- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05598918
Comparison of Early Passive and Active Mobilization Protocols in Flexor Tendon Repair Rehabilitation of the Hand
Comparison of Early Passive and Active Mobilization Protocols in Flexor Tendon Repair Rehabilitation of the Hand, and Investigation of Factors Affecting the Results
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Merve Demirci, MD
- Phone Number: 05076161431
- Email: mervedmrc__@hotmail.com
Study Contact Backup
- Name: canan Sanal Toprak, MD
- Phone Number: 05331381032
- Email: canansanal@hotmail.com
Study Locations
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İ̇stanbul (asya)
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Istanbul, İ̇stanbul (asya), Turkey, 34000
- Marmara University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: early passive mobilization
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.
|
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.
|
EXPERIMENTAL: early active mobilization
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.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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T0 : Patients were evaluated on postoperative 5-7 days.
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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.
|
T1 : Patients were evaluated on postoperative 3 weeks.
|
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.
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Shear wave velocity, measured in metres per second, was recorded using shear wave elastography.
|
T2 : Patients were evaluated on postoperative 8 weeks.
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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.
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Shear wave velocity, measured in metres per second, was recorded using shear wave elastography.
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T3 : Patients were evaluated on postoperative 12 weeks.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Handgrip strength
Time Frame: T0: Patients are evaluated on postoperative 12 weeks.
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The patient's handgrip strength, measured by JAMAR hand dynamometer, measured in Pounds.
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T0: Patients are evaluated on postoperative 12 weeks.
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Pinch grip strength
Time Frame: T0: Patients are evaluated on postoperative 12 weeks.
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The patient's pinch grip strength, measured by hydraulic pinch gauge, measured in Pounds.
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T0: Patients are evaluated on postoperative 12 weeks.
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Range of motion
Time Frame: T0: Patients are evaluated on postoperative 12 weeks.
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The range of motion of patient's fingers, measured by goniometer, measured in degrees.
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T0: Patients are evaluated on postoperative 12 weeks.
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Functionality
Time Frame: T0: Patients are evaluated on postoperative 12 weeks.
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Purdue peg board test, Nine hole test, measured in seconds.
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T0: Patients are evaluated on postoperative 12 weeks.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09.2021.118
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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