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

Primary Purpose

Spinal Cord Injury(SCI)

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
home-based ankle continuous passive motion machine.
Sponsored by
Chang Gung University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury(SCI) focused on measuring Reflex, Post activation, Spinal cord injury, Pre-synaptic inhibition, Machine driven passive strech

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Chang Gung UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

No Intervention

No Intervention

No Intervention

Experimental

Experimental

No Intervention

Arm Label

SCI subjects

Incomplete SCI subjects

Health subjects

SCI subjects with high muscle tone (High frequency)

SCI subjects with high muscle tone(low frequency)

SCI subjects with high muscle tone

Arm Description

Stage 1 subjects: pilot study:understand post activation depression with spinal cord injury to avoid the influence of the suprasegmental level.

Stage 2 subjects: pilot study:The strength of depression will be evaluated in individuals with and without SCI.

Stage 2 subjects: pilot study:The strength of depression will be evaluated in individuals with and without SCI.

Stage 3 subjects:A rehabilitation program of machine driven passive stretch(High frequency) will be executed .

Stage 3 subjects:A rehabilitation program of machine driven passive stretch(Low frequency) will be executed.

Stage 3 subjects:Control subjects

Outcomes

Primary Outcome Measures

Clinical muscle tone tests & Peripheral nerve Stimulation machine
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.

Secondary Outcome Measures

Full Information

First Posted
October 16, 2013
Last Updated
October 18, 2013
Sponsor
Chang Gung University
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1. Study Identification

Unique Protocol Identification Number
NCT01968096
Brief Title
The Reversal of Neuromuscular Adaptation in Human With Spinal Cord Injury II
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Unknown status
Study Start Date
August 2013 (undefined)
Primary Completion Date
July 2015 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chang Gung University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury(SCI)
Keywords
Reflex, Post activation, Spinal cord injury, Pre-synaptic inhibition, Machine driven passive strech

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SCI subjects
Arm Type
No Intervention
Arm Description
Stage 1 subjects: pilot study:understand post activation depression with spinal cord injury to avoid the influence of the suprasegmental level.
Arm Title
Incomplete SCI subjects
Arm Type
No Intervention
Arm Description
Stage 2 subjects: pilot study:The strength of depression will be evaluated in individuals with and without SCI.
Arm Title
Health subjects
Arm Type
No Intervention
Arm Description
Stage 2 subjects: pilot study:The strength of depression will be evaluated in individuals with and without SCI.
Arm Title
SCI subjects with high muscle tone (High frequency)
Arm Type
Experimental
Arm Description
Stage 3 subjects:A rehabilitation program of machine driven passive stretch(High frequency) will be executed .
Arm Title
SCI subjects with high muscle tone(low frequency)
Arm Type
Experimental
Arm Description
Stage 3 subjects:A rehabilitation program of machine driven passive stretch(Low frequency) will be executed.
Arm Title
SCI subjects with high muscle tone
Arm Type
No Intervention
Arm Description
Stage 3 subjects:Control subjects
Intervention Type
Device
Intervention Name(s)
home-based ankle continuous passive motion machine.
Intervention Description
A rehabilitation program of machine driven passive stretch.
Primary Outcome Measure Information:
Title
Clinical muscle tone tests & Peripheral nerve Stimulation machine
Description
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.
Time Frame
Participants will be followed for the duration of invention, an expected average of 24 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Chang Gung University
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ya-Ju Chang, PhD
Phone
88632118800
Ext
5515
Email
yjchang@mail.cgu.edu.tw

12. IPD Sharing Statement

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

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