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

• Sponsor: Chang Gung University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02003755
• Collaborator: (none)
• Enrollment: 8
• Location: 1
• Arm: 1
• Duration (Months): 24
• Patients Per Site Per Month: 0.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cerebral Palsy (CP)	Procedure: Ankle continuous passive motion machine.	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 8 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Apr 1, 2011
• Actual Primary Completion Date: Apr 1, 2013
• Actual Study Completion Date: Apr 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Muscle tone tests [Baseline, 1, and 4 months.]

   Measure of changes in Hypertonia measured by Modified Ashworth Scale (MAS).

2. Ankle range of motion [Baseline, 1, and 4 months.]

   Measure of changes in Ankle range of motion.

3. Hoffman reflex (H-reflex) [Baseline, 1, and 4 months.]

   Measure of changes in Hoffman reflex (H-reflex).

Secondary Outcome Measures

1. Leg girth [Baseline,1 ,and 4 mouths.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 50 Years
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chang Gung University	Taoyuan		Taiwan	333

Sponsors and Collaborators

• Chang Gung University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ya-Ju Chang, Professor, Chang Gung University
• ClinicalTrials.gov Identifier: NCT02003755
• Other Study ID Numbers: 99-3614B
• First Posted: Dec 6, 2013
• Last Update Posted: Dec 6, 2013
• Last Verified: Dec 1, 2013

• Keywords provided by Ya-Ju Chang, Professor, Chang Gung University: Cerebral palsy; Continuous passive motion; Hypertonia
• Additional relevant MeSH terms: Cerebral Palsy

Study Results

No Results Posted as of Dec 6, 2013