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

Stroke, Ischemic Clinical Trial

Official 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05196633
• Other study ID #: 2090/C.E.
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: August 2023

Study information

• Verified date: November 2022
• Source: Carol Davila University of Medicine and Pharmacy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: August 2023
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Balance; Distorted
• Gait Disorders, Neurologic
• Hemorrhagic Stroke
• Ischemic Stroke
• Muscle Spasticity
• Spastic Gait
• Spasticity as Sequela of Stroke
• Stroke
• Stroke Hemorrhagic
• Stroke, Ischemic

Intervention

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

Locations

Country	Name	City	State
Romania	Elias University Emergency Hospital	Bucharest

Sponsors (1)

Lead Sponsor	Collaborator
Carol Davila University of Medicine and Pharmacy

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spasticity grade change	The Modified Ashworth Scale (MAS)	Change from baseline Modified Ashworth Scale at 14 days
Secondary	Range of motion change	passive range of motion (PROM) parameter measured through a hand-held goniometer	Change from baseline Passive Range of Motion at 14 days
Secondary	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.	Change from baseline Visual Analogue Scale at 14 days
Secondary	Stabilometric outcomes change	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