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The Effect of Continuous Passive Motion Training on Neuromuscular Adaptation

Primary Purpose

Spinal Cord Injury(SCI)

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Ankle continuous passive motion machine.
Sponsored by
Chang Gung University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury(SCI) focused on measuring Spinal Cord Injury, Passive motion, Fatigue index, Hypertonia

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical diagnosis of chronic spinal cord injury

Sites / Locations

  • Chang Gung University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SCI

Arm Description

Outcomes

Primary Outcome Measures

Muscle tone tests
Measure of changes in Hypertonia measured by Modified Ashworth Scale (MAS) and Patient Reported Impact of Spasticity Measure (PPSIM).
Fatigue index of muscle
Measure of changes in Fatigue index of soleus and tibialis anterior (TA) muscles.

Secondary Outcome Measures

Full Information

First Posted
November 7, 2013
Last Updated
November 19, 2013
Sponsor
Chang Gung University
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1. Study Identification

Unique Protocol Identification Number
NCT01988142
Brief Title
The Effect of Continuous Passive Motion Training on Neuromuscular Adaptation
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chang Gung University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
After spinal cord injury (SCI), the muscular property altered due to the immobilization adaptation. The purpose of this study was to investigate the effect of remobilization with continuous passive exercise on the adapted paralyzed muscle properties after SCI.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury(SCI)
Keywords
Spinal Cord Injury, Passive motion, Fatigue index, Hypertonia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SCI
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Ankle continuous passive motion machine.
Intervention Description
A rehabilitation program of machine driven passive stretch.
Primary Outcome Measure Information:
Title
Muscle tone tests
Description
Measure of changes in Hypertonia measured by Modified Ashworth Scale (MAS) and Patient Reported Impact of Spasticity Measure (PPSIM).
Time Frame
Baseline, 1, 2,3, and 4 months.
Title
Fatigue index of muscle
Description
Measure of changes in Fatigue index of soleus and tibialis anterior (TA) muscles.
Time Frame
Baseline, 1, 2,3, and 4 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of chronic spinal cord injury
Facility Information:
Facility Name
Chang Gung University
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

The Effect of Continuous Passive Motion Training on Neuromuscular Adaptation

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