The Effects of Reaching Task Following Selective Trunk Stability Exercise

NCT05767437 | Completed Results

• 1 other identifier: ADIM exercise
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cerebral Stroke; Hemiplegia, Spastic

Keywords

Reaching task; Abdominal drawing-in maneuver; ADIM; Chronic stroke

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

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

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

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

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

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

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

Other Outcomes (2)

• Modified Ashworth Scale(MAS)_Stiffness of Chronic Stroke

  Baseline

• Fugl Meyer Assessment(FMA)_Health Status Chronic Stroke

  Baseline

Study Arms (2)

Abdominal drawing-in maneuver exercise, afterward Sham therapy(conventional physiotherapy)

EXPERIMENTAL

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; Behavioral: sham

Sham therapy(conventional physiotherapy), afterward Abdominal drawing-in maneuver exercise

EXPERIMENTAL

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; Behavioral: sham

Interventions

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

Also known as: Stabilizer pressure biofeedback

Abdominal drawing-in maneuver exercise, afterward Sham therapy(conventional physiotherapy); Sham therapy(conventional physiotherapy), afterward Abdominal drawing-in maneuver exercise

sham BEHAVIORAL

Release pain or upper limb mobilization

Also known as: Conventional therapy

Abdominal drawing-in maneuver exercise, afterward Sham therapy(conventional physiotherapy); Sham therapy(conventional physiotherapy), afterward Abdominal drawing-in maneuver exercise

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Valencia: lead
• Ulsan National Institute of Science and Technology: collaborator

Study Sites (1)

Ulsan National Institute of Science and Technology

Ulsan, Ulju, 44919, South Korea

Location

Related Publications (8)

• 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.

  PMID: 15468021 BACKGROUND

• 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.

  PMID: 10775539 BACKGROUND

• 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.

  PMID: 22234665 BACKGROUND

• 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.

  PMID: 15137564 BACKGROUND

• 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.

  PMID: 33297451 BACKGROUND

• 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.

  PMID: 32545550 BACKGROUND

• 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.

  PMID: 27821673 RESULT

• 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.

  PMID: 24481598 RESULT

MeSH Terms

Conditions

Stroke; Hemiplegia

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

we must acknowledge a limitation in our study related to the influence of a carryover effect and period effect. This phenomenon may be partially explained within the context of persistence of treatment and learned behavior. Secondly, our study employed a crossover design, spanning a three-month duration. Despite random allocation, four participants dropped out during the washout period, leading to a smaller sample size and uneven group distribution in period 2.

Results Point of Contact

• Title: Jose casaña Granell
• Organization: University of Valencia

jose.casana@uv.es

677361782

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: December 23, 2022
• First Posted: March 14, 2023
• Study Start: August 10, 2022
• Primary Completion: July 30, 2023
• Study Completion: August 10, 2023
• Last Updated: May 23, 2025
• Results First Posted: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)