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Cerebral StrokeNCT05767437

The Effects of Reaching Task Following Selective Trunk Stability Exercise

A study testing Abdominal drawing-in maneuver exercise in people with Cerebral Stroke and Hemiplegia, Spastic, run by University of Valencia at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is performed in a controlled randomized, two-period crossover design to test the efficacy of Abdominal drawing-in maneuver (ADIM) exercise compared to conventional physiotherapy in chronic stroke survivors. Read more about this study

Who is it for?
Ages 40 to 85 years
Conditions the study is for
Cerebral Stroke, Hemiplegia, Spastic
What is being tested?
Abdominal drawing-in maneuver exercise
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
20 participants
Where
1 siteSouth Korea
Study dates
10 Aug 2022to 10 Aug 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 40 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The subject consisted of the physician's confirmation of chronic hemiplegia
  • onset ≥ 6 months
  • Mini-mental state examination≥25
  • Biceps ≤2, Triceps≤2
  • Ability to Sit on a chair alone
  • FMA UE score ≥ 21points, FMA UE≤ 60 points

Who cannot join

  • Biceps>2, Triceps>2
  • Flaccid
  • Neglect syndrome
  • Have neurological disease and orthopedic disease
  • Lack of coordination

Trial locations and contacts

1 site in 1 country.

South Korea1 site
  • Ulsan National Institute of Science and Technology

    Ulsan, Ulju, 44919

Other trials in South Korea

About this study

Official title: The Effects of Reaching Task Following Selective Trunk Stability Exercise in Chronic Stroke Survivors

This study is performed in a controlled randomized, two-period crossover design to test the efficacy of Abdominal drawing-in maneuver (ADIM) exercise compared to conventional physiotherapy in chronic stroke survivors.

Read the detailed description

All participants provided written informed consent and are assigned to Group A or Group B. The inclusion criteria are Exclusion criteria are

Abdominal drawing-in maneuver exercise is following as:

It's for strengthening the Transversus Abdominis muscle(TrA). The simple device, that observes the pressure changes by the gauge. Subjects receive intervention 2 times a week for 4 weeks. Each session is 40 minutes. From the supine position to the hook-lying position (hip joint at 40 degrees and the knee joint at 80 degrees) and pull the navel deeply to the lumbar region through the Stabilizer™ Pressure Biofeedback that stabilizes transversus abdominis muscle. At this time, subjects are controlled to maintain contraction while keep breathing lightly, to contract slowly, also to not move the pelvis and chest while exercising The device assists in body control movements of the spine and abdominal muscle.

Conventional physiotherapy is following as:

Release pain, limb stretching, mobilization of joint and pelvic movement. Subjects receive 2 times a week for 4 weeks. Each session is 40 minutes. Group A received Abdominal drawing-in maneuver exercise for 4 weeks on period 1. Afterward washout period in a month, follow period 2 of conventional physiotherapy.

On the other side, Group B receives first conventional physiotherapy on period 1. Afterward washout period in a month, follow period 2 of Abdominal drawing-in maneuver exercise.

Being tested
Abdominal drawing-in maneuver exercise, sham
Keywords
Reaching task, Abdominal drawing-in maneuver, ADIM, Chronic stroke
Medical subject headings
Stroke, Hemiplegia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Abdominal drawing-in maneuver exerciseBehavioural

    Also called Stabilizer pressure biofeedback

    From the supine position to the hook-lying position (hip joint at 40 degrees and the knee joint at 80 degrees) and pull the navel deeply to the lumbar region through the Stabilizer™ Pressure Biofeedback that stabilize transversus abdominis muscle. At this time, subjects are controlled to maintain contraction while keep breathing lightly, to contract slowly, also to not move the pelvis and chest while exercising

  • shamBehavioural

    Also called Conventional therapy

    Release pain or upper limb mobilization

Study groups in NCT05767437
Study groupRoleWhat they receive
Abdominal drawing-in maneuver exercise, afterward Sham therapy(conventional physiotherapy)ExperimentalParticipants first received Abdominal drawing-in maneuver exercise 2 times a week for 4 weeks. Each session is 40 minutes for additional 10 min with conventional therapy. Afterward a washout period of one month, they then received sham therapy (conventional therapy_release pain or upper limb mobilization) 2 times a week for 4 weeks. Each session is 40 minutes.
Receives: Behavioral: Abdominal drawing-in maneuver exercise; Behavioral: sham
Sham therapy(conventional physiotherapy), afterward Abdominal drawing-in maneuver exerciseExperimentalParticipants first received sham therapy(release pain or upper limb mobilization)2 times a week for 4 weeks. Each session is 40 minutes. Afterward a washout period of one month, they then received Abdominal drawing-in maneuver exercise 2 times a week for 4 weeks. Each session is 40 minutes for additional 10 min with conventional therapy
Receives: Behavioral: Abdominal drawing-in maneuver exercise; Behavioral: sham

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Effect of a Particular Intervention During the Entire Course of the study_Trunk Dislocation

    We defined hand movement onset as the time when tangential velocity exceeded 10% of peak velocity and movement offset as when it fell below 10%.

    Participants who received that particular intervention during the entire course of the study. Effect of Abdominal Drawing-In Maneuver (AIDM) exercise and Shan therapy. Dislocation distance in millimeters(mm) for reaching phase

    Measured: Baseline, two period(each 4weeks), wash out(4weeks)

  2. The Effect of a Particular Intervention During the Entire Course of the Study_movement Unit

    We defined hand movement onset as the time when tangential velocity exceeded 10% of peak velocity and movement offset as when it fell below 10%.

