Cerebral Palsy (CP)NCT02003755
The Effects of Continuous Passive Motion on Hypertonia of Soleus in Individuals With Cerebral Palsy
A study testing Ankle continuous passive motion machine. in people with Cerebral Palsy (CP), run by Chang Gung University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 50 years
- Conditions the study is for
- Cerebral Palsy (CP)
- What is being tested?
- Ankle continuous passive motion machine.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2011to Apr 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Clinical diagnosis of Spastic CP
- Modified Ashworth scale of Soleus > 1
- Ankle range of motion > 10 degrees
Who cannot join
- Fracture on lower Lower extremities
- BOTOX on ankle < 5 mouths
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Cerebral Palsy (CP)
- Being tested
- Ankle continuous passive motion machine.
- Keywords
- Cerebral palsy, Continuous passive motion, Hypertonia
- Medical subject headings
- Cerebral Palsy, Muscle Hypertonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ankle continuous passive motion machine.Procedure or surgery
A rehabilitation program of machine driven passive stretch.
| Study group | Role | What they receive |
|---|---|---|
| Spastic CP | Experimental | continuous passive motion training Receives: Procedure: Ankle continuous passive motion machine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle tone tests
Measure of changes in Hypertonia measured by Modified Ashworth Scale (MAS).
Measured: Baseline, 1, and 4 months.
Ankle range of motion
Measure of changes in Ankle range of motion.
Measured: Baseline, 1, and 4 months.
Hoffman reflex (H-reflex)
Measure of changes in Hoffman reflex (H-reflex).
Measured: Baseline, 1, and 4 months.
Secondary outcomes (1)
Leg girth
Measured: Baseline,1 ,and 4 mouths.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2013 (estimated)
- Study startApr 2011
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy (CP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ya-Ju Chang, Chang Gung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02003755
- Sponsor's protocol ID
- 99-3614B
- Status last verified
- Dec 2013
- First submitted
- 3 Dec 2013
- Last updated
- 6 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Continuous Passive Motion on Hypertonia of Soleus in Individuals With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT02003755
- Acronym / sponsor ID
- 99-3614B
- Conditions
- Cerebral Palsy (CP)
- Keywords
- Cerebral palsy, Continuous passive motion, Hypertonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Chang Gung UniversityUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 6 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spastic CP | Experimental | Procedure: Ankle continuous passive motion machine.continuous passive motion training |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of Spastic CP
- Modified Ashworth scale of Soleus > 1
- Ankle range of motion > 10 degrees
Key exclusion criteria (2 listed)
- Fracture on lower Lower extremities
- BOTOX on ankle < 5 mouths
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ankle continuous passive motion machine.A rehabilitation program of machine driven passive stretch. | Procedure or surgery | Spastic CP |
Primary outcome
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).
1 secondary outcome
Leg girth
Time frame: Baseline,1 ,and 4 mouths.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ankle continuous passive motion machine. in people with Cerebral Palsy (CP), run by Chang Gung University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle tone tests (time frame: Baseline, 1, and 4 months.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2013.