The Effect of Continuous Passive Motion Training on Neuro... | NCT01988142

Studies
The Effect of Continuous Passive Motion Training on Neuromuscular Adaptation

NCT01988142

Sponsor

Chang Gung University

Status

Completed

Last Update Posted

Nov 20, 2013Estimated

Enrollment

7Actual

Phase

Not Applicable

Conditions

Spinal Cord Injury(SCI)

Interventions

Ankle continuous passive motion machine.

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2006

Primary Completion Date

Jul 2008Actual

Completion Date

Jul 2008Actual

First Submitted Date

Nov 7, 2013

First Submission Date that Met QC Criteria

Nov 19, 2013

First Posted Date

Nov 20, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 19, 2013

Last Update Posted Date

Nov 20, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

7Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SCI	Experimental		Procedure: Ankle continuous passive motion machine.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ankle continuous passive motion machine.	Procedure	A rehabilitation program of machine driven passive stretch.	SCI

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Muscle tone tests	Measure of changes in Hypertonia measured by Modified Ashworth Scale (MAS) and Patient Reported Impact of Spasticity Measure (PPSIM).	Baseline, 1, 2,3, and 4 months.
Fatigue index of muscle	Measure of changes in Fatigue index of soleus and tibialis anterior (TA) muscles.	Baseline, 1, 2,3, and 4 months.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical diagnosis of chronic spinal cord injury

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chang Gung University		Taoyuan		333	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D013119	Spinal Cord Injuries
D009122	Muscle Hypertonia

Ancestor Terms

ID	Term
D013118	Spinal Cord Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D020196	Trauma, Nervous System

Browse Leaves

Not provided

Browse Branches

Not provided