Comparing two rehabilitation methods for flexor tendon repair
A Randomized Controlled Trial Comparing Controlled Active Motion and Early Passive Mobilization Protocols for Rehabilitation of Repaired Flexor Tendons in Zone II
This study is testing which rehabilitation method, early passive mobilization or controlled active motion, helps people recover better after surgery for flexor tendon injuries in their hands.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 25 Years to 50 Years |
| Sex | All |
| Sponsor | University of Hail Academic / other |
| Locations | 2 sites (Ha'il and 1 other locations) |
| Trial ID | NCT06420648 on ClinicalTrials.gov |
What this trial studies
This clinical trial compares two rehabilitation approaches for patients who have undergone surgical repair of flexor tendons in the hand: early passive mobilization (EPM) and controlled active motion (CAM). Participants will be randomly assigned to one of the two treatment groups and assessed at baseline, 6 weeks, and 12 weeks post-intervention. The study aims to determine which method is more effective in improving total active motion and grip strength, as well as reducing disability levels. The findings could help clarify the best rehabilitation strategy for this common surgical procedure.
Who should consider this trial
Good fit: Ideal candidates are males and females aged 25-50 who have recently undergone surgical repair of the flexor digitorum profundus and superficialis tendons.
Not a fit: Patients outside the age range of 25-50, those with systemic diseases affecting hand joints, or those with concurrent injuries will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved rehabilitation protocols for patients recovering from flexor tendon repair, enhancing their functional outcomes.
How similar studies have performed: Previous studies have shown varying results regarding rehabilitation approaches for flexor tendon repair, indicating that this comparison is both relevant and necessary.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * males or females * between 25-50 years * Post-surgical repair of the flexor digitorum profundus (FDP) and superficialis (FDS) tendons of a single-digit * the case should be recent (2-3 days post-surgical) Exclusion Criteria: * age below 25 or above 50 * a systemic disease affecting hand joints such as rheumatic arthritis * thumb flexor tendon repair will be excluded * chronic cases * concurrent injuries such as phalangeal fractures, joint injuries, or significant skin loss
Where this trial is running
Ha'il and 1 other locations
- Hail University Poly Clinic — Ha'il, Saudi Arabia (Recruiting)
- Hisham Hussein — Ha'il, Saudi Arabia (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.