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

Chang Gung University

Status: Unknown

Conditions: Spinal Cord Injury(SCI)

Treatments: Device: home-based ankle continuous passive motion machine.

Study type: Interventional

Funder types: Other

Identifiers

NCT01968096

102-1780C

NSC102-2314-B-182-021-MY2

Details and patient eligibility

About

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.

Enrollment: 52 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 6 patient groups

SCI subjects

No Intervention group

Description:

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

Incomplete SCI subjects

No Intervention group

Description:

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

Health subjects

No Intervention group

Description:

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

SCI subjects with high muscle tone (High frequency)

Experimental group

Description:

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

Treatment:

Device: home-based ankle continuous passive motion machine.

SCI subjects with high muscle tone(low frequency)

Experimental group

Description:

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

Treatment:

Device: home-based ankle continuous passive motion machine.

SCI subjects with high muscle tone

No Intervention group

Description:

Stage 3 subjects:Control subjects