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.: PACTR202211899755437 Date of Approval: 02/11/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of shoulder stabilization exercises in rehabilitation of post-operative hand injuries patients
Official scientific title Effect of shoulder stabilization exercises in rehabilitation of post-operative hand injuries patients
Brief summary describing the background and objectives of the trial Hand injury is one of the important causes of loss of function for the young adults. The rehabilitation after an injury can be achieved with a timely and appropriately applied surgical treatment. The main goal of the rehabilitation of an injured hand is to achieve the most functioning hand. Postoperative rehabilitation includes brief immobilization while the pain and swelling diminish. The main goals of the rehabilitation programs usually focus on increasing the range of motion (ROM) and strengthening of the fingers, the hand, and the wrist. In our study we believe in the importance of kinetic chain of the upper limb in performing ADLs, so the main purpose of this study is to compare between the effects of hand, wrist and forearm and the hand, wrist, forearm and shoulder training exercises on pain severity and functional performance in the traumatic hand patients. Key words; hand, trauma, pain, exercises, wrist, shoulder, function.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Injury, Occupational Diseases, Poisoning,Musculoskeletal Diseases,Orthopaedics,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 28/04/2022
Actual trial start date
Anticipated date of last follow up 28/07/2022
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
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 GROUP A 12 SESSIONS EACH OTHER DAY 3 SESSIONS PER WEEK EACH SESSION LASTS FOR 40 MINUTES 40 MINUTES physical therapy and therapeutic exercises, every therapy session took 30 minutes 3 times weekly for one month. The therapeutic exercises will be passive, active-assistive, and active ROM and strengthening exercises for hand, wrist, and forearm 20
Control Group GROUP B 12 SESSIONS EACH OTHER DAY 3 SESSIONS PER WEEK EACH SESSION LASTS FOR 40 MINUTES 40 MINUTES physical therapy and the same exercise program with group A plus shoulder training exercises. 20 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Patients who had bone, tendon, or peripheral nerve injury in the hand or wrist with impaired hand function 2. Referred to physical therapy management immediately after injury. 3. Age ranges from 25 to 35 years 1. Bilateral injury 2. Brachial plexus lesion 3. Shoulder or elbow problems 4. Rheumatologic diseases involving the hand 5. Complex regional pain syndrome 6. Solely ring and small finger lesions 7. Burned hands Adult: 19 Year-44 Year 25 Year(s) 35 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
No 28/04/2022 faculty of physical therapy cairo university ethical committee
Ethics Committee Address
Street address City Postal code Country
7 ahmed elziat st. Giza 12612 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome the grip strength, a dynamometer (Jamar, Jackson, MI) will be used before and after treatment
Primary Outcome The range of opposition will be evaluated by measuring the distance between the pulps of the 1stand the 5th fingers. before and after treatment
Primary Outcome The range of abduction will be calculated as the sum of the distances between the pulps of the fingers except for the 1st. Finger pulp– distal palmar crease distance will be measured by refer-ring the 3rd finger; if the ROM limitations differed among fingers, then all of the FP-DPC distances will be measured and the mean values will be used. before and after treatment
Secondary Outcome QUICK DASH before and after treatment
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Cairo university 7 ahmed elziat st Giza 12612 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
ehab ali abdallah 7 - ahmed elziat st Giza 12612 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor Cairo university 7 - ahmed elziat Giza 12612 Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ehab Abdallah aliehab93@gmail.com 01223674916 7 - ahmed elziat st
City Postal code Country Position/Affiliation
Giza 12612 Egypt lecturer at horus university
Role Name Email Phone Street address
Public Enquiries hanan afify ananafify@yahoo.com 01119090772 7 - ahmed elziat st
City Postal code Country Position/Affiliation
Giza 12612 Egypt specialist qwesna hospital
Role Name Email Phone Street address
Scientific Enquiries Mahmoud Diab Dr.mahmoud_diab@yahoo.com 01119092772 7 ahmed elziat st
City Postal code Country Position/Affiliation
Giza 12612 Egypt Lecturer of physical therapy cairo university
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol 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