Clinical trial NCT05196633: Radial Extracorporeal Shock Wave Therapy and Visual Feedback Balance Training on Lower Limb Post-Stroke Spasticity, Trunk Performance and Balance:
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke, Ischemic
Stroke Hemorrhagic
Spasticity as Sequela of Stroke
Spastic Gait
Balance; Distorted
Keywords: stroke
spasticity
balance trainer
balance impairment
neurologic rehabilitation
Lead sponsor: Carol Davila University of Medicine and Pharmacy
Sponsor class: OTHER
First posted: 2022-01-19
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Spasticity grade change
timeFrame: Change from baseline Modified Ashworth Scale at 14 days
Secondary outcomes:
measure: Range of motion change
timeFrame: Change from baseline Passive Range of Motion at 14 days
measure: Pain intensity change
timeFrame: Change from baseline Visual Analogue Scale at 14 days
measure: Stabilometric outcomes change
timeFrame: Change from baseline Prokin system parameters at 14 days
Other outcomes:
Locations:
city: Bucharest
country: Romania
facility: Elias University Emergency Hospital
Study officials:
affiliation: Physical and Rehabilitation Medicine Department, Elias University Emergency Hospital
name: Mihai Berteanu
role: STUDY_DIRECTOR
References: