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Aerobic Fitness in Multiple Sclerosis: The Relationship Between Balance and Sensory Dual-Tasking

2026년 9월 14일 업데이트: Aleyna Özdamar Yücel, Suleyman Demirel University

The Effect of Aerobic Fitness on Balance-Related Sensory Dual-Task Performance in Patients With Multiple Sclerosis

The aim of this study is to comparatively examine the effect of aerobic fitness levels on walking and balance performance, sensory dual-task (proprioceptive and vestibular) performance, balance confidence, and fatigue levels in individuals diagnosed with MS.

Research hypotheses H1: MS patients with high aerobic fitness exhibit superior walking speed and balance performance compared to MS patients with low aerobic fitness.

H2: In sensory dual-task tests involving proprioceptive and vestibular manipulations (BOSU ball, soft surface, and head movements synchronized with a metronome), MS patients with high aerobic fitness demonstrate better performance than the group with low aerobic fitness.

H3: MS patients with high aerobic fitness report higher levels of balance confidence compared to the group with low aerobic fitness.

H4: Perceived fatigue is greater in MS patients with low aerobic fitness compared to the group with high aerobic fitness.

H5: There is a significant relationship between aerobic capacity levels and sensory dual-task performance, balance confidence, and fatigue severity in MS patients.

연구 개요

상태

아직 모집하지 않음

정황

상세 설명

The study will be conducted on volunteer patients diagnosed with multiple sclerosis by a specialist physician in the Department of Neurology of Isparta Süleyman Demirel University Hospital. All stages of the study will be conducted at Isparta Süleyman Demirel University. Informed consent form will be obtained from all patients participating in the study.The research protocol consists of two main phases. In Phase 1, "Basic Assessment and Grouping," participants' aerobic fitness will be determined using the 6-Minute Walk Test (6MWT). Based on the walking distance results, the sample will be divided into two groups: "Group 1: Those with High Aerobic Fitness" and "Group 2: Those with Low Aerobic Fitness."In Phase 2, the "Joint Clinical and Dual Task Protocol," data will be collected using a Personal Information Form, the Timed 25-Step Walk Test (T25WWT), the Timed Up and Walk Test (TUWT), the Berg Balance Scale (BBS), the Modified Clinical Sensory Interaction Test (MCIT), the Activity-Specific Balance Confidence Scale (ASBCS), and the Modified Fatigue Impact Scale (MFIS).

연구 유형

관찰

등록 (추정된)

70

연락처 및 위치

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

연구 연락처

연구 연락처 백업

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

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

샘플링 방법

확률 샘플

연구 인구

This study was planned as a cross-sectional study, and the target population of the research consists of individuals diagnosed with MS and followed up in Isparta province.

설명

Inclusion Criteria:

  • Having been diagnosed with Relapsing-Remitting or Progressive MS.
  • Being between 18-65 years of age.
  • Having an Expanded Disability Status Scale score between 1.5-5.
  • Being able to walk independently or with a unilateral assistive device.
  • Having full cooperation and orientation, and a cognitive level to understand given commands: Mini Mental Test score of 24 or higher.

Exclusion Criteria:

  • Having experienced an MS relapse or received acute corticosteroid treatment within the last 3 months.
  • Having an additional neurological, orthopedic, or rheumatological condition unrelated to MS that may affect balance and walking.
  • Having severe cardiovascular or respiratory disease that may make aerobic fitness assessment risky.
  • Having significant vision or hearing loss that would impede understanding test instructions.
  • Experiencing significant pain during measurements.
  • Having cognitive impairment that would prevent understanding or answering questions - scoring below 24 on the Minimental Test.

공부 계획

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

연구는 어떻게 설계됩니까?

디자인 세부사항

코호트 및 개입

그룹/코호트
Those with High Aerobic Fitness: Joint Clinical and Dual Duty Protocol
Data will be collected once using a Personal Information Form, the Timed 25-Step Walk Test (T25WWT), the Timed Up and Walk Test (TUWT), the Berg Balance Scale (BBS), the Modified Clinical Sensory Interaction Test (MCIET), the Activity-Specific Balance Confidence Scale (ASBCS), and the Modified Fatigue Impact Scale (MFIS).
Individuals with Low Aerobic Fitness: Joint Clinical and Dual Duty Protocol
Data will be collected once using a Personal Information Form, the Timed 25-Step Walk Test (T25WWT), the Timed Up and Walk Test (TUWT), the Berg Balance Scale (BBS), the Modified Clinical Sensory Interaction Test (MCIET), the Activity-Specific Balance Confidence Scale (ASBCS), and the Modified Fatigue Impact Scale (MFIS).

