Controlled Active Motion vs Early Passive Mobilization for Flexor Tendons Repair
- Conditions
- Flexor Tendon Rupture
- Registration Number
- NCT06420648
- Lead Sponsor
- University of Hail
- Brief Summary
a randomized controlled trial tends to compare 2 rehabilitation approaches - early passive mobilization (EPM) and controlled active motion (CAM) - that are commonly used in the treatment of post-surgical flexor tendon repair of the hand
- Detailed Description
a randomized controlled trial tends to compare 2 rehabilitation approaches commonly used in the treatment of post-surgical flexor tendon repair of the hand. in this study, the authors try to fill the gap in the literature regarding the more effective approach. the comparisons between both approaches were scarce in previous literature.
Participants will be randomly allocated to one of two treatment groups: early passive mobilization (EPM) using a modified Kleinert protocol or controlled active motion (CAM) using a modified Duran technique (n=20). Patients were assessed at baseline and then at the 6th and 12th weeks of interventions to quantify total active motion (TAM) of the proximal and distal interphalangeal joints using goniometry, and grip strength with dynamometry. the disability level will be assessed using the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 50
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Total active motion (TAM) after the 12th week of intervention This formula can determine the percentage of recovery of TAM. The results of TAM (%) are classified in four categories: "Excellent, good, fair, and poor" This formula determined the percentage of recovery of TAM. The results of TAM (%) were classified in four categories: "Excellent, good, fair, and poor"
handgrip strength after the 12th week of intervention Hand dynamometer (Jammer dynamometer) will be used to evaluate hand grip strength. Measurements will be taken for both hands for three times. The mean of three trials will be taken for every measurement occasion. The mean value in the injured hand will be expressed as percentage of the mean value in the non-injured hand as follows:
% of hand grip strength = Mean grip strength in the involved hand/ Mean grip strength in the uninvolved hand × 100.Functional disability after the 12th week of intervention The Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire will be used to measure the functional disabilities. It is a valid questionnaire used in a number of other disabling conditions of the hand. A DASH-questionnaire score, ranges from 0 to 100. A score of 0 means no difficulties in daily living and a score of 100 means maximum difficulties in performing tasks of daily living
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Hail University Poly Clinic
🇸🇦Hail, Saudi Arabia
Hisham Hussein
🇸🇦Hail, Saudi Arabia
Hail University Poly Clinic🇸🇦Hail, Saudi Arabia