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

The Effectiveness of Radial Extracorporeal Shock Wave Therapy as Additional Treatment Modality for Spastic Equinus Deformity in Chronic Hemiplegic Patients, A Double-Blinded, Randomized Controlled Study.

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) .

Study Overview

• Status: Recruiting
• Conditions: Hemiplegic Patients
• Intervention / Treatment: Device: radial extracorporeal shock wave therapy; Device: sham radial extracorporeal shock wave therapy

Detailed Description

Study design & Participants selection:

This is a prospective, randomized, placebo-controlled study that will be conducted from October 2022 to March 2023, on 112 consecutive adult ischemic or hemorrhagic hemiplegic stroke patients with calf muscles spasticity (grade 1 - 4) by the modified Ashworth scale (MAS) who will be recruited from out patient clinic of Rheumatology , Rehabilitation and Physical Medicine Department ,Tanta university Hospital, and will be assessed for study eligibility.

Inclusion criteria:

All 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.

Exclusion criteria:

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.

Randomization :

The closed envelop randomization method will be used for the randomization of the patients who will be also blinded to group allocation.

The patients will be allocated into two groups after eligibility testing& randomization:

Group I: will be exposed to rESWT once weekly for one month Group II: will be exposed to Sham rESWT once weekly for one month. During the study period, oral anti-spastic medications and stretching exercises will be similarly given for both groups. Tizanidine hydrochloride will be the oral anti-spastic used at a daily dosage of 2 mg for first 4 days and then 4 mg until the end of the follow up period. Stretching exercises will be included and given at 30 min/day, at 5 weekly sessions over the treatment period. Stretching exercises as well as rESWT will be provided by the same blinded well-trained physiatrist and the patients in both groups will not be allowed to change the dose of anti-spastic medication during the study period.

The used assessment measures will be explained to all patients before having their written informed consents to participate in this study.

All data and results of the research will be used for scientific purposes with assurance of patient privacy.

Evaluation protocol and outcome measurements:

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) .

A. Clinical assessment :

1. Plantar-flexor muscles spasticity: will be assessed by modified Ashworth scale (MAS). It is a 5-point scale , ranging from ( 0 ) as normal muscle tone to (4 ) which is limb rigid in flexion or extension.
2. Passive ankle dorsiflexion motion (PADFM) : of the affected side will be measured with a goniometer while the patient is lying in a supine position with the knee flexed.. The readings will be recorded and the mean score will be calculated. The degree of ankle planter flexion will be measured as a negative value, and the degree of ankle dorsiflexion will be measured as a positive value.
3. The timed 10 meters walk test (10 MWT) :

The 10 Meter Walking Test (10 MWT) assesses short duration walking speed (m/s) & measures the time required to walk 10 meters. The time taken by the patients will be recorded by stopwatch ,two consecutive trials will be done and the mean time will be calculated .

B. Electrophysiological assessment:

The H/M ratio (Ratio of maximum H reflex to maximum M response), will be assessed using Electromyography machine (Neuroback ,Nihinon Kohden 4 channel. Japan 2008). The maximal amplitude of H-reflex will be obtained with low intensity, with gradual increase of the stimulus intensity, the M-response amplitude was gradually increased while the H-reflex amplitude was gradually decreased . Two consecutive recording will be taken and the mean H/M ratio will be calculated.

C. Musculoskeletal ultrasound assessment:

Sonographic evaluation will be performed using a linear transducer scanning frequency of ( 4-13 MHz) SAMSUNG MEDISON ( UGEO H 60) on the affected spastic calf muscles to qualify muscle echo intensity using the Heckmatt scale.

Radial extracorporeal shock wave therapy (r ESWT ) protocol:

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 for the treatment group and without operating the machine for the sham group . No anesthetic or analgesic drugs will be administered to patients during the therapy session. Both groups will be put under the same physiotherapeutic program performed by the same well-trained physiatrist .

• Study Type: Interventional
• Enrollment (Anticipated): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Elgharbia Governorate
    • Tanta,, Elgharbia Governorate, Egypt, 31527
      • Recruiting
      • Faculty of medicine, Tanta university
      • Contact: Doaa Waseem Nada, MD; Phone Number: 00201069579672; Email: doaa.waseem@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group I; Will receive rESWT once weekly for one month	Device: radial extracorporeal shock wave therapy; 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
Sham Comparator: Group II; Will receive Sham rESWT once weekly for one month	Device: sham radial extracorporeal shock wave therapy; 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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Doaa Waseem Nada

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2022
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): March 1, 2023

Study Registration Dates

• First Submitted: October 30, 2022
• First Submitted That Met QC Criteria: November 11, 2022
• First Posted (Actual): November 14, 2022

Study Record Updates

• Last Update Posted (Actual): November 14, 2022
• Last Update Submitted That Met QC Criteria: November 11, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Spasticity,; Equinus foot ,; Hemiplegia,; Extracorporeal shock wave
• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Musculoskeletal Abnormalities; Limb Deformities, Congenital; Foot Deformities; Foot Deformities, Acquired; Foot Deformities, Congenital; Lower Extremity Deformities, Congenital; Clubfoot; Talipes; Equinus Deformity
• Other Study ID Numbers: Tanta University35910

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No