The Effectiveness of Core Stability Exercises

NCT03975985 | Terminated

• 1 other identifier: IIBSP-CSE-2017-56
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief Summary

This study assess the effectiveness of core stability exercises performed in subacute phase of stroke. Half of participants will receive conventional physiotherapy, while the other half will receive core stability exercises and core stability exercises plus transcutaneous electrical nerve stimulation (TENS).

Conditions

Brain Injury, Vascular; Sequelae; Stroke Syndrome; Movement; Disorder, Treatment-Induced; Physical Activity

Keywords

stroke; core stability; trunk control; sitting balance; gait; spasticity; falls; activities of daily living; standing balance

Outcome Measures

Primary Outcomes (2)

• Dynamic sitting balance and trunk control

  Trunk Impairment Scale Spanish-version TIS 2.0 (S-TIS 2.0), consisting of a dynamic balance subscale (with 10 items) and a coordination subscale (with 6 items). Total score ranges from a minimum of 0 to a maximum of 16. Each item will be performed 3 times and the highest score counts. The tests are verbally explained to the patient and can be demonstrated if needed. The highest possible total score for the S-TIS 2.0 (16 points) indicates a good dynamic sitting balance and correct trunk control and sitting coordination. On the contrary, if the patient cannot maintain a sitting position for 10 seconds without back and arm support, with hands on thighs, feet in contact with the ground and knees bent at 90° (starting position), the total scale-score is 0 points.

  Change from Baseline at week 5

• Stepping

  Brunel Balance Assessment (BBA) (section 3 stepping). Section 3 consists of 6 levels (number 7 to 12) each of which increase the demand on balance ability, ranging from assisted balance to moving within the base of support, and changes of the base of support. At each level, the patient receives a score (1 point) for his/her efforts. Total score ranges from a minimum of 0 to a maximum of 6. This gives an indication on whether the patient is improving within a level, even if he/she is not able to progress to the next level. The score also reflects how well the individual is functioning within this section. Higher values represent a better outcome.

  Change from Baseline at week 5

Secondary Outcomes (9)

• Sitting balance

  Change from Baseline at week 5

• Gait speed

  week 5

• Standing balance

  Change from Baseline at week 5

• Risk of falling

  Change from Baseline at week 5

• Postural control

  Change from Baseline at week 5

Study Arms (2)

Core stability exercises

EXPERIMENTAL

This group will be divided in two: core stability exercises (CSE) plus conventional therapy (CP) and CSE with transcutaneous electrical nerve stimulation (TENS) plus CP.

Other: Core stability exercises (CSE); Other: Conventional Physiotherapy

Conventional physiotherapy (CP)

ACTIVE COMPARATOR

CP consists in a variety (or combination) of multiple components such as tone normalization, exercises for maintain range of motion, passive mobilization of hemiparetic side, postural control, gait re-education to walking/standing between parallel bars or with a therapist, rehabilitation of the activity of daily living, etc.

Other: Conventional Physiotherapy

Interventions

Core stability exercises (CSE) OTHER

CSE are exercises focused on trunk muscle strengthening, proprioception, selective movements of the trunk and pelvis muscle, and coordination, and will be carried out in supine, sitting on a stable surface and sitting on an unstable surface (physioball). The exercise involves changes in the position of the body without resistance, aiming to improve strength, endurance, proprioception and coordination. \- TENS: Half of the patients assigned to CSE will also receive TENS (highfrequency TENS 100 Hz; 0.2 ms pulse width), administered via TENS stimulator with two disposable 0.9 mm diameter electrodes placed on the skin over the lumbar erector spinae (3 cm lateral to the L3 and L5 spinous process).

Also known as: trunk control exercises, sitting balance exercises

Core stability exercises

Conventional Physiotherapy OTHER

The common feature of CP is that it consists of a management by the physiotherapist according to the CP may consist in a variety (or combination) of multiple components such as tone normalization, exercises for maintain range of motion, passive mobilization of hemiparetic side, postural control, gait re-education to walking/standing between parallel bars or with a therapist, rehabilitation of the activity of daily living, etc.

Also known as: Usual Care

Conventional physiotherapy (CP); Core stability exercises

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• First ever stroke same and less than 30 days (diagnostic criteria according to the World Health Organization definition; corresponding to ICD-9 code 434) weather cortical or subcortical, and ischemic or haemorrhagic.
• Unilateral localization of the stroke verified by computed tomography (CT).
• More or equal than18 years.
• Ability to understand and execute simple instructions.
• Spanish Version of Trunk Impairment Scale.2.0 less than10 points.
• National institute of Health Stroke Scale (NIHSS) score \> 4 points.

