NCT04777955

Brief Summary

Stroke is often associated with secondary complications such as nutritional and metabolic disorders, endocrine dysfunction, mental problems, and cardiopulmonary disorders caused by neurological and musculoskeletal deficits. The absence of the paretic side muscles and the difficulty of movement together with restrictive pulmonary disorders trigger a secondary decrease in cardiopulmonary function and expose insufficient energy associated with gait resulting in a decrease in asymmetric trunk exercise endurance.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 2, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

May 4, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2022

Completed
24 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

August 29, 2022

Status Verified

August 1, 2022

Enrollment Period

1 year

First QC Date

March 1, 2021

Last Update Submit

August 24, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • Respiratory Function Tests

    Respiratory functions will be measured using portable spirometry.

    5 min

  • Muscle Thickness Measurement With Ultrasound

    Using external oblique (EO), Internal oblique (IO), Transversus abdominis (TrA), rectus abdominis muscles (RA) and diaphragm thickness, ultrasonic imaging system (M-TurboTM, Sono Site Canada, Inc., Markham, ON, Canada) It will be measured. A 5-2 MHz linear probe will be used to measure EO, IO, TrA and RA, and a 5-2 MHz convex probe for diaphragm measurement.

    10 min

  • Maximum inspiratory and expiratory oral pressures

    Respiratory muscle strength will be assessed by measuring maximal inspiratory and expiratory pressures.

    1 min

Secondary Outcomes (10)

  • Brunnstrom Evaluation Scale

    1 min

  • 10 Meter Walk Test

    1 min

  • Trunk Impairment Scale

    5 min

  • Stroke Impact Scale

    10 min

  • Functional Ambulation Scale

    1 min

  • +5 more secondary outcomes

Study Arms (3)

Group 1, core stabilization exercises group

EXPERIMENTAL

core stabilization exercises will be performed using swissball. Program: Sitting on the ball will include (weight shifts, forward, backward and lateral sides), (pelvic bridge), (curl-up), (curlsup with diagonal reaching), (bird-dog exercise), (push-up) exercises. The application will be carried out for 6 weeks, 3 days a week for 30-45 minutes daily.

Other: core stabilization exercises

Group 2, electrical stimulation

EXPERIMENTAL

An adaptation of a pre-designed protocol will be used for the application of the Normocular Electrical Stimulation in the diaphragm. Current to be applied; Synchronous impulse at 30 Hz frequency, 1 sec beat increase time, 1 sec "on" (muscle contraction), 1 sec beat reduction time and 20 sec "off" (no warning) time. Two channels, each with two electrodes, will be placed in the seventh and eighth anterior intercostal space above and below the right and left sides of the xiphoid protrusion. The other two channels, each with two electrodes, will be placed on the right and left midaxillary line of the seventh and eighth anterior intercostal space. The application will be carried out for 6 weeks, 3 days a week, for 30 minutes daily.

Other: core stabilization exercises

group 3, kinesiotape

EXPERIMENTAL

For anterior diaphragm banding, the patient will stand with arms raised. Next, the central part of the tape will be applied to the xiphoid protrusion with a tension of 50% to 70% after the maximum inhalation. While the patient is breathing, the ends of the tape will be pulled with 10 to 15% tension towards the lower ribs. To tape the rear diaphragm, the patient's body will bend forward, and the arms will be joined crosswise over the chest. After the maximum inhalation, the central part of the tape will be applied over the T10 with a tension of 50% to 70%. As the patient exhales and stretches the trunk, the ends of the tape will be attached to the lower ribs with a tension of 10 to 15%. The supine position will be used in the Kinesiological taping of the right and left external oblique and internal oblique muscles. The application will be carried out for 6 weeks, 3 days a week, for 30 minutes daily.

Other: core stabilization exercises

Interventions

Core is at the center of almost all kinetic chains in the body. Core force, balance, and motion control maximize all kinetic chains of upper and lower limb function. A stable and strong core can contribute to more efficient use of the lower extremities. Core stability is defined as the ability of the lumbo-pelvic hip complex to prevent bending of the vertebral column and return to balance after perturbation. Neuromuscular electrical stimulation (NMES) is a technique in which muscle contraction is electrically stimulated in the area where the surface electrodes are connected. It improves secondary muscle atrophy and weakness in immobilization by preventing a decrease in muscle protein synthesis. Kinesiological banding (CT) is a treatment method used in the treatment of various musculoskeletal and neuromuscular deficits. The mechanism of action of CT is to facilitate muscle activation, increase blood and lymph circulation and reduce pain due to neurological suppression.

Also known as: electrical stimulation, kinesiological banding
Group 1, core stabilization exercises groupGroup 2, electrical stimulationgroup 3, kinesiotape

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Unilateral and first time stroke
  • Ability to understand and follow verbal instructions
  • Brunnstrom healing phase being above 3 for lower limbs;
  • Ability to walk 10 m distance independently, with or without a mobility assistant.
  • Patients who can sit on a stable surface for 30 seconds
  • Patients without respiratory diseases or injuries

You may not qualify if:

  • Neurological disorders other than stroke that could potentially affect balance and ambulation;
  • Body failure scale score below 10 points
  • Apraxia and hemineglect
  • years and older
  • Orthopedic disorders or rib fracture
  • Patients with neglect syndrome
  • A history of seizures or a family history of epilepsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University Cerrahpasa

Istanbul, 34147, Turkey (Türkiye)

Location

Related Publications (6)

  • Kim M, Lee K, Cho J, Lee W. Diaphragm Thickness and Inspiratory Muscle Functions in Chronic Stroke Patients. Med Sci Monit. 2017 Mar 11;23:1247-1253. doi: 10.12659/msm.900529.

  • Jung JH, Kim NS. The correlation between diaphragm thickness, diaphragmatic excursion, and pulmonary function in patients with chronic stroke. J Phys Ther Sci. 2017 Dec;29(12):2176-2179. doi: 10.1589/jpts.29.2176. Epub 2017 Dec 13.

  • Porcari JP, Miller J, Cornwell K, Foster C, Gibson M, McLean K, Kernozek T. The effects of neuromuscular electrical stimulation training on abdominal strength, endurance, and selected anthropometric measures. J Sports Sci Med. 2005 Mar 1;4(1):66-75. eCollection 2005 Mar 1.

  • Lee J, Jeon J, Lee D, Hong J, Yu J, Kim J. Effect of trunk stabilization exercise on abdominal muscle thickness, balance and gait abilities of patients with hemiplegic stroke: A randomized controlled trial. NeuroRehabilitation. 2020;47(4):435-442. doi: 10.3233/NRE-203133.

  • 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.

  • Sharma V, Kaur J. Effect of core strengthening with pelvic proprioceptive neuromuscular facilitation on trunk, balance, gait, and function in chronic stroke. J Exerc Rehabil. 2017 Apr 30;13(2):200-205. doi: 10.12965/jer.1734892.446. eCollection 2017 Apr.

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Electric Stimulation

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Physical StimulationInvestigative Techniques

Study Officials

  • Rüstem Mustafaoğlu

    Istanbul University - Cerrahpasa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
closed envelope procedure
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Group 1, core stabilization exercises group; Group 2, core stabilization exercises + electrical stimulation group; Group 3, core stabilization exercises + kinesiological banding group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
specialist physiotherapist

Study Record Dates

First Submitted

March 1, 2021

First Posted

March 2, 2021

Study Start

May 4, 2021

Primary Completion

May 8, 2022

Study Completion

June 1, 2022

Last Updated

August 29, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations