Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202107600672683 Date of Approval: 07/07/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Radial Shock Wave in Treating Spasticity
Official scientific title Effect of Different Radial Shock Wave Therapy Protocols on Spasticity in Patients with Stroke
Brief summary describing the background and objectives of the trial Radial shock wave therapy (RSWT) is used to treat spasticity as well as a number of other medical conditions. The purpose of the study was to compare the therapeutic effect of introducing two different RSWT treatment protocols on reducing spasticity and increasing the range of motion of the upper limb in stroke patients
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nervous System Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 01/07/2021
Actual trial start date
Anticipated date of last follow up 31/12/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 40
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL https://www.clinicalschizophrenia.net/abstract/effect-of-different-radial-shock-wave-therapy-protocols-on-spasticity-in-patients-with-stroke-83869.html
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Group A 4 weeks Group A (agonist muscle stimulation) received Radial Shock Wave Therapy (RSWT) at wrist and elbow flexors muscles only, in addition to a traditional physical therapy program which consisted of proper positioning of the extremities, mobility training, range of motion exercises, balance training, and training of daily living activities. The traditional physical therapy program was given for 4 weeks, 3 sessions per week. 20 Active-Treatment of Control Group
Experimental Group Group B 4 weeks Group B (agonist-antagonist muscle stimulation) received Radial Shock Wave Therapy for both elbow and wrist flexors and extensors muscles respectively, in addition to the same traditional physical therapy program given for group A 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
patients suffered from unilateral stroke with hemiparesis for the first time, the duration of illness exceeded six months post-stroke, the grade of spasticity in the elbow and wrist flexors exceeding 1+ on the Modified Ashworth Scale, all patients were medically stable and had no cognitive disability that hinders in understanding the instructions or responding to the commands. To localize the lesion computed topography and/or magnetic resonance imaging were used. Patients were excluded if the affected upper extremity had severe orthopedic disease, joint contracture, surgical procedures, previous treatment of botulinum toxin or other medications used to reduce spasticity, or has any condition contraindicated for the use of radial shock wave. Middle Aged: 45 Year(s)-64 Year(s) 45 Year(s) 60 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 24/06/2020 Faculty of Physical Therapy Research Ethical committee
Ethics Committee Address
Street address City Postal code Country
El-Tahrir st. - in front of Ben El- Sarayat Traffic, Ad Doqi Giza 11432 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Spasticity of elbow and wrist flexors at the baseline and 4 weeks immediately after treatment
Secondary Outcome Passive range of motion of the elbow and wrist joints at the baseline and 4 weeks immediately after treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Shebin El Kom Teaching Hospital Gamal Abdel Nasser St. Shebin El Kom Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr. Khaled Fouda Gamal Abdelnasser St. Shebin El Kom Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Shebin El Kom Teaching Hospital Gamal Abdelnaser St. Shebin El Kom Egypt Hospital
Secondary Sponsor Faculty of Physical Therapy El-Tahrir st. - in front of Ben El- Sarayat Traffic, Ad Doqi Giza Egypt University
COLLABORATORS
Name Street address City Postal code Country
Dr. Waleed Talat Gamal Abdelnasser St. Shebin El Kom Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Khaled Fouda kzfouda2004@yahoo.com +966543321830 El-Tahrir st. - in front of Ben El- Sarayat Traffic, Ad Doqi
City Postal code Country Position/Affiliation
Giza Egypt Assistant Professor of Physical Therapy
Role Name Email Phone Street address
Public Enquiries Waleed Mansour waleed_talat73@yahoo.com +201005311168 El-Tahrir st. - in front of Ben El- Sarayat Traffic, Ad Doqi
City Postal code Country Position/Affiliation
Giza Egypt Professor of Physical Therapy
Role Name Email Phone Street address
Scientific Enquiries Wanees Alamir wanis_alamir@yahoo.com +201025656850 El-Tahrir st. - in front of Ben El- Sarayat Traffic, Ad Doqi
City Postal code Country Position/Affiliation
Giza Egypt Assistant Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The IPD will be shared including a summary of the results after the study completion date. Study Protocol The dead time for IPD will be 31 Dec. 2023 Shock wave therapy protocols, Spasticity, Stroke, Range of motion
URL Results Available Results Summary Result Posting Date First Journal Publication Date
https://www.clinicalschizophrenia.net/abstract/effect-of-different-radial-shock-wave-therapy-protocols-on-spasticity-in-patients-with-stroke-83869.html Yes 21/04/2022
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 21/04/2022
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information