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
About this trial
This is an interventional treatment trial for Hand Injury focused on measuring rehabilitation, functional MRI
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
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
NCT ID
NCT02465840
First Posted
December 16, 2014
Last Updated
July 22, 2018
Sponsor
Chang Gung Memorial Hospital
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
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Hand Injury Patients Receiving Different Rehabilitation Programs
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