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Amyotrophic Lateral SclerosisNCT00956501

Assessment of Postural Orientation and Equilibrium In Early Amyotrophic Lateral Sclerosis (ALS)

An observational study of Amyotrophic Lateral Sclerosis, run by Wake Forest University Health Sciences at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Amyotrophic Lateral Sclerosis
How many people
35 participants
Where
1 siteUnited States
Study dates
Feb 2009to Feb 2011
Phase
Observational
Are there results?
None posted in the registry

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 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Patients diagnosed with Amyotrophic Lateral Sclerosis

Who may be able to join

  • Probable or definite ALS according to World Federation of Neurology diagnostic criteria4.
  • Early stage ALS defined as presence of:
  • Normal lower extremities muscle strength (≥ 4/5 in manual muscle strength or ≥ 80% in the computerized dynamometer quantitative muscle strength);
  • ALSFRS score of ≥ than 30;
  • FVC of ≥75% predicted;
  • Ambulatory without the use of any assistive device.
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  • 18 - 75 years of age.
  • Able to provide informed consent.
  • Healthy 18 - 75 years of age without significant medical condition as defined by the investigator.
  • Able to provide informed consent.
  • Not having any of the exclusion criteria listed below.

Who cannot join

  • Age < 18 or > 75 years.
  • History of falls (2 or more in the last year), history of fainting, history of cerebrovascular accident (CVA) or myocardial infarction (MI), history of lower limb joint replacement.
  • History of neuromuscular dysfunction "except diagnosis of ALS for individuals with ALS".
  • Post-traumatic, septic, inflammatory, or neuropathic arthritis.
  • Lower extremity injury/surgery that may effect balance.
  • Vestibular pathology (i.e., inner ear problems, vertigo, meniere's).
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  • Peripheral neuropathy.
  • Parkinson's Disease.
  • Currently taking anti-convulsive medications (e.g., clonazepam, diazepam, lorazepam,phenytoin, zonegran, carbamazepine, depakote, gabapentin, lamotrigine, lamotrigine, oxcarbazepine, tiagabine, topiramate)
  • Diabetes Mellitus.
  • No history of neurological or medical condition that may interfere with balance as defined by investigators.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Carolinas ALS Clinical Research Center

    Charlotte, North Carolina, 28207

Other trials in United States

About this study

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.

Read the detailed description

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:

  1. 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.
  2. Motor Control Test Protocol The Motor Control Test (MCT), using the same apparatus will be performed to examine postural responses to external perturbations. During the MCT, subjects will receive perturbation from the force platform. Perturbations are expressed as translation movement (medium horizontal anterior to posterior movements of less than 1 sec. duration) or as rotation movements (at 6.0 degrees per second, which cause ankle dorsiflexion or plantarflexion). Six forward and six backward translations are generated. Five toes up and five toes down rotations are generated. The computer assures random delays of 1.5 to 2.5 seconds between translation trials and 3.0 to 5.0 seconds between rotation trials. During each perturbation, the computer monitors the subjects sway responses, measuring forces exerted against the dual force plate. These forces are expressed as weight symmetry and strength symmetry. Weight symmetry measures the distribution of total body weight over each leg, independent of other response strength and strength symmetry measures. Weight symmetry scores near 100 indicate a symmetrical weight distribution (EquiTest manual, 1991).

Outcome variables:

  1. 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
Keywords
fall, balance
Medical subject headings
Amyotrophic Lateral Sclerosis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. SOT equilibrium scores on conditions 1-6.

    Measured: 9 monthes

Secondary outcomes (1)
  1. MSS on conditions 1-6 Weight Symmetry Score on conditions 1-6 DGI score TUG score POMA-B score

    Measured: 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Aug 2009 (estimated)
  2. Study startFeb 2009
  3. Primary completionFeb 2010
  4. Study completionFeb 2011

Resources

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
Other
Time perspective
Prospective
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00956501
Sponsor's protocol ID
IRB# 02-09-12B
Status last verified
Jul 2013
First submitted
7 Aug 2009
Last updated
25 Apr 2022
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Amyotrophic Lateral Sclerosis, run by Wake Forest University Health Sciences 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?

The sponsor lists 11 inclusion and 11 exclusion criteria. 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: finished, as of the sponsor's last update on 25 Apr 2022. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SOT equilibrium scores on conditions 1-6. (time frame: 9 monthes). 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 25 Apr 2022.

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