Cervical MyelopathyNCT02842775
Clinical Evaluation and Rehabilitation System for Dynamic Balance Control in Cervical Myelopathy Patients
A study testing balance perturbation training in people with Cervical Myelopathy, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Cervical myelopathy is common among the aging population.One of the complications of cervical myelopathy is balance impairment.In this study, the patients with cervical myelopathy undergo biomechanical, imaging, neurophysiological and functional assessment. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cervical Myelopathy
- What is being tested?
- balance perturbation training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2016to 22 Jan 2018
- 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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 40-80 years old
- Diagnosed cervical myelopathy according MRI imaging
- Able to stand more than 30 seconds
Who cannot join
- With rheumatoid arthritis, ankylosing spondylitis,multiple sclerosis and other systemic disorders
- With musculoskeletal or neurological disorders,which can impair balance
- With previous spinal surgery
- Unable to communicate or follow instruction
- Not suit to cervical decompressive surgery or physical therapy due to other medical condition
Trial locations and contacts
1 site in 1 country.
About this study
Cervical myelopathy is common among the aging population.One of the complications of cervical myelopathy is balance impairment.In this study, the patients with cervical myelopathy undergo biomechanical, imaging, neurophysiological and functional assessment. Besides, the dynamic balance training is introduced to the patients with cervical decompression surgery.This study is expected to provide important empirical evidence to evaluate the prognosis of the surgery, to further guide the postoperative rehabilitation of myelopathy patients and to improve patients' long-term quality of life.
Read the detailed description
Taiwan is quickly becoming a nation of the aging population with myelopathy reporting to be one of the most common spinal cord disorders associated with spinal degeneration. Given the high prevalence rate of the condition, current project aims to investigate the impact of myelopathy on motor control from a biomechanical perspective with the overall aim to develop an interactive balance perturbation rehabilitation program targeting individual patients and identified the deficiency. The efficacy of the individual rehabilitation program will be assessed and determined to utilize a prospective longitudinal study design. A break down of the proposed three-year project are as follows:
Year 1: Myelopathy patients prepared to receive cervical decompression surgery as well as age-matched asymptomatic controls will be recruited and subjected to the following clinical evaluations: 3-dimensional biomechanical motion analysis, diagnostic Magnetic Resonance Imaging, pain and disability questionnaires, motor performance assessment, spinal curvature, muscle strength assessment as well as transcranial magnetic stimulation examination. Motor control and coordination of functional movements will also be evaluated.
Year 2: Continue to recruit potential participants and further develop the use of the interactive split-belt balance perturbation treadmill as modalities for gait and balance therapy.
Year 3: Physical Therapy rehabilitation programs at 3-month post surgery, one group will participate in a specific and personalized interactive balance perturbation training program targeting balance and gait retraining, while the other group receives the routine Physical Therapy program. Both treatment groups will be assessed pre-operatively, at 3, 6 and 12 months postoperatively. Patients will be classified based on their severity and grade of the spinal cord compression before being compared for any difference in treatment responses.
Year 4: Follow-up monitoring and documenting the number of falls experienced by patients at one year postoperatively as an outcome of effectiveness.
Expected outcome and significance The findings from the current project will provide important empirical evidence to guide the postoperative rehabilitation of myelopathy patients. Through detailed biomechanical motion analysis, it is anticipated that this project will provide an in-depth understanding of the influence of decompression surgery on motor control and spinal stability. The tailored and innovative rehabilitation program will also improve patients' long-term quality of life.
- Conditions
- Cervical Myelopathy
- Being tested
- balance perturbation training
- Keywords
- rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
balance perturbation trainingOther
perturbation training on the split-belt balance perturbance treadmill,
| Study group | Role | What they receive |
|---|---|---|
| Dynamic balance exercise group | Experimental | balance perturbation training Receives: Other: balance perturbation training |
| Control group | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kinematics (joint range of motion)
joint range of motion
Measured: 1 year
Electromyography(EMG)
EMG of lower extremity
Measured: 1 years
Muscle Strength Assessment by Dynamometer
Muscle strength of upper and lower extremity
Measured: 1 years
Kinetic(Ground reaction force)
Ground reaction force
Measured: 1 years
Transcranial magnetic stimulation (TMS)
Measured: 1 years
Secondary outcomes (7)
Visual Analog Scale (VAS)
Measured: 3 years
Neck Disability Index (NDI)
Measured: 3 years
Japanese Orthopaedic Association Myelopathy Evaluation Questionnaire(JOACMEQ)
Measured: 3 years
Nurick Classification
Measured: 3 years
Five Times Sit to Stand Test
Measured: 3 years
Timed Up & Go test (TUG)
Measured: 3 years
Dynamic Gait Index (DGI)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2016 (estimated)
- Study startJan 2016
- Primary completion22 Jan 2018
- Study completion22 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical MyelopathyStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wei-Li Hsu, Principal investigator, School and Graduate Institute of Physical Therapy, College of Medicine,National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02842775
- Sponsor's protocol ID
- 201512167RINB
- Status last verified
- Apr 2019
- First submitted
- 11 Jul 2016
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation and Rehabilitation System for Dynamic Balance Control in Cervical Myelopathy Patients
- ClinicalTrials.gov ID
- NCT02842775
- Acronym / sponsor ID
- 201512167RINB
- Conditions
- Cervical Myelopathy
- Keywords
- rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- 22 Jan 2018 (actual)
- Study completion
- 22 Jan 2018 (actual)
- First posted
- 25 Jul 2016 (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.
