Comparison of Early Passive and Active Mobilization Protocols in Flexor Tendon Repair Rehabilitation of the Hand

NCT05598918 | Completed

• 1 other identifier: 09.2021.118
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Many active and passive rehabilitation programs are applied in the rehabilitation processes after flexor tendon repair. There is no clear rehabilitation program accepted by the whole world. An accurate understanding of these injuries at the histological and biomechanical level is necessary to improve rehabilitation outcomes. Mechanical properties of tendons, such as their viscoelasticity, are affected by the increase in stiffness caused by the rupture, repair, and healing process. Previous studies have shown that the mechanical properties of a repaired tendon, such as stiffness, material properties and functionality of tendon tissue Shear-wave elastography can detect pathological changes in tendinopathy before they are visible on conventional Ultrasonography imaging. In addition, shear wave elastography allows the evaluation of quantitative measurements and is considered more objective because it provides reproducible results. Our aim in this study is to evaluate the changes in the mechanical properties of the hand flexor tendons repaired using shear wave elastography (SWE) during the rehabilitation process and natural process and their effect on functionality.

Conditions

Tendon Injuries

Outcome Measures

Primary Outcomes (4)

• tendon stiffness level tendon stiffness level tendon stiffness level tendon stiffness level tendon stiffness level

  Shear wave velocity, measured in metres per second, was recorded using shear wave elastography.

  T0 : Patients were evaluated on postoperative 5-7 days.

• tendon stiffness level tendon stiffness level tendon stiffness level tendon stiffness level tendon stiffness level

  Shear wave velocity, measured in metres per second, was recorded using shear wave elastography.

  T1 : Patients were evaluated on postoperative 3 weeks.

• tendon stiffness level tendon stiffness level tendon stiffness level tendon stiffness level tendon stiffness level

  Shear wave velocity, measured in metres per second, was recorded using shear wave elastography.

  T2 : Patients were evaluated on postoperative 8 weeks.

• tendon stiffness level tendon stiffness level tendon stiffness level tendon stiffness level tendon stiffness level

  Shear wave velocity, measured in metres per second, was recorded using shear wave elastography.

  T3 : Patients were evaluated on postoperative 12 weeks.

Secondary Outcomes (4)

• Handgrip strength

  T0: Patients are evaluated on postoperative 12 weeks.

• Pinch grip strength

  T0: Patients are evaluated on postoperative 12 weeks.

• Range of motion

  T0: Patients are evaluated on postoperative 12 weeks.

• Functionality

  T0: Patients are evaluated on postoperative 12 weeks.

Study Arms (2)

early passive mobilization

EXPERIMENTAL

ıt will begin to using an orthosis with 30\* flexion of the wrist,70\* flexion of metacarpophalangeal (MCP) joints,full extension of IF joints.Home exercises will be performed as passive flexion and active extension exercises with rubber band 10 times per hour on postoperative 3rd day for 3 weeks.Passive flexion and extension exercises will be performed ten times a day;four times a day on MCP+PIP+IF joints.3 weeks after repair and non-resistance active movement and tenodesis exercises will be started in presence of a physiotherapist.From the 6th week tendon gliding exercises and blocking exercises will be started.

Procedure: early passive mobilization

early active mobilization

EXPERIMENTAL

ıt will begin to using an orthosis that positions wrist in neutral position,MCP joints 50\*-70\* flexion,IF joints in full extension.After flexion active extension exercises,full passive flexion of fingers with the other intact hand and then keeping fingers in flexion position for 3-5 sec for 3 weeks.Rehabilitation program applied from 3rd week is the same as the passive group:3 weeks after repair and non-resistance active movement and tenodesis exercises will be started in presence of a physiotherapist.From the 6th week tendon gliding exercises and blocking exercises will be started.

Procedure: early active mobilization

Interventions

early active mobilization PROCEDURE

In the active rehabilitation group, active extension and passive flexion of the metacarpophalangeal, proximal interphalangeal and distal interphalangeal joints were performed with kleinert splint at angles suitable for active mobilization group.Then, the patients were asked to passively flex the injured side with their healthy hand and hold it in the flexion position for 3-5 seconds.

early active mobilization

early passive mobilization PROCEDURE

In the passive rehabilitation group, active extension and passive flexion of the metacarpophalangeal, proximal interphalangeal and distal interphalangeal joints were performed with kleinert splint at angles suitable for passive mobilization group.

early passive mobilization

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Forty patients aged 18-75 years who had flexor tendon injury and underwent primary surgical repair (within the first 10 days after injury) will be included in the study

You may not qualify if:

• Patients with a history of previous hand trauma, neurological or systemic disease affecting the hand, patients with a history of upper extremity surgery, concomitant extensor tendon injury, fracture and amputation will be excluded from the study.

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

Marmara University

Istanbul, İ̇stanbul (asya), 34000, Turkey (Türkiye)

Location

Related Publications (1)

• Demirci M, Temiz Erguden FH, Sahbat Y, Bugdayci O, Baysal O, Sanal C. Active versus passive rehabilitation after flexor tendon repair: clinical outcomes and shear wave elastography monitoring in a randomized pilot study. Arch Orthop Trauma Surg. 2026 Jan 7;146(1):29. doi: 10.1007/s00402-025-06172-5.

  PMID: 41498969 DERIVED

MeSH Terms

Conditions

Tendon Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The patients were randomized into two groups as active and passive rehabilitation groups by computer program. Patients, shear wave elastography practitioner and data evaluator were blinded to the treatment administered to the patient.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The patients were divided into two groups as early active and passive mobilization groups. The angles of the dorsal orthoses of the active and passive groups were different. In the home exercise program in the active group, in addition to the exercises in the passive group, flexion was continued for 3-5 seconds at the end of passive flexion. The rehabilitation program was similar apart from these distinctions.

Study Record Dates

• First Submitted: August 3, 2022
• First Posted: October 28, 2022
• Study Start: April 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: February 8, 2023

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)