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Completed

NCT Number: NCT05196633

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Radial Extracorporeal Shock Wave Therapy

Other

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 therapy

Other

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

Primary outcomes

  1. Spasticity grade change

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

    The Modified Ashworth Scale (MAS)

Secondary outcomes

  1. Range of motion change

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

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

  2. Pain intensity change

    Time frame: 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.

  3. Stabilometric outcomes change

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Carol Davila University of Medicine and Pharmacy

Other

Registry information

Official study title

Effectiveness of Radial Extracorporeal Shock Wave Therapy and Visual Feedback Balance Training on Lower Limb Post-Stroke Spasticity, Trunk Performance and Balance: A Randomized Controlled Trial

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 19, 2022
Registry last updated
Dec 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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