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

NCT05196633 | Completed

• 1 other identifier: 2090/C.E.
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

stroke; spasticity; balance trainer; balance impairment; neurologic rehabilitation

Outcome Measures

Primary Outcomes (1)

• Spasticity grade change

  The Modified Ashworth Scale (MAS)

  Change from baseline Modified Ashworth Scale at 14 days

Secondary Outcomes (3)

• Range of motion change

  Change from baseline Passive Range of Motion at 14 days

• Pain intensity change

  Change from baseline Visual Analogue Scale at 14 days

• Stabilometric outcomes change

  Change from baseline Prokin system parameters at 14 days

Study Arms (2)

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)

Other: radial extracorporeal shock wave therapy

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)

Other: sham radial extracorporeal shock wave therapy

Interventions

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.

Conventional physiotherapy, visual feedback training, rESWT

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.

Conventional physiotherapy, visual feedback training, sham rESWT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Carol Davila University of Medicine and Pharmacy: lead

Study Sites (1)

Elias University Emergency Hospital

Bucharest, 011461, Romania

Location

MeSH Terms

Conditions

Ischemic Stroke; Hemorrhagic Stroke; Gait Disorders, Neurologic; Stroke; Muscle Spasticity

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations

Study Officials

• Mihai Berteanu

  Physical and Rehabilitation Medicine Department, Elias University Emergency Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 21, 2021
• First Posted: January 19, 2022
• Study Start: January 1, 2021
• Primary Completion: June 30, 2021
• Study Completion: August 31, 2021
• Last Updated: December 3, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)