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

N/ACompletedNCT05196633

Carol Davila University of Medicine and Pharmacy23 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Stroke, Ischemic Stroke Hemorrhagic Spasticity as Sequela of Stroke

Interventions

radial extracorporeal shock wave therapyOTHER

rESWT (Endopuls 811; Enraf Nonius B.V. Va-reseweg 127, 3047 AT Rotterdam MedTech, Wessling, Germany) will be applied on the myotendinous junction of both the gastrocnemius and the soleus muscles in post-stroke spasticity patients. 2000 shots will be applied on the gastrocnemius and soleus myotendinous junction with a frequency of 10 Hz and energy density of 60 mJ (1 bar) within tolerable pain limits.

sham radial extracorporeal shock wave therapyOTHER

The control group will receive sound over the myotendinous junction of gastrocnemius and soleus with transducer-like contact.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Spasticity grade change

The Modified Ashworth Scale (MAS)

Time frame: Change from baseline Modified Ashworth Scale at 14 days

Secondary Outcomes

Range of motion change

passive range of motion (PROM) parameter measured through a hand-held goniometer

Time frame: Change from baseline Passive Range of Motion at 14 days

Pain intensity change

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.

Time frame: Change from baseline Visual Analogue Scale at 14 days

Stabilometric outcomes change

Prokin system (PK 252, TecnoBody, Bergamo, Italy) parameters: trunk (degrees), stance (degrees), static (mm\^2) and dynamic balance (mm\^2)

Time frame: Change from baseline Prokin system parameters at 14 days