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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02003755
First Posted: December 6, 2013
Last Update Posted: December 6, 2013
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.
Information provided by (Responsible Party):
Ya-Ju Chang, Chang Gung University
  Purpose
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 Intervention
Cerebral Palsy (CP) Procedure: Ankle continuous passive motion machine.

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Ya-Ju Chang, Chang Gung University:

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

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

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


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

Enrollment: 8
Study Start Date: April 2011
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Spastic CP
continuous passive motion training
Procedure: Ankle continuous passive motion machine.
A rehabilitation program of machine driven passive stretch.

  Eligibility

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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT02003755


Locations
Taiwan
Chang Gung University
Taoyuan, Taiwan, 333
Sponsors and Collaborators
Chang Gung University
  More Information

Responsible Party: Ya-Ju Chang, Professor, Chang Gung University
ClinicalTrials.gov Identifier: NCT02003755     History of Changes
Other Study ID Numbers: 99-3614B
First Submitted: December 3, 2013
First Posted: December 6, 2013
Last Update Posted: December 6, 2013
Last Verified: December 2013

Keywords provided by Ya-Ju Chang, Chang Gung University:
Cerebral palsy
Continuous passive motion
Hypertonia

Additional relevant MeSH terms:
Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases