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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Chang Gung University
Sponsor:
Information provided by (Responsible Party):
Ya-Ju Chang, Chang Gung University
ClinicalTrials.gov Identifier:
NCT01968096
First received: October 16, 2013
Last updated: October 18, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Spinal Cord Injury(SCI)
Device: home-based ankle continuous passive motion machine.

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Chang Gung University:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]

    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.



Estimated Enrollment: 52
Study Start Date: August 2013
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01968096

Locations
Taiwan
Chang Gung University Recruiting
Taoyuan, Taiwan, 333
Contact: Ya-Ju Chang, PhD    88632118800 ext 5515    yjchang@mail.cgu.edu.tw   
Sponsors and Collaborators
Chang Gung University
  More Information

No publications provided

Responsible Party: Ya-Ju Chang, Associate Professor, Chang Gung University
ClinicalTrials.gov Identifier: NCT01968096     History of Changes
Other Study ID Numbers: 102-1780C, NSC102-2314-B-182-021-MY2
Study First Received: October 16, 2013
Last Updated: October 18, 2013
Health Authority: Taiwan: Department of Health

Keywords provided by Chang Gung University:
Reflex
Post activation
Spinal cord injury
Pre-synaptic inhibition
Machine driven passive strech

Additional relevant MeSH terms:
Spinal Cord Injuries
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on October 23, 2014