Balance Assessment Scale and Strength Measurement Protocol to Measure Functionality in Adults With Spinal Deformity

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-79
SponsorUniversitaire Ziekenhuizen KU Leuven

About this trial

Develop reliable methods for functional assessment, for trunk strength, of Adult Spinal Deformity (ASD) patients and create a first clinical and normative database

1. Compare functionality of ASD and control subjects 2. Relate functionality of ASD patients to their pathology, in terms of spinal deformity and muscle condition

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Adult (>18 years old) subjects suffering from a adult spinal deformity with sagittal or coronal plane misalignment diagnosed on EOS imaging.

Ability to walk at least 50 meters distance independently without a walking aid.

No documented neurological disease or vestibular lesion affecting balance nor a current history of musculoskeletal disorders of the lower extremities affecting motor performance.

Adults (> 18 year old)

Disqualifiers

Age < 18 years old and > 79 years old

Absence of adult spinal deformity

Non-ability to walk at least 50 meters distance independently, with or without a walking aid.

Missing patient informed consent

Trial design

Design model

Parallel

Treatments tested in this trial

  • Trunk strength measurement

    Diagnostic test

    A trunk strength protocol in sitting position, using a hand-held dynamometer is developed.

  • EOS stereoradiographic full body exam

    Diagnostic test

    Every subject included in the study will undergo a stereoradiographic full body EOS exam completed with Gravity Line (GL) location, recorded by a force plate on the floor

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Control groupOther 2 interventions
Group B: ASD groupOther 2 interventions

Trial outcomes

Primary outcomes

1

Trunk muscle strength

Trunk muscle strength is measured according to a trunk strength hand-held dynamometer protocol and repeated within two weeks after the first measurement to assess both interrater and test-retest reliability.

Time frame
From screening till week 2

Secondary outcomes

1

Static 2D radiographic evaluation of spinopelvic parameters

Spinopelvic parameters are obtained on biplanar radiographic images. These will be related to trunk muscle strength.

Time frame
Day 1

Other outcomes

Sponsors and contacts

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