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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional physiotherapy, visual feedback training, rESWT | Experimental | conventional physiotherapy (5 times/week), visual feedback training (5 times/week), radial extracorporeal shock wave therapy (once/week for 2 weeks) |
|
| Conventional physiotherapy, visual feedback training, sham rESWT | Sham Comparator | conventional physiotherapy (5 times/week), visual feedback training (5 times/week), sham radial extracorporeal shock wave therapy (once/week for 2 weeks) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Spasticity grade change | The Modified Ashworth Scale (MAS) | Change from baseline Modified Ashworth Scale at 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mihai Berteanu | Physical and Rehabilitation Medicine Department, Elias University Emergency Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Elias University Emergency Hospital | Bucharest | 011461 | Romania |
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|
| 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. |
|
| Change from baseline Visual Analogue Scale at 14 days |
| 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 |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D000083302 | Hemorrhagic Stroke |
| D020233 | Gait Disorders, Neurologic |
| D020521 | Stroke |
| D009128 | Muscle Spasticity |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |
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