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

NCT ID: NCT04237415

Last Updated: 2020-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-10

Study Completion Date

2019-03-21

Brief Summary

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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.

Detailed Description

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Conditions

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Flexor Tendon Rupture Hand Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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EMG biofeedback group

Group Type EXPERIMENTAL

EMG biofeedback training

Intervention Type PROCEDURE

control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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EMG biofeedback training

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pamukkale University

OTHER

Sponsor Role lead

Responsible Party

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UMUT ERASLAN

Research Assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ali Kitis, PhD

Role: STUDY_DIRECTOR

Pamukkale University

Other Identifiers

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60116787-020/50298

Identifier Type: -

Identifier Source: org_study_id

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