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.: PACTR202403745485949 Date of Approval: 28/03/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of extracorporeal shock wave therapy on gait and risk of falling in patients with stroke: A randomized controlled trial
Official scientific title Effect of extracorporeal shock wave therapy on gait and risk of falling in patients with stroke: A randomized controlled trial
Brief summary describing the background and objectives of the trial Patients with stroke are more likely to be at risk of falling, which lead to limitation in their abilities to perform daily living activities and participation in society. Falling is due to a decline in gait ability resulting from ankle planter flexors spasticity. The aim of this research is to investigate the effect of extracorporeal shock wave therapy on spatiotemporal gait parameters and risk of falling in patients with stroke
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nervous System Diseases,Stroke
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 15/02/2023
Actual trial start date 20/02/2023
Anticipated date of last follow up 20/05/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 44
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
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
Experimental Group extracorporeal shock wave therapy one session per week for six weeks Focused extracorporeal shock wave therapy device (Optimus, Salus Talent 3, Seongnam-si, Korea) was used to apply shock waves to the triceps surae muscle in this study. The shock waves applied to the experimental groups had a frequency of 2 Hz, an energy density of 0.1 mJ/mm2, and a total of 6000 pulses per treatment session 22
Control Group Conventional exercises three sessions per week for six weeks Stretching, strengthening, gait training, task-orient approach 22 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The duration of illness will range from to six months to one year. • Patients 's age will range from 45 to 55 years. • The muscle tone of ankle planter flexors will range from 1+ to 2 according to Modified Ashworth Scale. • They will have sufficient cognition demonstrating to understand the requirements of the study. • All patients will be medically and psychologically stable. Patients who had a cognitive impairment • Patients who had other neurological disorders affecting gait ability. • Patients who had other orthopedic disorders affecting gait ability. • Patients had deformities of lower limb especially ankle. • Patients had impairment of deep sensation. • Patients had visual and perceptual dysfunctions. Middle Aged: 45 Year(s)-64 Year(s) 45 Year(s) 55 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 14/02/2023 Ethical committee office faculty of physical therapy Cairo University
Ethics Committee Address
Street address City Postal code Country
11 ahmed el zayat Giza 12612 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Gait spatio-temporal parameters using Biodex gait trainer pre and post intervention
Primary Outcome H M ratio by nerve conduction study pre and post intervention
Secondary Outcome Balance by Berg balance scale pre and post intervention
Secondary Outcome Morse fall scale for assessment of risk of fall pre and post intervention
Secondary Outcome 10 meter walk test to assess speed of walking pre and post intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Out patients clinics of faculty of physical therapy and al kasr al ainy medical school 11 ahmed el zayat st dokki giza Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Cairo University 11 ahmed el zayat dokki giza12612 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of physical therapy Cairo University 11 Ahmed el-zayat St. Dokki Giza 12612 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Nagwa Rehab Nagwa1102010@yahoo.com +201008124920 11 ahmed el-zayat St.
City Postal code Country Position/Affiliation
Giza Egypt Assistant Professor Department of Physical Therapy for Neurology Faculty of Physical Therapy Cairo University
Role Name Email Phone Street address
Public Enquiries Shimaa Abdelmageed dr_shimaaa@yahoo.com +201028202856 11 ahmed el-zayat
City Postal code Country Position/Affiliation
Giza Egypt Assistant Professor Department of Physical Therapy for Neurology Faculty of Physical Therapy Cairo University
Role Name Email Phone Street address
Scientific Enquiries Noura Elkafrawy noura.elkafrawy@pt.cu.edu.eg +201066366879 11 Ahmed El-zayat
City Postal code Country Position/Affiliation
Giza Egypt Lecturer Department of Physical Therapy for Neurology Faculty of Physical Therapy Cairo University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of Individual participant data collected during the trial, after deidentification will be shared for research purposes only. Informed Consent Form Data requests can be submitted starting 8 months after article publication and the data will be made accessible for up to 24 months only researchers in the project can see the data
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information