The Effects of Graded Motor Imagery Training Program in Patients With Flexor Tendon Repair
1 other identifier
interventional
26
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 15, 2022
CompletedFirst Submitted
Initial submission to the registry
October 8, 2023
CompletedFirst Posted
Study publicly available on registry
October 18, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2024
CompletedDecember 4, 2024
November 1, 2024
1.5 years
October 8, 2023
November 29, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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.
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.
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
baseline, postoperative 6th week, postoperatif 8th week
Secondary Outcomes (3)
Active Range of Motion
baseline, postoperative 6th week, postoperatif 8th week
Passive Range of Motion
baseline, postoperative 6th week, postoperatif 8th week
Visual Analog Scale
baseline, postoperative 6th week, postoperatif 8th week
Study Arms (2)
Early Passive Mobilization Group
EXPERIMENTALThis group will be given Modifiye Kleinert Protocol based rehabilitation
Graded Motor Imagery Training Group
EXPERIMENTALThis group will be given Modifiye Kleinert Protocol and Graded Motor Imagery Training
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Tendon transfer
- Orthopedic, neurologic, rheumatologic disease in the related extremity
- Associated fracture or nerve injury (except digital nerve)
- Cognitive impairment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Istanbul University-Cerrahpasa
Istanbul, Büyükçekmece, Turkey (Türkiye)
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
seher DURSUN
Istanbul Cerrahpaşa University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Researcher
Study Record Dates
First Submitted
October 8, 2023
First Posted
October 18, 2023
Study Start
December 15, 2022
Primary Completion
May 30, 2024
Study Completion
May 30, 2024
Last Updated
December 4, 2024
Record last verified: 2024-11