search
Back to results

The Effects of Reaching Task Following Selective Trunk Stability Exercise

Primary Purpose

Cerebral Stroke, Hemiplegia, Spastic

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Abdominal drawing-in maneuver exercise
sham
Sponsored by
University of Valencia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Stroke focused on measuring Reaching task, Abdominal drawing-in maneuver, ADIM, Chronic stroke

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ulsan National Institute of Science and TechnologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

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

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

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Change from baseline in compensatory trunk dislocation at 4weeks
Dislocation distance in millimeters(mm) for reaching phase
Change from baseline in smoothness movement at 4weeks
Number of movement units for reaching phase
Change from baseline in elbow angle at 4weeks
Elbow angle in degree for reaching phase -elbow angle: joining vector of acromion to lateral epicondyle and vector of lateral epicondyle and medial styloid process.

Secondary Outcome Measures

Change from baseline in reaching time at 4weeks
Duration of time in second(s) for reaching phase
Change from baseline in peak velocity at 4weeks
Hand distance and duration of time are combined in mm/s for reaching phase
Change from baseline in elbow angular velocity at 4weeks
Change in elbow angle and time rate are combined in rad/s for reaching phase

Full Information

First Posted
December 23, 2022
Last Updated
July 3, 2023
Sponsor
University of Valencia
Collaborators
Ulsan National Institute of Science and Technology
search

1. Study Identification

Unique Protocol Identification Number
NCT05767437
Brief Title
The Effects of Reaching Task Following Selective Trunk Stability Exercise
Official Title
The Effects of Reaching Task Following Selective Trunk Stability Exercise in Chronic Stroke Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 10, 2022 (Actual)
Primary Completion Date
July 30, 2023 (Anticipated)
Study Completion Date
August 10, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Valencia
Collaborators
Ulsan National Institute of Science and Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Stroke, Hemiplegia, Spastic
Keywords
Reaching task, Abdominal drawing-in maneuver, ADIM, Chronic stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
ParticipantInvestigator
Masking Description
Double-blind.
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Abdominal drawing-in maneuver exercise, afterward Sham therapy(conventional physiotherapy)
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham therapy(conventional physiotherapy), afterward Abdominal drawing-in maneuver exercise
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Abdominal drawing-in maneuver exercise
Other Intervention Name(s)
Stabilizer pressure biofeedback
Intervention Description
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
Intervention Name(s)
sham
Other Intervention Name(s)
Conventional therapy
Intervention Description
Release pain or upper limb mobilization
Primary Outcome Measure Information:
Title
Change from baseline in compensatory trunk dislocation at 4weeks
Description
Dislocation distance in millimeters(mm) for reaching phase
Time Frame
Baseline, two period(each 4weeks), wash out(4weeks)
Title
Change from baseline in smoothness movement at 4weeks
Description
Number of movement units for reaching phase
Time Frame
Baseline, two period(each 4weeks), wash out(4weeks)
Title
Change from baseline in elbow angle at 4weeks
Description
Elbow angle in degree for reaching phase -elbow angle: joining vector of acromion to lateral epicondyle and vector of lateral epicondyle and medial styloid process.
Time Frame
Baseline, two period(each 4weeks), wash out(4weeks)
Secondary Outcome Measure Information:
Title
Change from baseline in reaching time at 4weeks
Description
Duration of time in second(s) for reaching phase
Time Frame
Baseline, two period(each 4weeks), wash out(4weeks)
Title
Change from baseline in peak velocity at 4weeks
Description
Hand distance and duration of time are combined in mm/s for reaching phase
Time Frame
Baseline, two period(each 4weeks), wash out(4weeks)
Title
Change from baseline in elbow angular velocity at 4weeks
Description
Change in elbow angle and time rate are combined in rad/s for reaching phase
Time Frame
Baseline, two period(each 4weeks), wash out(4weeks)
Other Pre-specified Outcome Measures:
Title
Modified Ashworth Scale(MAS)_Stiffness of chronic stroke
Description
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
Time Frame
Baseline
Title
Range of motion_Health status chronic stroke
Description
Shoulder and elbow joint range of motion Shoulder: flexion, adduction, abduction, external rotation, internal rotation Elbow: flexion, extension
Time Frame
Baseline
Title
Trunk impairment scale(TIS)_Health status chronic stroke
Description
The total score ranges from minimum 0 to maximum 23 points, a higher score indicating a better performance. Static sitting balance Dynamic sitting balance Coordination Total score is 23 points
Time Frame
Baseline
Title
Postural assessment scale for stroke(PASS)_Health status chronic stroke
Description
-Maintaining posture Sitting without support Standing with support Standing without support Standing on non paretic leg Standing on paretic leg -Changing a posture Supine to paretic side lateral Supine to non-paretic side lateral Supine to sitting up on the edge mat Sitting on the edge of mat to supine Sitting to standing up Standing up to sitting down Standing, picking up a pencil from the floor Total scoring ranges from 0 to 36
Time Frame
Baseline
Title
Fugl Meyer Assessment(FMA)_Health status chronic stroke
Description
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
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ae Non Lee, Master
Phone
+811075442844
Email
aenon@alumni.uv.es
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jóse Casaña Granell, PhD
Organizational Affiliation
University of Valencia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joaquin Calatayud Villalba, PhD
Organizational Affiliation
University of Valencia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sang Hoon Kang, PhD
Organizational Affiliation
Ulsan National Institute of Science&Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ulsan National Institute of Science and Technology
City
Ulsan
State/Province
Ulju
ZIP/Postal Code
44919
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
HYEKYUNG HEO, Bachelor
Phone
+821085801981

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
15468021
Citation
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.
Results Reference
background
PubMed Identifier
10775539
Citation
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.
Results Reference
background
PubMed Identifier
22234665
Citation
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.
Results Reference
background
PubMed Identifier
15137564
Citation
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.
Results Reference
background
PubMed Identifier
33297451
Citation
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.
Results Reference
background
PubMed Identifier
32545550
Citation
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.
Results Reference
background
PubMed Identifier
27821673
Citation
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.
Results Reference
result
PubMed Identifier
24481598
Citation
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.
Results Reference
result

Learn more about this trial

The Effects of Reaching Task Following Selective Trunk Stability Exercise

We'll reach out to this number within 24 hrs