Effects of Continuous Passive Motion on the Spinal Circuitries and Its Adaptation in Patients With Spasticity Resulting From Upper Motor Neuron Lesions

April 23, 2014 updated by: Ya-Ju Chang, Chang Gung University
In animal and human studies, histochemical and physiological evidences showed that the muscle transferred from slow, fatigue-resistant muscle to fast, fatigable muscle after spinal cord injury. The alternation of muscular property was accompanied by the alternation of spinal circuitry property, and was related to the immobilization adaptation. Previous study showed that remobilization by continuous passive motion (CPM) for one month would restore the function of spinal circuitry in individual with chronic SCI. It is possible that long term application of CPM can reverse the adaptation of contractile properties of the paralyzed muscle after SCI. The purpose of this study is to investigate the effect of a four month CPM training on muscular properties in individuals with chronic SCI.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taoyuan, Taiwan, 333
        • Chang Gung University

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

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of complete spinal cord injury

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SCI
SCI participated in a 4-month robot-assisted passive ankle exercise regimen.
Procedure: Ankle continuous passive motion machine.
A rehabilitation program of machine driven passive stretch exercise on ankle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The contractile properties of the muscles
Time Frame: Baseline, 1 month, 2 months, 3 months, and 4 months
Measure of changes in contractile properties of soleus and tibialis anterior
Baseline, 1 month, 2 months, 3 months, and 4 months
Fatigue index
Time Frame: Baseline, 1 month, 2 months, 3 months, and 4 months
Measure of changes in Fatigue index of soleus and tibialis anterior.
Baseline, 1 month, 2 months, 3 months, and 4 months
Clinical muscle tone tests
Time Frame: Baseline, 1 month, 2 months, 3 months, and 4 months
Measure of changes in clinical muscle tone tests of soleus and tibialis anterior by Modified Ashworth Scale.
Baseline, 1 month, 2 months, 3 months, and 4 months
Patient Reported Impact of Spasticity Measure (PRISM)
Time Frame: Baseline, 1 month, 2 months, 3 months, and 4 months
Measure of changes in PRISM.
Baseline, 1 month, 2 months, 3 months, and 4 months
The potential adverse effects of ankle swelling
Time Frame: Baseline, 1 month, 2 months, 3 months, and 4 months
Measure of changes in the potential adverse effects of ankle swelling.
Baseline, 1 month, 2 months, 3 months, and 4 months

Collaborators and Investigators

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

Sponsor

Chang Gung University

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

January 1, 2010

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

April 17, 2014

First Submitted That Met QC Criteria

April 23, 2014

First Posted (Estimate)

April 24, 2014

Study Record Updates

Last Update Posted (Estimate)

April 24, 2014

Last Update Submitted That Met QC Criteria

April 23, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 96-1434B

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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