Clinical trial NCT05767437: 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
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Stroke
Hemiplegia, Spastic
Keywords: Reaching task
Abdominal drawing-in maneuver
ADIM
Chronic stroke
Lead sponsor: University of Valencia
Sponsor class: OTHER
Collaborators: name: Ulsan National Institute of Science and Technology
First posted: 2023-03-14
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The Effect of a Particular Intervention During the Entire Course of the study_Trunk Dislocation
timeFrame: Baseline, two period(each 4weeks), wash out(4weeks)
measure: The Effect of a Particular Intervention During the Entire Course of the Study_movement Unit
timeFrame: Baseline, two period(each 4weeks), wash out(4weeks)
measure: The Effect of a Particular Intervention During the Entire Course of the Study_Elbow Angle
timeFrame: Baseline, two period(each 4weeks), wash out(4weeks)
Secondary outcomes:
measure: The Effect of a Particular Intervention During the Entire Course of the Study_Total Time
timeFrame: Baseline, two period(each 4weeks), wash out(4weeks)
measure: The Effect of a Particular Intervention During the Entire Course of the Study_Hand Velocity
timeFrame: Baseline, two period(each 4weeks), wash out(4weeks)
measure: The Effect of a Particular Intervention During the Entire Course of the Study_Elbow Angular Velocity
timeFrame: Baseline, two period(each 4weeks), wash out(4weeks)
Other outcomes:
measure: Modified Ashworth Scale(MAS)_Stiffness of Chronic Stroke
timeFrame: Baseline
measure: Fugl Meyer Assessment(FMA)_Health Status Chronic Stroke
timeFrame: Baseline
Locations:
city: Ulsan
country: Korea, Republic of
facility: Ulsan National Institute of Science and Technology
state: Ulju
Study officials:
affiliation: University of Valencia
name: Jóse Casaña Granell, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Valencia
name: Joaquin Calatayud Villalba, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ulsan National Institute of Science&Technology
name: Sang Hoon Kang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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.
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.
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.
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.
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.
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.