The Reversal of Neuromuscular Adaptation in Human With Spinal Cord Injury II

October 18, 2013 updated by: Ya-Ju Chang, Chang Gung University

Following injury to the spinal cord, the spinal circuit undergoes a series of adaptations. In parallel with the spinal circuit adaptation, the muscular properties also adapt. In human and animal studies, histochemical and physiological evidences showed that the paralyzed muscle transferred from slow, fatigue-resistant to fast, fatigable after injury.

Reversal of neuromuscular property for persons with SCI needs to be resolved. Studies using high load electrical stimulations showed a reverse change of muscular properties, such as hypertrophy and reversal of fiber type transformations but failed to show a reversal of spinal circuitry function. Previous studies found that fast continuous passive motion (CPM) altered the H reflex excitability in human. Animal studies found that passive cycling and passive stretching delayed atrophy and influenced the transition of type I and IIa MHC. Theses findings lead to a hypothesis that mechanical stimulation might be able to reverse both spinal circuitry and muscular properties after SCI but it has not been confirmed in human study.

The purpose of this project is to investigate the effect of mechanical stimulation by fast CPM on the reversing adaptation of human paralyzed muscle after SCI.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taoyuan, Taiwan, 333
        • Recruiting
        • Chang Gung University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Stage 1 subjects: Spinal cord injury subject

Inclusion Criteria:

  • Clinical diagnosis of spinal cord injury < 2 years

Stage 2 subjects: Incomplete spinal cord injury subject

Inclusion Criteria:

  • Clinical diagnosis of incomplete spinal cord injury
  • ASIA classification:B, C, or D

Stage 3 subjects: Spinal cord injury subjects with high muscle tone

Inclusion Criteria:

  • Clinical diagnosis of spinal cord injury.
  • ASIA classification: A, B, C, or D

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: SCI subjects
Stage 1 subjects: pilot study:understand post activation depression with spinal cord injury to avoid the influence of the suprasegmental level.
No Intervention: Incomplete SCI subjects
Stage 2 subjects: pilot study:The strength of depression will be evaluated in individuals with and without SCI.
No Intervention: Health subjects
Stage 2 subjects: pilot study:The strength of depression will be evaluated in individuals with and without SCI.
Experimental: SCI subjects with high muscle tone (High frequency)
Stage 3 subjects:A rehabilitation program of machine driven passive stretch(High frequency) will be executed .
Device: home-based ankle continuous passive motion machine.
A rehabilitation program of machine driven passive stretch.
Experimental: SCI subjects with high muscle tone(low frequency)
Stage 3 subjects:A rehabilitation program of machine driven passive stretch(Low frequency) will be executed.
Device: home-based ankle continuous passive motion machine.
A rehabilitation program of machine driven passive stretch.
No Intervention: SCI subjects with high muscle tone
Stage 3 subjects:Control subjects

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical muscle tone tests & Peripheral nerve Stimulation machine
Time Frame: Participants will be followed for the duration of invention, an expected average of 24 weeks.

Clinical muscle tone test include Modified Ashworth Scale, Pendulum test ,and withdraw reflex,etc.. Normalization of muscle tone, and influence of muscle property will be evaluated.

Peripheral nerve Stimulation machine stimulate Soleus and Tibialis anterior. Restoration of post activation will be evaluated.
Participants will be followed for the duration of invention, an expected average of 24 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Anticipated)

July 1, 2015

Study Registration Dates

First Submitted

October 16, 2013

First Submitted That Met QC Criteria

October 18, 2013

First Posted (Estimate)

October 23, 2013

Study Record Updates

Last Update Posted (Estimate)

October 23, 2013

Last Update Submitted That Met QC Criteria

October 18, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 102-1780C
  • NSC102-2314-B-182-021-MY2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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