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NCT Number: NCT02122276

Effects of Continuous Passive Motion on the Spinal Circuitries and Its Adaptation in Patients With Spasticity Resulting From Upper Motor Neuron Lesions

In animal and human studies, histochemical and physiological evidences showed that the muscle transferred from slow, fatigue-resistant muscle to fast, fatigable muscle after spinal cord injury. The alternation of muscular property was accompanied by the alternation of spinal circuitry property, and was related to the immobilization adaptation. Previous study showed that remobilization by continuous passive motion (CPM) for one month would restore the function of spinal circuitry in individual with chronic SCI. It is possible that long term application of CPM can reverse the adaptation of contractile properties of the paralyzed muscle after SCI. The purpose of this study is to investigate the effect of a four month CPM training on muscular properties in individuals with chronic SCI.

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Key information

Conditions

Spinal Cord Injury(SCI) Central Nervous System Diseases Muscle Hypertonia Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chang Gung University

Taoyuan, 333, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of complete spinal cord injury

Treatment and study plan

Ankle continuous passive motion machine.

Procedure

A rehabilitation program of machine driven passive stretch exercise on ankle.

Primary outcomes

  1. The contractile properties of the muscles

    Time frame: Baseline, 1 month, 2 months, 3 months, and 4 months

    Measure of changes in contractile properties of soleus and tibialis anterior

  2. Fatigue index

    Time frame: Baseline, 1 month, 2 months, 3 months, and 4 months

    Measure of changes in Fatigue index of soleus and tibialis anterior.

  3. Clinical muscle tone tests

    Time frame: Baseline, 1 month, 2 months, 3 months, and 4 months

    Measure of changes in clinical muscle tone tests of soleus and tibialis anterior by Modified Ashworth Scale.

  4. Patient Reported Impact of Spasticity Measure (PRISM)

    Time frame: Baseline, 1 month, 2 months, 3 months, and 4 months

    Measure of changes in PRISM.

  5. The potential adverse effects of ankle swelling

    Time frame: Baseline, 1 month, 2 months, 3 months, and 4 months

    Measure of changes in the potential adverse effects of ankle swelling.

Sponsors and collaborators

Lead sponsor

Chang Gung University

Other

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Apr 24, 2014
Registry last updated
Apr 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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