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New study aims to unravel balance secrets in spine patients

NCT ID NCT04812730

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study looks at how adults with spinal deformities maintain balance while standing and walking. Researchers will use advanced imaging and motion analysis to understand muscle and joint compensation. The goal is to improve surgical planning and reduce complications. 265 participants aged 45 and older with specific spinal misalignments will be enrolled.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to better surgical planning and fewer complications for people with spinal deformities.
What could go wrong
This is an observational study, not testing a treatment. It may not directly improve patient outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 265 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2016

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 79 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Pathological group 1. Age \>= 45 years 2. Diagnosis of adult congenital, degenerative, idiopathic or iatrogenic spinal deformity 3. Scoring at least 25 out of 30 on Mini Mental State Examination 4. Ability to walk at least 50 meters distance independently without a walking aid 5. Sagittal malalignment: PI-LL ≥ 25 degrees; sagittal vertical axis \>5cm; pelvic tilt \>25° and/or thoracic kyphosis \> 60° and/or coronal malalignment: thoracic scoliosis 30 ≥ degrees; thoracolumbar/lumbar scoliosis ≥ 30 degrees; global coronal malalignment \>3cm, posterior spinal fusion \> 4 levels + iliac fixation. 6. Ability and willingness of patient to attend follow-up visits and complete patient questionnaires 7. Completed patient informed consent * Control group 1. Asymptomatic adults not suffering from a spinal deformity leading to a pathological sagittal alignment presenting as volunteer in the University Hospitals Leuven, Belgium 2. Age \>=45 years old 3. Scoring at least 27 out of 30 on Mini Mental State Examination 4. Ability to walk at least 1000 meters distance independently without a walking aid 5. Ability and willingness of patient to attend follow-up visits and complete patient questionnaires 6. Completed patient informed consent Exclusion Criteria: * Pathological group 1. Age \< 45 years old 2. Absence of adult spinal deformity 3. Scoring less than 25 out of 30 on Mini Mental State Examination 4. Non-ability to walk at least 50 meters distance independently, with or without a walking aid. 5. Missing patient informed consent 6. Patients presenting with a neurological disease affecting balance other than Parkinson's disease such as stroke and/or Vestibular lesion 7. Patients with a current history of diagnosed musculoskeletal disorders of the trunk and/or lower extremities affecting the motor performance such as severe hip arthrosis with or without flexion contracture, severe knee arthrosis, severe ankle arthrosis, severe leg length discrepancy (\> 3 cm) 8. BMI\>30 * Control group 1. Age \< 45 years old 2. Backpain and/or Sciatica at time of the study 3. Presence of adult spinal deformity leading to a pathological sagittal alignment 4. Scoring less than 27 out of 30 on Mini Mental State Examination 5. Non-ability to walk at least 1000 meters distance independently without a walking aid 6. Missing patient informed consent 7. Patients presenting with a neurological disease affecting balance such as Stroke, Parkinson's disease and/or Vestibular lesion 8. Patients with a current history of diagnosed musculoskeletal disorders of the trunk and/or lower extremities affecting the motor performance such as severe hip arthrosis with or without flexion contracture, severe knee arthrosis, severe ankle arthrosis, severe leg length discrepancy (\> 3 cm) 9. BMI \> 27

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • UZ Leuven

    RECRUITING

    Leuven, Vlaams-Brabant, 3000, Belgium

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