Clinical Evaluation and Rehabilitation System for Dynamic Balance Control in Cervical Myelopathy Patients

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02842775
Collaborator
(none)
16
1
2
24.7
0.6

Study Details

Study Description

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
  • Other: balance perturbation training
N/A

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

Study Type:
Interventional
Actual Enrollment :
16 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 :
Jan 1, 2016
Actual Primary Completion Date :
Jan 22, 2018
Actual Study Completion Date :
Jan 22, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Kinematics (joint range of motion) [1 year]

    joint range of motion

  2. Electromyography(EMG) [1 years]

    EMG of lower extremity

  3. Muscle Strength Assessment by Dynamometer [1 years]

    Muscle strength of upper and lower extremity

  4. Kinetic(Ground reaction force) [1 years]

    Ground reaction force

  5. Transcranial magnetic stimulation (TMS) [1 years]

Secondary Outcome Measures

  1. Visual Analog Scale (VAS) [3 years]

  2. Neck Disability Index (NDI) [3 years]

  3. Japanese Orthopaedic Association Myelopathy Evaluation Questionnaire(JOACMEQ) [3 years]

  4. Nurick Classification [3 years]

  5. Five Times Sit to Stand Test [3 years]

  6. Timed Up & Go test (TUG) [3 years]

  7. Dynamic Gait Index (DGI) [3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Taiwan University Hospital Taipei Taiwan 100

Sponsors and Collaborators

  • National Taiwan University Hospital

Investigators

  • Principal Investigator: Wei-Li Hsu, School and Graduate Institute of Physical Therapy, College of Medicine,National Taiwan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT02842775
Other Study ID Numbers:
  • 201512167RINB
First Posted:
Jul 25, 2016
Last Update Posted:
Feb 21, 2021
Last Verified:
Apr 1, 2019
Keywords provided by National Taiwan University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 21, 2021