Comparison of the Effects of Extracorporeal Shockwave Therapy and Pulsed Ultrasound on Spasticity neurophysiological and Functional outcomes in Patients with Stroke
trial aims to compare the effectiveness of ESWT and pulsed US in reducing plantar flexor spasticity in individuals with stroke
Design
Single-Blind Randomized Controlled Trial
Settings and conduct
patients referred to the Neurophysiotherapy Clinic at the School of Rehabilitation, as well as those attending neurological and neurorehabilitation clinics within TUMS, will be recruited for this study.will be conducted using a convenience sampling method
Participants/Inclusion and exclusion criteria
. inclusiion
1.First-ever stroke.
2. Stroke duration of at least 6 months and less than 48 months
3. Age 40-70 years
4. Ankle plantar flexor MMAS score ≥1
5. Be able to walk independently
6. Stable vital signs.
7. constant drug protocol doses
- Exclusion criteria
1. Sensation deficits in the foot area
2. Currently being treated for spasticity
3. Wound or infection in the affected lower limb (
4. Ultrasound and shockwave contraindications.
5. Radial extracorporeal shock wave therapy (rESWT) contraindications (pregnancy, On major
6. vessels and nerves, Pacemaker or other implanted devices, Open wounds, Joint
7. Fixed ankle joint contracture
8. History of Botox . alcohol or phenol block treatments within previous 6 months ago
9. Severe pain with rSWET
Intervention groups
1-Shock Wave Group (rESWT)
2-Ultrasound Group (Pulsed US)
Main outcome variables
1-Spasticity Severity
Modified Modified Ashworth Scale (MMAS)
Range of Motion
2-Active & Passive Ankle Dorsiflexion
3-Muscle Torque Passive Plantar Flexor Torque
4-Neurophysiology Hmax/Mmax Ratio (H-Reflex Recording)
5-Functional outcome
Timed Up and Go test
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20260823070769N1
Registration date:2026-08-31, 1405/06/09
Registration timing:prospective
Last update:2026-08-31, 1405/06/09
Update count:0
Registration date
2026-08-31, 1405/06/09
Registrant information
Name
Hussein Saraefi
Name of organization / entity
Country
Iraq
Phone
+964 771 442 5820
Email address
husseinsarafei@gmail.com
Recruitment status
Not yet recruiting
Funding source
Expected recruitment start date
2026-09-15, 1405/06/24
Expected recruitment end date
2027-03-15, 1405/12/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effects of Extracorporeal Shockwave Therapy and Pulsed Ultrasound on Spasticity neurophysiological and Functional outcomes in Patients with Stroke
Public title
Effect of Shockwave Therapy Versus Ultrasound on Muscle Spasticity After Stroke
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
First-ever stroke. .7
.Stroke duration of at least 6 months and less than 48 months
Age 40-70 years.
.Ankle plantar flexor MMAS score ≥1
Be able to walk independently
Stable vital signs
constant drug protocol doses
Exclusion criteria:
Sensation deficits in the foot area
. Currently being treated for spasticity
. Wound or infection in the affected lower limb
. Ultrasound and shockwave contraindications.
Radial extracorporeal shock wave therapy (rESWT) contraindications (pregnancy, On major )
vessels and nerves, Pacemaker or other implanted devices, Open wounds, Joint
Fixed ankle joint contracture .
History of Botox . alcohol or phenol block treatments within previous 6 months ago
Severe pain with rSWET
Age
From 40 years old to 70 years old
Gender
Both
Phase
4
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
A total of 30 patients will be randomly assigned into two groups of 15 participants each: the Extracorporeal Shockwave Therapy (ESWT) group and the Pulsed Ultrasound (PUS) group. Both groups will receive treatment 3 sessions per week. Randomization will be performed using a simple randomization method with sealed, opaque envelopes describing the treatment groups. In the first step, the name of each intervention will be written on 15 papers (equal to the sample size of each group) and placed in sealed envelopes. The envelopes will then be mixed, and at the first treatment session, the therapist will draw one envelope randomly to determine the participant’s assigned group and initiate the treatment accordingly.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study is a single-blinded randomized controlled trial. Due to the nature of the physiotherapy interventions, blinding of the therapist and participants is not possible. However, the outcome assessor is blinded to group allocation. All assessments are performed by an independent assessor who is not involved in treatment and is unaware of the intervention received by participants. Randomization and allocation concealment are performed to minimize assessment bias.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
School of Nursing and Midwifery & Rehabilitation - Tehran University of Medical Sciences
Street address
Mirkhani st.(East Nosrat), Tohid Sq. Tehran
City
Tehran
Province
Tehran
Postal code
1419733171
Approval date
2026-08-19, 1405/05/28
Ethics committee reference number
IR.TUMS.FNM.REC.1405.092
Health conditions studied
1
Description of health condition studied
lower limb spasticity after stroke
ICD-10 code
G81.1
ICD-10 code description
Spastic hemiplegia
Primary outcomes
1
Description
severity of spasticity assessed using the MMAS
Timepoint
Primary outcome will be measured at baseline before treatment (T0), immediately after the third treatment session (T1), one week after treatment completion (T2), and one month after treatment completion (T3).
