Tendon InjuriesNCT05598918
Comparison of Early Passive and Active Mobilization Protocols in Flexor Tendon Repair Rehabilitation of the Hand
A study testing early active mobilization and early passive mobilization in people with Tendon Injuries, run by Marmara University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Tendon Injuries
- What is being tested?
- early active mobilization and early passive mobilization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2022to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University
Istanbul, İ̇stanbul (asya), 34000
About this study
Official title: Comparison of Early Passive and Active Mobilization Protocols in Flexor Tendon Repair Rehabilitation of the Hand, and Investigation of Factors Affecting the Results
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.
Read the detailed description
Patients' affected tendons will be evaluated by shear wave elastography within 3 - 5 days after surgery. The tendons of the healthy hands of the patients will also be evaluated as the control group.
Afterwards, patients will be randomized into two groups by computer-assisted randomization.
Group 1: early passive mobilization Within 3 to 5 days following surgery, patients will begin using a dorsal forearm-based orthosis with 30* flexion of the wrist, 70* flexion of the metacarpophalangeal (MCP) joints, full extension of the interphalangeal (IF) joints. Home exercises will be performed as passive flexion and active extension exercises with rubber band 10 times per hour on the postoperative 3rd day for 3 weeks. Passive flexion and extension exercises will be performed ten times a day, four times a day, on the MCP + Proximal Interphalangeal (PIP) + IF joints. The bands will be removed at night and the fingers will be kept in full extension. In 3 weeks, the orthosis will be modified so that the wrist is in a neutral position and the MCP joints are extended a little more. Approximately 3 weeks after the repair, the dorsal orthosis will be removed during the exercises, and non-resistance active movement and tenodesis exercises will be started in the presence of a physiotherapist. From the 6th week, the dorsal orthosis will be worn only at night, tendon gliding exercises and blocking exercises will be started.
Group 2: early active mobilization Patients will begin to use a dorsal forearm-based orthosis that positions the wrist in a neutral position, metacarpophalangeal (MCP) joints 50* -70* flexion, IF joints in full extension within 3 to 5 days after surgery. After the flexion active extension exercises, full passive flexion of the fingers with the other intact hand and then gently keeping the fingers in the flexion position for 3-5 seconds when the contralateral hand is raised will be performed for 3 weeks, no force will be applied on the fingers. Passive flexion and extension exercises will be performed ten times a day, four times a day, on the MCP + PIP + IF joints. These exercises will be organized as a home exercise program. The patients will be evaluated by the physiotherapist and clinician once a week in the first two weeks of the exercises, and 3 days a week in the third week, in terms of monitoring the exercises, and the exercises will be shown again. The bands will be removed at night and the fingers will be kept in full extension. Approximately 3 weeks after the repair, the dorsal orthosis will be removed during the exercises, and the patients will be started with non-resistance active movement and tenodesis exercises in the form of a home exercise program 3 days a week with a physiotherapist on the remaining days. From the 6th week, the dorsal orthosis will be worn only at night, tendon gliding exercises and blocking exercises will be started.
Patients will be evaluated by an investigator blinded to the treatment groups at week 8 and week 12 using the following methods.
- Tendon elasticity will be evaluated with shear wave elastography
- Measurements of hand grip strength and pinch strength (only at 12 weeks) will be evaluated with a dynamometer device.
- Duruoz Hand Index will be filled.
- Total active movements of the fingers will be calculated.
- Conditions
- Tendon Injuries
- Being tested
- early active mobilization, early passive mobilization
- Medical subject headings
- Tendon Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
early active mobilizationProcedure or surgery
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 passive mobilizationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: early active mobilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: T3 : Patients were evaluated on postoperative 12 weeks.
Secondary outcomes (4)
Handgrip strength
The patient's handgrip strength, measured by JAMAR hand dynamometer, measured in Pounds.
Measured: T0: Patients are evaluated on postoperative 12 weeks.
Pinch grip strength
The patient's pinch grip strength, measured by hydraulic pinch gauge, measured in Pounds.
Measured: T0: Patients are evaluated on postoperative 12 weeks.
Range of motion
The range of motion of patient's fingers, measured by goniometer, measured in degrees.
Measured: T0: Patients are evaluated on postoperative 12 weeks.
Functionality
Purdue peg board test, Nine hole test, measured in seconds.
Measured: T0: Patients are evaluated on postoperative 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2022
- Study start1 Apr 2022
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tendon InjuriesStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05598918
- Sponsor's protocol ID
- 09.2021.118
- Status last verified
- Oct 2022
- First submitted
- 3 Aug 2022
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41498969
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Early Passive and Active Mobilization Protocols in Flexor Tendon Repair Rehabilitation of the Hand, and Investigation of Factors Affecting the Results
- ClinicalTrials.gov ID
- NCT05598918
- Acronym / sponsor ID
- 09.2021.118
- Conditions
- Tendon Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 28 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients' affected tendons will be evaluated by shear wave elastography within 3 - 5 days after surgery. The tendons of the healthy hands of the patients will also be evaluated as the control group.
