Hand Injury Patients Receiving Different Rehabilitation Programs

July 22, 2018 updated by: Chang Gung Memorial Hospital

The Functional Outcome and Brain Functional MRI of Hand Injury Patients After Different Rehabilitation Programs

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 70 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Immobilization programs
custom-made protective hand splint physical therapy and occupational therapy
Procedure: custom-made protective hand splint
Immobilization splint with gentle ROM exercises
Other Names:
  • resting hand splint
Other: physical therapy and occupational therapy
both the immobilization and Kleinert programs including physical therapy and occupational therapy for 2-3 times per week.
Experimental: Kleinert programs
custom-made dynamic hand splint physical therapy and occupational therapy
Other: physical therapy and occupational therapy
both the immobilization and Kleinert programs including physical therapy and occupational therapy for 2-3 times per week.
Procedure: custom-made dynamic hand splint
custom-made dynamic splinting with more early active exercises intervention.
Other Names:
  • Dynamic splint

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change from baseline in motor function
Time Frame: baseline, three months and six months
QuickDASH quesrtionnaire for upper extremity
baseline, three months and six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional MRI
Time Frame: baseline, three months and six months
"GE" Nuclear Magnetic Resonance Imaging System GE Medical Systems, LLC
baseline, three months and six months
wrist pain
Time Frame: baseline, three months and six months
visual analog scale
baseline, three months and six months
wrist sensory
Time Frame: baseline, three months and six months
light touch, pin prick, position sense
baseline, three months and six months
wrist range of motion
Time Frame: baseline, three months and six months
goniometer
baseline, three months and six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2016

Primary Completion (Actual)

December 31, 2017

Study Completion (Actual)

December 31, 2017

Study Registration Dates

First Submitted

December 16, 2014

First Submitted That Met QC Criteria

June 4, 2015

First Posted (Estimate)

June 9, 2015

Study Record Updates

Last Update Posted (Actual)

July 24, 2018

Last Update Submitted That Met QC Criteria

July 22, 2018

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMRPG8D0931

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

no available now

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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