Clinical Trials Directory

Trials / Completed

CompletedNCT06838871

Effects of Inspiratory Muscle Training and Abdominal Drawing-In Maneuver on Balance, Gait and Pulmonary Function in Stroke Patients

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
20 (actual)
Sponsor
Sahmyook University · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALInspiratory Muscle Training (IMT) with Abdominal Drawing-In Maneuver (ADIM) trainingADIM aims to enhance trunk stability by selectively activating the transversus abdominis. Participants begin in a supine position and practice drawing in their abdomen toward the spine while maintaining a stable trunk and pelvis. A therapist provides verbal instructions and manual guidance to ensure proper muscle activation. IMT is performed using the Threshold RMT device (IMT, GH INNOTEK, Busan, South Korea). Participants wear a nose clip and start with 30% of Maximal Inspiratory Pressure (MIP), gradually increasing by 10% per week to reach 60% MIP by the final week. Each session consists of five sets of 10-15 repetitions, with a one-minute rest between sets.
BEHAVIORALSham Inspiratory Muscle Training (IMT) with Abdominal Drawing-In Maneuver (ADIM) trainingSham IMT with ADIM training performs the same ADIM protocol as the IMT with ADIM training but undergoes IMT with minimal resistance (0 cmH₂O) to prevent actual muscle strengthening. This design ensures that the effects observed can be attributed to IMT rather than ADIM.

Timeline

Start date
2025-03-24
Primary completion
2025-04-25
Completion
2025-10-21
First posted
2025-02-21
Last updated
2025-12-26

Locations

1 site across 1 country: South Korea

Source: ClinicalTrials.gov record NCT06838871. Inclusion in this directory is not an endorsement.