Method of measurement
The patient will be positioned in supine lying with the lower limbs extended, the head in midline, and the upper limbs resting alongside the trunk. The examiner will stand on the side being tested, placing one hand under the ball of the foot and the other hand stabilizing the limb around the ankle joint. The ankle joint will then be moved from maximum plantar flexion into maximum possible dorsiflexion within approximately one second. The severity of spasticity will be scored from 0 to 4 based on the resistance encountered during passive movement of the ankle plantar flexor muscles, according to the MMAS criteria
2
Description
ankle dorsiflexion range of motion (ROM)
Timepoint
Primary outcome will be measured at baseline before treatment (T0), immediately after the third treatment session (T1), one week after treatment completion (T2), and one month after treatment completion (T3).
Method of measurement
A standard ankle goniometer will be used to assess dorsiflexion range of motion. The patient will be positioned supine with the knee extended and the ankle in a neutral resting position. The fixed arm of the goniometer will be aligned with the longitudinal axis of the leg, while the movable arm will be positioned along the sole of the affected foot. To measure active dorsiflexion, the patient will be instructed to dorsiflex the ankle as far as possible. The same procedure will be used to measure passive ankle dorsiflexion range of motion, except that the physiotherapist will move the ankle through the available range instead of the patient actively performing the movement.
3
Description
Functional outcome.Timed Up and Go (TUG).
Timepoint
Primary outcome will be measured at baseline before treatment (T0), immediately after the third treatment session (T1), one week after treatment completion (T2), and one month after treatment completion (T3).
Method of measurement
1. The participant begins seated in the chair, wearing regular footwear and using their usual walking aid if needed.2. On the command Go the participant stands up and walks at a safe, comfortable pace toward the 3-meter mark.3. After reaching the mark, the participant turns around, walks back to the chair, and sits down.4. Timing: Start the stopwatch on the word Go and stop it when the participant’s buttocks make contact with the seat.
4
Description
Neurophysiological outcomes.H reflex recording:
Timepoint
Primary outcome will be measured at baseline before treatment (T0), immediately after the third treatment session (T1), one week after treatment completion (T2), and one month after treatment completion (T3).
Method of measurement
The electromyography machine will be used to evaluate the maximal H-reflex, the maximal M-wave, and the H-reflex latency. The patient is placed in a prone position with feet off the table. bipolar recording electrodes will be placed on the apex of the triangle formed by the soleus muscle, and the stimulating electrode will be placed 4-5 cm distal from this electrode and will stimulate the posterior tibial nerve in the popliteal fossa. The electromyography (EMG) machine will be set with the band-pass filter at 5 Hz to 3 kHz, sweep speed at 5 msec/div and sensitivity at 500 µV-2 mV/div.
Secondary outcomes
1
Description
passive plantar flexion torque
Timepoint
Primary outcome will be measured at baseline before treatment (T0), immediately after the third treatment session (T1), one week after treatment completion (T2), and one month after treatment completion (T3)
Method of measurement
use a hand-held dynamometer to assess passive plantar flexor torque. The center of the sensitive pad of the dynamometer will be placed on the center of the metatarsal arch in alignment with the head of the third metatarsal, and a fast passive ankle dorsiflexion will be performed. The torque will be assessed. The maximum force obtained will be multiplied by the distance from the third metatarsal head to the ankle joint axis to calculate the maximum torque. Reliability and validity of ankle dynamometry have been confirmed in patients with spasticity
Intervention groups
1
Description
Shock wave group patients will receive 3 sessions of radial extracorporeal shock wave therapy (rESWT)(33, 34) (energy: 60 mJ) with a head applicator 15 mm, 2000 shots, frequency 5 Hz, energy density of 60mj (1 bar), energy applied 0.340 mJ/mm²on myotendinous junction and mid portion of gastrocnemius muscle belly.
Category
Treatment - Devices
2
Description
Intervention group: Ultrasound group . patients will receive 3 sessions of pulsed ultrasound on = 1 ms, off = 9 ms; Duty cycle = 10%) with the following protocol: frequency 1 MHz, intensity 1.5 W/cm², Area of applicator: 5 cm², duration 10 minutes) on the gastrocnemius muscle belly
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
the Physical Therapy Departments of Imam Al HusseinTeaching Hospital
Full name of responsible person
Hussein abdul razzaq Jabbar
Street address
Almulhak street , Karbala , Iraq
City
karbala
Postal code
1332337950
Phone
+964 771 442 5820
Email
husseinsarafei@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ramin Kordi
Street address
Number 21, Dameshgh St., Vali-e Asr Ave., Tehran
City
Tehran
Province
Tehran
Postal code
1416753955
Phone
+98 21 8889 6690
Email
Gsia@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
Sponsor: country of origin
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
center for hereditary blood diseases
Full name of responsible person
Hussein abdul razzaq jabbar
Position
karbala
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
karbala .teachers quarter
City
karbala
Province
karbala
Postal code
3292572210
Phone
+964 771 442 5820
Fax
Email
husseinsarafei@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Noureddin Nakhostin Ansari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Piche Shemiran, Enghelab Ave.,Tehran
City
tehran
Province
Tehran
Postal code
1148965111
Phone
+98 21 7753 5132
Email
nakhostin@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hussein abdul razzaq jabbar
Position
tehran
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Muktari, Haderi aram No 2
City
tehran
Province
Tehran
Postal code
1148965111
Phone
009647714425820
Email
husseinsarafei@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available