Clinical Evaluation and Rehabilitation System for Dynamic Balance Control in Cervical Myelopathy Patients
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|ClinicalTrials.gov Identifier: NCT02842775|
Recruitment Status : Recruiting
First Posted : July 25, 2016
Last Update Posted : April 10, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cervical Myelopathy||Other: balance perturbation training||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Evaluation and Rehabilitation System for Dynamic Balance Control in Cervical Myelopathy Patients|
|Study Start Date :||January 2016|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||July 2020|
Experimental: Dynamic balance exercise group
balance perturbation training
Other: balance perturbation training
perturbation training on the split-belt balance perturbance treadmill,
No Intervention: Control group
- Kinematics (joint range of motion) [ Time Frame: 1 year ]
- Electromyography(EMG) [ Time Frame: 1 years ]
- Muscle Strength Assessment by dynamometer [ Time Frame: 1 years ]
- Kinetic(Ground reaction force) [ Time Frame: 1 years ]
- Transcranial magnetic stimulation (TMS) [ Time Frame: 1 years ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02842775
|Contact: Wei-Li Hsufirstname.lastname@example.org|
|National Taiwan University Hospital||Not yet recruiting|
|Taipei, Taiwan, 100|
|Contact: Wei-Li Hsu 886-2-33668127 email@example.com|
|National Taiwan University Hospital||Recruiting|
|Taipei, Taiwan, 100|
|Contact: Wei-Li Hsu +886-2-33668127 firstname.lastname@example.org|
|Principal Investigator:||Wei-Li Hsu||School and Graduate Institute of Physical Therapy, College of Medicine,National Taiwan University|