Flexor Tendon RepairNCT06088173
The Effects of Graded Motor Imagery Training Program in Patients With Flexor Tendon Repair
A study testing exercises and Exercises and Education in people with Flexor Tendon Repair, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The aim of our study was to investigate the effects of graded motor imagery training applied during the immobilization period on hand functions, range of motion, proprioception and kinesiophobia before and after the rehabilitation program in patients with flexor tendon repair. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Flexor Tendon Repair
- What is being tested?
- exercises and Exercises and Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2022to 30 May 2024
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Becoming a volunteer
- Being between the ages of 18-65
- Having undergone primary flexor tendon repair
- Being in postoperative week 0-3
- Injury at zone 1-3 level
- At least one of the FDS and FDP tendons is severed
- Be able to use an Android phone
Who cannot join
- Tendon transfer
- Orthopedic, neurologic, rheumatologic disease in the related extremity
- Associated fracture or nerve injury (except digital nerve)
- Cognitive impairment
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University-Cerrahpasa
Istanbul, Büyükçekmece
About this study
Official title: The Effects of Graded Motor Imagery Training Before and After the Rehabilitation Program in Patients With Flexor Tendon Repair
The aim of our study was to investigate the effects of graded motor imagery training applied during the immobilization period on hand functions, range of motion, proprioception and kinesiophobia before and after the rehabilitation program in patients with flexor tendon repair.
Read the detailed description
After flexor tendon repair, conditions such as limitation of joint movement in the injured finger, contracture, decreased proprioception, decreased hand function and skills during activities of daily living may occur due to one or more reasons. Various protocols have been applied in rehabilitation after flexor tendon repair, but the search for new treatment methods to achieve the best results continues. In this study, our aim is to reorganize the cortex and incorporate graded motor imagery training, which has been proven to be more effective in the treatment of chronic pain but promising in terms of increasing body awareness, proprioception and function, into flexor tendon rehabilitation to provide flexor tendon repair patients with more functional results and to contribute to the search for new treatment methods in the literature.
The participants who volunteered to take part in the study will be randomly divided into two groups, namely the Early passive mobilization group (Group 1) and the graded motor imagery (GMI) training (Group 2) using a computerassisted randomization program. After the groups are assigned, Group 1 will receive Modified Kleinert protocol and Group 2 will receive GMI training in addition to Modified Kleinert protocol with the help of hand recognize mobile application. A total of 6 weeks of treatment will be applied. GMI will be taught in sessions and practice will be continued at home. Both groups will use a short modified Kleinert splint for postoperatif 6 weeks. This splint does not allow the use of the hand but allows passive flexion and active extension with the help of a tire. GMI training will be given and practiced as soon as rehabilitation starts. The progression will be 2 weeks lateralization 2 weeks imagery 2 weeks mirror therapy and when the splint is removed at the end of postop 6 weeks. In the remaining sessions, standard rehabilitation will be continued in both groups.
- Conditions
- Flexor Tendon Repair
- Being tested
- exercises, Exercises and Education
- Keywords
- flexor tendon, Kleinert protocol, graded motor imagery training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercisesOther
Patients in both group will use Kleinert splint. Sessions will start with ice application if there is edema and continue with scar tissue massage. After general hand massage, passive flexion, active extension exercises; tenodesis exercise and passive punch will be performed for the postoperative (postop) first two weeks. In postop 3-4 weeks, four finger sliding exercises, active half fist and NMES (Neuromuscular electrical stimulation) will be performed. In postop 5-6 weeks, blocking exercises, full punch, grappling hooks and small on-digits holding and releasing exercises will be performed additionally.
Exercises and EducationOther
In addition to the same treatment as the patients in the first group, in the first postoperative (postop) two weeks, the gmi will be explained to the patients and lateralization will be started. lateralization refers to right-left discrimination and the patients will be presented with visuals with the help of the noi recognise app and they will have to decide whether the visual is right or left hand. In the postop 3-4th weeks, the motor imagery stage will be started and imagery will be practiced with the help of the same app. In postop 5-6 weeks, mirror therapy will be practiced with the help of a mirror box.
| Study group | Role | What they receive |
|---|---|---|
| Early Passive Mobilization Group | Experimental | This group will be given Modifiye Kleinert Protocol based rehabilitation Receives: Other: exercises |
| Graded Motor Imagery Training Group | Experimental | This group will be given Modifiye Kleinert Protocol and Graded Motor Imagery Training Receives: Other: Exercises and Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quick-DASH
The QuickDASH is an abbreviated version of the original DASH outcome measure. In comparison to the original 30 item DASH outcome measure, the QuickDASH only contains 11 items. It is a questionnaire that measures an individual's ability to complete tasks, absorb forces, and severity of symptoms. The QuickDASH tool uses a 5-point Likert scale from which the patient can select an appropriate number corresponding to his/her severity/function level.
