NCT02122276

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.

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 Jan 2010

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

January 1, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

April 17, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 24, 2014

Completed
Last Updated

April 24, 2014

Status Verified

April 1, 2014

Enrollment Period

2 years

First QC Date

April 17, 2014

Last Update Submit

April 23, 2014

Conditions

Spinal Cord Injury(SCI)

Keywords

Spinal cord injuryPassive motionFatigue indexHypertonia

Outcome Measures

Primary Outcomes (5)

  • 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

  • Fatigue index

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

    Baseline, 1 month, 2 months, 3 months, and 4 months

  • 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

  • Patient Reported Impact of Spasticity Measure (PRISM)

    Measure of changes in PRISM.

    Baseline, 1 month, 2 months, 3 months, and 4 months

  • 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

Study Arms (1)

SCI

EXPERIMENTAL

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

Procedure: Ankle continuous passive motion machine.

Interventions

Ankle continuous passive motion machine.PROCEDURE

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

SCI

Eligibility Criteria

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

You may qualify if:

  • Clinical diagnosis of complete 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
Professor

Study Record Dates

First Submitted

April 17, 2014

First Posted

April 24, 2014

Study Start

January 1, 2010

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

April 24, 2014

Record last verified: 2014-04

Locations

TW(1)