Skip to main content
OpenTrials
Completed

NCT Number: NCT02465840

Hand Injury Patients Receiving 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

15 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

custom-made dynamic hand splint

Procedure

custom-made dynamic splinting with more early active exercises intervention.

Other names: Dynamic splint

custom-made protective hand splint

Procedure

Immobilization splint with gentle ROM exercises

Other names: resting hand splint

physical therapy and occupational therapy

Other

both the immobilization and Kleinert programs including physical therapy and occupational therapy for 2-3 times per week.

Primary outcomes

  1. change from baseline in motor function

    Time frame: baseline, three months and six months

    QuickDASH quesrtionnaire for upper extremity

Secondary outcomes

  1. Functional MRI

    Time frame: baseline, three months and six months

    "GE" Nuclear Magnetic Resonance Imaging System GE Medical Systems, LLC

  2. wrist pain

    Time frame: baseline, three months and six months

    visual analog scale

  3. wrist sensory

    Time frame: baseline, three months and six months

    light touch, pin prick, position sense

  4. wrist range of motion

    Time frame: baseline, three months and six months

    goniometer

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 9, 2015
Registry last updated
Jul 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.