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Hand Injury Patients Receiving Different Rehabilitation Programs

Primary Purpose

Hand Injury

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
custom-made dynamic hand splint
custom-made protective hand splint
physical therapy and occupational therapy
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hand Injury focused on measuring rehabilitation, functional MRI

Eligibility Criteria

15 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The patients have a hand trauma injury after operation (< 3 months)

Exclusion Criteria:

  • previous history of hand injury
  • infection disease; arthritis
  • systemic neuromuscular disease
  • single tendon injury.
  • central nerve system disorder

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Experimental

    Arm Label

    Immobilization programs

    Kleinert programs

    Arm Description

    custom-made protective hand splint physical therapy and occupational therapy

    custom-made dynamic hand splint physical therapy and occupational therapy

    Outcomes

    Primary Outcome Measures

    change from baseline in motor function
    QuickDASH quesrtionnaire for upper extremity

    Secondary Outcome Measures

    Functional MRI
    "GE" Nuclear Magnetic Resonance Imaging System GE Medical Systems, LLC
    wrist pain
    visual analog scale
    wrist sensory
    light touch, pin prick, position sense
    wrist range of motion
    goniometer

    Full Information

    First Posted
    December 16, 2014
    Last Updated
    July 22, 2018
    Sponsor
    Chang Gung Memorial Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02465840
    Brief Title
    Hand Injury Patients Receiving Different Rehabilitation Programs
    Official Title
    The Functional Outcome and Brain Functional MRI of Hand Injury Patients After Different Rehabilitation Programs
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2016 (Actual)
    Primary Completion Date
    December 31, 2017 (Actual)
    Study Completion Date
    December 31, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Chang Gung Memorial Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Hand injury is one of common occupational or traumatic injury at outpatient clinic of rehabilitation department. The motor or sensory deficits after hand trauma including bony fracture,tendon / nerve injury, joint stiffness, motion restriction, sensory impairment, or pain lead to impaired upper extremity function, ability for daily activity, or quality of life. Rehabilitation is a kind of therapy for disability after hand trauma. It could provide pain control, improvement of joint motion, stiffness reduction, preventing secondary trauma. The investigators consider that there are some deficits in hand function and range of motion, pain after injury, and some attenuation of brain functional MRI (fMRI) for hand motor control. Therefore, optimal and early intervention of rehabilitation programs may have some benefits for their hand functional outcome and improve the brain activities in fMRI images for the hand motor control. The aims of this study are to compare the differences in hand motor control area of brain functional MRI (fMRI) between normal subjects and hand injury patients before treatment and to investigate the improvement in brain fMRI activity and functional outcome after early rehabilitation in hand injury patients. The investigators will collect 40 patients with hand trauma after operation and 10 normal subjects in this study. The 10 normal subjects were allocated in the control group. These 40 patients were randomly divided into 2 experimental groups: 20 patients in group A and 20 patients in group B. In group A and B, the patients will perform immobilization and Kleinert programs respectively. All patients will perform rehabilitation regimen with 2-3 sessions per week for 3-6 months. Before and after rehabilitation, all patients will receive physical examinations, brain fMRI, and DASH questionnaire for daily activity.
    Detailed Description
    Rehabilitation regimen is a noninvasive therapy for hand injured patients after operation. Protected active/passive motion is the mostly used method. Rehabilitation therapy could provide pain control, improvement of joint motion, stiffness reduction, preventing secondary trauma. The investigators will collect 40 patients with hand trauma after operation and 10 normal subjects in this study. These 40 patients were divided into 2 experimental groups: 20 patients in group A ( immobilization program) and 20 patients in group B (Kleinert program). A.The immobilization program 0-4 week: dorsal prospective splint in the wrist and MCP joint flexion and IP joint full extension. 3-4 weeks: Hourly: 10 repetitions of passive digital flexion and extension with wrist at 10゚extension. Hourly: 10 repetitions of active tendon gliding exercises. 4-6 weeks: dorsal blocking splint discontinued. Gentle blocking exercises initiated 10 repetitions, 4-6 times daily added to passive flexion and tendon gliding. 6-8 weeks: gentle resistive exercise being and progresses gradually. B.The Kleinert program 0-3 day: dorsal protective splint applied with wrist and MCP joints in flexion and IP joints in full extension; elastic traction from fingernail, through palmar pulley, to volar forearm. Velcro strap to allow night release of elastic traction, splinting IPs in full extension. 0-4 weeks: hourly active extension to limits of splint, followed by flexion with elastic traction only. Wound and scar management and education. 4-6 weeks: dorsal protective splint discontinued, sometimes replaced with wrist cuff and elastic traction. Night protective splint to prevent flexion contracture. Active wrist and gentle active fisting initiated unless signs of minimal adhesions. At 6 weeks blocking exercises begin. 6-8 weeks: progressive resistive exercises begin. The investigators will perform the physical examination, brain fMRI, and QuickDASH questionnaire for each patient before the program, 3 and 6 months later. Functional magnetic resonance imaging (fMRI) will be also performed in normal participants. All patients will perform rehabilitation with 2-3 sessions per week. The investigators will perform the physical examination, brain fMRI, and QuickDASH questionnaire for each patient before the program, 3 and 6 months later. Functional magnetic resonance imaging (fMRI) will be also performed in normal participants.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hand Injury
    Keywords
    rehabilitation, functional MRI

