ScoliosisNCT06258161
Effect of Adult Spinal Deformity Surgery on Functional Reach
An observational study of Scoliosis and Scoliosis Kyphosis, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Scoliosis, Scoliosis Kyphosis
- What is being tested?
- Spinal Fusion
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jun 2024to Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The adult spinal deformity (ASD) group will consist of adults with a diagnosis of scoliosis who are eligible for spinal deformity correcting surgery at the University of Kansas Medical Center. The asymptomatic control group will consist of adults who do not have any spinal diagnoses, have not have prior spinal fusions, and do not have any other conditions that affect their ability to perform the study activities.
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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: Functional Reach Test as a Clinical Tool for Assessing Postural Balance Limits Among Adult Spinal Deformity Patients
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.
Read the detailed description
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.
- Conditions
- Scoliosis, Scoliosis Kyphosis
- Being tested
- Spinal Fusion, No intervention
- Keywords
- Balance
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal FusionProcedure or surgery
Realignment and fusion of adult spinal deformity
No interventionOther
No intervention for control group.
| Study group | Role | What they receive |
|---|---|---|
| Adult spinal deformity surgery patients | Adults diagnosed with spinal deformity and who are undergoing spinal realignment fusion surgery. Receives: Procedure: Spinal Fusion | |
| Asymptomatic adult controls | Adults with no history of spinal deformity or previous spinal fusions. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional reach distance
The distance a participant can reach forward (in cm), to the side, and 45 degrees to the side with each arm
Measured: Assessed preoperatively and at 3, 6, 12, and 24 month postoperative follow-ups
Center of pressure sway range
The range (in mm) that the participant's center of pressure moves in sagittal and coronal plane directions during the functional reach tests
Measured: Assessed preoperatively and at 3, 6, 12, and 24 month postoperative follow-ups
Center of pressure velocity
The maximum and average velocity (in m/s) that the participant's center of pressure reaches during the functional reach tests
Measured: Assessed preoperatively and at 3, 6, 12, and 24 month postoperative follow-ups
Center of pressure excursion
The summation of the distance (in mm) that the participant's center of pressure moves during the functional reach tests
Measured: Assessed preoperatively and at 3, 6, 12, and 24 month postoperative follow-ups
Secondary outcomes (3)
Patient reported pain level
Questionnaires assessing level of pain (0-10 on the numeric rating scale) for the mid-back, low-back, and both legs
Measured: Assessed preoperatively and at 3, 6, 12, and 24 month postoperative follow-ups
Patient reported disability
A questionnaire called the Oswestry disability index (ODI) that assesses level of disability in performing activities of daily living
Measured: Assessed preoperatively and at 3, 6, 12, and 24 month postoperative follow-ups
Timed up and go test
The time is takes to rise from a chair, walked forward 10 feet, turn around, and then sit back down
Measured: Assessed preoperatively and at 3, 6, 12, and 24 month postoperative follow-ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start8 Jun 2024
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScoliosisStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Scoliosis Research Society
- Responsible party
- Principal investigator, Damon Mar, PhD, University of Kansas Medical Center
- Investigators
- Damon Mar, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06258161
- Sponsor's protocol ID
- STUDY00150790
- Status last verified
- Apr 2026
- First submitted
- 18 Jan 2024
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data from this study may be shared with other researchers in the future, but the type of data and the method of sharing has not been determined yet.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Reach Test as a Clinical Tool for Assessing Postural Balance Limits Among Adult Spinal Deformity Patients
- ClinicalTrials.gov ID
- NCT06258161
- Acronym / sponsor ID
- STUDY00150790
- Conditions
- Scoliosis, Scoliosis Kyphosis
- Keywords
- Balance
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- Scoliosis Research Society
- Study start
- 8 Jun 2024 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 14 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adult spinal deformity surgery patients | – | Procedure: Spinal FusionAdults diagnosed with spinal deformity and who are undergoing spinal realignment fusion surgery. |
| Asymptomatic adult controls | – | Other: No interventionAdults with no history of spinal deformity or previous spinal fusions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The adult spinal deformity (ASD) group will consist of adults with a diagnosis of scoliosis who are eligible for spinal deformity correcting surgery at the University of Kansas Medical Center. The asymptomatic control group will consist of adults who do not have any spinal diagnoses, have not have prior spinal fusions, and do not have any other conditions that affect their ability to perform the study activities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal FusionRealignment and fusion of adult spinal deformity | Procedure or surgery | Adult spinal deformity surgery patients |
| No interventionNo intervention for control group. | Other | Asymptomatic adult controls |
Primary outcome
Functional reach distance
Time frame: Assessed preoperatively and at 3, 6, 12, and 24 month postoperative follow-ups
The distance a participant can reach forward (in cm), to the side, and 45 degrees to the side with each arm
Center of pressure sway range
Time frame: Assessed preoperatively and at 3, 6, 12, and 24 month postoperative follow-ups
The range (in mm) that the participant's center of pressure moves in sagittal and coronal plane directions during the functional reach tests
Center of pressure velocity
Time frame: Assessed preoperatively and at 3, 6, 12, and 24 month postoperative follow-ups
The maximum and average velocity (in m/s) that the participant's center of pressure reaches during the functional reach tests
Center of pressure excursion
Time frame: Assessed preoperatively and at 3, 6, 12, and 24 month postoperative follow-ups
The summation of the distance (in mm) that the participant's center of pressure moves during the functional reach tests
3 secondary outcomes
Patient reported pain level
Time frame: Assessed preoperatively and at 3, 6, 12, and 24 month postoperative follow-ups
Patient reported disability
Time frame: Assessed preoperatively and at 3, 6, 12, and 24 month postoperative follow-ups
Timed up and go test
Time frame: Assessed preoperatively and at 3, 6, 12, and 24 month postoperative follow-ups
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: Undecided. Data from this study may be shared with other researchers in the future, but the type of data and the method of sharing has not been determined yet.
Related trials for Scoliosis
Active, not recruiting
Diaphragm Mobilization in Adolescent Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis
Recruiting
Tranexamic Acid in Pediatric Idiopathic Scoliosis Surgery
Scoliosis Idiopathic, Scoliosis; Adolescence
RecruitingObservational study
Turkish Adaptation and Validation of the Scoliosis Misconception Scale in Adolescents With Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis (AIS)
Not yet recruitingObservational study
Clinical and Biological Parameters in Adolescent Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis (AIS)
Recruiting
Studying Melatonin and Recovery in Teens
Juvenile; Scoliosis, Scoliosis Idiopathic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Damon Mar principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Scoliosis and Scoliosis Kyphosis, run by University of Kansas Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Damon Mar (913-574-2310, dmar@kumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional reach distance (time frame: Assessed preoperatively and at 3, 6, 12, and 24 month postoperative follow-ups). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.