The Investigation of the Effect of Two Methods of Early Active and Passive Motion on Hand Function and Satisfaction in Patients with Flexor Tendon Injury in Zone 1 and 2
Comparison of the effect of Two Methods of Early Active and Passive Motion on Hand Function and Satisfaction in Patients with Flexor Tendon Injury in Zone 1and 2
Design
30 patients with flexor tendon injury in zone 1 and 2 who have criteria for entering the study will be included in the study and will be randomly assigned to one of the two early active motion or early passive motion groups. The sample size will be 15 people per group.
Settings and conduct
This study is an experimental randomized clinical trial in which patients with flexor tendon zone 1 and 2 who have performed their medical (surgical) operations in Hazrat Fatemeh Hospital in Tehran have been studied and then randomization will be placed in one of the two groups of early active motion and early premature motion. The Strickland protocol will be implemented for the early active movement group and the modified Duran protocol for the early passive motion group. Interventions and evaluations will be done in the hospital.
Participants/Inclusion and exclusion criteria
Restoration of flexor tendon in zone 1 and 2; passing of time 4 to 2 days after surgery; similar surgery method; 12 year old calendar; non fracture and extensor tendon injury in the same finger; initial tendon repair; cognitive test score MMSE 21 or higher; Lack of psychological problems; lack of neurological and orthopedic diseases;Person's willingness to work together
Intervention groups
An early active motion group will use the Strickland protocol. And in the early passive motion group is used the modified Duran protocol.
Main outcome variables
hand function;satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150721023277N7
Registration date:2018-08-14, 1397/05/23
Registration timing:registered_while_recruiting
Last update:2018-08-14, 1397/05/23
Update count:0
Registration date
2018-08-14, 1397/05/23
Registrant information
Name
Laleh Lajevardi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 8051
Email address
lajevardi.l@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-01, 1397/05/10
Expected recruitment end date
2019-03-01, 1397/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Investigation of the Effect of Two Methods of Early Active and Passive Motion on Hand Function and Satisfaction in Patients with Flexor Tendon Injury in Zone 1 and 2
Public title
The Investigation of the Effect of Two Methods of Early Active and Passive Motion in flexor tendon injury in zone 1and 2
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Sharp tendon injuries
Time lapse 4-2 days after surgery
restoration of flexor tendon in Zone 1 and 2
Age 12 years old
Not having injuries (fracture in the same limb, extensor tendon damage on the same finger)
Not having psychological problems (problems that cause not cooperating with the implementation of therapeutic protocols)
Having an acceptable level of cognitive performance, 21 or higher, in the Mini Mental Status Examination (MMSE)
The initial repair of the tendon without the need for a transfer or graft tendon
Not having a neurological disease (stroke, dementia, Parkinson, etc.) and orthopedic (arthritis and ...)
Similar restoration method
Exclusion criteria:
Unwillingness to continue cooperation
Age
From 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, simple randomization by individuals will be used based on table of random number.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is designed as double-blind in which participants and assessor are not aware of being in control or intervention group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
School of Rehabilitation, Shahid Shahnazari Street, Madar Square, Mirdamad Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
15459-13487
Approval date
2017-10-27, 1396/08/05
Ethics committee reference number
IR.IUMS.FMD.REC 1396.9511355005
Health conditions studied
1
Description of health condition studied
Flexor tendon injury in zone 1and 2
ICD-10 code
M66.3
ICD-10 code description
Spontaneous rupture of flexor tendons
Primary outcomes
1
Description
Score of hand function in Michigan hand outcomes questionnaire (MHQ)
Timepoint
Measure hand function at the beginning of the study (before the intervention), 8 weeks after intervention and after follow up (4 weeks)
Method of measurement
Michigan hand outcomes questionnaire (MHQ) to measure the hand function.
2
Description
Satisfaction in activity of daily living in the Canadian Occupational Performance Measure
Timepoint
Measuring satisfaction degree in activity of daily living at the beginning of the study (before the intervention), 8 weeks after the intervention and after follow up (4 weeks)
Method of measurement
Canadian Occupational Performance Measure Inventory to measure satisfaction in activity of daily living.
