NCT02003755

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 3, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 6, 2013

Completed
Last Updated

December 6, 2013

Status Verified

December 1, 2013

Enrollment Period

2 years

First QC Date

December 3, 2013

Last Update Submit

December 3, 2013

Conditions

Keywords

Cerebral palsyContinuous passive motionHypertonia

Outcome Measures

Primary Outcomes (3)

  • Muscle tone tests

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

    Baseline, 1, and 4 months.

  • Ankle range of motion

    Measure of changes in Ankle range of motion.

    Baseline, 1, and 4 months.

  • Hoffman reflex (H-reflex)

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

    Baseline, 1, and 4 months.

Secondary Outcomes (1)

  • Leg girth

    Baseline,1 ,and 4 mouths.

Study Arms (1)

Spastic CP

EXPERIMENTAL

continuous passive motion training

Procedure: Ankle continuous passive motion machine.

Interventions

A rehabilitation program of machine driven passive stretch.

Spastic CP

Eligibility Criteria

Age16 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung University

Taoyuan District, 333, Taiwan

Location

MeSH Terms

Conditions

Cerebral PalsyMuscle Hypertonia

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeuromuscular ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 3, 2013

First Posted

December 6, 2013

Study Start

April 1, 2011

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

December 6, 2013

Record last verified: 2013-12

Locations