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

NCT06838871 | Completed

• 1 other identifier: SYU 2025-01-008
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Subacute Stroke; Balance Deficits

Keywords

Inspiratory muscle training; balance; stroke; abdominal muscles; gait

Outcome Measures

Primary Outcomes (3)

• Change in Trunk Control as Measured by the Trunk Impairment Scale (TIS)

  The TIS assesses trunk stability, coordination, and dynamic sitting balance in participants. It consists of three subscales: static sitting balance (score range: 0-7), dynamic sitting balance (score range: 0-10), and trunk coordination (score range: 0-6). The total score ranges from 0 to 23, with higher scores indicating better trunk control. The test is conducted with the participant seated on a firm, stable surface without back or arm support.

  change from Baseline to 4 weeks post intervention

• Change in Functional Mobility as Measured by the Timed Up and Go (TUG) Test

  TUG Test assesses functional mobility and fall risk. Participants start seated, stand up at a signal, walk 3 meters, turn around, walk back, and sit down. The test is timed in seconds, with lower times indicating better mobility. A time exceeding 14 seconds suggests an increased fall risk.

  change from Baseline to 4 weeks post intervention

• Change in Balance Ability as Measured by the Berg Balance Scale (BBS)

  BBS evaluates balance and fall risk through 14 items, covering sitting, standing, and positional changes. Each item is scored from 0 (unable) to 4 (normal performance), with a total possible score of 0 to 56. Scores below 44 indicate a high fall risk.

  change from Baseline to 4 weeks post intervention

Secondary Outcomes (2)

• Change in Gait Performance as Measured by the Functional Gait Assessment (FGA)

  change from Baseline to 4 weeks post intervention

• Change in Respiratory Muscle Strength as Measured by Maximal Inspiratory Pressure (MIP) and Maximal Expiratory Pressure (MEP)

  change from Baseline to 4 weeks post intervention

Study Arms (2)

Inspiratory Muscle Training (IMT) with Abdominal Drawing-In Maneuver (ADIM) Group

EXPERIMENTAL

participants recieve in IMT using a threshold resistance device, starting at 30% of maximal inspiratory pressure and progressively increasing to 60% over four weeks. The ADIM is performed with verbal and manual guidance to ensure correct deep abdominal muscle engagement. Sessions are conducted five times per week for four weeks, with each session lasting 40 minutes (20 minutes for each intervention).

Behavioral: Inspiratory Muscle Training (IMT) with Abdominal Drawing-In Maneuver (ADIM) training

Sham Inspiratory Muscle Training(IMT) with Abdominal Drawing-In Maneuver(ADIM) Group

SHAM COMPARATOR

participants recieve simulated IMT with minimal resistance while performing the same ADIM as the experimental group. This design ensures that any effects observed can be attributed to inspiratory muscle training rather than ADIM. Sessions are conducted five times per week for four weeks, with each session lasting 40 minutes (20 minutes for each intervention).

Behavioral: Sham Inspiratory Muscle Training (IMT) with Abdominal Drawing-In Maneuver (ADIM) training

Interventions

Inspiratory Muscle Training (IMT) with Abdominal Drawing-In Maneuver (ADIM) training BEHAVIORAL

ADIM 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.

Inspiratory Muscle Training (IMT) with Abdominal Drawing-In Maneuver (ADIM) Group

Sham Inspiratory Muscle Training (IMT) with Abdominal Drawing-In Maneuver (ADIM) training BEHAVIORAL

Sham 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.

Sham Inspiratory Muscle Training(IMT) with Abdominal Drawing-In Maneuver(ADIM) Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sahmyook University: lead

Study Sites (1)

Zenith Hospital

Seoul, Seoul, 04993, South Korea

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

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: Physical Therapist

Model Details: Prospective, parallel-group randomized study

Study Record Dates

• First Submitted: February 16, 2025
• First Posted: February 21, 2025
• Study Start: March 24, 2025
• Primary Completion: April 25, 2025
• Study Completion: October 21, 2025
• Last Updated: December 26, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)