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NCT03513679
Gait in Adult Patients With Cervical Spondylotic Myelopathy
NA trial testing Surgical intervention in Cervical Spondylotic Myelopathy in 100 participants. Status unknown.
1 March 2020
Quick facts
| Lead sponsor | Texas Back Institute |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | basic science |
| Enrollment | 100 |
| Start date | 22 March 2018 |
| Primary completion | 1 March 2020 |
| Estimated completion | 1 December 2020 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Surgical intervention
Conditions studied
- Cervical Spondylotic Myelopathy — all drugs for Cervical Spondylotic Myelopathy →
Sponsor
Texas Back Institute
Who can join
30 and older, any sex, with Cervical Spondylotic Myelopathy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to evaluate the effect of cervical decompression surgery on the biomechanics of the lower extremities and spine during balance and gait in patients with cervical spondylotic myelopathy (CSM), before and after surgical intervention, and compare these parameters to an asymptomatic control group. To test our hypothesis that cervical decompression will improve preexisting gait disturbance, a gait analysis using dynamic surface EMG, video motion capture, and force plate analysis will be used. Patients 30 to 70 years old will be eligible for the study. Thirty subjects diagnosed with symptomatic CSM and are deemed appropriate surgical candidates, along with 30 healthy subjects with no spine pathology, will be enrolled in this study. Exclusion criteria include any history of previous lumbar/thoracic surgery or lower extremity surgery, BMI greater than 35, or currently pregnant. Each subject from the surgical group will be evaluated on 3 different occasions: 1) 1 week before surgery, 2) 3 months postoperative, and 3) 12 months postoperative. Control subject will only be evaluated once. Bilateral trunk and lower extremity neuromuscular activity will be measured during a full gait cycle using dynamic surface EMG measurements. Human video motion capture cameras will collect lumbar spine and lower and upper extremity joint angles. Ground reaction forces (GRFs) will be collected from a 5 foot stretch of force platforms in order to define a full gait cycle.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Currently open trials in the same condition.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03513679 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Texas Back Institute
- Last refreshed: 1 May 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03513679.
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