The Effectiveness of Core Stability Exercises — CORE  

Physical Activity Clinical Trial

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

Status Terminated

Clinical Trial 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).

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injury, Vascular
• Cerebrovascular Trauma
• Movement Disorders
• Movement; Disorder, Treatment-Induced
• Physical Activity
• Sequelae
• Stroke
• Stroke Syndrome
• Vascular System Injuries

• NCT number: NCT03975985
• Study type: Interventional
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Status: Terminated
• Phase: N/A
• Start date: January 15, 2019
• Completion date: March 15, 2022