NCT01988142

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

November 7, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 20, 2013

Completed
Last Updated

November 20, 2013

Status Verified

November 1, 2013

Enrollment Period

1.9 years

First QC Date

November 7, 2013

Last Update Submit

November 19, 2013

Conditions

Spinal Cord Injury(SCI)

Keywords

Spinal Cord InjuryPassive motionFatigue indexHypertonia

Outcome Measures

Primary Outcomes (2)

  • 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.

Study Arms (1)

SCI

EXPERIMENTAL
Procedure: Ankle continuous passive motion machine.

Interventions

Ankle continuous passive motion machine.PROCEDURE

A rehabilitation program of machine driven passive stretch.

SCI

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of chronic spinal cord injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung University

Taoyuan District, 333, Taiwan

Location

MeSH Terms

Conditions

Spinal Cord InjuriesMuscle Hypertonia

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesNeuromuscular ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 7, 2013

First Posted

November 20, 2013

Study Start

August 1, 2006

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

November 20, 2013

Record last verified: 2013-11

Locations

TW(1)