Balance Assessment, Cervical Myelopathy, Fall Risk
Conditions
Keywords
Surgery
Brief summary
The goal of this observational study is to determine if patients with cervical myelopathy who participate in a Tai Chi program will demonstrate improved gait and balance compared to patients who undergo usual care. Participants must be 18 years or older and have a diagnosis of cervical myelopathy.
Detailed description
Patients who meet inclusion criteria and choose to participate will be randomized to either participate in a Tai Chi falls-prevention program or continue with usual care. Those in the Tai Chi program will attend a pre-determined number of Tai Chi classes for a period of approximately 6-8 weeks. Investigators will assess their gait and balance at the time of enrollment and at several timepoints after they have participated in the class (similar timepoints for those randomized to usual care).
Interventions
OTHERTai Chi Program
Twelve sessions (six weeks) of a Tai Chi Program to assist with balance and fall risk.
Sponsors
West Virginia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of Cervical Myelopathy with planned surgery * 18 years of age or older * Able to participate in intervention (attend and participate in classes)
Exclusion criteria
* Wheelchair bound at initial visit * Other verified potential cause of gait instability/balance problems * Unable to participate in intervention (unable to attend/participate in classes)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Timed Up and Go Test - Baseline | Baseline | Establish a baseline score. The Timed Up and Go Test (TUG) assesses mobility, balance, walking ability, and fall risk in older adults. Setup: The person sits in a standard armchair. Instructions: On the command "Go," the person stands up, walks 3 meters (about 10 feet) at a comfortable pace, turns around, walks back to the chair, and sits down. Timing: The time taken from the command "Go" until the person sits back down is recorded. This is recorded in minutes:seconds. Scoring Normal Mobility: Completing the test in less than 10 seconds. Mild Mobility Impairment: Completing the test in 10-19 seconds. Moderate Mobility Impairment: Completing the test in 20-29 seconds. Severe Mobility Impairment: Taking 30 seconds or more to complete the test. A time of 12 seconds or more indicates a higher risk of falling. |
| Timed Up and Go Test - 6 weeks | 6 weeks post-operatively | The Timed Up and Go Test (TUG) assesses mobility, balance, walking ability, and fall risk in older adults. This is recorded in minutes:seconds. Setup: The person sits in a standard armchair. Instructions: On the command "Go," the person stands up, walks 3 meters (about 10 feet) at a comfortable pace, turns around, walks back to the chair, and sits down. Timing: The time taken from the command "Go" until the person sits back down is recorded. This is recorded in minutes:seconds. Scoring Normal Mobility: Completing the test in less than 10 seconds. Mild Mobility Impairment: Completing the test in 10-19 seconds. Moderate Mobility Impairment: Completing the test in 20-29 seconds. Severe Mobility Impairment: Taking 30 seconds or more to complete the test. A time of 12 seconds or more indicates a higher risk of falling. |
| Timed Up and Go Test - 3 months | 3 months post-operatively | The Timed Up and Go Test (TUG) assesses mobility, balance, walking ability, and fall risk in older adults. This is recorded in minutes:seconds. Setup: The person sits in a standard armchair. Instructions: On the command "Go," the person stands up, walks 3 meters (about 10 feet) at a comfortable pace, turns around, walks back to the chair, and sits down. Timing: The time taken from the command "Go" until the person sits back down is recorded. This is recorded in minutes:seconds. Scoring Normal Mobility: Completing the test in less than 10 seconds. Mild Mobility Impairment: Completing the test in 10-19 seconds. Moderate Mobility Impairment: Completing the test in 20-29 seconds. Severe Mobility Impairment: Taking 30 seconds or more to complete the test. A time of 12 seconds or more indicates a higher risk of falling. |
| Timed Up and Go Test - 6 months | 6 months post-operatively | The Timed Up and Go Test (TUG) assesses mobility, balance, walking ability, and fall risk in older adults. This is recorded in minutes:seconds. Setup: The person sits in a standard armchair. Instructions: On the command "Go," the person stands up, walks 3 meters (about 10 feet) at a comfortable pace, turns around, walks back to the chair, and sits down. Timing: The time taken from the command "Go" until the person sits back down is recorded. This is recorded in minutes:seconds. Scoring Normal Mobility: Completing the test in less than 10 seconds. Mild Mobility Impairment: Completing the test in 10-19 seconds. Moderate Mobility Impairment: Completing the test in 20-29 seconds. Severe Mobility Impairment: Taking 30 seconds or more to complete the test. A time of 12 seconds or more indicates a higher risk of falling. |
