The Effects of Reaching Task Following Selective Trunk Stability Exercise

NCT ID: NCT05767437

Last Updated: 2025-05-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-10

Study Completion Date

2023-08-10

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cerebral Stroke Hemiplegia, Spastic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
Double-blind.

Study Groups

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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.

Group Type EXPERIMENTAL

Abdominal drawing-in maneuver exercise

Intervention Type 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

sham

Intervention Type BEHAVIORAL

Release pain or upper limb mobilization

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

Group Type EXPERIMENTAL

Abdominal drawing-in maneuver exercise

Intervention Type 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

sham

Intervention Type BEHAVIORAL

Release pain or upper limb mobilization

Interventions

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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

Intervention Type BEHAVIORAL

sham

Release pain or upper limb mobilization

Intervention Type BEHAVIORAL

Other Intervention Names

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Stabilizer pressure biofeedback Conventional therapy

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ulsan National Institute of Science and Technology

UNKNOWN

Sponsor Role collaborator

University of Valencia

OTHER

Sponsor Role lead

Responsible Party

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José Casaña Granell

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jóse Casaña Granell, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Valencia

Joaquin Calatayud Villalba, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Valencia

Sang Hoon Kang, PhD

Role: PRINCIPAL_INVESTIGATOR

Ulsan National Institute of Science&Technology

Locations

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Ulsan National Institute of Science and Technology

Ulsan, Ulju, South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type BACKGROUND
PMID: 15468021 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10775539 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22234665 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15137564 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33297451 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32545550 (View on PubMed)

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.

Reference Type RESULT
PMID: 27821673 (View on PubMed)

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.

Reference Type RESULT
PMID: 24481598 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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ADIM exercise

Identifier Type: -

Identifier Source: org_study_id

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