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

• Sponsor: Chang Gung University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01968096
• Collaborator: (none)
• Enrollment: 52
• Location: 1
• Arms: 6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Spinal Cord Injury(SCI)	Device: home-based ankle continuous passive motion machine.	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 52 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Aug 1, 2013
• Anticipated Primary Completion Date: Jul 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Clinical muscle tone tests & Peripheral nerve Stimulation machine [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Chang Gung University	Taoyuan		Taiwan	333

Sponsors and Collaborators

• Chang Gung University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ya-Ju Chang, Associate Professor, Chang Gung University
• ClinicalTrials.gov Identifier: NCT01968096
• Other Study ID Numbers: 102-1780C; NSC102-2314-B-182-021-MY2
• First Posted: Oct 23, 2013
• Last Update Posted: Oct 23, 2013
• Last Verified: Oct 1, 2013

• Keywords provided by Ya-Ju Chang, Associate Professor, Chang Gung University: Reflex; Post activation; Spinal cord injury; Pre-synaptic inhibition; Machine driven passive strech
• Additional relevant MeSH terms: Spinal Cord Injuries

Study Results

No Results Posted as of Oct 23, 2013