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.: PACTR202306521966844 Date of Approval: 22/06/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Task-Oriented Approach on Functional Activity of Daily Living in Guillain Barre Syndrome
Official scientific title Effect of Task-Oriented Approach on Functional Activity of Daily Living in Guillain Barre Syndrome
Brief summary describing the background and objectives of the trial Background: In order for people with Guillain-Barre syndrome (GBS) to resume their independent daily lives as they did before the start of GBS, it is crucial to enhance their physical function. Objective: TO enhance Guillain-Barre syndrome patients' ability to carry out everyday activities, chest expansion, pain, and muscular strength. Activity demonstrates the diagnosis and treatment of Guillain-Barre syndrome and shows how the inter-professional team can help individuals with this illness receive better care. Task-oriented approach applies motor learning and motor control concepts, including rigorous training, varied practice, and intermittent feedback, in a highly personalized, client-centered rehabilitation strategy.
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 Task-Oriented Approach
Anticipated trial start date 01/10/2021
Actual trial start date 02/10/2021
Anticipated date of last follow up 01/09/2022
Actual Last follow-up date 29/09/2022
Anticipated target sample size (number of participants) 37
Actual target sample size (number of participants) 24
Recruitment status Closed to recruitment,follow-up continuing
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Traditional Physical Therapy program 60-minute sessions, three sessions per week a year Pain management, Range of motion exercises, Strengthing exercises, Stretching exercises 12 Active-Treatment of Control Group
Experimental Group Task Oriented Approach 60-minute sessions, three sessions per week a year respiratory exercises, rocker board training, sit-to-stand training, walking five steps, up and down stairs, gait training, and foam roller massage 12
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The ages of 18 and 50 A stable clinical condition Physical handicap in order to be eligible to enroll. Recruitment targeted those who have had the condition within six years. Pregnancy Amputation Physical therapy in the previous six months. Adult: 19 Year-44 Year 19 Year(s) 50 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 29/11/2022 Research Clinical Committee at Faculty of Physical Therapy Modern University for Technology and Information
Ethics Committee Address
Street address City Postal code Country
Elhadaba Elwosta, Mokatam Cairo 12566 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome functional independence baseline, after 6 months and after one year
Secondary Outcome Muscle strength, Fatigue, Pain, Quality of life, Chest expansion measurement Baseline, after 6 months and after one year
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Faculty of Physical Therapy Modern University for Technology and Information Elhadaba Elwosta, Mokatm Cairo Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Ahmed M Elshinnawy Fostat city, Old Egypt Cairo Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ahmed M. Elshinnawy Fostat city, Old Egypt Cairo Egypt Individual
Secondary Sponsor Zeezy S. Eraky Fostat City, Old Egypt Cairo Egypt Individual
Secondary Sponsor Ahmed Abd ElMoneim Abd ElHakim Elkanater Qalubya Egypt Individual
COLLABORATORS
Name Street address City Postal code Country
Zeezy S. Eraky Fostat City, Old Egypt Cairo Egypt
Ahmed Abd El Moneim Abd El Hakim Elkanatar Qalubya Egypt
Ahmed M. Elshinnawy Fostat city, Old Egypt Cairo Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ahmed M. Elshinnawy Dr.ahmed.m.elshinnawy@pt.mti.edu.eg 01092070555 Fostat city
City Postal code Country Position/Affiliation
Cairo Egypt Assistant Professor of Physical Therapy Department of Physical Therapy for Neuromuscular Disorders and its Surgery
Role Name Email Phone Street address
Public Enquiries Zeezy S. Eraky zeezyeraky@gmail.com 01003934051 Fostat City, Old Egypt
City Postal code Country Position/Affiliation
Cairo Egypt Lecturer of Physical Therapy Department of Physical Therapy for Internal Medicine and Elderly
Role Name Email Phone Street address
Scientific Enquiries Ahmed Abd ElMoneim Abd ElHakim dr.ahmedabdelmoneim85@gmail.com 01004896193 Elkanater
City Postal code Country Position/Affiliation
Qalubya Egypt Lecturer of Physical Therapy Department of Basic Sciences
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data obtained through this study may be provided to qualified researchers. Data or samples shared will be coded. Approval of the request and execution of all applicable agreements are prerequisites to sharing data with the requesting party. Statistical Analysis Plan,Study Protocol within one year open access
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