Cervical myelopathy is common among the aging population.One of the complications of cervical myelopathy is balance impairment.In this study, the patients with cervical myelopathy undergo biomechanical, imaging, neurophysiological and functional assessment. Besides, the dynamic balance training is introduced to the patients with cervical decompression surgery.This study is expected to provide important empirical evidence to evaluate the prognosis of the surgery, to further guide the postoperative rehabilitation of myelopathy patients and to improve patients' long-term quality of life.
Detailed description
Taiwan is quickly becoming a nation of the aging population with myelopathy reporting to be one of the most common spinal cord disorders associated with spinal degeneration. Given the high prevalence rate of the condition, current project aims to investigate the impact of myelopathy on motor control from a biomechanical perspective with the overall aim to develop an interactive balance perturbation rehabilitation program targeting individual patients and identified the deficiency. The efficacy of the individual rehabilitation program will be assessed and determined to utilize a prospective longitudinal study design. A break down of the proposed three-year project are as follows:
Year 1: Myelopathy patients prepared to receive cervical decompression surgery as well as age-matched asymptomatic controls will be recruited and subjected to the following clinical evaluations: 3-dimensional biomechanical motion analysis, diagnostic Magnetic Resonance Imaging, pain and disability questionnaires, motor performance assessment, spinal curvature, muscle strength assessment as well as transcranial magnetic stimulation examination. Motor control and coordination of functional movements will also be evaluated.
Year 2: Continue to recruit potential participants and further develop the use of the interactive split-belt balance perturbation treadmill as modalities for gait and balance therapy.
Year 3: Physical Therapy rehabilitation programs at 3-month post surgery, one group will participate in a specific and personalized interactive balance perturbation training program targeting balance and gait retraining, while the other group receives the routine Physical Therapy program. Both treatment groups will be assessed pre-operatively, at 3, 6 and 12 months postoperatively. Patients will be classified based on their severity and grade of the spinal cord compression before being compared for any difference in treatment responses.
Year 4: Follow-up monitoring and documenting the number of falls experienced by patients at one year postoperatively as an outcome of effectiveness.
Expected outcome and significance The findings from the current project will provide important empirical evidence to guide the postoperative rehabilitation of myelopathy patients. Through detailed biomechanical motion analysis, it is anticipated that this project will provide an in-depth understanding of the influence of decompression surgery on motor control and spinal stability. The tailored and innovative rehabilitation program will also improve patients' long-term quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dynamic balance exercise group | Experimental | Other: balance perturbation trainingbalance perturbation training |
| Control group | No intervention | –No intervention |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 40-80 years old
- Diagnosed cervical myelopathy according MRI imaging
- Able to stand more than 30 seconds
Key exclusion criteria (5 listed)
- With rheumatoid arthritis, ankylosing spondylitis,multiple sclerosis and other systemic disorders
- With musculoskeletal or neurological disorders,which can impair balance
- With previous spinal surgery
- Unable to communicate or follow instruction
- Not suit to cervical decompressive surgery or physical therapy due to other medical condition
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 |
|---|---|---|
| balance perturbation trainingperturbation training on the split-belt balance perturbance treadmill, | Other | Dynamic balance exercise group |
Primary outcome
Kinematics (joint range of motion)
Time frame: 1 year
joint range of motion
Electromyography(EMG)
Time frame: 1 years
EMG of lower extremity
Muscle Strength Assessment by Dynamometer
Time frame: 1 years
Muscle strength of upper and lower extremity
Kinetic(Ground reaction force)
Time frame: 1 years
Ground reaction force
Transcranial magnetic stimulation (TMS)
Time frame: 1 years
7 secondary outcomes
Visual Analog Scale (VAS)
Time frame: 3 years
Neck Disability Index (NDI)
Time frame: 3 years
Japanese Orthopaedic Association Myelopathy Evaluation Questionnaire(JOACMEQ)
Time frame: 3 years
Nurick Classification
Time frame: 3 years
Five Times Sit to Stand Test
Time frame: 3 years
Timed Up & Go test (TUG)
Time frame: 3 years
Dynamic Gait Index (DGI)
Time frame: 3 years
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 21 Feb 2021.
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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.
Wei-Li Hsu principal investigator
School and Graduate Institute of Physical Therapy, College of Medicine,National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing balance perturbation training in people with Cervical Myelopathy, run by National Taiwan University Hospital 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 5 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 21 Feb 2021. 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?
Kinematics (joint range of motion) (time frame: 1 year). 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 21 Feb 2021.