Radial Extracorporeal Shock Wave Therapy and Visual Feedback Balance Training on Lower Limb Post-Stroke Spasticity, Trunk Performance and Balance:

Not Applicable

Completed

• Conditions: Spasticity as Sequela of Stroke; Balance; Distorted; Stroke Hemorrhagic; Stroke, Ischemic; Spastic Gait
• Interventions: Other: radial extracorporeal shock wave therapy; Other: sham radial extracorporeal shock wave therapy

• Registration Number: NCT05196633
• Lead Sponsor: Carol Davila University of Medicine and Pharmacy

Brief Summary

This study assess the relationship between lower limb spasticity and trunk movements during static and dynamic balance in post-stroke patients who also underwent conventional physical therapy, visual feedback balance training and radial extracorporeal shock wave therapy intervention.

Detailed Description

The stabilometric assessment through Prokin system complemented the clinical evaluation and provided a more objective, global insight into the combined therapeutic effect.

The stabilometric computerized system is both an assessment tool and a training system for static, dynamic balance and trunk. To date, it was used in various clinical trials as a training tool for promoting stance and balance improvement in several neurorehabilitation programs.

Additional outcomes focused on the effectiveness on pain intensity, clonus, passive range of motion, lower limb sensorimotor function, and functionality. The adverse events were also attentively monitored during the trial.

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2021-06-30
• Study Completion: 2021-08-31
• Study First Submitted: 2021-12-21
• Study First Submitted QC: 2022-01-06
• Study First Posted: 2022-01-19
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-02
• Last Update Posted: 2024-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

• a hemorrhagic or ischemic stroke in acute, subacute or chronic phase;
• no history of previous stroke;
• lower limb post-stroke spasticity and spasticity grade ≥1 on the Modified Ashworth Scale (MAS);
• pain intensity measured on Visual Analogue Scale (VAS) ≥1;
• ability to stand unassisted in upright position for 30 seconds;
• no change in anti-spastic drug dose or treatment and no changes in analgesic medication, as it could affect the results on the Modified Ashworth Scale and the Visual Analogue Scale
• adult patients (>18 years old)

Exclusion Criteria

• other neurological and orthopaedic disorders or lower limb deformities that could in-terfere with motor performance and balance;
• myopathies;
• severe cognitive impairment, severe aphasia or inability to understand instructions;
• severe spasticity;
• visual field conditions or hemineglect;
• patients unable to undergo follow-up evaluation and excluded from the final analysis;
• anticoagulant medication or any contraindication to receive radial extracorporeal shockwave therapy (rESWT), or any contraindication to physical therapy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional physiotherapy, visual feedback training, rESWT	radial extracorporeal shock wave therapy	conventional physiotherapy (5 times/week), visual feedback training (5 times/week), radial extracorporeal shock wave therapy (once/week for 2 weeks)
Conventional physiotherapy, visual feedback training, sham rESWT	sham radial extracorporeal shock wave therapy	conventional physiotherapy (5 times/week), visual feedback training (5 times/week), sham radial extracorporeal shock wave therapy (once/week for 2 weeks)

Primary Outcome Measures

Name	Time	Method
Spasticity grade change	Change from baseline Modified Ashworth Scale at 14 days	The Modified Ashworth Scale (MAS)

Secondary Outcome Measures

Name	Time	Method
Pain intensity change	Change from baseline Visual Analogue Scale at 14 days	Visual Analogue Scale (VAS) through a vertical 10-cm line (0 - starting pain-free to 10 - the worst imaginable pain). The higher the score means a worse outcome.
Range of motion change	Change from baseline Passive Range of Motion at 14 days	passive range of motion (PROM) parameter measured through a hand-held goniometer
Stabilometric outcomes change	Change from baseline Prokin system parameters at 14 days	Prokin system (PK 252, TecnoBody, Bergamo, Italy) parameters: trunk (degrees), stance (degrees), static (mm\^2) and dynamic balance (mm\^2)

Trial Locations

Locations (1)

Elias University Emergency Hospital; 🇷🇴 Bucharest, Romania