You may not qualify if:

• Rankin scale more or equal than 2 points before stroke.
• Orthopaedic and other neurological disorders that hamper sitting balance.
• Relevant psychiatric disorders that may prevent from following instructions.
• Other treatments that could influence the effects of the interventions.
• Contraindication to physical activity (e.g., heart failure).
• Using cardiac pacemakers.
• Moderate to severe cognitive impairments as indicated by Minimental test score \< 24 points.
• Patients with haemorrhagic stroke that have undergone surgery.

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead
• Universitat Internacional de Catalunya: collaborator
• Parc Taulí Hospital Universitari: collaborator
• Hospital de Terrassa: collaborator
• Hospital de la Santa Creu de Vic: collaborator
• University Ramon Llull: collaborator
• Hospital Sociosanitari Mutuam Girona: collaborator
• Parc de Salut Mar: collaborator
• FIDMAG Germanes Hospitalàries: collaborator

Study Sites (1)

Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.

Barcelona, Catalonia, 08025, Spain

Location

Related Publications (8)

• Cabanas-Valdes R, Bagur-Calafat C, Girabent-Farres M, Caballero-Gomez FM, Hernandez-Valino M, Urrutia Cuchi G. The effect of additional core stability exercises on improving dynamic sitting balance and trunk control for subacute stroke patients: a randomized controlled trial. Clin Rehabil. 2016 Oct;30(10):1024-1033. doi: 10.1177/0269215515609414. Epub 2015 Oct 8.

  PMID: 26451007 BACKGROUND

• Cabanas-Valdes R, Bagur-Calafat C, Girabent-Farres M, Caballero-Gomez FM, du Port de Pontcharra-Serra H, German-Romero A, Urrutia G. Long-term follow-up of a randomized controlled trial on additional core stability exercises training for improving dynamic sitting balance and trunk control in stroke patients. Clin Rehabil. 2017 Nov;31(11):1492-1499. doi: 10.1177/0269215517701804. Epub 2017 Mar 29.

  PMID: 28351168 BACKGROUND

• Cabanas-Valdes R, Girabent-Farres M, Canovas-Verge D, Caballero-Gomez FM, German-Romero A, Bagur-Calafat C. [Spanish translation and validation of the Postural Assessment Scale for Stroke Patients (PASS) to assess balance and postural control in adult post-stroke patients]. Rev Neurol. 2015 Feb 16;60(4):151-8. Spanish.

  PMID: 25670044 BACKGROUND

• Cabanas-Valdes R, Cuchi GU, Bagur-Calafat C. Trunk training exercises approaches for improving trunk performance and functional sitting balance in patients with stroke: a systematic review. NeuroRehabilitation. 2013;33(4):575-92. doi: 10.3233/NRE-130996.

  PMID: 24018373 BACKGROUND

• Cabanas-Valdes R, Urrutia G, Bagur-Calafat C, Caballero-Gomez FM, German-Romero A, Girabent-Farres M. Validation of the Spanish version of the Trunk Impairment Scale Version 2.0 (TIS 2.0) to assess dynamic sitting balance and coordination in post-stroke adult patients. Top Stroke Rehabil. 2016 Aug;23(4):225-32. doi: 10.1080/10749357.2016.1151662. Epub 2016 Mar 11.

  PMID: 26922850 BACKGROUND

• Cabanas-Valdes R, Bagur-Calafat C, Caballero-Gomez FM, Cervera-Cuenca C, Moya-Valdes R, Rodriguez-Rubio PR, Urrutia G. Validation and reliability of the Spanish version of the Function in Sitting Test (S-FIST) to assess sitting balance in subacute post-stroke adult patients. Top Stroke Rehabil. 2017 Sep;24(6):472-478. doi: 10.1080/10749357.2017.1316548. Epub 2017 Apr 13.

  PMID: 28406071 BACKGROUND

• Cabanas-Valdes R, Boix-Sala L, Grau-Pellicer M, Guzman-Bernal JA, Caballero-Gomez FM, Urrutia G. The Effectiveness of Additional Core Stability Exercises in Improving Dynamic Sitting Balance, Gait and Functional Rehabilitation for Subacute Stroke Patients (CORE-Trial): Study Protocol for a Randomized Controlled Trial. Int J Environ Res Public Health. 2021 Jun 19;18(12):6615. doi: 10.3390/ijerph18126615.

  PMID: 34205457 RESULT

• Salgueiro C, Urrutia G, Cabanas-Valdes R. Telerehabilitation for balance rehabilitation in the subacute stage of stroke: A pilot controlled trial. NeuroRehabilitation. 2022;51(1):91-99. doi: 10.3233/NRE-210332.

  PMID: 35311721 RESULT

MeSH Terms

Conditions

Cerebrovascular Trauma; Stroke; Motor Activity; Muscle Spasticity

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries; Behavior; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2019
• First Posted: June 5, 2019
• Study Start: January 15, 2019
• Primary Completion: March 15, 2022
• Study Completion: March 15, 2022
• Last Updated: May 9, 2023

Record last verified: 2023-05

Locations

ES (1)