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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202607530995553 Date of Registration: 24/07/2026
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Shoulder Exercise Program to Improve Hand Function After Flexor Tendon Repair
Official scientific title Effect of Proximal Kinetic Chain Training on Upper Extremity Functional Recovery Following Flexor Tendon Repair: A Randomized Controlled Trial
Brief summary describing the background and objectives of the trial Flexor tendon injuries often result in persistent limitations in hand function despite advances in surgical repair and conventional rehabilitation. Current rehabilitation protocols primarily focus on tendon healing, range of motion, and hand strengthening, while the potential contribution of the proximal upper-extremity kinetic chain to functional recovery has received limited attention. This randomized controlled trial aims to investigate whether adding a structured proximal kinetic chain training program to conventional postoperative rehabilitation improves upper-extremity functional recovery following flexor tendon repair. Forty-two participants will be randomly assigned to either a conventional rehabilitation group or a conventional rehabilitation plus proximal kinetic chain training group. Outcome measures include patient-reported hand function, total active motion, grip strength, and manual dexterity. The findings of this study may provide evidence for integrating proximal kinetic chain training into standard rehabilitation protocols following flexor tendon repair.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Orthopaedics,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Rehabilitation
Anticipated trial start date 05/07/2026
Actual trial start date 20/07/2026
Anticipated date of last follow up 30/11/2026
Actual Last follow-up date 10/12/2026
Anticipated target sample size (number of participants) 46
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
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Proximal Kinetic Chain Training plus Conventional Rehabilitation Two supervised sessions per week for 12 weeks in addition to a standardized home exercise program 12 weeks Participants received a standardized postoperative rehabilitation program following flexor tendon repair together with a structured proximal kinetic chain training program. The intervention included progressive strengthening exercises targeting the scapular stabilizers, rotator cuff muscles, and shoulder musculature in addition to conventional hand rehabilitation consisting of edema management, scar management, tendon gliding exercises, protected active mobilization, progressive range-of-motion exercises, and strengthening according to the stage of tendon healing. 23
Control Group Conventional Rehabilitation Two supervised sessions per week 12 weeks Participants received the standard postoperative rehabilitation program following flexor tendon repair, including edema management, scar management, tendon gliding exercises, protected active mobilization, progressive range-of-motion exercises, and strengthening according to the stage of tendon healing. 23 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adults aged 18–55 years. Patients with surgically repaired flexor tendon injuries of the hand. Normal shoulder joint condition at the time of enrollment. Ability to understand and follow study instructions. Associated fractures requiring prolonged immobilization. Peripheral nerve injuries affecting upper-extremity function. Associated shoulder fractures or shoulder joint dislocations. Severe soft tissue loss. Finger or distal phalanx amputation. Missing three or more scheduled treatment sessions. Any neurological or musculoskeletal disorder affecting upper-extremity function. Adult: 18 Year(s)-44 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 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 23/05/2026 Deraya scientific research office
Ethics Committee Address
Street address City Postal code Country
Deraya University, New Minia Minia 16283 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Patient-reported hand function assessed using the Arabic version of the Functional Index for Hand Osteoarthritis (FIHOA). Baseline and Week 12
Secondary Outcome Grip strength measured using a calibrated hand dynamometer. Baseline and Week 12
Secondary Outcome Total Active Motion (TAM) measured according to the American Society for Surgery of the Hand (ASSH) guidelines. Baseline and 12 weeks
Secondary Outcome Manual dexterity assessed using the Box and Block Test (BBT). Baseline and 12 weeks
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Assiut University Assiut st Assiut 12008 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Alaaeldin Khaireldin Assiut st Assiut Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Deraya University Minia Minia Egypt University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Alaaeldin Khaireldin alaa.khaireldin@giu-uni.de 00201111093600 Al-Ahram st
City Postal code Country Position/Affiliation
Benha 13511 Egypt Associate professor
Role Name Email Phone Street address
Public Enquiries Ahmed Aref Ahmed.aref@deraya.edu.eg 00201126039391 benha
City Postal code Country Position/Affiliation
benha Egypt associate professor
Role Name Email Phone Street address
Scientific Enquiries Alaaeldin Khaireldin alaa.khaireldin@giu-uni.de 00201111093600 benha
City Postal code Country Position/Affiliation
benha Egypt Associate professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes De-identified individual participant data underlying the reported results will be available upon reasonable request to the corresponding author. Study Protocol Data will be available beginning 6 months after publication and will remain available for 5 years Access will be granted to qualified researchers who submit a methodologically sound research proposal. Data will be shared after approval by the corresponding author and the research team, subject to institutional and ethical requirements.
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
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 11/07/2026 The title in the ethical approval letter is the official title of a Master's thesis under my supervision, which had already been approved and registered by the Faculty Council before the clinical trial registration. The registered protocol title was selected to reflect the conceptual framework of the intervention, whereas the thesis title describes the specific therapeutic intervention implemented in the study (proximal shoulder muscle strengthening). Both titles refer to the same study, and there have been been no changes to the study objectives, intervention, methodology, outcome measures, or study design. The difference is limited to the wording of the title only and does not represent any modification to the registered protocol. Effect of Proximal Kinetic Chain Training on Upper Extremity Functional Recovery Following Flexor Tendon Repair: A Randomized Controlled Triشم Effect of Proximal Kinetic Chain Training on Upper Extremity Functional Recovery Following Flexor Tendon Repair: A Randomized Controlled Trial
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 11/07/2026 to match the sample size Experimental Group, Proximal Kinetic Chain Training plus Conventional Rehabilitation, Two supervised sessions per week for 12 weeks in addition to a standardized home exercise program, 12 weeks, Participants received a standardized postoperative rehabilitation program following flexor tendon repair together with a structured proximal kinetic chain training program. The intervention included progressive strengthening exercises targeting the scapular stabilizers, rotator cuff muscles, and shoulder musculature in addition to conventional hand rehabilitation consisting of edema management, scar management, tendon gliding exercises, protected active mobilization, progressive range-of-motion exercises, and strengthening according to the stage of tendon healing., 23,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 11/07/2026 to match the sample size Control Group, Conventional Rehabilitation, Two supervised sessions per week, 12 weeks, Participants received the standard postoperative rehabilitation program following flexor tendon repair, including edema management, scar management, tendon gliding exercises, protected active mobilization, progressive range-of-motion exercises, and strengthening according to the stage of tendon healing., 23, Active-Treatment of Control Group
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 11/07/2026 to complete the data no external funding , NA, NA, , Egypt, Self Funded, no external funding , NA, Banha, , Egypt, Self Funded,
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 18/07/2026 to complete the data no external funding , NA, Banha, , Egypt, Self Funded, Alaaeldin Khaireldin, Assiut st, Assiut , , Egypt, Self Funded,