The Effectiveness of Radial Extracorporeal Shock Wave Therapy as Additional Treatment Modality for Spastic Equinus Deformity in Chronic Hemiplegic Patients

NCT05615493 | Unknown

• 1 other identifier: Tanta University35910
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, double blinded randomized, placebo-controlled study that will be conducted on 112 adult ischemic or hemorrhagic hemiplegic stroke patients with calf muscles spasticity so as to evaluate the effectiveness of radial extracorporeal shock wave therapy (r ESWT) as an additional treatment modality for spastic equinus deformity in those patients. Allocation of patients into two groups after eligibility testing \& randomization will be done: Group I: patients will receive rESWT once weekly for one month , Group II: patients will receive Sham rESWT once weekly for one month. Each patient will be evaluated by the same well trained physiatrist for clinical, Electrophysiological and Musculoskeletal Ultrasound (MSKUS) assessments at baseline (t0), and after 1 month (t1) and after 2 months (t2) .

Conditions

Hemiplegic Patients

Keywords

Spasticity,; Equinus foot ,; Hemiplegia,; Extracorporeal shock wave

Outcome Measures

Primary Outcomes (5)

• Reduction in modified Ashworth scale (MAS) for spastic plantar flexor muscles

  about 6 months

• Improvement of Passive ankle dorsiflexion range of motion ( PADFM) .

  about 6 months

• Reduction in time required to walk 10 meters (10 MWT).

  about 6 months

• Reduction in H/M ratio.

  about 6 months

• Change in spastic calf muscles echogenicity on Heckmatt scale.

  about 6 months

Study Arms (2)

Group I

ACTIVE COMPARATOR

Will receive rESWT once weekly for one month

Device: radial extracorporeal shock wave therapy

Group II

SHAM COMPARATOR

Will receive Sham rESWT once weekly for one month

Device: sham radial extracorporeal shock wave therapy

Interventions

radial extracorporeal shock wave therapy DEVICE

Radial extracorporeal shock wave therapy (r ESWT) will be applied by Dornier AR2 machine (Dornier MedTech GmbH, Wessling, Germany) under ultrasound guidance, at musculotendinous junction of medial and lateral head of the gastrocnemius for spastic calf (gastrocnemius muscle and the soleus) muscles . 1.500 pulses will be applied by an R20 probe with a focusing depth of 4cm.The intensity will be 0.10 mJ to 0.3mJ/mm2 (2.5 bar), with frequency 4 Hz every week for one month .No anesthetic or analgesic drugs will be administered to patients during the therapy session

Group I

sham radial extracorporeal shock wave therapy DEVICE

Dornier AR2 machine (Dornier MedTech GmbH, Wessling, Germany) used under ultrasound guidance, at musculotendinous junction of medial and lateral head of the gastrocnemius for spastic calf (gastrocnemius muscle and the soleus) muscles . 1.500 pulses will be applied by an R20 probe with intensity of 0.10 mJ to 0.3mJ/mm2 (2.5 bar), \& frequency 4 Hz every week for one month without operating the machine .

Group II

Eligibility Criteria

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

You may qualify if:

• Adult ischemic or hemorrhagic hemiplegic patients who exhibited signs of unilateral spastic equinus foot for at least 6 months before the enrollment in the study will be selected to reduce the confounding effect of natural recovery.

You may not qualify if:

• Patients with fixed contractures or deformities at the ankle, fractures, cognitive impairment, different types of neuropathies or myopathies, implanted pacemaker and prior /or planned treatment using antispastic medications (i.e intrathecal baclofen or Botox injection ) or chemo -denervation ( phenol or alcohol nerve blocks ) within the last 6 months preceding the study , will be excluded.

Sponsors & Collaborators

• Doaa Waseem Nada: lead

Study Sites (1)

Faculty of Medicine, Tanta University

Tanta, Elgharbia Governorate, 31527, Egypt

RECRUITING

MeSH Terms

Conditions

Muscle Spasticity; Hemiplegia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Paralysis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The closed envelop method will be used for the randomization of the patients who will be blinded to group allocation. The assessments will be done by the first physiatrist (A), who will not involved in patients' sessions. The randomization will be performed by the second physiatrist (B ) who will not be involved in patients' assessment and ESWT sessions . ESWT Sessions for both groups will be will be carried out by the third physiatrist (C ) who will not take part in the assessments or patients' randomization . Both (C) and (A) were blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Model Details: adult ischemic or hemorrhagic hemiplegic stroke patients with unilateral spastic equinus foot for at least 6 months before enrollment to reduce the confounding effect of natural recovery

Study Record Dates

• First Submitted: October 30, 2022
• First Posted: November 14, 2022
• Study Start: October 15, 2022
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: November 14, 2022

Record last verified: 2022-11

Locations

EG (1)