Effectiveness of Occupation-Based Exercise Program in Zone 2 Flexor Tendon Injuries

NCT ID: NCT07046416

Last Updated: 2025-07-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-31
• Study Completion Date: 2025-12-31

Brief Summary

Aim of the study is to evaluate the effects of a 4-week occupation-based exercise program given in addition to the conventional rehabilitation program on hand functions, range of motion, grip strength, pain and kinesiophobia in the post-operative rehabilitation of patients aged 18-65 years with zone 2 flexor tendon repair.

Expected results: To prove the effectiveness of occupation-based exercises in order to reduce the failure rates seen in the rehabilitation of zone 2 flexor tendon injuries, to increase patient compliance and motivation during the rehabilitation process, to improve functional outcomes by ensuring its inclusion in conventional treatment and to increase patient satisfaction.

Conditions

Tendon Injuries; Zone 2 Flexor Tendon Lacerations of the Hand

Study Design

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

Study Groups

Occupation-based exercise group

Group Type: EXPERIMENTAL

Occupation-Based Exercise Program

Intervention Type: OTHER

In the occupation-based exercise program, while trying to improve the range of motion and muscle strength of the hand, it is aimed to successfully return to daily life activities. For this reason daily activities are used instead of memorized range movements. In this way, the occupation-based exercise program provides a physical recovery in patients with hand injuries, while providing positive improvements in parameters related to the mind and spirit. Patients' participation, motivation and compliance with the treatment are increased in the hand rehabilitation process, which can be challenging for patients.

In addition to the conventional treatment program, the study/experimental group, will be given occupation-based exercises for a total of 4 weeks between the 6th and 10th weeks postoperatively, 2 days a week with a physiotherapist and the other days with a home program.

Conventional therapy group

Group Type: ACTIVE_COMPARATOR

Conventional therapy group

Intervention Type: OTHER

Conventional group treatment will be according the early passive hand rehabilitation program. Conventional group will be followed with a cast-splint made by the surgical team for the first 4 weeks within the scope of the conventional treatment program. From the 4th week onwards, the duration of splint use is gradually reduced and is completely discontinued from the 6th week onwards. At the end of the 4th week, depending on the wound condition, contrast bath, scar massage, retrograde massage, active and passive flexion, active extension and tendon shifting exercises are applied as tolerated. After the 6th week, isolated block exercises and stretching exercises are added if there is contracture. Strengthening exercises are started from the 8th-10th week.

Interventions

Occupation-Based Exercise Program

In the occupation-based exercise program, while trying to improve the range of motion and muscle strength of the hand, it is aimed to successfully return to daily life activities. For this reason daily activities are used instead of memorized range movements. In this way, the occupation-based exercise program provides a physical recovery in patients with hand injuries, while providing positive improvements in parameters related to the mind and spirit. Patients' participation, motivation and compliance with the treatment are increased in the hand rehabilitation process, which can be challenging for patients.

In addition to the conventional treatment program, the study/experimental group, will be given occupation-based exercises for a total of 4 weeks between the 6th and 10th weeks postoperatively, 2 days a week with a physiotherapist and the other days with a home program.

Intervention Type: OTHER

Conventional therapy group

Conventional group treatment will be according the early passive hand rehabilitation program. Conventional group will be followed with a cast-splint made by the surgical team for the first 4 weeks within the scope of the conventional treatment program. From the 4th week onwards, the duration of splint use is gradually reduced and is completely discontinued from the 6th week onwards. At the end of the 4th week, depending on the wound condition, contrast bath, scar massage, retrograde massage, active and passive flexion, active extension and tendon shifting exercises are applied as tolerated. After the 6th week, isolated block exercises and stretching exercises are added if there is contracture. Strengthening exercises are started from the 8th-10th week.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Between the ages of 18-65
• Flexor zone 2 injury
• At least 1 flexor digitorum superfisialis or flexor digitorum profundus tendon repair
• No visual and hearing impairment
• Have the cognitive function to coordinate and carry out simple commands

Exclusion Criteria

• Concomitant flexor pollicis longus tendon injury
• Concomitant extensor tendon injury
• Accompanying fracture
• Associated median/ulnar/radial nerve injury
• Less than 50% partial flexor tendon injury
• Cognitive impairment resulting in an inability to understand and carry out simple commands
• Not being able to comply with the rehabilitation protocol to be applied after surgery

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul University

OTHER

Sponsor Role: collaborator

Berat Güngör

OTHER

Sponsor Role: lead

Responsible Party

Berat Güngör

Dr.

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Istanbul Unıversity, Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Facility Contacts

Berat Güngör

Role: primary

drberatgungor@gmail.com

+905525101695

Other Identifiers

3005950

Identifier Type: -

Identifier Source: org_study_id