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Completed

NCT Number: NCT05767437

The Effects of Reaching Task Following Selective Trunk Stability Exercise

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.

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Key information

Conditions

Cerebral Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemiplegia Hemiplegia, Spastic Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Stroke Vascular Diseases

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ulsan National Institute of Science and Technology

Ulsan, Ulju, 44919, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

Abdominal drawing-in maneuver exercise

Behavioral

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

Other names: Stabilizer pressure biofeedback

Sham

Behavioral

Release pain or upper limb mobilization

Other names: Conventional therapy

Primary outcomes

  1. 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)

    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

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

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

    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

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

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

    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.

Secondary outcomes

  1. The Effect of a Particular Intervention During the Entire Course of the Study_Total Time

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

    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

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

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

    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

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

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

    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.

Other outcomes

  1. Modified Ashworth Scale(MAS)_Stiffness of Chronic Stroke

    Time frame: Baseline

    Scoring for Biceps and Triceps

    • MAS 0: No increase in tone
    • MAS 1: slight increase in tone giving a catch when slight increase in muscle t-tone, manifested by the limb was moved in flexion or extension.
    • MAS 1+: slight increase in muscle tone, manifested by a catch followed by minimal resistance throughout (ROM )
    • MAS 2: more marked increase in tone but more marked increased in muscle tone through most limb easily flexed
    • MAS 3: considerable increase in tone, passive movement difficult
    • MAS 4: limb rigid in flexion or extension (MAS grade of 1 is equivalent to 1, whereas a MAS grade of 1+ includes grade of 2, 2->3, 3->4 in our study)

  2. Fugl Meyer Assessment(FMA)_Health Status Chronic Stroke

    Time frame: Baseline

    Upper extremity(UE) Commonly used FMA-UE cutoff scores defined each category: 0 to 20 severe, 21 to 50 moderate, and 51 to 66 mild.

    • Shoulder, Elbow and Forearm
    • Reflex activity
    • Volitional movement within synergies
    • Volitional movement mixing synergies
    • Volitional movement with little or no synergy
    • Normal reflex activity
    • Wrist
    • Hand
    • Coordination/Speed Total score is 66 points

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Collaborators

  • Ulsan National Institute of Science and Technology

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 14, 2023
Registry last updated
May 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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