Clinical trial NCT06838871: Effects of Inspiratory Muscle Training and Abdominal Drawing-In Maneuver on Balance, Gait and Pulmonary Function in Stroke Patients
Official title: Effect of Inspiratory Muscle Training Combined With Abdominal Drawing-In Maneuver on Balance, Gait, and Pulmonary Function in Subacute Stroke Patients: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Subacute Stroke
Balance Deficits
Keywords: Inspiratory muscle training
balance
stroke
abdominal muscles
gait
Lead sponsor: Sahmyook University
Sponsor class: OTHER
First posted: 2025-02-21
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, parallel-group randomized study
Primary purpose: TREATMENT

Brief summary: This study examines how Inspiratory Muscle Training (IMT) combined with the Abdominal Drawing-In Maneuver (ADIM) affects balance, gait, and breathing in stroke patients. It aims to determine whether this combined intervention improves mobility and respiratory function more effectively than standard rehabilitation.

Detailed description: This study investigates the effects of Inspiratory Muscle Training (IMT) and Abdominal Drawing-In Maneuver (ADIM) on stroke rehabilitation. IMT involves resistance-based breathing exercises to strengthen the inspiratory muscles and improve pulmonary function, while ADIM focuses on activating the deep abdominal muscles, particularly the transversus abdominis, to enhance trunk stability and postural control. Participants in the intervention group perform IMT using a threshold resistance device, starting at 30% of MIP and progressively increasing to 60% MIP over four weeks. ADIM exercises are conducted with verbal and manual guidance to ensure proper engagement of core muscles. Sessions are held five times per week for four weeks, with each session lasting 40 minutes (20 minutes for each intervention). The control group receives conventional rehabilitation without resistance-based inspiratory training.

The study utilizes TIS, BBS and TUG to assess balance, FGA to evaluate gait performance, and MIP and MEP to measure respiratory function. Assessments are conducted before and after the intervention to evaluate changes resulting from the treatment.

Eligible participants are individuals with subacute stroke (onset within 1-6 months), an MMSE-K score of 24 or higher, and the ability to walk at least 6 meters with or without an assistive device. Exclusion criteria include conditions prohibiting the Valsalva maneuver (e.g., glaucoma, aneurysm, pulmonary hypertension), acute respiratory infections, severe cognitive or language impairments, prior inspiratory muscle training within the past six months, unstable medical conditions, and neurological or musculoskeletal disorders affecting gait and balance.

This study aims to determine whether the combined application of IMT and ADIM enhances functional recovery, improves postural control, and promotes better respiratory health in stroke patients. The findings may contribute to the development of more effective rehabilitation strategies for improving quality of life in individuals recovering from stroke.

Eligibility criteria: Inclusion Criteria:

* Participants diagnosed with subacute stroke (1-6 months post-onset)
* Mini-Mental State Examination-Korean (MMSE-K) score of 24 or higher
* Ability to walk at least 6 meters, with or without an assistive device

Exclusion Criteria:

* Conditions prohibiting the Valsalva maneuver (e.g., glaucoma, aneurysm, pulmonary hypertension)
* Acute respiratory infections
* Severe language or cognitive impairments preventing communication
* Previous inspiratory muscle training within the last 6 months
* Unstable medical conditions (e.g., uncontrolled hypertension, diabetes)
* Neurological disorders affecting function and balance (e.g., Parkinson's disease, multiple sclerosis)
* Severe musculoskeletal impairments limiting functional mobility.

Primary outcomes:
measure: Change in Trunk Control as Measured by the Trunk Impairment Scale (TIS)
timeFrame: change from Baseline to 4 weeks post intervention
measure: Change in Functional Mobility as Measured by the Timed Up and Go (TUG) Test
timeFrame: change from Baseline to 4 weeks post intervention
measure: Change in Balance Ability as Measured by the Berg Balance Scale (BBS)
timeFrame: change from Baseline to 4 weeks post intervention
Secondary outcomes:
measure: Change in Gait Performance as Measured by the Functional Gait Assessment (FGA)
timeFrame: change from Baseline to 4 weeks post intervention
measure: Change in Respiratory Muscle Strength as Measured by Maximal Inspiratory Pressure (MIP) and Maximal Expiratory Pressure (MEP)
timeFrame: change from Baseline to 4 weeks post intervention
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Zenith Hospital
Study officials:
References: