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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
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Cervical Myelopathy Other: balance perturbation training Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
No intervention



Primary Outcome Measures :
  1. Kinematics (joint range of motion) [ Time Frame: 1 year ]
  2. Electromyography(EMG) [ Time Frame: 1 years ]
  3. Muscle Strength Assessment by dynamometer [ Time Frame: 1 years ]
  4. Kinetic(Ground reaction force) [ Time Frame: 1 years ]
  5. Transcranial magnetic stimulation (TMS) [ Time Frame: 1 years ]

Secondary Outcome Measures :
  1. Visual Analog Scale (VAS) [ Time Frame: 3 years ]
  2. Neck Disability Index (NDI) [ Time Frame: 3 years ]
  3. Japanese Orthopaedic Association Myelopathy Evaluation Questionnaire(JOACMEQ) [ Time Frame: 3 years ]
  4. Nurick Classification [ Time Frame: 3 years ]
  5. Five Times Sit to Stand Test [ Time Frame: 3 years ]
  6. Timed Up & Go test (TUG) [ Time Frame: 3 years ]
  7. Dynamic Gait Index (DGI) [ Time Frame: 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • Aged 40-80 years old
  • Diagnosed cervical myelopathy according MRI imaging
  • Able to stand more than 30 seconds

Exclusion criteria:

  • 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

Information from the National Library of Medicine

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


Contacts
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Contact: Wei-Li Hsu 886-2-33668127 wlhsu@ntu.edu.tw

Locations
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Taiwan
National Taiwan University Hospital Not yet recruiting
Taipei, Taiwan, 100
Contact: Wei-Li Hsu    886-2-33668127    wlhsu@ntu.edu.tw   
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Wei-Li Hsu    +886-2-33668127    wlhsu@ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Wei-Li Hsu School and Graduate Institute of Physical Therapy, College of Medicine,National Taiwan University

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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT02842775     History of Changes
Other Study ID Numbers: 201512167RINB
First Posted: July 25, 2016    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: July 2017

Keywords provided by National Taiwan University Hospital:
rehabilitation

Additional relevant MeSH terms:
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Spinal Cord Diseases
Bone Marrow Diseases
Central Nervous System Diseases
Nervous System Diseases
Hematologic Diseases