NCT03975985

The Effectiveness of Core Stability Exercises

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
OTHER	Core stability exercises (CSE)	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).
OTHER	Conventional Physiotherapy	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.

Timeline

• Start date: 2019-01-15
• Primary completion: 2022-03-15
• Completion: 2022-03-15
• First posted: 2019-06-05
• Last updated: 2023-05-09

Locations

1 site across 1 country: Spain