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

Primary Purpose

Cervical Myelopathy

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
balance perturbation training
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Myelopathy focused on measuring rehabilitation

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • National Taiwan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Dynamic balance exercise group

Control group

Arm Description

balance perturbation training

No intervention

Outcomes

Primary Outcome Measures

Kinematics (joint range of motion)
joint range of motion
Electromyography(EMG)
EMG of lower extremity
Muscle Strength Assessment by Dynamometer
Muscle strength of upper and lower extremity
Kinetic(Ground reaction force)
Ground reaction force
Transcranial magnetic stimulation (TMS)

Secondary Outcome Measures

Visual Analog Scale (VAS)
Neck Disability Index (NDI)
Japanese Orthopaedic Association Myelopathy Evaluation Questionnaire(JOACMEQ)
Nurick Classification
Five Times Sit to Stand Test
Timed Up & Go test (TUG)
Dynamic Gait Index (DGI)

Full Information

First Posted
July 11, 2016
Last Updated
February 17, 2021
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02842775
Brief Title
Clinical Evaluation and Rehabilitation System for Dynamic Balance Control in Cervical Myelopathy Patients
Official Title
Clinical Evaluation and Rehabilitation System for Dynamic Balance Control in Cervical Myelopathy Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
January 22, 2018 (Actual)
Study Completion Date
January 22, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Myelopathy
Keywords
rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dynamic balance exercise group
Arm Type
Experimental
Arm Description
balance perturbation training
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Other
Intervention Name(s)
balance perturbation training
Intervention Description
perturbation training on the split-belt balance perturbance treadmill,
Primary Outcome Measure Information:
Title
Kinematics (joint range of motion)
Description
joint range of motion
Time Frame
1 year
Title
Electromyography(EMG)
Description
EMG of lower extremity
Time Frame
1 years
Title
Muscle Strength Assessment by Dynamometer
Description
Muscle strength of upper and lower extremity
Time Frame
1 years
Title
Kinetic(Ground reaction force)
Description
Ground reaction force
Time Frame
1 years
Title
Transcranial magnetic stimulation (TMS)
Time Frame
1 years
Secondary Outcome Measure Information:
Title
Visual Analog Scale (VAS)
Time Frame
3 years
Title
Neck Disability Index (NDI)
Time Frame
3 years
Title
Japanese Orthopaedic Association Myelopathy Evaluation Questionnaire(JOACMEQ)
Time Frame
3 years
Title
Nurick Classification
Time Frame
3 years
Title
Five Times Sit to Stand Test
Time Frame
3 years
Title
Timed Up & Go test (TUG)
Time Frame
3 years
Title
Dynamic Gait Index (DGI)
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei-Li Hsu
Organizational Affiliation
School and Graduate Institute of Physical Therapy, College of Medicine,National Taiwan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan

12. IPD Sharing Statement

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

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