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

Not Applicable

• Conditions: Spinal Cord Injury(SCI)
• Interventions: Device: home-based ankle continuous passive motion machine.

• Registration Number: NCT01968096
• Lead Sponsor: Chang Gung University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Status Verified: 2013-10
• Study First Submitted: 2013-10-16
• Study First Submitted QC: 2013-10-18
• Last Update Submitted: 2013-10-18
• Study First Posted: 2013-10-23
• Last Update Posted: 2013-10-23
• Primary Completion: 2015-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 52

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SCI subjects with high muscle tone(low frequency)	home-based ankle continuous passive motion machine.	Stage 3 subjects:A rehabilitation program of machine driven passive stretch(Low frequency) will be executed.
SCI subjects with high muscle tone (High frequency)	home-based ankle continuous passive motion machine.	Stage 3 subjects:A rehabilitation program of machine driven passive stretch(High frequency) will be executed .

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Chang Gung University; 🇨🇳 Taoyuan, Taiwan