Hand Tendon InjuryNCT05347940
EFFICACY OF MIRROR THERAPY IN IMPROVING HAND FUNCTION POST FLEXOR TENDON REPAIR
A study testing mirror therapy and traditional physiotherapy protocol for flexor tendon repair in people with Hand Tendon Injury, run by Cairo University at 2 sites in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 to 45 years
- Conditions the study is for
- Hand Tendon Injury
- What is being tested?
- mirror therapy and traditional physiotherapy protocol for flexor tendon repair
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesEgypt
- Study dates
- 5 Jun 2022to 30 Jul 2022
- 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 20 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 20-45 Males and females Flexor tendons repair All patients enrolled to the study will have their informed consent.
Who cannot join
- Open fractures Associated vascular injury Cruch injuries Cognitive disorders
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Cairo University
Giza
intsar salem waked, 00201060832268, intsarswaked@cu.edu
- Recruiting
Cairo university
Giza
Ahmed Mohamed Nagy, 00201285237368, amnagy@msa.edu.eg
About this study
This current study will be designed to prove the therapeutic effect of mirror therapy on physical function of the hand after flexor tendon repair
Read the 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
- Conditions
- Hand Tendon Injury
- Being tested
- mirror therapy, traditional physiotherapy protocol for flexor tendon repair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mirror therapyOther
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.
traditional physiotherapy protocol for flexor tendon repairOther
include stretching exercises and active ROM exercises
| Study group | Role | What they receive |
|---|---|---|
| Study group (A) | Experimental | Study group (A):15 patient received traditional physical therapy program in addition to motor imagery in form of mirror therapy. Receives: Other: mirror therapy |
| Study group (B) | Experimental | Study group (B):15 patient received traditional physical therapy program only. Receives: Other: traditional physiotherapy protocol for flexor tendon repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Active ROM
Active ROM of the finger with repaired tendon using Standard geniometer
Measured: 8 weeks
Hand function
Hand function using Michigan Hand Questionnaire
Measured: 8 weeks
pain assessment
pain assessment using Visual analog scale
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study start5 Jun 2022 (estimated)
- Primary completion22 Jul 2022 (estimated)
- Study completion30 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand Tendon InjuryStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ahmed mohamed nagy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05347940
- Sponsor's protocol ID
- P.T.REC/012/003533
- Status last verified
- Jun 2022
- First submitted
- 21 Apr 2022
- Last updated
- 3 Jun 2022
- Results posted
- No
- 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 3 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFICACY OF MIRROR THERAPY IN IMPROVING HAND FUNCTION POST FLEXOR TENDON REPAIR
- ClinicalTrials.gov ID
- NCT05347940
- Acronym / sponsor ID
- P.T.REC/012/003533
- Conditions
- Hand Tendon Injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 5 Jun 2022 (estimated)
- Primary completion
- 22 Jul 2022 (estimated)
- Study completion
- 30 Jul 2022 (estimated)
- First posted
- 27 Apr 2022 (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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Study group (A) | Experimental | Other: mirror therapyStudy group (A):15 patient received traditional physical therapy program in addition to motor imagery in form of mirror therapy. |
| Study group (B) | Experimental | Other: traditional physiotherapy protocol for flexor tendon repairStudy group (B):15 patient received traditional physical therapy program only. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Age 20-45 Males and females Flexor tendons repair All patients enrolled to the study will have their informed consent.
Key exclusion criteria (1 listed)
- Open fractures Associated vascular injury Cruch injuries Cognitive disorders
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 |
|---|---|---|
| mirror therapyA 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. | Other | Study group (A) |
| traditional physiotherapy protocol for flexor tendon repairinclude stretching exercises and active ROM exercises | Other | Study group (B) |
Primary outcome
Active ROM
Time frame: 8 weeks
Active ROM of the finger with repaired tendon using Standard geniometer
Hand function
Time frame: 8 weeks
Hand function using Michigan Hand Questionnaire
pain assessment
Time frame: 8 weeks
pain assessment using Visual analog scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2022.
- Individual participant dataSharing planned: No
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3D Hand Orthosis Trial
Hand Injuries and Disorders, Neurological Conditions
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Effects of Different Wrist Positions in Dorsal Blocking Orthoses After Flexor Tendon Repair
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Vibratory Anesthesia on Pain Following Corticosteroid Injections
Bilateral Arthritis of Wrist, Tendinopathy
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mirror therapy and traditional physiotherapy protocol for flexor tendon repair in people with Hand Tendon Injury, run by Cairo University at 2 sites in Egypt.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 3 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact intsar salem waked (00201060832268, intsarswaked@cu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Active ROM (time frame: 8 weeks). The study lists 3 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 3 Jun 2022.