Hand FracturesNCT01503762
Mirror Therapy and Hand Rehabilitation
A study testing Mirror therapy and Classical rehabilitation techniques in people with Hand Fractures, run by Ahvaz Jundishapur University of Medical Sciences at 1 site in Iran.
Trial summary
Objective: The purpose of this study is to determine effects of mirror therapy in restoring hand function in patients with flexor lag following orthopedic injuries. Methods: In a prospective randomized controlled trial, 22 patients with Flexor Lag will be measured. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hand Fractures
- What is being tested?
- Mirror therapy and Classical rehabilitation techniques
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteIran
- Study dates
- Jan 2009to Dec 2011
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- hand orthopedic Injuries
- more active range of motion than passive range of motion
Who cannot join
- crush injuries
- hand deformities
- not treated fractures and tendon ruptures
- complex regional pain syndrome
- psychiatric problems
Trial locations and contacts
1 site in 1 country.
Iran1 site
Musculoskeletal Rehabilitation Research Center, Ahvaz Jundishapur university of medical sciences
Ahvāz, Khouzestan
About this study
Official title: Mirror Therapy in Patients With Hand Orthopedic Disorders
Objective: The purpose of this study is to determine effects of mirror therapy in restoring hand function in patients with flexor lag following orthopedic injuries.
Methods: In a prospective randomized controlled trial, 22 patients with Flexor Lag will be measured. Intervention group will receive mirror therapy, 30-minute a day, 5 days a week for 3-week, as well, half an hour conventional rehabilitation after each mirror therapy session. Patients in the control group will receive the same treatment program, but instead of mirror, they will directly observe the affected hand. Outcome measures including Total Active Motion (TAM), and Disabilities of Arm, Shoulder and Hand (DASH) questionnaire will be administered before and after the treatment period and 3 weeks after the final treatment session.
- Conditions
- Hand Fractures
- Being tested
- Mirror therapy, Classical rehabilitation techniques
- Keywords
- Hand Flexor tendon Injuries, hand Extensor Tendon Injuries, Hand Joint Dislocations and subluxation
- Medical subject headings
- Joint Dislocations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mirror therapyOther
mirror therapy
Classical rehabilitation techniquesOther
splinting, tendon gliding, active range of motion, activities of daliy living
| Study group | Role | What they receive |
|---|---|---|
| Mirror Therapy Group | Experimental | Mirror Therapy Group Receives: Other: Mirror therapy |
| Control Group | Sham comparator | Control Group receive classical rehabilitation techniques including splinting, tendon gliding, ... Receives: Other: Classical rehabilitation techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Active Motion
Sum of Range of Motion in Metacarpophalangeal, Proximal Interphalangeal and Distal Interphalangeal Joints.
Measured: 6 Weeks
Secondary outcomes (1)
Disabilities of the Shoulder, Arm, hand
Measured: 6 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2012 (estimated)
- Study startJan 2009
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hand FracturesStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahvaz Jundishapur University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hamid Reza Rostami, Ahvaz Jundishapur University of Medical Sciences
- Investigators
- Hamid Reza Rostami, Principal investigator, Ahvaz Jundishapur University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01503762
- Sponsor's protocol ID
- pht-9006
- Status last verified
- Feb 2012
- First submitted
- 4 Dec 2011
- Last updated
- 28 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rostami HR, Arefi A, Tabatabaei S. Effect of mirror therapy on hand function in patients with hand orthopaedic injuries: a randomized controlled trial. Disabil Rehabil. 2013 Sep;35(19):1647-51. doi: 10.3109/09638288.2012.751132. Epub 2013 Jan 22.
PubMed 23336124
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mirror Therapy in Patients With Hand Orthopedic Disorders
- ClinicalTrials.gov ID
- NCT01503762
- Acronym / sponsor ID
- pht-9006
- Conditions
- Hand Fractures
- Keywords
- Hand Flexor tendon Injuries, hand Extensor Tendon Injuries, Hand Joint Dislocations and subluxation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Ahvaz Jundishapur University of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 4 Jan 2012 (estimated)
- 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.
Objective: The purpose of this study is to determine effects of mirror therapy in restoring hand function in patients with flexor lag following orthopedic injuries.
Methods: In a prospective randomized controlled trial, 22 patients with Flexor Lag will be measured. Intervention group will receive mirror therapy, 30-minute a day, 5 days a week for 3-week, as well, half an hour conventional rehabilitation after each mirror therapy session. Patients in the control group will receive the same treatment program, but instead of mirror, they will directly observe the affected hand. Outcome measures including Total Active Motion (TAM), and Disabilities of Arm, Shoulder and Hand (DASH) questionnaire will be administered before and after the treatment period and 3 weeks after the final treatment session.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mirror Therapy Group | Experimental | Other: Mirror therapyMirror Therapy Group |
| Control Group | Sham comparator | Other: Classical rehabilitation techniquesControl Group receive classical rehabilitation techniques including splinting, tendon gliding, ... |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- hand orthopedic Injuries
- more active range of motion than passive range of motion
Key exclusion criteria (5 listed)
- crush injuries
- hand deformities
- not treated fractures and tendon ruptures
- complex regional pain syndrome
- psychiatric problems
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 therapymirror therapy | Other | Mirror Therapy Group |
| Classical rehabilitation techniquessplinting, tendon gliding, active range of motion, activities of daliy living | Other | Control Group |
Primary outcome
Total Active Motion
Time frame: 6 Weeks
Sum of Range of Motion in Metacarpophalangeal, Proximal Interphalangeal and Distal Interphalangeal Joints.
1 secondary outcome
Disabilities of the Shoulder, Arm, hand
Time frame: 6 Weeks
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 28 Feb 2012.
- Derived from this study: PubMed 23336124Rostami HR, Arefi A, Tabatabaei S. Effect of mirror therapy on hand function in patients with hand orthopaedic injuries: a randomized controlled trial. Disabil Rehabil. 2013 Sep;35(19):1647-51. doi: 10.3109/09638288.2012.751132. Epub 2013 Jan 22.
Related trials for Hand Fractures
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Repair of Extra-articular Fractures of the Metacarpals and First Phalanges of the Long Fingers
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Comparing Pre-adaptation of In-stock Mesh Over In-house 3D Patient Specific Model to Reconstruct Unilateral Primary Orbital Fracture With and Without Intraoperative Navigation vs Conventional Intraoperative Free-hand Mesh Bending
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Lipofilling in Operative Hand Fracture Treatment
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Early Functional Response as a Predictor of Clinical Outcomes in Hand Rehabilitation: A Prospective Feasibility Study Using a Digital Monitoring System
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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.
Hamid Reza Rostami principal investigator
Ahvaz Jundishapur University of Medical Sciences
1 site 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 Classical rehabilitation techniques in people with Hand Fractures, run by Ahvaz Jundishapur University of Medical Sciences at 1 site in Iran.
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 2 inclusion and 5 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 28 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. 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. Some participants in this study may receive a placebo. 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?
Total Active Motion (time frame: 6 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01503762, which also lists 1 linked publication.
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 28 Feb 2012.