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Effect of Adult Spinal Deformity Surgery on Functional Reach

Study Purpose

Adult spinal deformity (ASD) is a common spinal condition that often impacts an individual's ability to stand and maintain an upright posture. Poor balance often limits an individual's ability to perform basic activities of daily life (ADL) and can lead to disability. Current considerations of correcting ASD to improve balance focus on the amount of sway that one exhibits during normal standing. However, current tests do not provide insight into the limits of balance during normal ADL. The goal of this research is to develop a new balance assessment that includes a functional reach test (FRT) to provide numerical data on the limits of one's ability to maintain balance. The study will include both ASD patients and matched healthy adults and will compare postural sway measures between them. Wearable motion tracking sensors and a force plate will be used to monitor body movement and changes in the center of pressure under foot during normal standing and during a FRT. Data from this study will inform spine surgeons of ASD patient's risk of balance loss in daily life and enable further research on the effects of surgical techniques to restore balance among ASD surgery patients.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Adult Spinal Deformity Patient

Inclusion Criteria:

  • - Adults over the age of 18.
  • - Diagnosed with adult spinal deformity according to the SRS-Schwab Adult Spinal Deformity Classification System.
  • - Indicated for deformity corrective surgery including multilevel spinal fusion of three or more levels.
  • - Lowest instrumented level includes S1 or pelvic fixation.
  • - Able to perform functional activities without the use of any assistance or support.
  • - devices.
Adult Spinal Deformity Patient

Exclusion Criteria:

  • - Indicated for spinal fusion due to spinal tumor, trauma, or infection.
  • - ASD patients who do not plan to be available for all follow-up evaluations at our institution.
  • - Pregnancy during any time point within the participation duration.
Asymptomatic Control Participant

Inclusion Criteria:

  • - Adults over the age of 18.
  • - No current or prior spine pathology or surgery.
  • - Able to perform the functional activities without the use of any assistance or support devices.
Asymptomatic Control Participant

Exclusion Criteria:

  • - Any current or prior spine or lower extremity pathology or surgery that impacts the subject's ability to perform the functional activities.
- Pregnancy at the time of the evaluation

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06258161
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 University of Kansas Medical Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Damon Mar
Principal Investigator Affiliation University of Kansas Medical Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Scoliosis, Scoliosis Kyphosis
Additional Details

While functional balance metrics are increasingly being recognized as important objective indicators of disability associated with ASD, there is a need for a refinement of existing balance assessments to provide more clinically relevant information to better assist in the development of treatment strategies and in assessing treatment outcomes. The use of force plates and wearable sensors is growing among spine surgeons during patient assessments, so it is pertinent to refine test protocols that utilize this equipment rather than propose new methods with unproven or unfamiliar equipment. Standardization of a test protocol that utilizes existing technology to provide a more robust assessment of ASD patient balance performance will help spine surgeons better understand the characteristics of balance that are most affected by each patient's unique deformity and incorporate them into planning treatment strategies. Additionally, demonstration of the time requirements for this evaluation protocol is a critical step in establishing clinical relevance and efficacy for ASD patient care. Data generated from this study will serve as important pilot data for additional studies focusing on the efficacy of the functional reach test to provide clinically relevant information on limits of functional balance among ASD patients. Information will provide guidance for both clinical decision-making and for objective techniques to assess postural balance of ASD patients. The objectives of this research are as follows: 1) develop a clinically relevant protocol for assessing functional balance limits for ASD patients utilizing the functional reach test, 2) provide estimates of time requirements to conduct balance assessments in a spine clinic setting, and 3) provide preliminary data on postural balance limits of ASD patients and compare to them to matched asymptomatic controls.

Arms & Interventions

Arms

: Adult spinal deformity surgery patients

Adults diagnosed with spinal deformity and who are undergoing spinal realignment fusion surgery.

: Asymptomatic adult controls

Adults with no history of spinal deformity or previous spinal fusions.

Interventions

Procedure: - Spinal Fusion

Realignment and fusion of adult spinal deformity

Other: - No intervention

No intervention for control group.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Kansas Medical Center, Kansas City, Kansas

Status

Recruiting

Address

University of Kansas Medical Center

Kansas City, Kansas, 66160

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