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Non-Randomized
    Enrollment
    11 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Immobilization programs
    Arm Type
    Placebo Comparator
    Arm Description
    custom-made protective hand splint physical therapy and occupational therapy
    Arm Title
    Kleinert programs
    Arm Type
    Experimental
    Arm Description
    custom-made dynamic hand splint physical therapy and occupational therapy
    Intervention Type
    Procedure
    Intervention Name(s)
    custom-made dynamic hand splint
    Other Intervention Name(s)
    Dynamic splint
    Intervention Description
    custom-made dynamic splinting with more early active exercises intervention.
    Intervention Type
    Procedure
    Intervention Name(s)
    custom-made protective hand splint
    Other Intervention Name(s)
    resting hand splint
    Intervention Description
    Immobilization splint with gentle ROM exercises
    Intervention Type
    Other
    Intervention Name(s)
    physical therapy and occupational therapy
    Intervention Description
    both the immobilization and Kleinert programs including physical therapy and occupational therapy for 2-3 times per week.
    Primary Outcome Measure Information:
    Title
    change from baseline in motor function
    Description
    QuickDASH quesrtionnaire for upper extremity
    Time Frame
    baseline, three months and six months
    Secondary Outcome Measure Information:
    Title
    Functional MRI
    Description
    "GE" Nuclear Magnetic Resonance Imaging System GE Medical Systems, LLC
    Time Frame
    baseline, three months and six months
    Title
    wrist pain
    Description
    visual analog scale
    Time Frame
    baseline, three months and six months
    Title
    wrist sensory
    Description
    light touch, pin prick, position sense
    Time Frame
    baseline, three months and six months
    Title
    wrist range of motion
    Description
    goniometer
    Time Frame
    baseline, three months and six months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    15 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: The patients have a hand trauma injury after operation (< 3 months) Exclusion Criteria: previous history of hand injury infection disease; arthritis systemic neuromuscular disease single tendon injury. central nerve system disorder
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Huang Yu Chi, Bachelor
    Organizational Affiliation
    Chang Gung Memorial Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    no available now
    Citations:
    PubMed Identifier
    15882604
    Citation
    Vucekovich K, Gallardo G, Fiala K. Rehabilitation after flexor tendon repair, reconstruction, and tenolysis. Hand Clin. 2005 May;21(2):257-65. doi: 10.1016/j.hcl.2004.11.006.
    Results Reference
    background
    PubMed Identifier
    21187807
    Citation
    Chesney A, Chauhan A, Kattan A, Farrokhyar F, Thoma A. Systematic review of flexor tendon rehabilitation protocols in zone II of the hand. Plast Reconstr Surg. 2011 Apr;127(4):1583-1592. doi: 10.1097/PRS.0b013e318208d28e.
    Results Reference
    background
    Citation
    Karen Pettengill, MS, OTR/L, CHT, Gwendolyn Van Strien, LPT, MSC. Postoperative Management of Flexor Tendon Injuries
    Results Reference
    background
    Citation
    Diane Cifaldi Collins, Laurie Schwarze, Early progressive resistance following immobilization of flexor tendon repairs. July-September 1991, Pages 111-116
    Results Reference
    background
    Citation
    Duran RJ, House RG. Controlled passive motion following flexor tendon repairs in zone 2and 3. In: American Academy of Orthopedic Surgeons: Symposium on Tendon Surgery in the Hand. St. Louis : CV Mosby Co.; 1975
    Results Reference
    background
    PubMed Identifier
    9811004
    Citation
    Iwuagwu FC, McGrouther DA. Early cellular response in tendon injury: the effect of loading. Plast Reconstr Surg. 1998 Nov;102(6):2064-71. doi: 10.1097/00006534-199811000-00038.
    Results Reference
    background
    PubMed Identifier
    8124441
    Citation
    Evans RB, Thompson DE. The application of force to the healing tendon. J Hand Ther. 1993 Oct-Dec;6(4):266-84. doi: 10.1016/s0894-1130(12)80328-0.
    Results Reference
    background
    Citation
    Bunnell S. Repair of nerves and tendons of the hand. J Bone Joint Surg 1928; 10:1
    Results Reference
    background
    PubMed Identifier
    20516313
    Citation
    Trumble TE, Vedder NB, Seiler JG 3rd, Hanel DP, Diao E, Pettrone S. Zone-II flexor tendon repair: a randomized prospective trial of active place-and-hold therapy compared with passive motion therapy. J Bone Joint Surg Am. 2010 Jun;92(6):1381-9. doi: 10.2106/JBJS.H.00927.
