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

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.

Study Overview

• Status: Completed
• Conditions: Cervical Myelopathy
• Intervention / Treatment: Other: balance perturbation training

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 Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; No intervention
Experimental: Dynamic balance exercise group; balance perturbation training	Other: balance perturbation training; perturbation training on the split-belt balance perturbance treadmill,

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kinematics (joint range of motion)	joint range of motion	1 year
Electromyography(EMG)	EMG of lower extremity	1 years
Muscle Strength Assessment by Dynamometer	Muscle strength of upper and lower extremity	1 years
Kinetic(Ground reaction force)	Ground reaction force	1 years
Transcranial magnetic stimulation (TMS)		1 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Visual Analog Scale (VAS)	3 years
Neck Disability Index (NDI)	3 years
Japanese Orthopaedic Association Myelopathy Evaluation Questionnaire(JOACMEQ)	3 years
Nurick Classification	3 years
Five Times Sit to Stand Test	3 years
Timed Up & Go test (TUG)	3 years
Dynamic Gait Index (DGI)	3 years

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): January 22, 2018
• Study Completion (Actual): January 22, 2018

Study Registration Dates

• First Submitted: July 11, 2016
• First Submitted That Met QC Criteria: July 20, 2016
• First Posted (Estimate): July 25, 2016

Study Record Updates

• Last Update Posted (Actual): February 21, 2021
• Last Update Submitted That Met QC Criteria: February 17, 2021
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: rehabilitation
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Hematologic Diseases; Spinal Cord Diseases; Bone Marrow Diseases
• Other Study ID Numbers: 201512167RINB