NCT04237415

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2016

Typical duration for not_applicable

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

October 10, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 21, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 23, 2020

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

2.2 years

First QC Date

January 15, 2020

Last Update Submit

January 23, 2020

Conditions

Flexor Tendon RuptureHand Therapy

Outcome Measures

Primary Outcomes (11)

  • Finger joint range of motion

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

    5th week

  • Finger joint range of motion

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

    12th week

  • Finger joint range of motion

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

    24th week

  • Electrical muscle activity

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

    5th week

  • Electrical muscle activity

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

    12th week

  • Electrical muscle activity

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

    24th week

  • Grip strength

    Gross and pinch strength were evaluated by hand dynamometer.

    12th week

  • Grip strength

    Gross and pinch strength were evaluated by hand dynamometer.

    24th week

  • 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.

    5th week

  • 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.

    12th week

  • 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.

    24th week

Study Arms (2)

EMG biofeedback group

EXPERIMENTAL
Procedure: EMG biofeedback training

control group

NO INTERVENTION

Interventions

EMG biofeedback trainingPROCEDURE
EMG biofeedback group

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • \<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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Ali Kitis, PhD

    Pamukkale University

    STUDY DIRECTOR

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
Research Assistant

Study Record Dates

First Submitted

January 15, 2020

First Posted

January 23, 2020

Study Start

October 10, 2016

Primary Completion

December 10, 2018

Study Completion

March 21, 2019

Last Updated

January 27, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share