Secondary outcomes
1
Description
Scale of range of motion from goniometer
Timepoint
Measuring the range of motion at the beginning of the study (before the intervention), 8 weeks after the start of the intervention and after the follow up (4 weeks)
Method of measurement
Goniometer to measure the range of motion
2
Description
Score the pain of the scale of the Visual Analogue Scale
Timepoint
Pain measurements at the beginning of the study (before the intervention), 8 weeks after the start of the intervention and after the follow up (4 weeks)
Method of measurement
Visual Analogue Scale to measure pain
3
Description
Disability Score in the Disability of the Arm, Shoulder and Hand Questionnaire
Timepoint
Measurement of disability at the beginning of the study (before the intervention), 8 weeks after the start of the intervention and after the follow-up period (4 weeks)
Method of measurement
Questionnaire for disability of the arm, shoulder and hand outcome questionnaire to measure disability
4
Description
Scale of gross motor performance in Box and Blocks test
Timepoint
Measurement of gross motor function 8 weeks after the start of the intervention and after the follow-up period (4 weeks)
Method of measurement
Box and Blocks test to measure gross motor performance
5
Description
Fine motor performance score in Purdue Pegboard Test
Timepoint
Measurement of fine motor function 8 weeks after the start of the intervention and after the follow-up period (4 weeks)
Method of measurement
Purdue pegboard test to measure fine motor performance
6
Description
Score of grasp power from dynamometer
Timepoint
Measuring the grasp power 8 weeks after the start of the intervention and after the follow-up period (4 weeks)
Method of measurement
Dynamometer to measure grasp power
7
Description
Score of Power pinch of pinch gauge
Timepoint
Measure the power of the pinch 8 weeks after the start of the intervention and after the follow up (4 weeks)
Method of measurement
Pinch gauge to measure pinch power
Intervention groups
1
Description
Intervention group: The clients will be referred to the occupational therapist within 24-24 hours after surgery. In this group, regular rehabilitation programs and the Strickland protocol will be implemented. The treatment sessions will be performed by the therapist for 45 minutes, 3 days a week for 8 weeks. In this method, two splints are used: 1: Dorsal Block Splint, which is made of plaster, and wrist joint in 20 degrees of flexion, metacarpophalangeal at 50 degrees of flexion and interphalangeal in the extension and most of the time, 2: Splint is a thermoplastic training. The ankle part is hinged and allows full flexion to the wrist, metacarpophalangeal and interphalangeal joints, but limits the wrist at 30 degrees of extension, metacarpophalangeal at 60 degrees and interphalangeal at 25 degrees of flexion. Week 4-0: Every hour the exercises will be performed by 15 times repetitive exercises in splint Dorsal Block and the flexion Place and Hold practice with 15 repetitions in splint, These exercises will be presented in writing and videos recorded for them at home. Week 8-4: splint training will be lifted, but splint Dorsal Block will be covered except during training, and exercises will be done every 2 hours. At 6-5 weeks, the blocking and hook fist exercises will be performed. 7-8 weeks of progressive resistance exercises and daily routine activities will be added. At week 14, complete resistance exercises and heavy daily activities will be performed.
Category
Rehabilitation
2
Description
Intervention group: Intervention group: The client will be referred to the occupational therapist within 24-24 hours after surgery. A therapist will be performed a traditional rehabilitation program modified Duran protocol of 40 minutes, three days per week, for eight weeks. In this group, a dorsal block splint will be used, which will place the wrist joint at 20 ° flexion and metacarpophalangeal at 50 ° flexion and allowing the interphalangeal joints to be fully extended. At week 0-3, the client each hour will carry out the joints passive flexion and active extensions exercises . Week 5-4: In addition to the previous exercises active wrist movements are performed , week 7-6:Light activities of daily living and blocking exercises will be added.Progressive resistance exercises will begin from the 8 week. In addition, these exercises will be provided in writing and videos recorded to perform at home.
School of Rehabilitation, Shahid Shahnazari Street, Madar Square, Mirdamad Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
15459-13487
Phone
+98 21 2222 8051
Email
Lajevardi.l@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Laleh Lajevardi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
School of Rehabilitation, Shahid Shahnazari Street, Madar Square, Mirdamad Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
15459-13487
Phone
+98 21 2222 8051
Email
lajevardi.l@iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Iran University of Medical Sciences
Position
Laleh Lajevardi
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
School of Rehabilitation, Shahid Shahnazari Street, Madar Square, Mirdamad Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
15459-13487
Phone
+98 21 2222 8051
Email
lajevardi.l@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Laleh Lajevardi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Occupational Therapy
Street address
School of Rehabilitation, Shahid Shahnazari Street, Madar Square, Mirdamad Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
15459-13487
Phone
+98 21 2222 8051
Email
lajevardi.l@iums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
playgerism
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Information on the primary and secondary outcome measures
When the data will become available and for how long
After publishing the articles
To whom data/document is available
Researchers intending to research in this field.
Under which criteria data/document could be used
Obtaining written permission from the research team - Mention the source of information
From where data/document is obtainable
Mina Khosravi: School of Rehabilitation, Shahid Shahnazari Street, Madar Square, Mirdamad Blvd, Tehran. Email Adress: khosravi.mina73@gmail.com -Dr. Laleh Lajevardi: School of Rehabilitation, Shahid Shahnazari Street, Madar Square, Mirdamad Blvd, Tehran. Email Adress: Lajevardi.l@iums.ac.i
What processes are involved for a request to access data/document
After sending the email to the researcher and requesting the document, the researcher will request the opinion of other members of the research team regarding the provision of this information and, if the members agree, the documents will be sent as soon as possible but sending the documents requires the acceptance of the criteria mentioned above.