이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

경직이 있는 사람을 위한 주문형 외골격을 사용한 다리 스트레칭

2026년 9월 29일 업데이트: VA Office of Research and Development

경직이 있는 사람들을 위해 필요에 따라 제어 가능한 웨어러블 외골격을 사용한 다리 스트레칭

The purpose of this research study is to develop a protocol using a fully wearable, portable lower-limb exoskeleton for improving leg and walking function in people with movement disorders. The study investigates the effects of wearing the device during a set of experiments including leg stretching, treadmill walking and overground walking in muscle activity, joint motion, and gait performance. The goal is to develop an effective lower-limb strategy to restore lost leg function (e.g., range of motion) and gait ability, and improve quality of life in people with movement deficits following a neurological disorder.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

People with neurological conditions, including individuals with upper motor neuron injury, experience motor and sensory deficits, muscle weakness, limited range of motion, low weight-bearing capacity, and impaired balance that limit ambulation and interfere with the ability to perform activities of daily living. Lower-limb rehabilitation robots can assist with physical therapy and alleviate the burden of caregivers and nurses. Thus, the goal of this project is to develop wearable and portable technology to assist leg motion and stretching, and correspondingly activate muscles in people with neurological conditions who experience spasticity.

Spasticity results from increased muscle tone and interferes with the ability to functionally use voluntary muscle contraction for limb coordination and range of motion, which limits body transfers, ambulation, and exercise. Severe or intractable spasticity can lead to loss of body control and balance, resulting in falls and injuries, pressure injury of the skin, contractures, pain, wheelchair seating difficulties, in addition to other problems. Existent treatments to manage spasticity and overcome functional deficits related to spasticity include medications, neurosurgery, whole body or limb vibration, physical therapy, passive cycling, functional electrical stimulation (FES), along with other methods. However, medications may induce significant side effects including drowsiness, malaise, muscle weakness and pain (e.g., at the injection site); in addition, their effectiveness is sensitive to dosing fluctuations. Neurosurgery and direct spinal cord stimulation can treat intractable or focal spasticity, but they carry surgical risks, and their long-term benefits vary across individuals.

Stretching can decrease the excitability of motor neurons, maintain the viscoelastic properties of muscles and joints, provide relief from muscles spasms, and improve range of motion and gait function; further, stretching can be combined with oral medications to manage spasticity. Stretching is performed routinely by therapists, nurses, and caregivers to provide muscle stretching or preserve range of motion in joints with relatively low adverse effects. However, providing on-demand, reliable, manual limb stretching throughout the day and night imposes a heavy burden on caregivers and nurses both at home and in medical facilities. Hence, a critical need exists to develop a wearable approach to applying on-demand, safe, and customized dynamic stretching to manage spasticity after SCI, which can minimize the burden of caregivers and nurses.

This project exploits the recent technological advances in wearable sensors and fully wearable exoskeletons with reduced form factor and weight, which the investigators have not exploited (nor developed) in our previous research protocols at Syracuse University. These novel wearable exoskeletons are smart garments that conform to the human body and provide leg assistance in people with muscle weakness or hemiplegia. Light-weight exoskeletons have the potential to expand the breadth of tasks and environments in which exoskeletons are used for. Hence, this project introduces a lightweight, wearable exoskeleton to assist leg motion and stretching (e.g., targeting people with spasticity) under different postures (e.g., while lying down on a mat or bed, sitting on a chair or in a wheelchair).

Aim 1 characterizes the performance of the wearable device and its closed-loop control algorithm to apply precise adjustments for safe, automatic limb stretching and motion of single joints (e.g., joints in isolation while sitting or lying on a mat). The methods in this aim include the following: 1) design a control algorithm to apply safe leg forces exploiting joint kinematics and inertial feedback data using wearable sensors and 2) examine the magnitude and timing of the applied forces to the hip, knee and ankle joints, and toes. The research tasks in this aim will enable the customization of the applied forces across participants.

Aim 2 expands the implementation of the closed-loop controller from Aim 1 to different body postures and activities that involve multi-joint control. Participants wear the device to experience the applied forces by the wearable exoskeleton while lying down on a bed/mat or sitting down. Since the device is fully wearable, it serves as a powerful tool to examine the motion and limb-stretching of individuals with neurological conditions and spasticity. Thus, the device is not limited to fixed/stationary experimental conditions.

The last aim collects qualitative data from participants, caregivers, nurses, and clinicians (if involved) about the ease of use and satisfaction from using the wearable device. Questionnaires and surveys are used to gather qualitative data. Ease of use of the wearable device is assessed by examining if the protocol can be implemented within the expected duration including the time to don and doff the exoskeleton; further, it will be determined if the adherence to the protocol is achieved for all participants.

