search
Back to results

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

Primary Purpose

Hemiplegic Patients

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
radial extracorporeal shock wave therapy
sham radial extracorporeal shock wave therapy
Sponsored by
Doaa Waseem Nada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemiplegic Patients focused on measuring Spasticity,, Equinus foot ,, Hemiplegia,, Extracorporeal shock wave

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of Medicine, Tanta UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Group I

Group II

Arm Description

Will receive rESWT once weekly for one month

Will receive Sham rESWT once weekly for one month

Outcomes

Primary Outcome Measures

Reduction in modified Ashworth scale (MAS) for spastic plantar flexor muscles
Improvement of Passive ankle dorsiflexion range of motion ( PADFM) .
Reduction in time required to walk 10 meters (10 MWT).
Reduction in H/M ratio.
Change in spastic calf muscles echogenicity on Heckmatt scale.

Secondary Outcome Measures

Full Information

First Posted
October 30, 2022
Last Updated
November 11, 2022
Sponsor
Doaa Waseem Nada
search

1. Study Identification

Unique Protocol Identification Number
NCT05615493
Brief Title
The Effectiveness of Radial Extracorporeal Shock Wave Therapy as Additional Treatment Modality for Spastic Equinus Deformity in Chronic Hemiplegic Patients
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 15, 2022 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Doaa Waseem Nada

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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) .
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 : 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. 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. 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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiplegic Patients
Keywords
Spasticity,, Equinus foot ,, Hemiplegia,, Extracorporeal shock wave

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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
Masking
ParticipantCare ProviderInvestigator
Masking Description
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.
Allocation
Randomized
Enrollment
112 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group I
Arm Type
Active Comparator
Arm Description
Will receive rESWT once weekly for one month
Arm Title
Group II
Arm Type
Sham Comparator
Arm Description
Will receive Sham rESWT once weekly for one month
Intervention Type
Device
Intervention Name(s)
radial extracorporeal shock wave therapy
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
sham radial extracorporeal shock wave therapy
Intervention Description
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 .
Primary Outcome Measure Information:
Title
Reduction in modified Ashworth scale (MAS) for spastic plantar flexor muscles
Time Frame
about 6 months
Title
Improvement of Passive ankle dorsiflexion range of motion ( PADFM) .
Time Frame
about 6 months
Title
Reduction in time required to walk 10 meters (10 MWT).
Time Frame
about 6 months
Title
Reduction in H/M ratio.
Time Frame
about 6 months
Title
Change in spastic calf muscles echogenicity on Heckmatt scale.
Time Frame
about 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Faculty of Medicine, Tanta University
City
Tanta,
State/Province
Elgharbia Governorate
ZIP/Postal Code
31527
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Doaa Waseem Nada, MD
Phone
00201069579672
Email
doaa.waseem@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs