Spinal Cord Injury(SCI)NCT01968096
The Reversal of Neuromuscular Adaptation in Human With Spinal Cord Injury II
A study testing home-based ankle continuous passive motion machine. in people with Spinal Cord Injury(SCI), run by Chang Gung University at 1 site in Taiwan.
Trial summary
Following injury to the spinal cord, the spinal circuit undergoes a series of adaptations. In parallel with the spinal circuit adaptation, the muscular properties also adapt. In human and animal studies, histochemical and physiological evidences showed that the paralyzed muscle transferred from slow, fatigue-resistant… Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injury(SCI)
- What is being tested?
- home-based ankle continuous passive motion machine.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2013to Jul 2015
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of spinal cord injury < 2 years
- Stage 2 subjects: Incomplete spinal cord injury subject
- Clinical diagnosis of incomplete spinal cord injury
- ASIA classification:B, C, or D
- Stage 3 subjects: Spinal cord injury subjects with high muscle tone
- Clinical diagnosis of spinal cord injury.
- ASIA classification: A, B, C, or D
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung University
Taoyuan, 333
Ya-Ju Chang, PhD, 88632118800 ext. 5515, yjchang@mail.cgu.edu.tw
About this study
Following injury to the spinal cord, the spinal circuit undergoes a series of adaptations. In parallel with the spinal circuit adaptation, the muscular properties also adapt. In human and animal studies, histochemical and physiological evidences showed that the paralyzed muscle transferred from slow, fatigue-resistant to fast, fatigable after injury.
Reversal of neuromuscular property for persons with SCI needs to be resolved. Studies using high load electrical stimulations showed a reverse change of muscular properties, such as hypertrophy and reversal of fiber type transformations but failed to show a reversal of spinal circuitry function. Previous studies found that fast continuous passive motion (CPM) altered the H reflex excitability in human. Animal studies found that passive cycling and passive stretching delayed atrophy and influenced the transition of type I and IIa MHC. Theses findings lead to a hypothesis that mechanical stimulation might be able to reverse both spinal circuitry and muscular properties after SCI but it has not been confirmed in human study.
The purpose of this project is to investigate the effect of mechanical stimulation by fast CPM on the reversing adaptation of human paralyzed muscle after SCI.
- Conditions
- Spinal Cord Injury(SCI)
- Being tested
- home-based ankle continuous passive motion machine.
- Keywords
- Reflex, Post activation, Spinal cord injury, Pre-synaptic inhibition, Machine driven passive strech
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
home-based ankle continuous passive motion machine.Device
A rehabilitation program of machine driven passive stretch.
| Study group | Role | What they receive |
|---|---|---|
| SCI subjects | No intervention | Stage 1 subjects: pilot study:understand post activation depression with spinal cord injury to avoid the influence of the suprasegmental level. |
| Incomplete SCI subjects | No intervention | Stage 2 subjects: pilot study:The strength of depression will be evaluated in individuals with and without SCI. |
| Health subjects | No intervention | Stage 2 subjects: pilot study:The strength of depression will be evaluated in individuals with and without SCI. |
| SCI subjects with high muscle tone (High frequency) | Experimental | Stage 3 subjects:A rehabilitation program of machine driven passive stretch(High frequency) will be executed . Receives: Device: home-based ankle continuous passive motion machine. |
| SCI subjects with high muscle tone(low frequency) | Experimental | Stage 3 subjects:A rehabilitation program of machine driven passive stretch(Low frequency) will be executed. Receives: Device: home-based ankle continuous passive motion machine. |
| SCI subjects with high muscle tone | No intervention | Stage 3 subjects:Control subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical muscle tone tests & Peripheral nerve Stimulation machine
Clinical muscle tone test include Modified Ashworth Scale, Pendulum test ,and withdraw reflex,etc.. Normalization of muscle tone, and influence of muscle property will be evaluated.
Peripheral nerve Stimulation machine stimulate Soleus and Tibialis anterior. Restoration of post activation will be evaluated.
