Controlled Active Motion vs Early Passive Mobilization for Flexor Tendons Repair

NCT ID: NCT06420648

Last Updated: 2024-06-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-04
• Study Completion Date: 2024-12-30

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.

Conditions

Flexor Tendon Rupture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Early passive mobilization group

The modified Kleinert protocol will be used as an EPM procedure. Within 3 to 5 days following surgery, the affected hand will be placed inside the dorsal slab Kleinert splint with the wrist in 30-40 flexion; metacarpophalangeal joint (MP) in 60-70-degree flexion; PIP and DIP joints in extension. Rubber band traction will be directed to the fingernail from the wrist, with a palmar pulley system. All patients will perform passive flexion and active extension exercises with an active hold for 2-3 seconds 10 times per hour. Traction will be removed at the end of 3rd week and very gentle active flexion will start at the 4th week. The splint will be removed in the 5th-6th weeks. Blocking exercises will be started at 7th-8th weeks and resisted exercises will be started after the 8th week with the full function permitted by week 12th week .

Group Type: EXPERIMENTAL

Early passive mobilization

Intervention Type: OTHER

a rehabilitation protocol for post-surgical repair of flexor tendons of the hand

Controlled active motion group

A modified CAM protocol will be used. Exercises will be performed hourly for 10 repetitions in the form of passive flexion and active extension exercises with an active hold of the fingers in the flexed position for 2-3 seconds.

Group Type: EXPERIMENTAL

Controlled active motion

Intervention Type: OTHER

a rehabilitation protocol for post-surgical repair of flexor tendons of the hand

Interventions

Early passive mobilization

a rehabilitation protocol for post-surgical repair of flexor tendons of the hand

Intervention Type: OTHER

Controlled active motion

a rehabilitation protocol for post-surgical repair of flexor tendons of the hand

Intervention Type: OTHER

Other Intervention Names

modified Kleinert protocol

Eligibility 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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Hail

OTHER

Sponsor Role: lead

Responsible Party

Hisham Mohamed Hussein

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hail University Poly Clinic

Hail, , Saudi Arabia

Site Status: RECRUITING

Hisham Hussein

Hail, , Saudi Arabia

Site Status: RECRUITING

Countries

Saudi Arabia

Facility Contacts

Hisham Hussein

Role: primary

hm.hussein@uoh.edu.sa

0543704108

Hisham Hussein

Role: primary

hm.hussein@uoh.edu.sa

0543704108

Other Identifiers

H-2024- 366

Identifier Type: -

Identifier Source: org_study_id