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

Spinal Cord Injury(SCI) Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02122276
• Other study ID #: 96-1434B
• Status: Completed
• Phase: N/A
• First received: April 17, 2014
• Last updated: April 23, 2014
• Start date: January 2010
• Est. completion date: January 2012

Study information

• Verified date: April 2014
• Source: Chang Gung University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of complete spinal cord injury

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury(SCI)

Intervention

Procedure:
• Ankle continuous passive motion machine.
A rehabilitation program of machine driven passive stretch exercise on ankle.

Locations

Country	Name	City	State
Taiwan	Chang Gung University	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The contractile properties of the muscles	Measure of changes in contractile properties of soleus and tibialis anterior	Baseline, 1 month, 2 months, 3 months, and 4 months	Yes
Primary	Fatigue index	Measure of changes in Fatigue index of soleus and tibialis anterior.	Baseline, 1 month, 2 months, 3 months, and 4 months	Yes
Primary	Clinical muscle tone tests	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	Yes
Primary	Patient Reported Impact of Spasticity Measure (PRISM)	Measure of changes in PRISM.	Baseline, 1 month, 2 months, 3 months, and 4 months	Yes
Primary	The potential adverse effects of ankle swelling	Measure of changes in the potential adverse effects of ankle swelling.	Baseline, 1 month, 2 months, 3 months, and 4 months	Yes