    It was defined by velocity peaks exceeding 20mm/s, with a minimum 150 ms interval.

    Participants who received that particular intervention during the entire course of the study.

    Number of movement units for reaching phase

    Measured: Baseline, two period(each 4weeks), wash out(4weeks)

  3. The Effect of a Particular Intervention During the Entire Course of the Study_Elbow Angle

    We defined hand movement onset as the time when tangential velocity exceeded 10% of peak velocity and movement offset as when it fell below 10% Elbow angle in degree for reaching phase Participants who received that particular intervention during the entire course of the study.

    -elbow angle: joining vector of acromion to lateral epicondyle and vector of lateral epicondyle and medial styloid process.

    Measured: Baseline, two period(each 4weeks), wash out(4weeks)

Secondary outcomes (3)
  1. The Effect of a Particular Intervention During the Entire Course of the Study_Total Time

    We defined hand movement onset as the time when tangential velocity exceeded 10% of peak velocity and movement offset as when it fell below 10%.

    Participants who received that particular intervention during the entire course of the study.

    Duration of time in second(s) for reaching phase

    Measured: Baseline, two period(each 4weeks), wash out(4weeks)

  2. The Effect of a Particular Intervention During the Entire Course of the Study_Hand Velocity

    We defined hand movement onset as the time when tangential velocity exceeded 10% of peak velocity and movement offset as when it fell below 10%.

    Participants who received that particular intervention during the entire course of the study.

    We analyzed peak hand velocity (mm/s) as velocity per unit time

    Measured: Baseline, two period(each 4weeks), wash out(4weeks)

  3. The Effect of a Particular Intervention During the Entire Course of the Study_Elbow Angular Velocity

    We defined hand movement onset as the time when tangential velocity exceeded 10% of peak velocity and movement offset as when it fell below 10%.

    Participants who received that particular intervention during the entire course of the study.

    Peak angular velocity (rad/s) for the elbow were assessed during extension.

    Measured: Baseline, two period(each 4weeks), wash out(4weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2023
  2. Study start10 Aug 2022
  3. Primary completion30 Jul 2023
  4. Study completion10 Aug 2023

Resources

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
Crossover
Model description
One group is the abdominal drawing-in maneuver exercise, afterward conventional physiotherapy in Participants With stroke survivors. On the contrary, Another group is conventional physiotherapy afterward the abdominal drawing-in maneuver exercise.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05767437
Sponsor's protocol ID
ADIM exercise
Status last verified
May 2025
First submitted
23 Dec 2022
Last updated
23 May 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Messier S, Bourbonnais D, Desrosiers J, Roy Y. Dynamic analysis of trunk flexion after stroke. Arch Phys Med Rehabil. 2004 Oct;85(10):1619-24. doi: 10.1016/j.apmr.2003.12.043.

    PubMed 15468021
  • Cirstea MC, Levin MF. Compensatory strategies for reaching in stroke. Brain. 2000 May;123 ( Pt 5):940-53. doi: 10.1093/brain/123.5.940.

    PubMed 10775539
  • Velozo CA, Woodbury ML. Translating measurement findings into rehabilitation practice: an example using Fugl-Meyer Assessment-Upper Extremity with patients following stroke. J Rehabil Res Dev. 2011;48(10):1211-22. doi: 10.1682/jrrd.2010.10.0203.

    PubMed 22234665
  • Verheyden G, Nieuwboer A, Mertin J, Preger R, Kiekens C, De Weerdt W. The Trunk Impairment Scale: a new tool to measure motor impairment of the trunk after stroke. Clin Rehabil. 2004 May;18(3):326-34. doi: 10.1191/0269215504cr733oa.

    PubMed 15137564
  • Lee PY, Huang JC, Tseng HY, Yang YC, Lin SI. Effects of Trunk Exercise on Unstable Surfaces in Persons with Stroke: A Randomized Controlled Trial. Int J Environ Res Public Health. 2020 Dec 7;17(23):9135. doi: 10.3390/ijerph17239135.

    PubMed 33297451
  • Kelli A, Kellis E, Galanis N, Dafkou K, Sahinis C, Ellinoudis A. Transversus Abdominis Thickness at Rest and Exercise in Individuals with Poststroke Hemiparesis. Sports (Basel). 2020 Jun 12;8(6):86. doi: 10.3390/sports8060086.

    PubMed 32545550
  • Haruyama K, Kawakami M, Otsuka T. Effect of Core Stability Training on Trunk Function, Standing Balance, and Mobility in Stroke Patients. Neurorehabil Neural Repair. 2017 Mar;31(3):240-249. doi: 10.1177/1545968316675431. Epub 2016 Nov 9.

    PubMed 27821673
  • Wu CY, Liing RJ, Chen HC, Chen CL, Lin KC. Arm and trunk movement kinematics during seated reaching within and beyond arm's length in people with stroke: a validity study. Phys Ther. 2014 Jun;94(6):845-56. doi: 10.2522/ptj.20130101. Epub 2014 Jan 30.

    PubMed 24481598

Questions about this trial

What is this clinical trial studying?

A study testing Abdominal drawing-in maneuver exercise in people with Cerebral Stroke and Hemiplegia, Spastic, run by University of Valencia 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 6 inclusion and 5 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 23 May 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. 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?

Yes. Results are posted in the registry (first posted 23 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

The Effect of a Particular Intervention During the Entire Course of the study_Trunk Dislocation (time frame: Baseline, two period(each 4weeks), wash out(4weeks)). 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?

On the ClinicalTrials.gov record for NCT05767437, which also lists 8 linked publications.

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 23 May 2025; AzTrials last refreshed its copy on 30 Oct 2026.

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