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.


Trunk impairment produces disorders of motor control, balance and gait. Core stability exercises (CSE) are a good strategy to improve local strength of trunk, balance and gait. Methods and analysis: This is a single-blind multicenter randomized controlled trial. Two parallel groups are compared, and both perform the same type of therapy. A control group (CG) (n = 110) performs conventional physiotherapy (CP) (1 h per session) focused on improving balance. An experimental group (EG) (n = 110) performs CSE (30 min) in addition to CP (30 min) (1 h/session in total). EG is divided in two subgroups, in which only half of patients (n = 55) perform CSE plus transcutaneous electrical nerve stimulation (TENS). Primary outcome measures are dynamic sitting, assessed by a Spanish version of Trunk Impairment Scale and stepping, assessed by Brunel Balance Assessment. Secondary outcomes are postural control, assessed by Postural Assessment Scale for Stroke patients; standing balance and risk of fall assessed by Berg Balance Scale; gait speed by BTS G-Walk (accelerometer); rate of falls, lower-limb spasticity by Modified Ashworth Scale; activities of daily living by Barthel Index; and quality of life by EQ-5D-5L. These are evaluated at baseline (T0), at three weeks (T1), at five weeks (end of the intervention) (T2), at 17 weeks (T3) and at 29 weeks (T4). Study duration per patient is 29 weeks (a five-week intervention, followed by a 24-week post-intervention).

Trial registration: NCT03975985.

Keywords: core stability training; exercise therapy; gait; postural balance; sitting position; stroke; trunk exercises.

Publication types

  • Clinical Trial Protocol
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Activities of Daily Living
  • Exercise Therapy
  • Gait
  • Humans
  • Multicenter Studies as Topic
  • Postural Balance
  • Quality of Life
  • Randomized Controlled Trials as Topic
  • Single-Blind Method
  • Sitting Position
  • Stroke Rehabilitation*
  • Stroke*
  • Treatment Outcome

Associated data