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

Carol Davila University of Medicine and Pharmacy

Status: Completed

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

Treatments: Other: sham radial extracorporeal shock wave therapy; Other: radial extracorporeal shock wave therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05196633

2090/C.E.

Details and patient eligibility

About

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.

Full 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.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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23 participants in 2 patient groups

Conventional physiotherapy, visual feedback training, rESWT

Experimental group

Description:

conventional physiotherapy (5 times/week), visual feedback training (5 times/week), radial extracorporeal shock wave therapy (once/week for 2 weeks)

Treatment:

Other: radial extracorporeal shock wave therapy

Conventional physiotherapy, visual feedback training, sham rESWT

Sham Comparator group

Description:

conventional physiotherapy (5 times/week), visual feedback training (5 times/week), sham radial extracorporeal shock wave therapy (once/week for 2 weeks)

Treatment:

Other: sham radial extracorporeal shock wave therapy