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.: PACTR202407725870510 Date of Approval: 12/07/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of plyometric exercises of lower limb on strength, postural control, and risk of falling in stroke patients
Official scientific title Effect of plyometric exercises of lower limb on strength, postural control, and risk of falling in stroke patients
Brief summary describing the background and objectives of the trial Background: Stroke patients not only suffer from the first neural insult, but also from the Musculo-skeletal complications that follow this insult because of spasticity, muscle weakness, and joint stiffness. These complications result in abnormal postural control, high risk of falling. Plyometric exercises have been used mainly among athletes. However, application of these exercises for both lower limbs (affected and non affected) in stroke patients to mange these complications and their consequences has not been illustrated yet. Purpose: To determine the Effect of Plyometric Exercises of affected and less affected lower limb on strength, Postural Control, and Risk of Falling 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 10/01/2024
Actual trial start date 10/01/2024
Anticipated date of last follow up 05/08/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 20
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,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Study group A Three times per week For eight weeks For 60 minutes each sessions : 40 minutes plyometric exercises followed by 20 minutes of selected physical therapy program Plyometric exercises for both lower limbs affected and non-affected including step up over a box forward and sideward, Marching over a foam pad , and forward jumping in addition to selected physical therapy program 20
Control Group Study group B Three times per week for eight weeks For 60 Minutes each sessions for 8 weeks Selected physical therapy program including range of motion exercises, stretching, strengthening exercises , balancing exercises and gait training 20 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients suffered a stroke for the first time. Patients with hemiplegia duration more than six months. Patient’s age ranging from 40-65 years. Patients with grade 1 and+1 on modified ashworth scale . Body mass index of patients from 18 to 30 Patient walks independently Patients of both sex Right-handed patients. The patients will be excluded if they have any of the followings: -Severe Cognitive Impairment: Excluding individuals with severe cognitive impairments or communication difficulties that would hinder their ability to understand and follow instructions during the plyometric exercise interventions or assessments. -Severe Musculoskeletal Conditions: Excluding individuals with severe musculoskeletal conditions or injuries that would limit their ability to perform plyometric exercises safely as severe osteoarthritis of lower extremity joints -Other Neurological Conditions: Excluding individuals with other significant neurological conditions, such as Parkinson's disease or multiple sclerosis -Patients with recurrent stroke Middle Aged: 45 Year(s)-64 Year(s) 40 Year(s) 65 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 07/11/2023 Ethical committee of Faculty of physical therapy. Cairo university
Ethics Committee Address
Street address City Postal code Country
11 Ahmed El-Zayat street , Dokki Giza 12612 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Lower limb Hip extensors and abductors, and knee extensors strength by Hand held dynamometer pre intervention and after six weeks post intervention
Primary Outcome Postural control measured by Biodex Balance System pre intervention and after six weeks post intervention
Secondary Outcome Risk of falling by Biodex balance system pre intervention and after six weeks post intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Outpatients clinics of Faculty of Physical Therapy 11 Ahmed El-Zayat street , Dokki Giza 12612 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculty of physical therapy Cairo university 11 Ahmed El-Zayat street , Dokki Giza 12612 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of physical therapy 11 Ahmed El-Zayat street , Dokki Giza 12612 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed Kamel Abd Elsabour Abd Elsabour Ahmedmahmoud.1995888@Gmail.com 00201013920126 Beni Suef Qusm
City Postal code Country Position/Affiliation
Beni Suef Egypt Teaching assistant at faculty of physical therapy at Beni Suef University
Role Name Email Phone Street address
Public Enquiries Hoda Mohamed Zakria alsaid_mostafa@pt.cu.edu.eg 00201013107750 11 Ahmed El-Zayat street , Dokki
City Postal code Country Position/Affiliation
Giza Egypt Professor of Physical therapy. Faculty of Physical therapy Cairo university
Role Name Email Phone Street address
Scientific Enquiries Ebtesam Mohamed Fahmy em_fahmy@kasralainy.edu.eg 00201002007077 11 Ahmed El-Zayat Street , Dokki
City Postal code Country Position/Affiliation
Giza Egypt Professor of neurology at al aksr al ainy Cairo university
Role Name Email Phone Street address
Scientific Enquiries Shreen Ibrahim Sleim shreen_taha@pt.bsu.edu.eg 00201016167521 Qism Bani Sweif, Beni Suef, Beni Suef Governorate
City Postal code Country Position/Affiliation
Beni Suef Egypt Assistant Professor Faculty of Physical therapy Beni Suef university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of Individual Participant Data (IPD) collected during the trial , After deidentification will be shared for research purposes only Informed Consent Form Data requests can be submitted starting 9 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