Afterwards, patients will be randomized into two groups by computer-assisted randomization.
Group 1: early passive mobilization Within 3 to 5 days following surgery, patients will begin using a dorsal forearm-based orthosis with 30* flexion of the wrist, 70* flexion of the metacarpophalangeal (MCP) joints, full extension of the interphalangeal (IF) joints. Home exercises will be performed as passive flexion and active extension exercises with rubber band 10 times per hour on the postoperative 3rd day for 3 weeks. Passive flexion and extension exercises will be performed ten times a day, four times a day, on the MCP + Proximal Interphalangeal (PIP) + IF joints. The bands will be removed at night and the fingers will be kept in full extension. In 3 weeks, the orthosis will be modified so that the wrist is in a neutral position and the MCP joints are extended a little more. Approximately 3 weeks after the repair, the dorsal orthosis will be removed during the exercises, and non-resistance active movement and tenodesis exercises will be started in the presence of a physiotherapist. From the 6th week, the dorsal orthosis will be worn only at night, tendon gliding exercises and blocking exercises will be started.
Group 2: early active mobilization Patients will begin to use a dorsal forearm-based orthosis that positions the wrist in a neutral position, metacarpophalangeal (MCP) joints 50* -70* flexion, IF joints in full extension within 3 to 5 days after surgery. After the flexion active extension exercises, full passive flexion of the fingers with the other intact hand and then gently keeping the fingers in the flexion position for 3-5 seconds when the contralateral hand is raised will be performed for 3 weeks, no force will be applied on the fingers. Passive flexion and extension exercises will be performed ten times a day, four times a day, on the MCP + PIP + IF joints. These exercises will be organized as a home exercise program. The patients will be evaluated by the physiotherapist and clinician once a week in the first two weeks of the exercises, and 3 days a week in the third week, in terms of monitoring the exercises, and the exercises will be shown again. The bands will be removed at night and the fingers will be kept in full extension. Approximately 3 weeks after the repair, the dorsal orthosis will be removed during the exercises, and the patients will be started with non-resistance active movement and tenodesis exercises in the form of a home exercise program 3 days a week with a physiotherapist on the remaining days. From the 6th week, the dorsal orthosis will be worn only at night, tendon gliding exercises and blocking exercises will be started.
Patients will be evaluated by an investigator blinded to the treatment groups at week 8 and week 12 using the following methods.
- Tendon elasticity will be evaluated with shear wave elastography
- Measurements of hand grip strength and pinch strength (only at 12 weeks) will be evaluated with a dynamometer device.
- Duruoz Hand Index will be filled.
- Total active movements of the fingers will be calculated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| early passive mobilization | Experimental | Procedure: early passive mobilizationıt 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. |
| early active mobilization | Experimental | Procedure: early active mobilizationıt 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| early active mobilizationIn 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. | Procedure or surgery | early active mobilization |
| early passive mobilizationIn 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. | Procedure or surgery | early passive mobilization |
Primary outcome
tendon stiffness level tendon stiffness level tendon stiffness level tendon stiffness level tendon stiffness level
Time frame: T0 : Patients were evaluated on postoperative 5-7 days.
Shear wave velocity, measured in metres per second, was recorded using shear wave elastography.
tendon stiffness level tendon stiffness level tendon stiffness level tendon stiffness level tendon stiffness level
Time frame: T1 : Patients were evaluated on postoperative 3 weeks.
Shear wave velocity, measured in metres per second, was recorded using shear wave elastography.
tendon stiffness level tendon stiffness level tendon stiffness level tendon stiffness level tendon stiffness level
Time frame: T2 : Patients were evaluated on postoperative 8 weeks.
Shear wave velocity, measured in metres per second, was recorded using shear wave elastography.
tendon stiffness level tendon stiffness level tendon stiffness level tendon stiffness level tendon stiffness level
Time frame: T3 : Patients were evaluated on postoperative 12 weeks.
Shear wave velocity, measured in metres per second, was recorded using shear wave elastography.
4 secondary outcomes
Handgrip strength
Time frame: T0: Patients are evaluated on postoperative 12 weeks.
Pinch grip strength
Time frame: T0: Patients are evaluated on postoperative 12 weeks.
Range of motion
Time frame: T0: Patients are evaluated on postoperative 12 weeks.
Functionality
Time frame: T0: Patients are evaluated on postoperative 12 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Derived from this study: PubMed 41498969Demirci 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing early active mobilization and early passive mobilization in people with Tendon Injuries, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tendon stiffness level tendon stiffness level tendon stiffness level tendon stiffness level tendon stiffness level (time frame: T0 : Patients were evaluated on postoperative 5-7 days.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05598918, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.