Walking With Overground Robotic Exoskeleton Device to Increase Behavioral Responsiveness in Patients With Disorders of Consciousness (WALK DOC) (WALK DOC)
2026년 7월 13일 업데이트: Chad, Swank, Spaulding Rehabilitation Hospital
The goal of this observational study is to learn whether walking with an overground robotic exoskeleton (ORE) can improve responsiveness and brain activity in adults with disorders of consciousness (DoC) during inpatient rehabilitation after a severe brain injury. Participants include adults ages 18-70 who are in a coma, unresponsive wakefulness syndrome, or minimally conscious state and are receiving rehabilitation care at Spaulding Rehabilitation Hospital.
The main questions it aims to answer are:
- Does using an ORE improve behavioral responsiveness compared with lying down, sitting, or standing?
- Does using an ORE increase brain activity, and are changes in brain activity related to changes in responsiveness?
- Is ORE therapy safe, tolerable, and feasible for people with DoC during inpatient rehabilitation?
Researchers will compare participants' responses during sessions involving lying down, sitting, standing, and walking with the robotic exoskeleton to see if the exoskeleton leads to greater improvements in responsiveness and brain activity.
Participants will:
- Complete an initial screening session to determine whether they can safely use the robotic exoskeleton.
- Participate in six study sessions over about two weeks during their rehabilitation stay. During these sessions, participants will complete activities that may include lying down, sitting, standing, and walking with a robotic exoskeleton. The order of activities will be assigned at random.
- Have their level of responsiveness measured before and after each session using a standardized assessment called the Coma Recovery Scale-Revised (CRS-R).
- Wear a wireless EEG cap before, during, and after sessions so researchers can measure brain activity.
- Have their heart rate and safety monitored throughout the study sessions.
연구 개요
상태
상태
아직 모집하지 않음
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
관찰
등록 (추정된)
등록
18
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
연구 연락처
- 이름: Jenny Zhang, MS
- 전화번호: 6179526354
- 이메일: jzhang71@mgb.org
연구 장소
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Massachusetts
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Boston, Massachusetts, 미국, 02129
- Spaulding Rehabilitation Hospital
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수석 연구원:
- Chad Swank, PhD
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연락하다:
- Clinical Research Project Manager
- 전화번호: 6179526354
- 이메일: jzhang71@mgb.org
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
샘플링 방법
비확률 샘플
연구 인구
The study population will be selected from inpatient rehabilitation patients with disorders of consciousness (DoC) receiving medical care and rehabilitation at inpatient rehabilitation units in an inpatient rehabilitation facility (IRF) or long-term acute care hospital (LTAC).
Patients will be identified from those admitted for inpatient rehabilitation and screened using the eligibility criteria outlined, through the hospital's standard clinical and medical record review processes.
설명
Inclusion Criteria:
- Medical diagnosis of disorders of consciousness (DoC) confirmed by the Coma Recovery Scale - Revised (CRS-R), including patient classified as Minimally Conscious State (MCS), Unresponsive Wakefulness Syndrome (UWS), or coma.
- Acute/Subacute phase of recovery
- Medically stable as deemed by a physician
- Undergoing medical care and rehabilitation at hospital
- Both sexes and all races and ethnicities
- Meet the robotic exoskeleton frame limitations
- Continence of or a program for bladder and bowel management
Exclusion Criteria:
- Concurrent spinal cord injury (SCI)
- Degenerative diagnoses, pre-morbid developmental disability, significant psychological diagnosis such as bipolar disorder and schizophrenia
- Any contraindication to use the exoskeleton device, including:
- Contracture in the hip, knee and ankle joints.
- Uncorrectable Equinovarus foot deformation.
- Severe muscular spasticity of the lower extremities (Modified Ashworth Scale Grade 3 higher).
- Fractures or incomplete bone junctions in the spine, pelvis, and/or lower extremities.
- Osteoporosis or lower bone mineral density -3.5, and history(ies) of osteoporotic fracture(s).
- Skin disorders including Stage I pressure injuries at the hip, lower limbs, and Exoskeleton contact areas, according to the National and European Pressure Ulcer Classification System (NPUAP-EPUAP).
