exercise capacity assessed using the Six-Minute Walk Test (6MWT). The outcome is the total distance walked during 6 minutes, reported in meters (m). Higher values indicate better functional exercise capacity.	Baseline (Day 1) and end of Week 8
Change in Health-Related Quality of Life	Health-related quality of life assessed using the EuroQol Five-Dimension Five-Level Questionnaire (EQ-5D-5L). The EQ-5D-5L Index Score ranges from less than 0 (health states worse than death) to 1.0 (perfect health). Higher scores indicate better health-related quality of life.	Baseline (Day 1) and end of Week 8

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 20, 2026

Study Registration Dates

• First Submitted: July 16, 2026
• First Submitted That Met QC Criteria: July 21, 2026
• First Posted (Actual): July 27, 2026

Study Record Updates

• Last Update Posted (Actual): July 27, 2026
• Last Update Submitted That Met QC Criteria: July 21, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Inspiratory muscle training; Gait rehabilitation; Stroke rehabilitation; Chronic stroke; Functional capacity; Walking ability; Respiratory muscle training; Gait parameters; Functional inspiratory muscle training; Spatiotemporal gait analysis
• Other Study ID Numbers: CU-PT-FIMT-STROKE-2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No