Mirror Therapy and Hand Rehabilitation | NCT01503762

Studies
Mirror Therapy and Hand Rehabilitation

NCT01503762

Sponsor

Ahvaz Jundishapur University of Medical Sciences

Status

Completed

Last Update Posted

Feb 28, 2012Estimated

Enrollment

23Actual

Phase

Not Applicable

Conditions

Hand Fractures

Interventions

Mirror therapy
Classical rehabilitation techniques

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2009

Primary Completion Date

Dec 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

Dec 4, 2011

First Submission Date that Met QC Criteria

Jan 3, 2012

First Posted Date

Jan 4, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 27, 2012

Last Update Posted Date

Feb 28, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hamid Reza Rostami, Ms.C. Lecturer of Occupational Therapy Department, Ahvaz Jundishapur University of Medical SciencesPrincipal Investigator

Lead Sponsor

Ahvaz Jundishapur University of Medical SciencesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

23Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Mirror Therapy Group	Experimental	Mirror Therapy Group	Other: Mirror therapy
Control Group	Sham Comparator	Control Group receive classical rehabilitation techniques including splinting, tendon gliding, ...	Other: Classical rehabilitation techniques

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mirror therapy	Other	mirror therapy	Mirror Therapy Group
Classical rehabilitation techniques

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Total Active Motion	Sum of Range of Motion in Metacarpophalangeal, Proximal Interphalangeal and Distal Interphalangeal Joints.	6 Weeks

Secondary Outcomes

Measure	Description	Time Frame
Disabilities of the Shoulder, Arm, hand		6 Weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

hand orthopedic Injuries
more active range of motion than passive range of motion

Exclusion Criteria:

crush injuries
hand deformities
not treated fractures and tendon ruptures
complex regional pain syndrome
psychiatric problems

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hamid Reza Rostami	Ahvaz Jundishapur University of Medical Sciences	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Musculoskeletal Rehabilitation Research Center, Ahvaz Jundishapur university of medical sciences		Ahvāz	Khouzestan		Iran

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23336124	Derived	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.

ID	Term
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D014947	Wounds and Injuries

ID	Term
D026741	Physical Therapy Modalities
D012046	Rehabilitation
D013812	Therapeutics