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

NCT ID: NCT06088173

Last Updated: 2024-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-15

Study Completion Date

2024-05-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Flexor Tendon Repair

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Early Passive Mobilization Group

This group will be given Modifiye Kleinert Protocol based rehabilitation

Group Type EXPERIMENTAL

exercises

Intervention Type OTHER

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.

Graded Motor Imagery Training Group

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

Group Type EXPERIMENTAL

Exercises and Education

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

exercises

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

Exercises and Education

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Istanbul University - Cerrahpasa

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

seher karaçam

Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

seher DURSUN

Role: PRINCIPAL_INVESTIGATOR

Istanbul Cerrahpaşa University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Istanbul University-Cerrahpasa

Istanbul, Büyükçekmece, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IstanbulUCSD

Identifier Type: -

Identifier Source: org_study_id