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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01968096
Enrollment
52
Registered
2013-10-23
Start date
2013-08-31
Completion date
Unknown
Last updated
2013-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Cord Injury(SCI)

Keywords

Reflex, Post activation, Spinal cord injury, Pre-synaptic inhibition, Machine driven passive strech

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.

Interventions

DEVICEhome-based ankle continuous passive motion machine.

A rehabilitation program of machine driven passive stretch.

Sponsors

Chang Gung University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Clinical muscle tone tests & Peripheral nerve Stimulation machineParticipants 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.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026