CompletedNot Applicable

Postural Stability in Cervical Spinal Myelopathy

United States8 participantsStarted 2019-02-07

Plain-language summary

Veterans are at heightened risk of developing cervical spondylotic myelopathy (CSM) from rigors of military service. Balance and posturography are negatively affected in CSM, but require expensive equipment, and extensive training of personnel for data acquisition and interpretation. The Virtual Environment TBI Screen (VETS) is a simple and inexpensive construct that could be implemented as an aid in diagnosis and as an objective means to compare treatment modalities and track recovery. The goal for the SPiRE is to generate the critical data to support rigorous Merit studies of posturography for assessments of clinical course in the treatment and rehabilitation of CSM. The investigators' ultimate goal, if the SPiRE is successful, is to phase in objective posturography assessments as VA standard of care in CSM.

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: Patients in the CSM group will be selected based on clinical criteria. Inclusion criteria for the CSM group are: * symptoms of myelopathy in upper and lower extremities and stenosis of the cervical spine demonstrated by MRI or myelography * lower extremity muscle strength of 4 as quantified by manual muscle test (MMT) 36 or above * ability to stand without support with eyes closed for 30 s or more * Veterans in the control group will be recruited from the SVAMC and surrounding community using printed advertisements Exclusion Criteria: Exclusion criteria for all study participants are: * presence of lower extremity or lumbar spine disease * peripheral neuropathy * history of other neurological disorder * inability to stand in an upright position with both feet together and eyes closed * Although the SVAMC population is predominately Caucasian and male, every effort will be made to recruit minorities and women * The proposed study will neither target for recruitment nor will the investigators exclude pregnant women

What they're measuring

Virtual Environment TBI System (VETS) Assessment of Static Posturography

Timeframe: Pre-Surgery compared to otherwise healthy Veterans

Change in Static Posturography (VETS)

Timeframe: Pre-surgery compared to 2 weeks, 6 weeks, and 6 months post-surgery VETS factors. The Post-surgery endpoints are normally scheduled clinical follow ups.

Trial details

NCT IDNCT03810781

SponsorVA Office of Research and Development

Sponsor typeFED

Study typeOBSERVATIONAL

Primary completion2022-09-01

Results submitted2024-03-18

View on ClinicalTrials.gov More Cervical Spondylotic Myelopathy trials