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IRCT20150721023277N7 IRCT 2018-08-14 Iran University of Medical Sciences The Investigation of the Effect of Two Methods of Early Active and Passive Motion in flexor tendon injury in zone 1and 2 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 2018-08-01 anticipated 30 Complete https://irct.ir/trial/28585 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, simple randomization by individuals will be used based on table of random number, Blinding description: This study is designed as double-blind in which participants and assessor are not aware of being in control or intervention group. N/A Flexor tendon injury in zone 1and 2. Intervention 1: 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. Intervention 2: 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. No - There is not a plan to make this available Justification or reason for not sharing IPD is playgerism
public Laleh Lajevardi
School of Rehabilitation, Shahid Shahnazari Street, Madar Square, Mirdamad Blvd, Tehran
Tehran Iran (Islamic Republic of) 15459-13487 +98 21 2222 8051 lajevardi.l@iums.ac.ir Iran University of Medical Sciences scientific Iran University of Medical Sciences
School of Rehabilitation, Shahid Shahnazari Street, Madar Square, Mirdamad Blvd, Tehran
Tehran Iran (Islamic Republic of) 15459-13487 +98 21 2222 8051 lajevardi.l@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) 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 12 years no limit Both Unwillingness to continue cooperation M66.3 Spontaneous rupture of flexor tendons Rehabilitation Rehabilitation 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. Iran University of Medical Sciences Approved 2017-10-27 Ethics Committee of Iran University of Medical Sciences School of Rehabilitation, Shahid Shahnazari Street, Madar Square, Mirdamad Blvd, Tehran Tehran Tehran Iran (Islamic Republic of)