| Timed Up and Go Test - 12 months | 12 months post-operatively | The Timed Up and Go Test (TUG) assesses mobility, balance, walking ability, and fall risk in older adults. This is recorded in minutes:seconds. Setup: The person sits in a standard armchair. Instructions: On the command "Go," the person stands up, walks 3 meters (about 10 feet) at a comfortable pace, turns around, walks back to the chair, and sits down. Timing: The time taken from the command "Go" until the person sits back down is recorded. This is recorded in minutes:seconds. Scoring Normal Mobility: Completing the test in less than 10 seconds. Mild Mobility Impairment: Completing the test in 10-19 seconds. Moderate Mobility Impairment: Completing the test in 20-29 seconds. Severe Mobility Impairment: Taking 30 seconds or more to complete the test. A time of 12 seconds or more indicates a higher risk of falling. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 10-Step Tandem Gait Test - Baseline | Baseline | Establish a baseline score. The 10-Step Tandem Gait Test asks participants to walk a straight line making a toe-to-heal touch with each step at the subject's own velocity. The number of steps made before the first misstep is counted. After first 10-step tandem gait test, the subject turns around and repeats the tandem gait test in the same line and the number of steps is counted in the same manner. This is a graded score from 0-4. The higher grade demonstrates better gait. Scoring Grade 4: Completes all 10 steps without any instability. Grade 3: Completes 8-9 steps with minimal instability. Grade 2: Completes 6-7 steps with moderate instability. Grade 1: Completes 4-5 steps with significant instability. Grade 0: Completes fewer than 4 steps or is unable to perform the test due to severe instability. |
| 10-Step Tandem Gait Test - 6 weeks | 6 weeks post-operatively | The 10-Step Tandem Gait Test asks participants to walk a straight line making a toe-to-heal touch with each step at the subject's own velocity. The number of steps made before the first misstep is counted. After first 10-step tandem gait test, the subject turns around and repeats the tandem gait test in the same line and the number of steps is counted in the same manner. This is a graded score from 0-4. The higher grade demonstrates better gait. Scoring Grade 4: Completes all 10 steps without any instability. Grade 3: Completes 8-9 steps with minimal instability. Grade 2: Completes 6-7 steps with moderate instability. Grade 1: Completes 4-5 steps with significant instability. Grade 0: Completes fewer than 4 steps or is unable to perform the test due to severe instability. |
| 10-Step Tandem Gait Test - 3 months | 3 months post-operatively | The 10-Step Tandem Gait Test asks participants to walk a straight line making a toe-to-heal touch with each step at the subject's own velocity. The number of steps made before the first misstep is counted. After first 10-step tandem gait test, the subject turns around and repeats the tandem gait test in the same line and the number of steps is counted in the same manner. This is a graded score from 0-4. The higher grade demonstrates better gait. Scoring Grade 4: Completes all 10 steps without any instability. Grade 3: Completes 8-9 steps with minimal instability. Grade 2: Completes 6-7 steps with moderate instability. Grade 1: Completes 4-5 steps with significant instability. Grade 0: Completes fewer than 4 steps or is unable to perform the test due to severe instability. |
| 10-Step Tandem Gait Test - 6 months | 6 months post-operatively | The 10-Step Tandem Gait Test asks participants to walk a straight line making a toe-to-heal touch with each step at the subject's own velocity. The number of steps made before the first misstep is counted. After first 10-step tandem gait test, the subject turns around and repeats the tandem gait test in the same line and the number of steps is counted in the same manner. This is a graded score from 0-4. The higher grade demonstrates better gait. Scoring Grade 4: Completes all 10 steps without any instability. Grade 3: Completes 8-9 steps with minimal instability. Grade 2: Completes 6-7 steps with moderate instability. Grade 1: Completes 4-5 steps with significant instability. Grade 0: Completes fewer than 4 steps or is unable to perform the test due to severe instability. |
| 10-Step Tandem Gait Test - 12 Month | 12 months post-operatively | The 10-Step Tandem Gait Test asks participants to walk a straight line making a toe-to-heal touch with each step at the subject's own velocity. The number of steps made before the first misstep is counted. After first 10-step tandem gait test, the subject turns around and repeats the tandem gait test in the same line and the number of steps is counted in the same manner. This is a graded score from 0-4. The higher grade demonstrates better gait. Scoring Grade 4: Completes all 10 steps without any instability. Grade 3: Completes 8-9 steps with minimal instability. Grade 2: Completes 6-7 steps with moderate instability. Grade 1: Completes 4-5 steps with significant instability. Grade 0: Completes fewer than 4 steps or is unable to perform the test due to severe instability. |
Contacts
CONTACTJennifer Eicher, BS, CCRP
PRINCIPAL_INVESTIGATORScott Daffner, MD
West Virginia University School of Medicine, Department of Orthopaedics
STUDY_DIRECTORAndrya Durr, PhD
West Virginia University School of Public Health
Outcome results
None listed