NCT05196633

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Carol Davila University of Medicine and Pharmacy · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2021-01-01
• Primary completion: 2021-06-30
• Completion: 2021-08-31
• First posted: 2022-01-19
• Last updated: 2024-12-03

Locations

1 site across 1 country: Romania