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

NCT07727902 | Not Yet Recruiting

• 1 other identifier: CU-PT-FIMT-STROKE-2026
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Chronic Stroke Patient; Stroke Rehabilitation

Keywords

Chronic stroke; Stroke rehabilitation; Functional inspiratory muscle training; Inspiratory muscle training; Respiratory muscle training; Gait parameters; Spatiotemporal gait analysis; Gait rehabilitation; Walking ability; Functional capacity; Randomized controlled trial

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (2)

• Change in Functional Exercise Capacity

  Baseline (Day 1) and end of Week 8

• Change in Health-Related Quality of Life

  Baseline (Day 1) and end of Week 8

Study Arms (2)

Functional Inspiratory Muscle Training Group

EXPERIMENTAL

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

Conventional Inspiratory Muscle Training Group

ACTIVE COMPARATOR

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

Interventions

Functional Inspiratory Muscle Training BEHAVIORAL

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.

Functional Inspiratory Muscle Training Group

Conventional Inspiratory Muscle Training BEHAVIORAL

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.

Conventional Inspiratory Muscle Training Group

Eligibility Criteria

• Age: 55 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Central Study Contacts

Shimaa Taha, PhD

CONTACT

+201021088610; shimaa.taha@cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Cardiovascular &Respiratory Disorder and Geriatrics, Faculty of Physical Therapy, Cairo University

Model Details: Participants will be randomly assigned into two parallel groups. The functional inspiratory muscle training group will receive functional inspiratory muscle training combined with conventional rehabilitation, while the active comparator group will receive conventional inspiratory muscle training combined with the same rehabilitation program. Both groups will receive interventions for 8 weeks.

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: July 27, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 20, 2026
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share