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The Effects of Graded Motor Imagery Training Program in Patients With Flexor Tendon Repair

Primary Purpose

Flexor Tendon Repair

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
exercises
Exercises and Education
Sponsored by
Istanbul University - Cerrahpasa (IUC)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Flexor Tendon Repair focused on measuring flexor tendon, Kleinert protocol, graded motor imagery training

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: Tendon transfer Orthopedic, neurologic, rheumatologic disease in the related extremity Associated fracture or nerve injury (except digital nerve) Cognitive impairment

Sites / Locations

  • Istanbul University-CerrahpasaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Early Passive Mobilization Group

Graded Motor Imagery Training Group

Arm Description

This group will be given Modifiye Kleinert Protocol based rehabilitation

This group will be given Modifiye Kleinert Protocol and Graded Motor Imagery Training

Outcomes

Primary Outcome Measures

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.
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.
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

Secondary Outcome Measures

Active Range of Motion
measured with a finger goniometer
Passive Range of Motion
measured with a finger goniometer
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.

Full Information

First Posted
October 8, 2023
Last Updated
October 12, 2023
Sponsor
Istanbul University - Cerrahpasa (IUC)
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1. Study Identification

Unique Protocol Identification Number
NCT06088173
Brief Title
The Effects of Graded Motor Imagery Training Program in Patients With Flexor Tendon Repair
Official Title
The Effects of Graded Motor Imagery Training Before and After the Rehabilitation Program in Patients With Flexor Tendon Repair
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 8, 2023 (Anticipated)
Primary Completion Date
May 30, 2024 (Anticipated)
Study Completion Date
May 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Flexor Tendon Repair
Keywords
flexor tendon, Kleinert protocol, graded motor imagery training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Early Passive Mobilization Group
Arm Type
Experimental
Arm Description
This group will be given Modifiye Kleinert Protocol based rehabilitation
Arm Title
Graded Motor Imagery Training Group
Arm Type
Experimental
Arm Description
This group will be given Modifiye Kleinert Protocol and Graded Motor Imagery Training
Intervention Type
Other
Intervention Name(s)
exercises
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Exercises and Education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Quick-DASH
Description
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.
Time Frame
baseline, postoperative 6th week, postoperatif 8th week
Title
Tampa Scale for Kinesiophobia
Description
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.
Time Frame
baseline, postoperative 6th week, postoperatif 8th week
Title
Duruöz Hand Index
Description
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
Time Frame
baseline, postoperative 6th week, postoperatif 8th week
Secondary Outcome Measure Information:
Title
Active Range of Motion
Description
measured with a finger goniometer
Time Frame
baseline, postoperative 6th week, postoperatif 8th week
Title
Passive Range of Motion
Description
measured with a finger goniometer
Time Frame
baseline, postoperative 6th week, postoperatif 8th week
Title
Visual Analog Scale
Description
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.
Time Frame
baseline, postoperative 6th week, postoperatif 8th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Tendon transfer Orthopedic, neurologic, rheumatologic disease in the related extremity Associated fracture or nerve injury (except digital nerve) Cognitive impairment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
seher DURSUN
Phone
05392031872
Email
seher.dursun@ahievran.edu.tr
First Name & Middle Initial & Last Name or Official Title & Degree
Saime Nilay ARMAN, Doc.Dr.
Email
nilayarman@iuc.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
seher DURSUN
Organizational Affiliation
Istanbul Cerrahpaşa University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul University-Cerrahpasa
City
Istanbul
State/Province
Büyükçekmece
Country
Turkey
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

The Effects of Graded Motor Imagery Training Program in Patients With Flexor Tendon Repair

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