Flexor Tendon RuptureNCT04237415
Electromyographic (EMG) Biofeedback Training in Zone I-III Flexor Tendon Injuries
A study testing EMG biofeedback training in people with Flexor Tendon Rupture and Hand Therapy, run by Pamukkale University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Flexor Tendon Rupture, Hand Therapy
- What is being tested?
- EMG biofeedback training
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- 10 Oct 2016to 21 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- <18 years of age,
- Pregnancy,
- Thumb flexor tendon cuts,
- Digital nerve injury,
- Accompanying fracture, joint capsule injury or skin loss,
- Crush injury,
Show all 9Show fewer
- Patients with pacemakers,
- Patients with cardiac arrhythmias,
- Epilepsy.
About this study
Official title: The Effect of Electromyographic (EMG) Biofeedback Training on Electrical Muscle Activity and Functional Status in Zone I-III Flexor Tendon Injuries
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.
- Conditions
- Flexor Tendon Rupture, Hand Therapy
- Being tested
- EMG biofeedback training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMG biofeedback trainingProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| EMG biofeedback group | Experimental | Not described Receives: Procedure: EMG biofeedback training |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Finger joint range of motion
Finger motion was measured by goniometer.Total active motion protocol was used.
Measured: 5th week
Finger joint range of motion
Finger motion was measured by goniometer.Total active motion protocol was used.
Measured: 12th week
Finger joint range of motion
Finger motion was measured by goniometer.Total active motion protocol was used.
Measured: 24th week
Electrical muscle activity
Flexor muscle electrical activity was measured by EMG biofeedback device. For this purpose, surface electrodes were used.
Measured: 5th week
Electrical muscle activity
Flexor muscle electrical activity was measured by EMG biofeedback device. For this purpose, surface electrodes were used.
Measured: 12th week
Electrical muscle activity
Flexor muscle electrical activity was measured by EMG biofeedback device. For this purpose, surface electrodes were used.
Measured: 24th week
Grip strength
Gross and pinch strength were evaluated by hand dynamometer.
Measured: 12th week
Grip strength
Gross and pinch strength were evaluated by hand dynamometer.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start10 Oct 2016
- Primary completion10 Dec 2018
- Study completion21 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Flexor Tendon RuptureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, UMUT ERASLAN, Pamukkale University
- Investigators
- Ali Kitis, PhD, Study director, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04237415
- Sponsor's protocol ID
- 60116787-020/50298
- Status last verified
- Jan 2020
- First submitted
- 15 Jan 2020
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Electromyographic (EMG) Biofeedback Training on Electrical Muscle Activity and Functional Status in Zone I-III Flexor Tendon Injuries
- ClinicalTrials.gov ID
- NCT04237415
- Acronym / sponsor ID
- 60116787-020/50298
- Conditions
- Flexor Tendon Rupture, Hand Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 10 Oct 2016 (actual)
- Primary completion
- 10 Dec 2018 (actual)
- Study completion
- 21 Mar 2019 (actual)
- First posted
- 23 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EMG biofeedback group | Experimental | Procedure: EMG biofeedback training |
| control group | No intervention | – |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (9 listed)
- <18 years of age,
- Pregnancy,
- Thumb flexor tendon cuts,
- Digital nerve injury,
- Accompanying fracture, joint capsule injury or skin loss,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EMG biofeedback training | Procedure or surgery | EMG biofeedback group |
Primary outcome
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.
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: 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.
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: 12th week
Gross and pinch strength were evaluated by hand dynamometer.
Grip strength
Time frame: 24th 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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali Kitis, PhD study director
Pamukkale University
Questions about this trial
What is this clinical trial studying?
A study testing EMG biofeedback training in people with Flexor Tendon Rupture and Hand Therapy, run by Pamukkale University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Finger joint range of motion (time frame: 5th week). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2020; AzTrials last refreshed its copy on 31 Oct 2026.