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
About this trial
This is an interventional treatment trial for Flexor Tendon Rupture
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.
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
NCT ID
NCT04237415
First Posted
January 15, 2020
Last Updated
January 23, 2020
Sponsor
Pamukkale University
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
Learn more about this trial
Electromyographic (EMG) Biofeedback Training in Zone I-III Flexor Tendon Injuries
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