Research Design- Methodology

A candidate for the study will be asked to complete a Screening Questionnaire by phone or in person to check for eligibility. If the potential participant is eligible to enroll in the study, the participant will receive more information regarding the enrollment process. Participant will then complete a Demographics Questionnaire and answer questions about personal health and physical functioning.

Each lab visit may take up to 2 hours (including fitting the device, warm-up, testing procedures, rest breaks, unfitting the device, and removing the electrodes and wearable sensors).

Raw data will be collected from wearable sensors including the following: joint angles, 3D leg motion, muscle electromyography (EMG), and motor currents from the wearable device. Digital data recorded from experiments will be stored in .mat files (or .csv), password protected. There are no biological specimens collected.

Metadata will be applied to each component of the dataset following acquisition to ensure data is prepared for proper archiving. Metadata will include type, format, date, time, storage location, and context of data. Data generated during this project use conventional digital formats including:

  • MS Word, Power Point, Excel, Portable Data Format (PDF), and LaTeX (tex) files
  • Graphics, figures, tables, animations, videos from tests (jpeg, png, eps, mp4 files)
  • Code including MATLAB/Simulink files, C++ code, and ASCII text files

The paper participation records will be kept in locked file cabinets in the laboratory and/or offices, and the digital data will be stored on password-protected computers/servers or encrypted electronic storage devices in the offices and laboratory of the PIs' research team.

연구 유형

중재적

등록 (추정된)

10

단계

  • 해당 없음

연락처 및 위치

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

연구 연락처

연구 장소

    • New York
      • Syracuse, New York, 미국, 13210-2716
        • 모병
        • Syracuse VA Medical Center, Syracuse, NY
        • 연락하다:
        • 수석 연구원:
          • Steven W Brose

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 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Veteran individuals with spasticity due to spinal cord injury (SCI) at least 6 months post SCI
  • Capable of providing informed consent and reporting age, gender, and neurological condition
  • Neurologically stable (>6 months post-SCI) and can wear the device and the sensors, provide written informed consent, and follow instruction

Exclusion Criteria:

  • Participants should not experience another neurological disorder except their primary diagnosed neurological condition (spinal cord injury)
  • Participants should not be pregnant
  • Participants should weigh less than 300 lbs
  • Participants should not have experienced signs of hip/knee pain during the past 2-3 weeks that limits mobility (i.e., reaching, walking, lifting, etc.)
  • Participants should be recovered from any previous surgical interventions, joint injuries, muscle strain, or extreme muscle soreness following surgery
  • Participants should not take medications known to affect bone metabolism, muscle strength or cardiovascular performance or have any ailments causing high fever, high blood pressure, or high heart rate

공부 계획

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

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Robotic Exoskeleton

All participants will be interfered with a wearable robotic exoskeleton.

  • Participant preparation, placement of wearable sensors and monitoring, and wearable device fitting.
  • Lower-limb joint rotations and leg stretching protocol (40-60 minutes). The wearable exoskeleton and its control algorithm are evaluated to rotate leg joints and apply stretching similarly to the forces applied by nurses and caregivers when providing manual forces. Joint rotation and limb stretching is conducted while participants sit down (e.g., in a wheelchair, on a chair, on one side of a bed, or on a clinical mat) or lay down on a bed/mat. The protocol involves ankle plantarflexion and dorsiflexion, knee extension, hip flexion with the knee flexed, and toe flexion and extension (bilaterally) assisted by the exoskeleton, and each movement is repeated at a low-to-moderate rate of 10-30 cycles/minute.
  • Treadmilll and Overground Walking (60-90 minutes including rest periods)
  • Cool down (5-10 minutes)

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
3D postures
기간: Through study completion, an average of 24 weeks

3D postures will be assessed using the device, combining measurements of multiple joints in space

Through study completion, an average of 24 weeks
Joint angles
기간: Through study completion, an average of 24 weeks

Hip and knee joint angles measured in degrees will be assessed using the device

Through study completion, an average of 24 weeks
Joint angular velocities
기간: Through study completion, an average of 24 weeks

Hip and knee joint velocities measured in radians per second or degrees per second will be assessed using the device

Through study completion, an average of 24 weeks

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

협력자

수사관

  • 수석 연구원: Steven W Brose, Syracuse VA Medical Center, Syracuse, NY

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 (실제)

2026년 2월 9일

기본 완료 (추정된)

2027년 4월 30일

연구 완료 (추정된)

2027년 4월 30일

연구 등록 날짜

최초 제출

2023년 6월 22일

QC 기준을 충족하는 최초 제출

2023년 6월 22일

처음 게시됨 (실제)

2023년 7월 3일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 10월 2일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 29일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

키워드

기타 연구 ID 번호

  • A4652-P
  • 1I21RX004652-01A1 (미국 NIH 보조금/계약)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

미국에서 제조되어 미국에서 수출되는 제품

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. .