The Effects of Reaching Task Following Selective Trunk Stability Exercise

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Stroke; Hemiplegia, Spastic
• Intervention / Treatment: Behavioral: Abdominal drawing-in maneuver exercise; Behavioral: sham

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Ulju
    • Ulsan, Ulju, Korea, Republic of, 44919
      • Ulsan National Institute of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Abdominal drawing-in maneuver exercise, afterward Sham therapy(conventional physiotherapy); Participants 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.	Behavioral: Abdominal drawing-in maneuver exercise; 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; Behavioral: sham; Release pain or upper limb mobilization; Other Names: Conventional therapy
Experimental: Sham therapy(conventional physiotherapy), afterward Abdominal drawing-in maneuver exercise; Participants 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	Behavioral: Abdominal drawing-in maneuver exercise; 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; Behavioral: sham; Release pain or upper limb mobilization; Other Names: Conventional therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline, two period(each 4weeks), wash out(4weeks)
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	Baseline, two period(each 4weeks), wash out(4weeks)
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.	Baseline, two period(each 4weeks), wash out(4weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline, two period(each 4weeks), wash out(4weeks)
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	Baseline, two period(each 4weeks), wash out(4weeks)
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.	Baseline, two period(each 4weeks), wash out(4weeks)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Ashworth Scale(MAS)_Stiffness of Chronic Stroke	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)	Baseline
Fugl Meyer Assessment(FMA)_Health Status Chronic Stroke	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 ForearmReflex activityVolitional movement within synergiesVolitional movement mixing synergiesVolitional movement with little or no synergyNormal reflex activity; Wrist; Hand; Coordination/Speed Total score is 66 points	Baseline

Collaborators and Investigators

• Sponsor: University of Valencia
• Collaborators: Ulsan National Institute of Science and Technology
• Investigators: Principal Investigator: Jóse Casaña Granell, PhD, University of Valencia; Principal Investigator: Joaquin Calatayud Villalba, PhD, University of Valencia; Principal Investigator: Sang Hoon Kang, PhD, Ulsan National Institute of Science&Technology

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2022
• Primary Completion (Actual): July 30, 2023
• Study Completion (Actual): August 10, 2023

Study Registration Dates

• First Submitted: December 23, 2022
• First Submitted That Met QC Criteria: March 8, 2023
• First Posted (Actual): March 14, 2023

Study Record Updates

• Last Update Posted (Actual): May 23, 2025
• Last Update Submitted That Met QC Criteria: May 21, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Chronic stroke; Reaching task; Abdominal drawing-in maneuver; ADIM
• Additional Relevant MeSH Terms: Neurologic Manifestations; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Paralysis; Stroke; Hemiplegia
• Other Study ID Numbers: ADIM exercise

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No