An observational study in Amyotrophic Lateral Sclerosis, sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-25.
Sponsored by Wake Forest University Health Sciences · Observational
The purpose of this pilot study is to characterize changes in postural orientation and equilibrium in early diagnosed ALS patient. The investigators plan to cross validate the use of a standardized test of equilibrium (EquiTest, Computerized Dynamic Posturography - CDP) in early diagnosed ALS patients.
ALS is a progressive neurodegenerative disorder involving primarily upper and lower motor neurons. The progressive loss in motor neurons leads to weakness, fatigue, spasticity, and loss of balance. Falls are reported in 30-35% of ALS patients prior to enrolment to ALS clinic. This early loss of balance may not be detected by the classical neurological exam, or the standard clinical balance scales. Understanding the impairments in the balance control system which leads to fall during the course of ALS is a prerequisite for the clinical decision-making process in order to develop a proper balance rehabilitation program and fall prevention strategies for these patients.
Patients and control subjects will undergo balance system evaluation consisting of the following testing:
Sensory Organization Test Protocol
Standardized EquiTest assessment protocol:
Sensory Organization Test (SOT) - will be used to measure change how well participants maintain balance under progressively more difficult test conditions, which either disrupt or remove visual and proprioceptive feedback. Visual and proprioceptive environments will be altered systematically for fixed support and sway-referenced support and surround conditions, and under normal (eyes open), absent (eyes closed), and sway-referenced vision (eyes sway-referenced). Under sway-referenced conditions, the platform on which the subject stands and/or the visual surround also move proportionally to their AP sway. During SRC the floor and visual surround are controlled by a servomechanism (Gain=1.0) to follow movements of the subjects' center of gravity. Sway-referencing eliminates accurate somatosensory and/or visual information used to orient the body. Performance under sway-referenced visual conditions shows the participant's ability to suppress conflicting visual inputs and to rely on alternative systems for maintaining equilibrium (table 1).
Participants are carefully positioned on the platform by aligning the lateral malleoli with the axis of rotation of the platform and visual surround. Participants wear a harness during all testing, which protects participants from falling. As an additional safety measure, the technician stands behind the participant. There are three trials per condition with each trial lasting 20 seconds. When a participant takes a step, touches the surround panels, or needs assistance from the technician, that trial is marked as a fall and the participant receives an equilibrium score of zero for that trial.
In addition to the ES, movement strategy scores (MSS) will be measured by horizontal shear forces. Movement strategy scores reflect the relative use of movement about the ankle, hips and upper body to maintain balance during the SOT. Scores around 100 reflect a predominant use of ankle strategy to maintain balance, whereas low scores are indicative of the use of hip strategies to restore stability.
Outcome variables:
i. Sensory Organization Test (SOT) scores on conditions 1-6. ii. Movement Strategy Score on conditions 1-6 iii. Weight Symmetry Score on conditions 1-6
717 studies on the registry are indexed under Motor Neuron Disease; 137 are open to participants now.
This study's enrollment of 35 is below the median of 109 across 217 observational studies indexed under Motor Neuron Disease.
Browse Motor Neuron Disease studies →Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.
Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients diagnosed with Amyotrophic Lateral Sclerosis
Inclusion Criteria:
Inclusion Criteria for subjects with early ALS:
Early stage ALS defined as presence of:
Inclusion Criteria for control subjects:
Exclusion Criteria:
SOT equilibrium scores on conditions 1-6.
Time frame: 9 monthes
MSS on conditions 1-6 Weight Symmetry Score on conditions 1-6 DGI score TUG score POMA-B score
Time frame: 9 months
This study is completed, as verified in Jul 2013. You cannot join it, but the record below documents what was studied.
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Wake Forest University Health Sciences