Measured: baseline, postoperative 6th week, postoperatif 8th week
Tampa Scale for Kinesiophobia
TSK is a self-reported questionnaire that quantifies fear of movement, or (re)injury. In its original form, the TSK is a 17 item assessment checklist. [1] It uses a 4-point Likert scale (Strongly Disagree-Disagree-Agree-Strongly Agree) with statements that have been later linked to the model of fear-avoidance, fear of work-related activities, fear of movement, and fear of re-injury.
Measured: baseline, postoperative 6th week, postoperatif 8th week
Duruöz Hand Index
18 questions regarding ability to carry out manual tasks. Questions are grouped in five domains: In the kitchen (8), dressing (2), hygiene (2), in the office (2), and other (4).
The patient is instructed to answer each question in terms of the level of difficulty they experience completing various tasks without help from another person or assistive device. Individual items are scored on a 6-point Likert scale where 0=without difficulty and 5=impossible. The 18 individual scores are summed to obtain a composite score The total score ranges from 0-90 with higher scores indicating poorer hand functioning
Measured: baseline, postoperative 6th week, postoperatif 8th week
Secondary outcomes (3)
Active Range of Motion
measured with a finger goniometer
Measured: baseline, postoperative 6th week, postoperatif 8th week
Passive Range of Motion
measured with a finger goniometer
Measured: baseline, postoperative 6th week, postoperatif 8th week
Visual Analog Scale
The patient marks on the line the point that they feel represents their perception of their current state. 0 represents no pain and 10 represents unbearable pa,n. The VAS score is determined by measuring in millimetres from the left hand end of the line to the point that the patient marks.
Measured: baseline, postoperative 6th week, postoperatif 8th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start15 Dec 2022
- Primary completion30 May 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Flexor Tendon RepairStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe 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
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, seher karaçam, Istanbul University - Cerrahpasa
- Investigators
- seher DURSUN, Principal investigator, Istanbul Cerrahpaşa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06088173
- Sponsor's protocol ID
- IstanbulUCSD
- Status last verified
- Nov 2024
- First submitted
- 8 Oct 2023
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Graded Motor Imagery Training Before and After the Rehabilitation Program in Patients With Flexor Tendon Repair
- ClinicalTrials.gov ID
- NCT06088173
- Acronym / sponsor ID
- IstanbulUCSD
- Conditions
- Flexor Tendon Repair
- Keywords
- flexor tendon, Kleinert protocol, graded motor imagery training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 18 Oct 2023 (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.
The aim of our study was to investigate the effects of graded motor imagery training applied during the immobilization period on hand functions, range of motion, proprioception and kinesiophobia before and after the rehabilitation program in patients with flexor tendon repair.
Detailed description
After flexor tendon repair, conditions such as limitation of joint movement in the injured finger, contracture, decreased proprioception, decreased hand function and skills during activities of daily living may occur due to one or more reasons. Various protocols have been applied in rehabilitation after flexor tendon repair, but the search for new treatment methods to achieve the best results continues. In this study, our aim is to reorganize the cortex and incorporate graded motor imagery training, which has been proven to be more effective in the treatment of chronic pain but promising in terms of increasing body awareness, proprioception and function, into flexor tendon rehabilitation to provide flexor tendon repair patients with more functional results and to contribute to the search for new treatment methods in the literature.
