EFFICACY OF MIRROR THERAPY IN IMPROVING HAND FUNCTION POST FLEXOR TENDON REPAIR
Primary Purpose
Hand Tendon Injury
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
mirror therapy
traditional physiotherapy protocol for flexor tendon repair
Sponsored by
About this trial
This is an interventional treatment trial for Hand Tendon Injury
Eligibility Criteria
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
Sites / Locations
- Cairo UniversityRecruiting
- Cairo universityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Study group (A)
Study group (B)
Arm Description
Study group (A):15 patient received traditional physical therapy program in addition to motor imagery in form of mirror therapy.
Study group (B):15 patient received traditional physical therapy program only.
Outcomes
Primary Outcome Measures
Active ROM
Active ROM of the finger with repaired tendon using Standard geniometer
Hand function
Hand function using Michigan Hand Questionnaire
pain assessment
pain assessment using Visual analog scale
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05347940
Brief Title
EFFICACY OF MIRROR THERAPY IN IMPROVING HAND FUNCTION POST FLEXOR TENDON REPAIR
Official Title
EFFICACY OF MIRROR THERAPY IN IMPROVING HAND FUNCTION POST FLEXOR TENDON REPAIR
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 5, 2022 (Anticipated)
Primary Completion Date
July 22, 2022 (Anticipated)
Study Completion Date
July 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This current study will be designed to prove the therapeutic effect of mirror therapy on physical function of the hand after 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:
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.
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:
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hand Tendon Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study group (A)
Arm Type
Experimental
Arm Description
Study group (A):15 patient received traditional physical therapy program in addition to motor imagery in form of mirror therapy.
Arm Title
Study group (B)
Arm Type
Experimental
Arm Description
Study group (B):15 patient received traditional physical therapy program only.
Intervention Type
Other
Intervention Name(s)
mirror therapy
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
traditional physiotherapy protocol for flexor tendon repair
Intervention Description
include stretching exercises and active ROM exercises
Primary Outcome Measure Information:
Title
Active ROM
Description
Active ROM of the finger with repaired tendon using Standard geniometer
Time Frame
8 weeks
Title
Hand function
Description
Hand function using Michigan Hand Questionnaire
Time Frame
8 weeks
Title
pain assessment
Description
pain assessment using Visual analog scale
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
intsar salem waked
Phone
00201060832268
Email
intsarswaked@cu.edu
Facility Information:
Facility Name
Cairo University
City
Giza
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
intsar salem waked
Phone
00201060832268
Email
intsarswaked@cu.edu
Facility Name
Cairo university
City
Giza
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed Mohamed Nagy
Phone
00201285237368
Email
amnagy@msa.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
No
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EFFICACY OF MIRROR THERAPY IN IMPROVING HAND FUNCTION POST FLEXOR TENDON REPAIR
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