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The Effects of Continuous Passive Motion on Hypertonia of Soleus in Individuals With Cerebral Palsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02003755
Recruitment Status : Completed
First Posted : December 6, 2013
Last Update Posted : December 6, 2013
Information provided by (Responsible Party):
Ya-Ju Chang, Chang Gung University

Brief Summary:
Cerebral palsy (CP) is a group of disorders of the development of movement and posture but often changing motor impairment syndromes. The spastic subtypes are the most common manifestations of cerebral palsy who perform movement difficultly due to hypertonia. Decease of spinal cord pathway, hyperactivity of alpha and gamma motoneuron and reduction of presynaptic inhibition may cause tendon reflex increase and hypertonia in individuals with CP. There are many ways to improve the hypertonia. In the past studies, the fast repeated range of motion could reduce muscle's activation effectively. The polyarticular movement training might increase joint range of motion and reduce the muscle activation. But the polyarticular movement training is difficulty for some individuals with CP. The single joint movement training may achieve the same effect as the polyarticular movement training. The purpose of this study was to investigate the effects of continuation passive range of motion (CPM) training whether could get the improvement of soleus hypertonia in individuals with CP.

Condition or disease Intervention/treatment Phase
Cerebral Palsy (CP) Procedure: Ankle continuous passive motion machine. Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : April 2011
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Spastic CP
continuous passive motion training
Procedure: Ankle continuous passive motion machine.
A rehabilitation program of machine driven passive stretch.

Primary Outcome Measures :
  1. Muscle tone tests [ Time Frame: Baseline, 1, and 4 months. ]
    Measure of changes in Hypertonia measured by Modified Ashworth Scale (MAS).

  2. Ankle range of motion [ Time Frame: Baseline, 1, and 4 months. ]
    Measure of changes in Ankle range of motion.

  3. Hoffman reflex (H-reflex) [ Time Frame: Baseline, 1, and 4 months. ]
    Measure of changes in Hoffman reflex (H-reflex).

Secondary Outcome Measures :
  1. Leg girth [ Time Frame: Baseline,1 ,and 4 mouths. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Clinical diagnosis of Spastic CP
  • Modified Ashworth scale of Soleus > 1
  • Ankle range of motion > 10 degrees

Exclusion Criteria:

  • Fracture on lower Lower extremities
  • BOTOX on ankle < 5 mouths

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02003755

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Chang Gung University
Taoyuan, Taiwan, 333
Sponsors and Collaborators
Chang Gung University
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Responsible Party: Ya-Ju Chang, Professor, Chang Gung University Identifier: NCT02003755    
Other Study ID Numbers: 99-3614B
First Posted: December 6, 2013    Key Record Dates
Last Update Posted: December 6, 2013
Last Verified: December 2013
Keywords provided by Ya-Ju Chang, Chang Gung University:
Cerebral palsy
Continuous passive motion
Additional relevant MeSH terms:
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Cerebral Palsy
Nervous System Diseases
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases