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

2022년 4월 19일 업데이트: Wake Forest University Health Sciences
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.

연구 개요

상태

완전한

상세 설명

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:

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

연구 유형

관찰

등록 (실제)

35

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

    • North Carolina
      • Charlotte, North Carolina, 미국, 28207
        • Carolinas ALS Clinical Research Center

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

연구 대상 성별

모두

샘플링 방법

비확률 샘플

연구 인구

Patients diagnosed with Amyotrophic Lateral Sclerosis

설명

Inclusion Criteria:

Inclusion Criteria for subjects with early ALS:

  • Probable or definite ALS according to World Federation of Neurology diagnostic criteria4.
  • Early stage ALS defined as presence of:

    1. Normal lower extremities muscle strength (≥ 4/5 in manual muscle strength or ≥ 80% in the computerized dynamometer quantitative muscle strength);
    2. ALSFRS score of ≥ than 30;
    3. FVC of ≥75% predicted;
    4. Ambulatory without the use of any assistive device.
  • 18 - 75 years of age.
  • Able to provide informed consent.

Inclusion Criteria for control subjects:

  • 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.

Exclusion Criteria:

  • 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).
  • 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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
기간
SOT equilibrium scores on conditions 1-6.
기간: 9 monthes
9 monthes

2차 결과 측정

결과 측정
기간
MSS on conditions 1-6 Weight Symmetry Score on conditions 1-6 DGI score TUG score POMA-B score
기간: 9 months
9 months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Mohammed Sanjak, PhD, PT, MBA, Carolinas Healthcare Sysetm

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2009년 2월 1일

기본 완료 (실제)

2010년 2월 1일

연구 완료 (실제)

2011년 2월 1일

연구 등록 날짜

최초 제출

2009년 8월 7일

QC 기준을 충족하는 최초 제출

2009년 8월 10일

처음 게시됨 (추정)

2009년 8월 11일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2022년 4월 25일

QC 기준을 충족하는 마지막 업데이트 제출

2022년 4월 19일

마지막으로 확인됨

2013년 7월 1일

추가 정보

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

3
구독하다