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Clinical Trials/NCT04237415
NCT04237415CompletedNot Applicable

The Effect of Electromyographic (EMG) Biofeedback Training on Electrical Muscle Activity and Functional Status in Zone I-III Flexor Tendon Injuries

Pamukkale University0 sites22 target enrollmentStarted: October 10, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
22
Primary Endpoint
Finger joint range of motion

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 64 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

EMG biofeedback group

Experimental

Intervention: EMG biofeedback training (Procedure)

control group

No Intervention

Outcomes

Primary Outcomes

Finger joint range of motion

Time Frame: 24th week

Finger motion was measured by goniometer.Total active motion protocol was used.

Electrical muscle activity

Time Frame: 24th week

Flexor muscle electrical activity was measured by EMG biofeedback device. For this purpose, surface electrodes were used.

Grip strength

Time Frame: 24th week

Gross and pinch strength were evaluated by hand dynamometer.

Michigan Hand Questionnaire

Time Frame: 24th week

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.

Finger joint range of motion

Time Frame: 5th week

Finger motion was measured by goniometer.Total active motion protocol was used.

Finger joint range of motion

Time Frame: 12th week

Finger motion was measured by goniometer.Total active motion protocol was used.

Electrical muscle activity

Time Frame: 5th week

Flexor muscle electrical activity was measured by EMG biofeedback device. For this purpose, surface electrodes were used.

Electrical muscle activity

Time Frame: 12th week

Flexor muscle electrical activity was measured by EMG biofeedback device. For this purpose, surface electrodes were used.

Grip strength

Time Frame: 12th week

Gross and pinch strength were evaluated by hand dynamometer.

Michigan Hand Questionnaire

Time Frame: 5th week

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

Time Frame: 12th week

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 Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

UMUT ERASLAN

Research Assistant

Pamukkale University

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