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Electromyographic (EMG) Biofeedback Training in Zone I-III Flexor Tendon Injuries

Primary Purpose

Flexor Tendon Rupture, Hand Therapy

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
EMG biofeedback training
Sponsored by
Pamukkale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Flexor Tendon Rupture

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Being olunteer,
  • No history of neurological, orthopedic, rheumatologic disease or trauma in the related extremity,
  • No history of neuropathy due to a metabolic disease (diabetes, etc.),
  • Incision of at least one of the FDS or FDP tendons,
  • At least one of the FDS or FDP tendons repaired within 2 weeks after the injury,
  • No communication problems.

Exclusion Criteria:

  • <18 years of age,
  • Pregnancy,
  • Thumb flexor tendon cuts,
  • Digital nerve injury,
  • Accompanying fracture, joint capsule injury or skin loss,
  • Crush injury,
  • Patients with pacemakers,
  • Patients with cardiac arrhythmias,
  • Epilepsy.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    EMG biofeedback group

    control group

    Arm Description

    Outcomes

    Primary Outcome Measures

    Finger joint range of motion
    Finger motion was measured by goniometer.Total active motion protocol was used.
    Finger joint range of motion
    Finger motion was measured by goniometer.Total active motion protocol was used.
    Finger joint range of motion
    Finger motion was measured by goniometer.Total active motion protocol was used.
    Electrical muscle activity
    Flexor muscle electrical activity was measured by EMG biofeedback device. For this purpose, surface electrodes were used.
    Electrical muscle activity
    Flexor muscle electrical activity was measured by EMG biofeedback device. For this purpose, surface electrodes were used.
    Electrical muscle activity
    Flexor muscle electrical activity was measured by EMG biofeedback device. For this purpose, surface electrodes were used.
    Grip strength
    Gross and pinch strength were evaluated by hand dynamometer.
    Grip strength
    Gross and pinch strength were evaluated by hand dynamometer.
    Michigan Hand Questionnaire
    This questionnaire evaluates the functionality of the hand and consists of 63 questions in total. Each question is scored between 1-5 and the score of each section varies between 0-100. High total score indicates high satisfaction.
    Michigan Hand Questionnaire
    This questionnaire evaluates the functionality of the hand and consists of 63 questions in total. Each question is scored between 1-5 and the score of each section varies between 0-100. High total score indicates high satisfaction.
    Michigan Hand Questionnaire
    This questionnaire evaluates the functionality of the hand and consists of 63 questions in total. Each question is scored between 1-5 and the score of each section varies between 0-100. High total score indicates high satisfaction.

    Secondary Outcome Measures

    Full Information

    First Posted
    January 15, 2020
    Last Updated
    January 23, 2020
    Sponsor
    Pamukkale University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04237415
    Brief Title
    Electromyographic (EMG) Biofeedback Training in Zone I-III Flexor Tendon Injuries
    Official Title
    The Effect of Electromyographic (EMG) Biofeedback Training on Electrical Muscle Activity and Functional Status in Zone I-III Flexor Tendon Injuries
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    October 10, 2016 (Actual)
    Primary Completion Date
    December 10, 2018 (Actual)
    Study Completion Date
    March 21, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Pamukkale University

    4. Oversight

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

    5. Study Description

    Brief Summary
    Aim: The aim of the study was to investigate the effect of electromyographic (EMG) biofeedback training applied in addition to early passive motion protocol on electrical muscle activity (EMA) and functional status in zone I-III flexor tendon injuries. Materials and Methods: Cases who underwent surgery for flexor tendon injuries in zone I-III were included in this prospective randomized controlled trial. Cases were randomly divided into two groups of 11 cases each by block randomization. In the first group, EMG biofeedback training was applied in addition to the early passive motion method (modified Duran protocol), while the second group was followed only by early passive motion method. The treatment program was performed by the same physiotherapist three times a week, for 12 weeks. At the postoperative 5th, 12th and 24th weeks, joint range of motion (ROM) and EMA were evaluated, and the Michigan Hand Outcome Questionnaire (MHQ) was administered to the patients. The grip strength at 12th and 24th weeks were also assessed. The Mann-Whitney U Test was used to compare the two groups.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Flexor Tendon Rupture, Hand Therapy

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    EMG biofeedback group
    Arm Type
    Experimental
    Arm Title
    control group
    Arm Type
    No Intervention
    Intervention Type
    Procedure
    Intervention Name(s)
    EMG biofeedback training
    Primary Outcome Measure Information:
    Title
    Finger joint range of motion
    Description
    Finger motion was measured by goniometer.Total active motion protocol was used.
    Time Frame
    5th week
    Title
    Finger joint range of motion
    Description
    Finger motion was measured by goniometer.Total active motion protocol was used.
    Time Frame
    12th week
    Title
    Finger joint range of motion
    Description
    Finger motion was measured by goniometer.Total active motion protocol was used.
    Time Frame
    24th week
    Title
    Electrical muscle activity
    Description
    Flexor muscle electrical activity was measured by EMG biofeedback device. For this purpose, surface electrodes were used.
    Time Frame
    5th week
    Title
    Electrical muscle activity
    Description
    Flexor muscle electrical activity was measured by EMG biofeedback device. For this purpose, surface electrodes were used.
    Time Frame
    12th week
    Title
    Electrical muscle activity
    Description
    Flexor muscle electrical activity was measured by EMG biofeedback device. For this purpose, surface electrodes were used.
    Time Frame
    24th week
    Title
    Grip strength
    Description
    Gross and pinch strength were evaluated by hand dynamometer.
    Time Frame
    12th week
    Title
    Grip strength
    Description
    Gross and pinch strength were evaluated by hand dynamometer.
    Time Frame
    24th week
    Title
    Michigan Hand Questionnaire
    Description
    This questionnaire evaluates the functionality of the hand and consists of 63 questions in total. Each question is scored between 1-5 and the score of each section varies between 0-100. High total score indicates high satisfaction.
    Time Frame
    5th week
    Title
    Michigan Hand Questionnaire
    Description
    This questionnaire evaluates the functionality of the hand and consists of 63 questions in total. Each question is scored between 1-5 and the score of each section varies between 0-100. High total score indicates high satisfaction.
    Time Frame
    12th week
    Title
    Michigan Hand Questionnaire
    Description
    This questionnaire evaluates the functionality of the hand and consists of 63 questions in total. Each question is scored between 1-5 and the score of each section varies between 0-100. High total score indicates high satisfaction.
    Time Frame
    24th week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    64 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Being olunteer, No history of neurological, orthopedic, rheumatologic disease or trauma in the related extremity, No history of neuropathy due to a metabolic disease (diabetes, etc.), Incision of at least one of the FDS or FDP tendons, At least one of the FDS or FDP tendons repaired within 2 weeks after the injury, No communication problems. Exclusion Criteria: <18 years of age, Pregnancy, Thumb flexor tendon cuts, Digital nerve injury, Accompanying fracture, joint capsule injury or skin loss, Crush injury, Patients with pacemakers, Patients with cardiac arrhythmias, Epilepsy.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ali Kitis, PhD
    Organizational Affiliation
    Pamukkale University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Electromyographic (EMG) Biofeedback Training in Zone I-III Flexor Tendon Injuries

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