Measured: Participants will be followed for the duration of invention, an expected average of 24 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2013 (estimated)
- Study startAug 2013
- Primary completionJul 2015 (estimated)
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
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
- NCT01968096
- Sponsor's protocol ID
- 102-1780C
- Other IDs
- NSC102-2314-B-182-021-MY2
- Status last verified
- Oct 2013
- First submitted
- 16 Oct 2013
- Last updated
- 23 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Reversal of Neuromuscular Adaptation in Human With Spinal Cord Injury II
- ClinicalTrials.gov ID
- NCT01968096
- Acronym / sponsor ID
- 102-1780C
- Conditions
- Spinal Cord Injury(SCI)
- Keywords
- Reflex, Post activation, Spinal cord injury, Pre-synaptic inhibition, Machine driven passive strech
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Chang Gung UniversityUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Jul 2015 (estimated)
- First posted
- 23 Oct 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.
Following injury to the spinal cord, the spinal circuit undergoes a series of adaptations. In parallel with the spinal circuit adaptation, the muscular properties also adapt. In human and animal studies, histochemical and physiological evidences showed that the paralyzed muscle transferred from slow, fatigue-resistant to fast, fatigable after injury.
Reversal of neuromuscular property for persons with SCI needs to be resolved. Studies using high load electrical stimulations showed a reverse change of muscular properties, such as hypertrophy and reversal of fiber type transformations but failed to show a reversal of spinal circuitry function. Previous studies found that fast continuous passive motion (CPM) altered the H reflex excitability in human. Animal studies found that passive cycling and passive stretching delayed atrophy and influenced the transition of type I and IIa MHC. Theses findings lead to a hypothesis that mechanical stimulation might be able to reverse both spinal circuitry and muscular properties after SCI but it has not been confirmed in human study.
The purpose of this project is to investigate the effect of mechanical stimulation by fast CPM on the reversing adaptation of human paralyzed muscle after SCI.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| SCI subjects | No intervention | –Stage 1 subjects: pilot study:understand post activation depression with spinal cord injury to avoid the influence of the suprasegmental level. |
| Incomplete SCI subjects | No intervention | –Stage 2 subjects: pilot study:The strength of depression will be evaluated in individuals with and without SCI. |
| Health subjects | No intervention | –Stage 2 subjects: pilot study:The strength of depression will be evaluated in individuals with and without SCI. |
| SCI subjects with high muscle tone (High frequency) | Experimental | Device: home-based ankle continuous passive motion machine.Stage 3 subjects:A rehabilitation program of machine driven passive stretch(High frequency) will be executed . |
| SCI subjects with high muscle tone(low frequency) | Experimental | Device: home-based ankle continuous passive motion machine.Stage 3 subjects:A rehabilitation program of machine driven passive stretch(Low frequency) will be executed. |
| SCI subjects with high muscle tone | No intervention | –Stage 3 subjects:Control subjects |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Clinical diagnosis of spinal cord injury < 2 years
- Stage 2 subjects: Incomplete spinal cord injury subject
- Clinical diagnosis of incomplete spinal cord injury
- ASIA classification:B, C, or D
- Stage 3 subjects: Spinal cord injury subjects with high muscle tone
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 |
|---|---|---|
| home-based ankle continuous passive motion machine.A rehabilitation program of machine driven passive stretch. | Device | SCI subjects with high muscle tone (High frequency), SCI subjects with high muscle tone(low frequency) |
Primary outcome
Clinical muscle tone tests & Peripheral nerve Stimulation machine
Time frame: Participants will be followed for the duration of invention, an expected average of 24 weeks.
Clinical muscle tone test include Modified Ashworth Scale, Pendulum test ,and withdraw reflex,etc.. Normalization of muscle tone, and influence of muscle property will be evaluated. Peripheral nerve Stimulation machine stimulate Soleus and Tibialis anterior. Restoration of post activation will be evaluated.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing home-based 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 7 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: status not confirmed, as of the sponsor's last update on 23 Oct 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical muscle tone tests & Peripheral nerve Stimulation machine (time frame: Participants will be followed for the duration of invention, an expected average of 24 weeks.). 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 23 Oct 2013.