Radial Extracorporeal Shock Wave Therapy and Visual Feedback Balance Training on Lower Limb Post-Stroke Spasticity, Trunk Performance and Balance:
NCT ID: NCT05196633
Last Updated: 2024-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
23 participants
INTERVENTIONAL
2021-01-01
2021-08-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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)
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.
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)
sham radial extracorporeal shock wave therapy
The control group will receive sound over the myotendinous junction of gastrocnemius and soleus with transducer-like contact.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Carol Davila University of Medicine and Pharmacy
OTHER
Responsible Party
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Emanuela Elena Mihai
Principal Investigator
Principal Investigators
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Mihai Berteanu
Role: STUDY_DIRECTOR
Physical and Rehabilitation Medicine Department, Elias University Emergency Hospital
Locations
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Elias University Emergency Hospital
Bucharest, , Romania
Countries
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Other Identifiers
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2090/C.E.
Identifier Type: -
Identifier Source: org_study_id