Subacute StrokeNCT06838871
Effects of Inspiratory Muscle Training and Abdominal Drawing-In Maneuver on Balance, Gait and Pulmonary Function in Stroke Patients
A study testing Inspiratory Muscle Training (IMT) with Abdominal Drawing-In Maneuver (ADIM) training in people with Subacute Stroke and Balance Deficits, run by Sahmyook University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Subacute Stroke, Balance Deficits
- What is being tested?
- Inspiratory Muscle Training (IMT) with Abdominal Drawing-In Maneuver (ADIM) training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Mar 2025to 21 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Subacute Stroke, Balance Deficits
- Being tested
- Inspiratory Muscle Training (IMT) with Abdominal Drawing-In Maneuver (ADIM) training, Sham Inspiratory Muscle Training (IMT) with Abdominal Drawing-In Maneuver (ADIM) training
- Keywords
- Inspiratory muscle training, balance, stroke, abdominal muscles, gait
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory Muscle Training (IMT) with Abdominal Drawing-In Maneuver (ADIM) trainingBehavioural
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.
Sham Inspiratory Muscle Training (IMT) with Abdominal Drawing-In Maneuver (ADIM) trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Behavioral: Sham Inspiratory Muscle Training (IMT) with Abdominal Drawing-In Maneuver (ADIM) training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: change from Baseline to 4 weeks post intervention
Secondary outcomes (2)
Change in Gait Performance as Measured by the Functional Gait Assessment (FGA)
FGA evaluates dynamic walking ability. It consists of 10 tasks, including walking with head turns, speed changes, and obstacle navigation. Each item is scored from 0 (severe impairment) to 3 (normal performance), with a total possible score of 0 to 30. A lower score indicates greater functional impairment.
Measured: 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)
MIP and MEP measure respiratory muscle strength using a manometer (Pony Fx, Cosmed, Italy). MIP reflects diaphragm and inspiratory muscle strength, while MEP measures expiratory muscle power. Participants are seated, wear a nose clip, and perform three attempts with the highest value recorded.
Measured: change from Baseline to 4 weeks post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start24 Mar 2025
- Primary completion25 Apr 2025
- Study completion21 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subacute StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, parallel-group randomized study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahmyook University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DOHYOUNG KIM, Sahmyook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06838871
- Sponsor's protocol ID
- SYU 2025-01-008
- Status last verified
- Apr 2025
- First submitted
- 16 Feb 2025
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06838871
- Acronym / sponsor ID
- SYU 2025-01-008
- Conditions
- Subacute Stroke, Balance Deficits
- Keywords
- Inspiratory muscle training, balance, stroke, abdominal muscles, gait
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Sahmyook UniversityUniversity, hospital or other
- Study start
- 24 Mar 2025 (actual)
- Primary completion
- 25 Apr 2025 (actual)
- Study completion
- 21 Oct 2025 (actual)
- First posted
- 21 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, parallel-group randomized study
| Arm | Type | Receives |
|---|---|---|
| Inspiratory Muscle Training (IMT) with Abdominal Drawing-In Maneuver (ADIM) Group | Experimental | Behavioral: Inspiratory Muscle Training (IMT) with Abdominal Drawing-In Maneuver (ADIM) trainingparticipants 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). |
| Sham Inspiratory Muscle Training(IMT) with Abdominal Drawing-In Maneuver(ADIM) Group | Sham comparator | Behavioral: Sham Inspiratory Muscle Training (IMT) with Abdominal Drawing-In Maneuver (ADIM) trainingparticipants 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). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inspiratory 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. | Behavioural | Inspiratory Muscle Training (IMT) with Abdominal Drawing-In Maneuver (ADIM) Group |
| Sham 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. | Behavioural | Sham Inspiratory Muscle Training(IMT) with Abdominal Drawing-In Maneuver(ADIM) Group |
Primary outcome
Change in Trunk Control as Measured by the Trunk Impairment Scale (TIS)
Time frame: change from Baseline to 4 weeks post intervention
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 in Functional Mobility as Measured by the Timed Up and Go (TUG) Test
Time frame: change from Baseline to 4 weeks post intervention
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 in Balance Ability as Measured by the Berg Balance Scale (BBS)
Time frame: change from Baseline to 4 weeks post intervention
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.
2 secondary outcomes
Change in Gait Performance as Measured by the Functional Gait Assessment (FGA)
Time frame: 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)
Time frame: change from Baseline to 4 weeks post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory Muscle Training (IMT) with Abdominal Drawing-In Maneuver (ADIM) training in people with Subacute Stroke and Balance Deficits, run by Sahmyook University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Trunk Control as Measured by the Trunk Impairment Scale (TIS) (time frame: change from Baseline to 4 weeks post intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.