Clinical trial NCT03975985: The Effectiveness of Core Stability Exercises
Official title: The Effect of Additional Core Stability Exercises on Improving Dynamic Sitting Balance, Trunk Control and Functional Rehabilitation for Subacute Stroke Patients: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
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
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
Collaborators: name: Universitat Internacional de Catalunya
name: Parc Taulí Hospital Universitari
name: Hospital de Terrassa
name: Hospital de la Santa Creu de Vic
name: University Ramon Llull
name: Hospital Sociosanitari Mutuam Girona
name: Parc de Salut Mar
name: FIDMAG Germanes Hospitalàries
First posted: 2019-06-05
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Detailed description: Background: The majority of subjects who have suffered a first-time stroke have balance disability in the subacute phase. Trunk impairment, restricted balance, and impaired postural control in patients with stroke are correlated with increasing risk of falls and impaired mobility. This creates disability and dependency in their activities of daily living. The core is central to almost all kinetic chains in the body. Several studies and a systematic review have shown that implementing core stability exercises may be a viable strategy for improving trunk performance and dynamic sitting balance, standing balance, and gait in post-stroke patients.

Main objective: To compare the efficacy of conventional physiotherapy versus an approach based on a Core Stability Exercises (CSEs) program, in terms of dynamic balance, gait and functional rehabilitation at the end of the intervention (5 weeks) and in the long term (sustained effect over time at 3 and 6 months), in sub-acute post-stroke patients. A secondary objective will be to develop and evaluate the feasibility and efficacy of a specific mobile application (app) to reinforce the adherence to unsupervised home-based CSEs by the own patient in the long term.

Methodology: Multicentre blinded-assessor randomized controlled (parallel group) trial. Study duration per patient will be 29 weeks (intervention period: 5 weeks, followed by 24 weeks follow-up). The study will consist in two parts: 1) A main study (CORE Trial) where physiotherapy modalities will be compared (main comparisons), and 2) an ancillary substudy (CORE-App Study) where the effect of a mobile application (app) will be evaluated (secondary comparison).

Expected results: The study will provide useful information on the short and long term effects of a physiotherapy rehabilitation program based on core stability exercises, as well as the potential use of a mobile app to reinforce long term adherence to unsupervised home-based physiotherapy.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Dynamic sitting balance and trunk control
timeFrame: Change from Baseline at week 5
measure: Stepping
timeFrame: Change from Baseline at week 5
Secondary outcomes:
measure: Sitting balance
timeFrame: Change from Baseline at week 5
measure: Gait speed
timeFrame: week 5
measure: Standing balance
timeFrame: Change from Baseline at week 5
measure: Risk of falling
timeFrame: Change from Baseline at week 5
measure: Postural control
timeFrame: Change from Baseline at week 5
measure: Activities of daily living
timeFrame: Change from Baseline at week 5
measure: Spasticity
timeFrame: Change from Baseline at week 5
measure: Rate of falls
timeFrame: week 5
measure: Health-related quality of life: EQ-5D-5L
timeFrame: week 5
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau.
state: Catalonia
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.