Walking With Overground Robotic Exoskeleton Device to Increase Behavioral Responsiveness in Patients With Disorders of Consciousness (WALK DOC) (WALK DOC)
2026年7月13日 更新者：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.
調査の概要
研究の種類
観察的
入学 (推定)
18
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Jenny Zhang, MS
- 電話番号：6179526354
- メール：jzhang71@mgb.org
研究場所
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Massachusetts
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Boston、Massachusetts、アメリカ、02129
- Spaulding Rehabilitation Hospital
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主任研究者：
- Chad Swank, PhD
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コンタクト：
- Clinical Research Project Manager
- 電話番号：6179526354
- メール：jzhang71@mgb.org
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
サンプリング方法
非確率サンプル
調査対象母集団
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.
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Coma Recovery Scale-Revised (CRS-R)
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Disability Rating Scale (DRS)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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.
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).
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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) - N400
時間枠：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).
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Measured throughout 6 study assessment sessions conducted over 2 weeks during inpatient rehabilitation.
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Rate of Adverse Events (AE)
時間枠：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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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)
時間枠：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)
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Chad Swank, PhD、Spaulding Rehabilitation Hospital
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年8月1日
一次修了 (推定)
2028年4月1日
研究の完了 (推定)
2028年10月1日
試験登録日
最初に提出
2026年7月7日
QC基準を満たした最初の提出物
2026年7月13日
最初の投稿 (実際)
2026年7月16日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月16日
QC基準を満たした最後の更新が送信されました
2026年7月13日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- 2026P000662
- HT94252510986 (その他の助成金/資金番号：CDMRP)
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
はい
米国で製造され、米国から輸出された製品。
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。