Spinal Cord Injury(SCI)NCT02122276
Effects of Continuous Passive Motion on the Spinal Circuitries and Its Adaptation in Patients With Spasticity Resulting From Upper Motor Neuron Lesions
A study testing Ankle continuous passive motion machine. in people with Spinal Cord Injury(SCI), run by Chang Gung University at 1 site in Taiwan.
Trial summary
In animal and human studies, histochemical and physiological evidences showed that the muscle transferred from slow, fatigue-resistant muscle to fast, fatigable muscle after spinal cord injury. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Spinal Cord Injury(SCI)
- 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
- 7 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2010to Jan 2012
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of complete spinal cord injury
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
In animal and human studies, histochemical and physiological evidences showed that the muscle transferred from slow, fatigue-resistant muscle to fast, fatigable muscle after spinal cord injury. The alternation of muscular property was accompanied by the alternation of spinal circuitry property, and was related to the immobilization adaptation. Previous study showed that remobilization by continuous passive motion (CPM) for one month would restore the function of spinal circuitry in individual with chronic SCI. It is possible that long term application of CPM can reverse the adaptation of contractile properties of the paralyzed muscle after SCI. The purpose of this study is to investigate the effect of a four month CPM training on muscular properties in individuals with chronic SCI.
- Conditions
- Spinal Cord Injury(SCI)
- Being tested
- Ankle continuous passive motion machine.
- Keywords
- Spinal cord injury, Passive motion, Fatigue index, Hypertonia
- Medical subject headings
- Spinal Cord Injuries, 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 exercise on ankle.
| Study group | Role | What they receive |
|---|---|---|
| SCI | Experimental | SCI participated in a 4-month robot-assisted passive ankle exercise regimen. Receives: Procedure: Ankle continuous passive motion machine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The contractile properties of the muscles
Measure of changes in contractile properties of soleus and tibialis anterior
Measured: Baseline, 1 month, 2 months, 3 months, and 4 months
Fatigue index
Measure of changes in Fatigue index of soleus and tibialis anterior.
Measured: Baseline, 1 month, 2 months, 3 months, and 4 months
Clinical muscle tone tests
Measure of changes in clinical muscle tone tests of soleus and tibialis anterior by Modified Ashworth Scale.
Measured: Baseline, 1 month, 2 months, 3 months, and 4 months
Patient Reported Impact of Spasticity Measure (PRISM)
Measure of changes in PRISM.
Measured: Baseline, 1 month, 2 months, 3 months, and 4 months
The potential adverse effects of ankle swelling
Measure of changes in the potential adverse effects of ankle swelling.
Measured: Baseline, 1 month, 2 months, 3 months, and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2014 (estimated)
- Study startJan 2010
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord Injury(SCI)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
- 7 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
- NCT02122276
- Sponsor's protocol ID
- 96-1434B
- Status last verified
- Apr 2014
- First submitted
- 17 Apr 2014
- Last updated
- 24 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Continuous Passive Motion on the Spinal Circuitries and Its Adaptation in Patients With Spasticity Resulting From Upper Motor Neuron Lesions
- ClinicalTrials.gov ID
- NCT02122276
- Acronym / sponsor ID
- 96-1434B
- Conditions
- Spinal Cord Injury(SCI)
- Keywords
- Spinal cord injury, Passive motion, Fatigue index, Hypertonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Chang Gung UniversityUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 24 Apr 2014 (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.
In animal and human studies, histochemical and physiological evidences showed that the muscle transferred from slow, fatigue-resistant muscle to fast, fatigable muscle after spinal cord injury. The alternation of muscular property was accompanied by the alternation of spinal circuitry property, and was related to the immobilization adaptation. Previous study showed that remobilization by continuous passive motion (CPM) for one month would restore the function of spinal circuitry in individual with chronic SCI. It is possible that long term application of CPM can reverse the adaptation of contractile properties of the paralyzed muscle after SCI. The purpose of this study is to investigate the effect of a four month CPM training on muscular properties in individuals with chronic SCI.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SCI | Experimental | Procedure: Ankle continuous passive motion machine.SCI participated in a 4-month robot-assisted passive ankle exercise regimen. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of complete spinal cord injury
Key exclusion criteria (0 listed)
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 exercise on ankle. | Procedure or surgery | SCI |
Primary outcome
The contractile properties of the muscles
Time frame: Baseline, 1 month, 2 months, 3 months, and 4 months
Measure of changes in contractile properties of soleus and tibialis anterior
Fatigue index
Time frame: Baseline, 1 month, 2 months, 3 months, and 4 months
Measure of changes in Fatigue index of soleus and tibialis anterior.
Clinical muscle tone tests
Time frame: Baseline, 1 month, 2 months, 3 months, and 4 months
Measure of changes in clinical muscle tone tests of soleus and tibialis anterior by Modified Ashworth Scale.
Patient Reported Impact of Spasticity Measure (PRISM)
Time frame: Baseline, 1 month, 2 months, 3 months, and 4 months
Measure of changes in PRISM.
The potential adverse effects of ankle swelling
Time frame: Baseline, 1 month, 2 months, 3 months, and 4 months
Measure of changes in the potential adverse effects of ankle swelling.
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 24 Apr 2014.
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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 Spinal Cord Injury(SCI), 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 1 inclusion and 0 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 24 Apr 2014. 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?
The contractile properties of the muscles (time frame: Baseline, 1 month, 2 months, 3 months, and 4 months). The study lists 5 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 24 Apr 2014.