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.: PACTR201802003028136 Date of Approval: 29/01/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Establishment of normative data-using Jebsen Taylor Hand Function Test (JHFT) for normal Egyptians in different ages
Official scientific title Establishment of normative data using Jebsen Taylor Hand Function Test (JHFT) for normal Egyptians in different ages
Brief summary describing the background and objectives of the trial The JHFT examines a broad range of hand function commonly used in activities of daily living and attempts to provide information on the impact of functional limitation. The purpose of this study is to 1- Investigate if there were differences between age groups in Egyptian population. 2-Investigate if gender differences would influence normative data. 3-Investigate if hand dominance would influence normative data.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Normal individals
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 20/02/2018
Actual trial start date
Anticipated date of last follow up 24/04/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 150
Actual target sample size (number of participants)
Recruitment status Not yet 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
Crossover: all participants receive all interventions in different sequence during study Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Jebsen Hand Function Test Single application, age group from 20-29 single application Seven subtests include: a) Writing a 24-letter, 3rd grade reading difficulty sentence b) Card turning c) Picking up small common objects (pennies, paper clips, bottle caps) and placing them in a container d) Stacking checkers e) Simulated feeding f) Moving light objects (empty cans) g) Moving heavy objects (weighted cans (1 lb) 50
Experimental Group Jebsen Hand Function Test Single application, age group from 30-39 single application Seven subtests include: a) Writing a 24-letter, 3rd grade reading difficulty sentence b) Card turning c) Picking up small common objects (pennies, paper clips, bottle caps) and placing them in a container d) Stacking checkers e) Simulated feeding f) Moving light objects (empty cans) g) Moving heavy objects (weighted cans (1 lb) 50
Experimental Group Jebsen Hand Function Test Single application, age group from 40-50 single application Seven subtests include: a) Writing a 24-letter, 3rd grade reading difficulty sentence b) Card turning c) Picking up small common objects (pennies, paper clips, bottle caps) and placing them in a container d) Stacking checkers e) Simulated feeding f) Moving light objects (empty cans) g) Moving heavy objects (weighted cans (1 lb) 50
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
¿ Normal upper extremity structures (based on general observation of the upper limbs - no amputees, missing digits). ¿ Full range of movement in all upper limb joints (assessed by asking the patient to complete all expected range of movements of the upper limb joints as part of the screening). ¿ adequate strength in the upper limbs (by manual muscle testing grade 5 ¿ subject will be asked if strength is a restriction in any current activity of daily living), ¿ unimpaired sensation ( sensation test; subjects were asked to close their eyes, stimulus presented to upper limb, subjects will be asked to accurately locate the stimulus while eyes remained closed), ¿ intact co-ordination (finger to nose test; clients being able to complete finger to nose test rhythmically and accurately), ¿ Coherent and able to answer questions asked, ability to read and write a sentence in English (subjects were asked if they had attended school and could write and read English). 1- Individuals with any form of previous injury to the upper limbs. 2- Not able to read and write an entire sentence in English. 3- Lack of coordination or any neurological condition that may affect upper extremity function. 20 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 16/10/2017 The Board Council of Higher Education of the School of Physical Therapy, Cairo university
Ethics Committee Address
Street address City Postal code Country
El-Tahrir st. - in front of Ben El- Sarayat traffic - Dokki - Giza, Giza, 11432 Cairo 11432 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Jebsen taylor hand function test Single application: The time taken to complete all tests will be measured using a stop watch
Secondary Outcome Jebsen taylor subtest hand function test single application: a- Subtest score = time (seconds) to complete task b- Max time allowed per subtest is 120 seconds c- Lower score = greater function
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
faculty of physical therapy Cairo University El-Tahrir st. - in front of Ben El- Sarayat Tra c - Dokki -Giza, Giza, 11432 Cairo 11432 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mary Kamal Nassif Takla El-Tahrir st. - in front of Ben El- Sarayat Tra c - Dokki -Giza, Giza, 11432 Cairo 11432 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor School of Physical Therapy, Cairo University El-Tahrir st. - in front of Ben El- Sarayat Tra c - Dokki -Giza, Giza, 11432 Cairo 11432 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Mary Kamal Nassif Takla El-Tahrir st. - in front of Ben El- Sarayat Tra c - Dokki -Giza, Giza, 11432 Cairo 11432 Egypt
Neveen Abd El-Latif El-Tahrir st. - in front of Ben El- Sarayat Tra c - Dokki -Giza, Giza, 11432 Cairo 11432 Egypt
ENAS ABDUL KHALIQ SAYED MAHMOUD El-Tahrir st. - in front of Ben El- Sarayat Tra c - Dokki -Giza, Giza, 11432 Cairo 11432 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mary Takla marynassif@pt.cu.edu.eg 00201222817512 El-Tahrir st. - in front of Ben El- Sarayat Traffic - Dokki -Giza, Giza, 11432
City Postal code Country Position/Affiliation
Cairo 11432 Egypt Assis Prof
Role Name Email Phone Street address
Public Enquiries Mary Takla marynassif@pt.cu.edu.eg 00201222817512 El-Tahrir st. - in front of Ben El- Sarayat Traffic - Dokki -Giza, Giza, 11432
City Postal code Country Position/Affiliation
Cairo 11432 Egypt Assis Prof
Role Name Email Phone Street address
Scientific Enquiries Mary Takla marynassif@pt.cu.edu.eg 00201222817512 El-Tahrir st. - in front of Ben El- Sarayat Traffic - Dokki -Giza, Giza, 11432
City Postal code Country Position/Affiliation
Cairo 11432 Egypt Assis Prof
REPORTING
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