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

Primary Purpose

Cerebral Palsy (CP)

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Ankle continuous passive motion machine.
Sponsored by
Chang Gung University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy (CP) focused on measuring Cerebral palsy, Continuous passive motion, Hypertonia

Eligibility Criteria

16 Years - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chang Gung University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Spastic CP

Arm Description

continuous passive motion training

Outcomes

Primary Outcome Measures

Muscle tone tests
Measure of changes in Hypertonia measured by Modified Ashworth Scale (MAS).
Ankle range of motion
Measure of changes in Ankle range of motion.
Hoffman reflex (H-reflex)
Measure of changes in Hoffman reflex (H-reflex).

Secondary Outcome Measures

Leg girth

Full Information

First Posted
December 3, 2013
Last Updated
December 3, 2013
Sponsor
Chang Gung University
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1. Study Identification

Unique Protocol Identification Number
NCT02003755
Brief Title
The Effects of Continuous Passive Motion on Hypertonia of Soleus in Individuals With Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chang Gung University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy (CP)
Keywords
Cerebral palsy, Continuous passive motion, Hypertonia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Spastic CP
Arm Type
Experimental
Arm Description
continuous passive motion training
Intervention Type
Procedure
Intervention Name(s)
Ankle continuous passive motion machine.
Intervention Description
A rehabilitation program of machine driven passive stretch.
Primary Outcome Measure Information:
Title
Muscle tone tests
Description
Measure of changes in Hypertonia measured by Modified Ashworth Scale (MAS).
Time Frame
Baseline, 1, and 4 months.
Title
Ankle range of motion
Description
Measure of changes in Ankle range of motion.
Time Frame
Baseline, 1, and 4 months.
Title
Hoffman reflex (H-reflex)
Description
Measure of changes in Hoffman reflex (H-reflex).
Time Frame
Baseline, 1, and 4 months.
Secondary Outcome Measure Information:
Title
Leg girth
Time Frame
Baseline,1 ,and 4 mouths.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Chang Gung University
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan

12. IPD Sharing Statement

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

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