NCT06088173

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 8, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 18, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2024

Completed
Last Updated

December 4, 2024

Status Verified

November 1, 2024

Enrollment Period

1.5 years

First QC Date

October 8, 2023

Last Update Submit

November 29, 2024

Conditions

Keywords

flexor tendonKleinert protocolgraded motor imagery training

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

EXPERIMENTAL

This group will be given Modifiye Kleinert Protocol based rehabilitation

Other: exercises

Graded Motor Imagery Training Group

EXPERIMENTAL

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

Other: Exercises and Education

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.

Early Passive Mobilization Group

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.

Graded Motor Imagery Training Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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)

Location

MeSH Terms

Interventions

ExerciseEducational Status

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaSocioeconomic FactorsPopulation Characteristics

Study Officials

  • seher DURSUN

    Istanbul Cerrahpaşa University

    PRINCIPAL INVESTIGATOR

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

Locations