EFFICACY OF MIRROR THERAPY IN IMPROVING HAND FUNCTION POST FLEXOR TENDON REPAIR

June 1, 2022 updated by: ahmed mohamed nagy, Cairo University
This current study will be designed to prove the therapeutic effect of mirror therapy on physical function of the hand after flexor tendon repair

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Purpose of the study are to clarify the effectiveness of mirror therapy (MT) on pain, range of motion and hand function in post tendons repair patients. 30 adult of both sexes will participate in this study and selected from outpatient clinic of faculty of physical therapy Cairo university. Their ages range from 20 to 45 years.

Informed consent will be taken from all patients. All the adult were divided into two groups of equal number (15) Study group (A): received traditional physical therapy program in addition to motor imagery in form of mirror therapy.

Study group (B): received traditional physical therapy program only.

Procedures of the study:

  • A verbal explanation about the importance of this study procedures, main aims and conceptual approach were explained to every patient.
  • The procedures of this study will be divided into two main categories:

Measurement procedures:

  1. Preparatory phase

    In this phase, each patient was achieved the following steps:

    • All participants will be signed an institutional review board approved informed consent statement prior to testing.
    • Subjects will be familiarized with equipment and test procedures before testing commenced.
    • All patients will be given an explanatory session before the evaluation procedure based on the protocols set.

    Primary brief medical history had been obtained, and demographic data had been recorded, including age, sex, height, weight, general health status, and activity level to decide if the patient was able to undergo the experiment.

    • Each subject's history will be taken carefully to collect information about his general condition, physical activity and current medication.
    • Measurements will be performed under standardized conditions as the following:

    Measurements will be carried out by the same investigator.

    -The measurements procedures will be conducted two times, before treatment application (pre-treatment) and after eight weeks of treatment application (post-treatment).

    Patients will be introduced to the lab at the scheduled dates, had taken the general knowledge about the system, and revised the evaluation procedures prior to onset of evaluation.

    Each subject will be tested in a single session.

  2. Measuring phase

    • Standard geniometer to measure Active ROM.
    • Michigan Hand Questionnaire for hand function.
    • Visual analog scale for pain assessment.

Therapeutic procedures:

This current study will be designed to prove the therapeutic effect of mirror therapy on physical function of the hand after flexor tendon repair, so the treatment protocol will be applied through the following steps and phases:

Therapeutic intervention for the study was started at the same time for all groups of the study as following;

Exercise therapy protocol:

  1. Preparatory phase

    Preparation of the patients:

    The patients will be checked carefully to make sure there will be no contraindications.

    Every patient will be given information about the measurement and treatment procedures before the beginning of the treatment.

    All participants will be asked to be cooperating with treatment program.

  2. Application phase:

Mirror therapy :

A Mirror box will be used to easily create illusion. It' is a box with one mirror in the center where on each side of it, the hands are placed in a manner that the affected limb is kept covered always and the unaffected limb is kept on the other side whose reflection can be seen on the mirror.

Mirror therapy will be performed for 30 min 3 times per week for 8 weeks

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Egypt
      • Giza, Egypt
        • Recruiting
        • Cairo University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Age 20-45 Males and females Flexor tendons repair All patients enrolled to the study will have their informed consent.

Exclusion Criteria:

Open fractures Associated vascular injury Cruch injuries Cognitive disorders

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Study group (A)
Study group (A):15 patient received traditional physical therapy program in addition to motor imagery in form of mirror therapy.
Other: mirror therapy
A Mirror box will be used to easily create illusion. It' is a box with one mirror in the center where on each side of it, the hands are placed in a manner that the affected limb is kept covered always and the unaffected limb is kept on the other side whose reflection can be seen on the mirror.
Experimental: Study group (B)
Study group (B):15 patient received traditional physical therapy program only.
Other: traditional physiotherapy protocol for flexor tendon repair
include stretching exercises and active ROM exercises

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Active ROM
Time Frame: 8 weeks
Active ROM of the finger with repaired tendon using Standard geniometer
8 weeks
Hand function
Time Frame: 8 weeks
Hand function using Michigan Hand Questionnaire
8 weeks
pain assessment
Time Frame: 8 weeks
pain assessment using Visual analog scale
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 5, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 22, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 21, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 27, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 3, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P.T.REC/012/003533

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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