    Results Reference
    background
    PubMed Identifier
    15882599
    Citation
    Tang JB. Clinical outcomes associated with flexor tendon repair. Hand Clin. 2005 May;21(2):199-210. doi: 10.1016/j.hcl.2004.11.005.
    Results Reference
    background
    PubMed Identifier
    24341058
    Citation
    Hundozi H, Murtezani A, Hysenaj V, Hysenaj V, Mustafa A. Rehabilitation after surgery repair of flexor tendon injuries of the hand with Kleinert early passive mobilization protocol. Med Arch. 2013;67(2):115-9. doi: 10.5455/medarh.2013.67.115-119.
    Results Reference
    background
    PubMed Identifier
    17298858
    Citation
    Tang JB. Indications, methods, postoperative motion and outcome evaluation of primary flexor tendon repairs in Zone 2. J Hand Surg Eur Vol. 2007 Apr;32(2):118-29. doi: 10.1016/J.JHSB.2006.12.009. Epub 2007 Feb 12.
    Results Reference
    background
    PubMed Identifier
    4598164
    Citation
    Kleinert HE, Kutz JE, Atasoy E, Stormo A. Primary repair of flexor tendons. Orthop Clin North Am. 1973 Oct;4(4):865-76. No abstract available.
    Results Reference
    background
    PubMed Identifier
    336675
    Citation
    Lister GD, Kleinert HE, Kutz JE, Atasoy E. Primary flexor tendon repair followed by immediate controlled mobilization. J Hand Surg Am. 1977 Nov;2(6):441-51. doi: 10.1016/s0363-5023(77)80025-7.
    Results Reference
    background
    PubMed Identifier
    3331174
    Citation
    Strickland JW. Flexor tendon injuries. Part 1. Anatomy, physiology, biomechanics, healing, and adhesion formation around a repaired tendon. Orthop Rev. 1986 Oct;15(10):632-45.
    Results Reference
    background
    PubMed Identifier
    12690845
    Citation
    Boyer MI, Strickland JW, Engles D, Sachar K, Leversedge FJ. Flexor tendon repair and rehabilitation: state of the art in 2002. Instr Course Lect. 2003;52:137-61.
    Results Reference
    background
    PubMed Identifier
    12015728
    Citation
    Angeles JG, Heminger H, Mass DP. Comparative biomechanical performances of 4-strand core suture repairs for zone II flexor tendon lacerations. J Hand Surg Am. 2002 May;27(3):508-17. doi: 10.1053/jhsu.2002.32619.
    Results Reference
    background
    PubMed Identifier
    12132086
    Citation
    Xie RG, Zhang S, Tang JB, Chen F. Biomechanical studies of 3 different 6-strand flexor tendon repair techniques. J Hand Surg Am. 2002 Jul;27(4):621-7. doi: 10.1053/jhsu.2002.34311.
    Results Reference
    background
    Citation
    Mandeville JB, Rosen BR. Functional MRI. In: Toga AW, MazziottaJC, editors. Brain mapping: the methods. 2nd ed. New York: Academic; 2002. p. 315-49
    Results Reference
    background
    PubMed Identifier
    16649202
    Citation
    Harel N, Ugurbil K, Uludag K, Yacoub E. Frontiers of brain mapping using MRI. J Magn Reson Imaging. 2006 Jun;23(6):945-57. doi: 10.1002/jmri.20576.
    Results Reference
    background
    PubMed Identifier
    10194013
    Citation
    McLarney E, Hoffman H, Wolfe SW. Biomechanical analysis of the cruciate four-strand flexor tendon repair. J Hand Surg Am. 1999 Mar;24(2):295-301. doi: 10.1053/jhsu.1999.0295.
    Results Reference
    background
    PubMed Identifier
    17315146
    Citation
    Van der Linden A, Van Camp N, Ramos-Cabrer P, Hoehn M. Current status of functional MRI on small animals: application to physiology, pathophysiology, and cognition. NMR Biomed. 2007 Aug;20(5):522-45. doi: 10.1002/nbm.1131.
    Results Reference
    background
    PubMed Identifier
    12942228
    Citation
    Rudin M, Mueggler T, Allegrini PR, Baumann D, Rausch M. Characterization of CNS disorders and evaluation of therapy using structural and functional MRI. Anal Bioanal Chem. 2003 Nov;377(6):973-81. doi: 10.1007/s00216-003-2170-0. Epub 2003 Aug 26.
    Results Reference
    background
    PubMed Identifier
    11347844
    Citation
    Tang JB, Wang B, Chen F, Pan CZ, Xie RG. Biomechanical evaluation of flexor tendon repair techniques. Clin Orthop Relat Res. 2001 May;(386):252-9. doi: 10.1097/00003086-200105000-00033.
    Results Reference
    background
    PubMed Identifier
    15542211
    Citation
    Sirotakova M, Elliot D. Early active mobilization of primary repairs of the flexor pollicis longus tendon with two Kessler two-strand core sutures and a strengthened circumferential suture. J Hand Surg Br. 2004 Dec;29(6):531-5. doi: 10.1016/j.jhsb.2004.07.002.
    Results Reference
    background
    PubMed Identifier
    12475505
    Citation
    Elliot D. Primary flexor tendon repair--operative repair, pulley management and rehabilitation. J Hand Surg Br. 2002 Dec;27(6):507-13. doi: 10.1054/jhsb.2002.0800. No abstract available.
    Results Reference
    background

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