NCT02842775

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 11, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 25, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2018

Completed
Last Updated

February 21, 2021

Status Verified

April 1, 2019

Enrollment Period

2.1 years

First QC Date

July 11, 2016

Last Update Submit

February 17, 2021

Conditions

Cervical Myelopathy

Keywords

rehabilitation

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (2)

Dynamic balance exercise group

EXPERIMENTAL

balance perturbation training

Other: balance perturbation training

Control group

NO INTERVENTION

No intervention

Interventions

balance perturbation trainingOTHER

perturbation training on the split-belt balance perturbance treadmill,

Dynamic balance exercise group

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Study Officials

  • Wei-Li Hsu

    School and Graduate Institute of Physical Therapy, College of Medicine,National Taiwan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2016

First Posted

July 25, 2016

Study Start

January 1, 2016

Primary Completion

January 22, 2018

Study Completion

January 22, 2018

Last Updated

February 21, 2021

Record last verified: 2019-04

Locations

TW(1)