- Inability to communicate with an Assistant due to cognitive and language disorders.
- Severe arthritis, acute arthritis, or synovitis after total or partial lower limb joint replacement.
- Orthostatic hypotension, essential hypertension, and a condition in which blood pressure is not controlled.
- Myocardial infarction or angina or ischemic heart disease within the last 6 months.
- Tachycardia, bradycardia, arrhythmia and other cardiac functions that are not controlled.
- Uncontrolled autonomic dysreflexia (AD).
- Uncontrolled diabetes.
- Infectious diseases or other serious complications.
- Uncorrectable leg length discrepancy over 2 cm when using additional correction tools.
- III-IV spine scoliotic deformity.
- Pregnant women should consult their physician prior to use.
- Amputations and lower limb prostheses.
- Morphological characteristics out of the device limitations.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
그룹/코호트 수
1
코호트 및 개입
그룹/코호트그룹/코호트 |
개입 / 치료개입 / 치료 |
|---|---|
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Patients with Disorders of Consciousness
Adults with a disorder of consciousness, such as coma, unresponsive wakefulness syndrome, or a minimally conscious state, who are receiving inpatient rehabilitation after a severe brain injury.
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Participants will receive overground robotic exoskeleton-assisted standing and walking as part of inpatient rehabilitation.
Following a screening session to assess device fit and tolerance, participants complete supervised ORE sessions.
The intervention is distinguished by the use of assisted overground walking and upright mobility in individuals with disorders of consciousness and is evaluated in relation to behavioral responsiveness, brain activity, safety, tolerability, and feasibility.
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Coma Recovery Scale-Revised (CRS-R)
기간: From enrollment to end of study at 2 weeks
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The Coma Recovery Scale-Revised (CRS-R) is a 23-item behavioral assessment used to evaluate consciousness in patients with brain injuries.
It measures auditory, visual, motor, oromotor, and communication functions.
The total score ranges from a minimum of 0 to a maximum of 23, with higher scores indicating a higher level of neurobehavioral function and conscious awareness.
CRS-R scores help characterize a patient's level of consciousness, including coma, vegetative state/unresponsive wakefulness syndrome, or minimally conscious state.
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From enrollment to end of study at 2 weeks
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Disability Rating Scale (DRS)
기간: Discharge from inpatient rehabilitation, an average of 8 weeks
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The Disability Rating Scale (DRS) is an 8-item clinical tool used to track a patient's recovery from a moderate-to-severe traumatic brain injury (TBI) from the coma stage through to community living.
Scores range from 0 (no disability) to 29 (extreme vegetative state)
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Discharge from inpatient rehabilitation, an average of 8 weeks
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CARE (Continuity Assessment Record and Evaluation)
기간: From inpatient admission through discharge from inpatient stay, assessed at routine intervals.
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The CARE (Continuity Assessment Record and Evaluation) tool is a standardized CMS assessment used to measure the medical, functional, cognitive, and social needs of Medicare post-acute care patients The assessment evaluates four major domains:
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From inpatient admission through discharge from inpatient stay, assessed at routine intervals.
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Electroencephalogram (EEG)
기간: Measured throughout 6 study assessment sessions conducted over 2 weeks during inpatient rehabilitation.
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Cortical activity will be recorded continuously during the study sessions using a 24-channel mobile electroencephalography (EEG) system.
Key positional changes will be marked in the EEG recording.
EEG spectral power, including power within predefined brain wave frequency bands, will be evaluated before, during, and after positional changes.
Changes in these measures will be used to evaluate cortical activity across study conditions.
EEG frequency measures will be reported in hertz (Hz).
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Measured throughout 6 study assessment sessions conducted over 2 weeks during inpatient rehabilitation.
|
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Event-Related Potential (ERP) - N100
기간: Measured throughout 6 study assessment sessions conducted over 2 weeks during inpatient rehabilitation.
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Event-related potentials (ERP) will be recorded before and immediately after each study session.
N100 ERP responses will be assessed, reflecting auditory sensory processing.
For each response, the timing of the brain response (peak latency) will be measured.
ERP latency measures will be reported in milliseconds (ms).
