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

December 2, 2024 updated by: Emanuela Elena Mihai, Carol Davila University of Medicine and Pharmacy

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Romania
      • Bucharest, Romania, 011461
        • Elias University Emergency Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Conventional physiotherapy, visual feedback training, rESWT
conventional physiotherapy (5 times/week), visual feedback training (5 times/week), radial extracorporeal shock wave therapy (once/week for 2 weeks)
Other: radial extracorporeal shock wave therapy
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 Comparator: Conventional physiotherapy, visual feedback training, sham rESWT
conventional physiotherapy (5 times/week), visual feedback training (5 times/week), sham radial extracorporeal shock wave therapy (once/week for 2 weeks)
Other: sham radial extracorporeal shock wave therapy
The control group will receive sound over the myotendinous junction of gastrocnemius and soleus with transducer-like contact.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Spasticity grade change
Time Frame: Change from baseline Modified Ashworth Scale at 14 days
The Modified Ashworth Scale (MAS)
Change from baseline Modified Ashworth Scale at 14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Change from baseline Passive Range of Motion at 14 days
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.
Change from baseline Visual Analogue Scale at 14 days
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)
Change from baseline Prokin system parameters at 14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carol Davila University of Medicine and Pharmacy

Investigators

  • Study Director: Mihai Berteanu, Physical and Rehabilitation Medicine Department, Elias University Emergency Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Actual)

June 30, 2021

Study Completion (Actual)

August 31, 2021

Study Registration Dates

First Submitted

December 21, 2021

First Submitted That Met QC Criteria

January 6, 2022

First Posted (Actual)

January 19, 2022

Study Record Updates

Last Update Posted (Actual)

December 3, 2024

Last Update Submitted That Met QC Criteria

December 2, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2090/C.E.

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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