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
6-Minute Walk Test
기간: Day 1
Participants' aerobic fitness, walking endurance, and functional exercise capacity will be assessed using the 6DKYT. Participants are asked to walk for 6 minutes at their own determined maximum safe pace in a 30-meter straight corridor, and the total distance covered is recorded in meters.
Day 1

2차 결과 측정

결과 측정
측정값 설명
기간
Timed 25-Step Walking Test
기간: Day 1
To assess participants' baseline walking performance and speed, the Z25AYT, a subtest of the universal Multiple Sclerosis Functional Composite Battery, will be administered. Participants will be asked to walk a distance of 25 steps (approximately 7.62 meters) as quickly and safely as possible, and the elapsed time will be measured with a stopwatch and recorded in seconds.
Day 1
Dual Task Performance Test: Standing (Static Balance) Tasks
기간: Day 1
  1. Proprioceptive Task: The goal is to restrict/modify the proprioceptive inputs from the participant's support surface. For this purpose, the participant is asked to stand on an unstable surface (BOSU ball) to examine the effect of uncertainty in deep sensory inputs on static postural control.
  2. Vestibular Task: The participant's proprioceptive inputs are stabilized by having them stand on a hard, stable surface. The role of the vestibular system in balance is assessed by having the participant stand while making rhythmic head movements (accompanied by a metronome). Thus, by manipulating the inputs from the vestibular apparatus, the stability of static balance, excluding visual and somatosensory inputs, is measured.
Day 1
Dual Task Performance Test: Walking (Dynamic Balance) Tasks
기간: Day 1
  1. Vestibular Task (GKST + Head Movement): During the standard GKST, participants will be asked to perform rhythmic head movements to the accompaniment of a metronome to assess the effect of the vestibular system on mobility.
  2. Proprioceptive Task (GKST + Soft Surface): To manipulate ground proprioception, the standard GKST protocol will be repeated on a soft foam surface of a specific density instead of a hard surface. This method will record walking stability and task completion time under conditions where proprioceptive feedback is limited.
Day 1
Berg Balance Scale
기간: Day 1
Participants' objective balance and fall risk will be measured using the BDI (Brain Stability Inventory). The scale consists of 14 different functional balance tasks, including sitting, standing, reaching, and turning, and is evaluated on a scale of 0-56 points. Lower scores indicate an increased risk of falls.
Day 1
Activity-Specific Balance Confidence Scale
기간: Day 1
The 16-item Fall Fear and Balance Confidence Scale (FDSS) will be administered to assess fall fear and balance confidence during daily living activities. The FDSS consists of 16 items scored between 0 and 100. Each item asks the individual to rate their confidence in their ability to maintain their balance without falling during a specific activity, on a scale of 0 (not confident at all) to 100 (completely confident). The total score is calculated by taking the arithmetic mean of all items, resulting in a value between 0 and 100. A higher total score indicates that the individual has high balance confidence and reduced fall fear during daily living activities.
Day 1
Modified Fatigue Impact Scale
기간: Day 1
To assess the impact of fatigue on physical, cognitive, and psychosocial functions, a 21-item fatigue risk assessment scale will be used. The fatigue risk assessment scale consists of 21 items that inquire about fatigue experiences over the past four weeks. Each item evaluates the impact of fatigue on daily life using a Likert-type scale ranging from 0 (never) to 4 (always). The total score obtainable from the scale ranges from 0 to 84. An increase in the total score indicates a greater negative impact of fatigue on the patient's physical, cognitive, and psychosocial functions, and a greater impact on quality of life.
Day 1

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Suleyman Demirel University

수사관

  • 연구 책임자: MELİKE DOĞAN ÜNLÜ, NEUROLOGIST ASSOCIATE PROFESSO, Suleyman Demirel University

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 (추정된)

2026년 9월 15일

기본 완료 (추정된)

2027년 1월 15일

연구 완료 (추정된)

2027년 5월 15일

연구 등록 날짜

최초 제출

2026년 9월 7일

QC 기준을 충족하는 최초 제출

2026년 9월 7일

처음 게시됨 (실제)

2026년 9월 11일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 17일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 14일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • SüleymanDU-126/9

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

The data for the primary and secondary objectives of the research will be compared after they are received.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

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. .

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