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Measured throughout 6 study assessment sessions conducted over 2 weeks during inpatient rehabilitation.
|
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Event-Related Potential (ERP) - P300
기간: Measured throughout 6 study assessment sessions conducted over 2 weeks during inpatient rehabilitation.
|
Event-related potentials (ERP) will be recorded before and immediately after each study session.
P300 ERP responses will be assessed, reflecting basic attention processing.
For each response, the timing of the brain response (peak latency) will be measured.
ERP latency measures will be reported in milliseconds (ms).
|
Measured throughout 6 study assessment sessions conducted over 2 weeks during inpatient rehabilitation.
|
|
Event-Related Potential (ERP) - N400
기간: Measured throughout 6 study assessment sessions conducted over 2 weeks during inpatient rehabilitation.
|
Event-related potentials (ERP) will be recorded before and immediately after each study session.
N400 ERP responses will be assessed, reflecting cognitive processing.
For each response, the timing of the brain response (peak latency) will be measured.
ERP latency measures will be reported in milliseconds (ms).
|
Measured throughout 6 study assessment sessions conducted over 2 weeks during inpatient rehabilitation.
|
|
Rate of Adverse Events (AE)
기간: Measured throughout study participation, including during 6 study assessment sessions conducted over 2 weeks and at routine intervals as part of standard clinical care during inpatient rehabilitation.
|
Safety of the study will be measure via Rate of Adverse Events (AE).
Reported exoskeleton-emergent AE will include: increase in pain behavior or agitation, disconcerting changes in cardiovascular function (e.g., sudden drop in blood pressure), skin irritation or orthopedic injuries caused by the robotic exoskeleton device, sudden changes in alertness (e.g., somnolence), autonomic storming, and seizure activity.
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Measured throughout study participation, including during 6 study assessment sessions conducted over 2 weeks and at routine intervals as part of standard clinical care during inpatient rehabilitation.
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Heart Rate Reserve (HRR)
기간: Measured throughout study participation, including during 6 study assessment sessions conducted over 2 weeks and at routine intervals as part of standard clinical care during inpatient rehabilitation.
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Heart Rate Reserve (HRR) will be recorded as a measure of cardiovascular tolerability during the intervention.
A heart rate monitor will be used to record the amount of time spent in each heart rate zone during ORE sessions: very light (<30% HRR), light (30-39%), moderate (40-59%), vigorous (60-89%), and near maximal (>90%).
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Measured throughout study participation, including during 6 study assessment sessions conducted over 2 weeks and at routine intervals as part of standard clinical care during inpatient rehabilitation.
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Session completion rate (SCR)
기간: Measured throughout study participation, including during 6 study assessment sessions conducted over 2 weeks and at routine intervals as part of standard clinical care during inpatient rehabilitation.
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Session completion rate (SCR) will be used to assess the feasibility of completing the scheduled overground robotic exoskeleton sessions.
Feasibility will be measured by the percentage of scheduled sessions that each participant completes.
Based on prior clinical experience delivering exoskeleton sessions to patients with disorders of consciousness, successful session completion will be defined as completing at least 75% of the scheduled overground robotic exoskeleton sessions.
For any missed session, the reason for the missed session and whether the session was rescheduled or made up will be documented.
The time needed to complete any make-up sessions will also be recorded.
These data will help determine whether the intervention schedule is practical and manageable for participants.
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Measured throughout study participation, including during 6 study assessment sessions conducted over 2 weeks and at routine intervals as part of standard clinical care during inpatient rehabilitation.
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
수사관
- 수석 연구원: Chad Swank, PhD, Spaulding Rehabilitation Hospital
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)
연구 시작
2026년 8월 1일
기본 완료 (추정된)
기본 완료
2028년 4월 1일
연구 완료 (추정된)
연구 완료
2028년 10월 1일
연구 등록 날짜
최초 제출
최초 제출
2026년 7월 7일
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
2026년 7월 13일
처음 게시됨 (실제)
처음 게시됨
2026년 7월 16일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
2026년 7월 16일
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 13일
마지막으로 확인됨
마지막으로 확인됨
2026년 7월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- 2026P000662
- HT94252510986 (기타 보조금/기금 번호: CDMRP)
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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. .