scholarly journals The effectiveness of additional core stability exercises in improving dynamic sitting balance, standing balance, lower-limb spasticity, falls and gait in subacute stroke patients (CORE-trial). Study protocol for a Randomized Controlled Trial

Author(s):  
Rosa Cabanas-Valdés ◽  
Lidia Boix-Sala ◽  
Montserrat Grau-Pellicer ◽  
Juan Antonio Guzmán-Bernal ◽  
Fernanda Maria Caballero-Gómez ◽  
...  

Abstract BackgroundTrunk impairment produces disorders of motor control, balance, and gait that are correlated with increased risk of falls and reduced mobility in stroke survivors. This creates disability and dependency to perform their activities of daily living. Alterations in body alignment occur, requiring treatment strategies focused on improving the postural control. bearing. Core stability exercises (CSE) are a good strategy to improve local strength of trunk, dynamic sitting, standing balance, and gait. There is some evidence about its effectiveness but it is still necessary to run a large multicenter trial to ratify that existing evidence.MethodsThis 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 hour per session) focused on improving balance. An experimental group (EG) (n=110) performs CSE (30 minutes) in addition to CP (30 minutes) (1 hour/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 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 3 weeks (T1), at 5 weeks -at the end of the intervention (T2), at 17 weeks (T3) and at 29 weeks (T4). Study duration per patient is 29 weeks (a 5-week intervention, followed by a 24-week post-intervention). DiscussionThe study will provide useful information on the short and long term effects of a physiotherapy rehabilitation program based on core stability exercises performed in subacute phase.Trial registrationClinicalTrials.gov Identifier NCT03975985. Data registration June 5th, 2019. Retrospectively registered. Date of registration in primary registry: June 5, 2019. Protocol version 1

2016 ◽  
Vol 30 (10) ◽  
pp. 1024-1033 ◽  
Author(s):  
Rosa Cabanas-Valdés ◽  
Caritat Bagur-Calafat ◽  
Montserrat Girabent-Farrés ◽  
Fernanda Mª Caballero-Gómez ◽  
Montserrat Hernández-Valiño ◽  
...  

Author(s):  
Rosa Cabanas-Valdés ◽  
Lídia Boix-Sala ◽  
Montserrat Grau-Pellicer ◽  
Juan Antonio Guzmán-Bernal ◽  
Fernanda Maria Caballero-Gómez ◽  
...  

Background: 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).


Toxins ◽  
2019 ◽  
Vol 11 (4) ◽  
pp. 210 ◽  
Author(s):  
Nicoletta Cinone ◽  
Sara Letizia ◽  
Luigi Santoro ◽  
Salvatore Facciorusso ◽  
Raffaella Armiento ◽  
...  

Botulinum toxin A (BoNT-A) has been shown effective for poststroke lower limb spasticity. Following injections, a wide range of multidisciplinary approach has been previously provided. The purpose of this pilot, single-blind, randomized controlled trial was to determine whether BoNT-A combined with a regime of a four-week ankle isokinetic treatment has a positive effect on function and spasticity, compared with BoNT-A alone. Secondly, the validity of the use of an isokinetic dynamometer to measure the stretch reflex at the ankle joint and residual strength has been investigated. Twenty-five chronic stroke patients were randomized to receive combined treatment (n = 12; experimental group) or BoNT-A alone (n = 13; control group). Outcome measures were based on the International Classification of Functioning, Disability and Health. An isokinetic dynamometer was also used for stretch reflex and strength assessment. Patients were evaluated at baseline (t0), after five (t1) and eight weeks after the injection (t2). The experimental group reported significantly greater improvements on lower limb spasticity, especially after eight weeks from baseline. Gait speed (10-m walk test) and walking capacity (6-min walking test) revealed statistically significantly better improvement in the experimental than in control group. Peak resistive ankle torque during growing angular velocities showed a significant reduction at the higher velocities after BoNT-A injections in the experimental group. Peak dorsiflexor torque was significantly increased in the experimental group and peak plantarflexor torque was significantly decreased in control group. Alternative rehabilitation strategies that combine BoNT-A and an intense ankle isokinetic treatment are effective in reducing tone and improving residual strength and motor function in patients with chronic hemiparesis.


2021 ◽  
Vol 2021 ◽  
pp. 1-9
Author(s):  
Jingwen Li ◽  
Kaiqi Su ◽  
Jinjin Mei ◽  
Yiying Wang ◽  
Shuai Yin ◽  
...  

Background. Lower limb spasticity is a common complication after stroke, which seriously affects the quality of life and rehabilitation of patients. There are different treatment methods for poststroke spasticity. It has been found in clinical practice that governor vessel electroacupuncture (GV-EA) can effectively relieve poststroke upper extremity spasticity, but the efficacy of treatment of lower extremity spasticity needs to be further verified. This study aims to design a randomized controlled trial to evaluate the efficacy of GV-EA in the treatment of poststroke lower limb spasticity. Methods/Design. This is a randomized, controlled trial. Patients (N = 177) will be randomized to receive routine therapeutic drug and rehabilitation treatment plus GV-EA (experimental group) or routine therapeutic drug and rehabilitation treatment plus EA (control group 1) or routine therapeutic drug and rehabilitation treatment (control group 2). All patients will receive 20 sessions of treatment for 4 weeks. The primary outcomes are the RMS value and the Modified Ashworth Scale. Secondary outcomes include the Fugl–Meyer Assessment for Lower Extremity (FMA-LE) and the Modified Barthel Index score. All outcome measures will be evaluated at the beginning and after the intervention (4 weeks). Discussion. This trial will observe the clinical effect of GV-EA on lower extremity spasticity after stroke, especially its influence on surface electromyography characteristics, and provide high-quality experimental evidence for the clinical application of GV-EA based on surface electromyography in the treatment of poststroke lower limb spasticity. Trial Registration. China Clinical Trials Registry No. ChiCTR1900027969. Registered on 7 December 2019.


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