The Effects of Reaching Task Following Selective Trunk Stability Exercise

Cerebral Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05767437
• Other study ID #: ADIM exercise
• Status: Recruiting
• Phase: N/A
• Start date: August 10, 2022
• Est. completion date: August 10, 2023

Study information

• Verified date: November 2022
• Source: University of Valencia
• Contact: Ae Non Lee, Master
• Phone: +811075442844
• Email: aenon[@]alumni.uv.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 10, 2023
• Est. primary completion date: July 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Stroke
• Hemiplegia
• Hemiplegia, Spastic
• Stroke

Intervention

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
• sham
Release pain or upper limb mobilization

Locations

Country	Name	City	State
Korea, Republic of	Ulsan National Institute of Science and Technology	Ulsan	Ulju

Sponsors (2)

Lead Sponsor	Collaborator
University of Valencia	Ulsan National Institute of Science and Technology

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (8)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	Baseline
Other	Range of motion_Health status chronic stroke	Shoulder and elbow joint range of motion; Shoulder: flexion, adduction, abduction, external rotation, internal rotation; Elbow: flexion, extension	Baseline
Other	Trunk impairment scale(TIS)_Health status chronic stroke	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	Baseline
Other	Postural assessment scale for stroke(PASS)_Health status chronic stroke	-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	Baseline
Other	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 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	Baseline
Primary	Change from baseline in compensatory trunk dislocation at 4weeks	Dislocation distance in millimeters(mm) for reaching phase	Baseline, two period(each 4weeks), wash out(4weeks)
Primary	Change from baseline in smoothness movement at 4weeks	Number of movement units for reaching phase	Baseline, two period(each 4weeks), wash out(4weeks)
Primary	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.	Baseline, two period(each 4weeks), wash out(4weeks)
Secondary	Change from baseline in reaching time at 4weeks	Duration of time in second(s) for reaching phase	Baseline, two period(each 4weeks), wash out(4weeks)
Secondary	Change from baseline in peak velocity at 4weeks	Hand distance and duration of time are combined in mm/s for reaching phase	Baseline, two period(each 4weeks), wash out(4weeks)
Secondary	Change from baseline in elbow angular velocity at 4weeks	Change in elbow angle and time rate are combined in rad/s for reaching phase	Baseline, two period(each 4weeks), wash out(4weeks)