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

Primary Purpose

Spinal Cord Injury(SCI)

Status

Completed

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

Ankle continuous passive motion machine.

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 complete spinal cord injury

Sites / Locations

Chang Gung University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SCI

Arm Description

SCI participated in a 4-month robot-assisted passive ankle exercise regimen.

Outcomes

Primary Outcome Measures

The contractile properties of the muscles

Measure of changes in contractile properties of soleus and tibialis anterior

Fatigue index

Measure of changes in Fatigue index of soleus and tibialis anterior.

Clinical muscle tone tests

Measure of changes in clinical muscle tone tests of soleus and tibialis anterior by Modified Ashworth Scale.

Patient Reported Impact of Spasticity Measure (PRISM)

Measure of changes in PRISM.

The potential adverse effects of ankle swelling

Measure of changes in the potential adverse effects of ankle swelling.

Secondary Outcome Measures

Full Information

NCT ID

NCT02122276

First Posted

April 17, 2014

Last Updated

April 23, 2014

Sponsor

Chang Gung University

1. Study Identification

Unique Protocol Identification Number

NCT02122276

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2014

Overall Recruitment Status

Completed

Study Start Date

January 2010 (undefined)

Primary Completion Date

January 2012 (Actual)

Study Completion Date

January 2012 (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

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.

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

Arm Description

SCI participated in a 4-month robot-assisted passive ankle exercise regimen.

Intervention Type

Procedure

Intervention Name(s)

Ankle continuous passive motion machine.

Intervention Description

A rehabilitation program of machine driven passive stretch exercise on ankle.

Primary Outcome Measure Information:

Title

The contractile properties of the muscles

Description

Measure of changes in contractile properties of soleus and tibialis anterior

Time Frame