The participants who volunteered to take part in the study will be randomly divided into two groups, namely the Early passive mobilization group (Group 1) and the graded motor imagery (GMI) training (Group 2) using a computerassisted randomization program. After the groups are assigned, Group 1 will receive Modified Kleinert protocol and Group 2 will receive GMI training in addition to Modified Kleinert protocol with the help of hand recognize mobile application. A total of 6 weeks of treatment will be applied. GMI will be taught in sessions and practice will be continued at home. Both groups will use a short modified Kleinert splint for postoperatif 6 weeks. This splint does not allow the use of the hand but allows passive flexion and active extension with the help of a tire. GMI training will be given and practiced as soon as rehabilitation starts. The progression will be 2 weeks lateralization 2 weeks imagery 2 weeks mirror therapy and when the splint is removed at the end of postop 6 weeks. In the remaining sessions, standard rehabilitation will be continued in both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Passive Mobilization Group | Experimental | Other: exercisesThis group will be given Modifiye Kleinert Protocol based rehabilitation |
| Graded Motor Imagery Training Group | Experimental | Other: Exercises and EducationThis group will be given Modifiye Kleinert Protocol and Graded Motor Imagery Training |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Becoming a volunteer
- Being between the ages of 18-65
- Having undergone primary flexor tendon repair
- Being in postoperative week 0-3
- Injury at zone 1-3 level
Key exclusion criteria (4 listed)
- Tendon transfer
- Orthopedic, neurologic, rheumatologic disease in the related extremity
- Associated fracture or nerve injury (except digital nerve)
- Cognitive impairment
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 |
|---|---|---|
| exercisesPatients in both group will use Kleinert splint. Sessions will start with ice application if there is edema and continue with scar tissue massage. After general hand massage, passive flexion, active extension exercises; tenodesis exercise and passive punch will be performed for the postoperative (postop) first two weeks. In postop 3-4 weeks, four finger sliding exercises, active half fist and NMES (Neuromuscular electrical stimulation) will be performed. In postop 5-6 weeks, blocking exercises, full punch, grappling hooks and small on-digits holding and releasing exercises will be performed additionally. | Other | Early Passive Mobilization Group |
| Exercises and EducationIn addition to the same treatment as the patients in the first group, in the first postoperative (postop) two weeks, the gmi will be explained to the patients and lateralization will be started. lateralization refers to right-left discrimination and the patients will be presented with visuals with the help of the noi recognise app and they will have to decide whether the visual is right or left hand. In the postop 3-4th weeks, the motor imagery stage will be started and imagery will be practiced with the help of the same app. In postop 5-6 weeks, mirror therapy will be practiced with the help of a mirror box. | Other | Graded Motor Imagery Training Group |
Primary outcome
Quick-DASH
Time frame: baseline, postoperative 6th week, postoperatif 8th week
The QuickDASH is an abbreviated version of the original DASH outcome measure. In comparison to the original 30 item DASH outcome measure, the QuickDASH only contains 11 items. It is a questionnaire that measures an individual's ability to complete tasks, absorb forces, and severity of symptoms. The QuickDASH tool uses a 5-point Likert scale from which the patient can select an appropriate number corresponding to his/her severity/function level.
Tampa Scale for Kinesiophobia
Time frame: baseline, postoperative 6th week, postoperatif 8th week
TSK is a self-reported questionnaire that quantifies fear of movement, or (re)injury. In its original form, the TSK is a 17 item assessment checklist. [1] It uses a 4-point Likert scale (Strongly Disagree-Disagree-Agree-Strongly Agree) with statements that have been later linked to the model of fear-avoidance, fear of work-related activities, fear of movement, and fear of re-injury.
Duruöz Hand Index
Time frame: baseline, postoperative 6th week, postoperatif 8th week
18 questions regarding ability to carry out manual tasks. Questions are grouped in five domains: In the kitchen (8), dressing (2), hygiene (2), in the office (2), and other (4). The patient is instructed to answer each question in terms of the level of difficulty they experience completing various tasks without help from another person or assistive device. Individual items are scored on a 6-point Likert scale where 0=without difficulty and 5=impossible. The 18 individual scores are summed to obtain a composite score The total score ranges from 0-90 with higher scores indicating poorer hand functioning
3 secondary outcomes
Active Range of Motion
Time frame: baseline, postoperative 6th week, postoperatif 8th week
Passive Range of Motion
Time frame: baseline, postoperative 6th week, postoperatif 8th week
Visual Analog Scale
Time frame: baseline, postoperative 6th week, postoperatif 8th week
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 4 Dec 2024.
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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.
seher DURSUN principal investigator
Istanbul Cerrahpaşa University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercises and Exercises and Education in people with Flexor Tendon Repair, run by Istanbul University - Cerrahpasa 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 7 inclusion and 4 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 4 Dec 2024. 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?
Quick-DASH (time frame: baseline, postoperative 6th week, postoperatif 8th week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Dec 2024.