The Effectiveness of Core Stability Exercises (CORE)

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

Status: Terminated

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03975985

IIBSP-CSE-2017-56

Details and patient eligibility

About

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).

Full 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.

Enrollment: 87 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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87 participants in 2 patient groups

Core stability exercises

Experimental group

Description:

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.

Treatment:

Other: Conventional Physiotherapy

Other: Core stability exercises (CSE)

Conventional physiotherapy (CP)

Active Comparator group

Description:

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.

Treatment:

Other: Conventional Physiotherapy