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

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: Recruiting
• Conditions: Hand Tendon Injury
• Intervention / Treatment: Other: mirror therapy; Other: traditional physiotherapy protocol for flexor tendon repair

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: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: intsar salem waked; Phone Number: 00201060832268; Email: intsarswaked@cu.edu

Study Locations

• Egypt
  • Giza, Egypt
    • Recruiting
    • Cairo University
    • Contact: Ahmed Mohamed Nagy; Phone Number: 00201285237368; Email: amnagy@msa.edu.eg

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Active ROM	Active ROM of the finger with repaired tendon using Standard geniometer	8 weeks
Hand function	Hand function using Michigan Hand Questionnaire	8 weeks
pain assessment	pain assessment using Visual analog scale	8 weeks

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): June 5, 2022
• Primary Completion (Anticipated): July 22, 2022
• Study Completion (Anticipated): July 30, 2022

Study Registration Dates

• First Submitted: April 21, 2022
• First Submitted That Met QC Criteria: April 21, 2022
• First Posted (Actual): April 27, 2022

Study Record Updates

• Last Update Posted (Actual): June 3, 2022
• Last Update Submitted That Met QC Criteria: June 1, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Tendon Injuries
• Other Study ID 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