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The Study of Cognitive Rehabilitation Effectiveness for Mild Traumatic Brain Injury (SCORE)

2015年2月6日 更新者：Amy Bowles, M.D.、Brooke Army Medical Center

Phase IV Study of Cognitive Rehabilitation Effectiveness for Mild Traumatic Brain Injury

The objective of this trial is to evaluate the effectiveness of cognitive rehabilitation in OIF/OEF service members with a history of mild traumatic brain injury and persistent (3-24 months post injury) cognitive complaints. This is a prospective, randomized, control treatment trial of cognitive rehabilitation for OEF/OIF Service Members with a history of mild traumatic brain injury (mTBI) and persistent (3-24 months post-injury) cognitive complaints. Subjects will be recruited from consecutive patient referrals to the TBI Service at SAMMC-North. Patients who meet eligibility criteria and consent to participate in the treatment trial will be randomly assigned to one of four, 6-week treatment arms of the study. Subjects will be evaluated prior to the start of treatment and 3, 6, 12, and 18 weeks following the initiation of the study. The total number of patients to be studied is 160 (maximum), which is approximately 20 patients per month.

調査の概要

状態

完了

条件

介入・治療

詳細な説明

This is a prospective, randomized, control treatment trial of cognitive rehabilitation for OEF/OIF Service Members with a history of mild traumatic brain injury (mTBI) and persistent (3-24 months post-injury) cognitive complaints. Subjects will be recruited from consecutive patient referrals to the TBI Service at SAMMC-North. Patients who meet eligibility criteria and consent to participate in the treatment trial will be randomly assigned to one of four, 6-week treatment arms of the study: 1. Psychoeducational control group; 2. Non-therapist directed, computerized cognitive rehabilitation; 3. Therapist-directed individualized cognitive rehabilitation; and 4. Integrated interdisciplinary cognitive rehabilitation combined with cognitive-behavioral psychotherapy. (Components of the treatment arms are described in detail in section 4.6; Research Design and Methods.) All subjects enrolled in the study will receive the standard of care in management of chronic post-concussive symptoms, consistent with the VA/DoD Clinical Practice Guidelines for the Management of Concussion/mild TBI (Barth et al., 2009), regardless of treatment assignment. The standard of care includes provision of patient education materials (adapted from existing studies to address more persistent rather than acute symptom management), regular scheduled follow-up with a medical provider every three weeks, and symptom-based treatment of post-concussive complaints (e.g., medication trials for headache and co-occurring psychiatric disorders, physical therapy for vestibular complaints, case management, and supportive counseling with social work for soldiers assigned to the Warriors-in-Transition Battalion). Study participants who are assigned to treatment arms 2, 3, or 4 will additionally receive manualized cognitive rehabilitation therapies during the 6-week treatment phase of the study. Cognitive rehabilitation treatment intensity (i.e., number of hours of treatment per week) will be matched for individuals assigned to treatment arms 2, 3, or 4. Participants assigned to the control treatment group (treatment arm 1) will be offered individualized cognitive rehabilitation therapy if their cognitive complaints do not abate following the completion of the six-week treatment trial.

Study participants will be evaluated prior to the initiation of treatment, as well as at 3-weeks, 6-weeks, 12-weeks, and 18-weeks following the start of treatment. Study evaluators will be blind to treatment assignment. Pre-treatment baseline assessments and peri-/post-treatment outcome assessments will include demographic information, injury-related variables, self-report inventories, performance on neuropsychological testing, and functional status (e.g., work status; healthcare utilization). Detailed descriptions of the data to be collected including primary and secondary outcome measures, as well as co-variate measures can be found in section 4.8: Instrumentation.

研究の種類

介入

入学 (実際)

143

段階

  • フェーズ 4

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。

研究場所

  • アメリカ
    • Texas
      • San Antonio、Texas、アメリカ、78234
        • Brooke Army Medical Center

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

18年歳以上 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  • Diagnosis of mTBI as defined in the VA/DoD Clinical Practice Guidelines for the Management of Concussion/mild TBI (Barth et al., 2009) which occurred during deployment in support of OEF/OIF within 3-24 months of study enrollment;
  • Presence of cognitive complaints (NSI score of 3 or higher on any of the four cognitive symptoms)
  • Ability to understand and communicate in English.

Exclusion Criteria:

  • Medical/psychiatric/neurologic co-morbidities of: blindness/low vision; uncontrolled seizure disorder; psychosis; history of moderate, severe TBI or penetrating BI; or Spinal Cord Injury with no use of upper extremities;
  • Active participation in intensive (> 5 appointments per week) treatment for amputation, orthopedic trauma, burns, substance abuse, or post-traumatic stress disorder which would preclude full participation in an intensive cognitive rehabilitation program; or
  • Daily use of narcotic pain medication(s).

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

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：階乗代入
  • マスキング：ダブル

武器と介入

参加者グループ / アーム
介入・治療
他の：Standard of Care for mTBI Provider Arm
Arm 1: Psychoeducational Control Group. Individuals assigned to arm 1 will receive psychoeducational materials specifically adapted for persistent management of symptoms and routine follow-up with medical providers (every three weeks). Additionally, subjects assigned to this group will receive medical care (e.g., psychopharmacological management of depression) and/or referral for symptom management (e.g., vestibular rehabilitation) of non-cognitive complaints, consistent with the current standard of care treatment model for managing post-concussive symptoms (see Figure below adapted with permission from authors; Brenner et al., 2009).
行動：Informational Handout/Provider Visits
Provider based visits every three weeks and informational handout given to patient in regulation with current standard of care procedures.
実験的：Computer Based Therapy Group
Arm 2: Non-therapist directed computerized cognitive rehabilitation. Individuals assigned to treatment arm 2 will receive ten hours of in-clinic, computerized treatment per week throughout the 6-week treatment trial. Participants will be scheduled for 2 hours per day, proctored by clinic staff (certified recreation therapist or neuropsychology technician) who will be responsible for recording daily performance, providing positive reinforcement of participation, and effort. Computer programs selected for this treatment trial include both skill-specific training (e.g., attention processes) and general cognitive activation. These computer programs are commercially available and advertised as "brain fitness" or "brain training."
行動：Informational Handout/Provider Visits
Provider based visits every three weeks and informational handout given to patient in regulation with current standard of care procedures.
行動：Brainworks
POSIT
他の名前：
  • POSIT
実験的：Cognitive Rehab Group
Arm 3: Therapist-directed individualized cognitive rehabilitation. Individuals assigned to treatment arm 3 will receive 10 hours of individual and group cognitive rehabilitation treatment (including homework assignments) per week conducted by credentialed speech therapists and occupational therapists. The treatment components will include five hours of weekly individual therapy (one-hour sessions; two hours focused on compensatory strategies and three hours focused on restorative strategies), two hours of weekly group therapy (one hour sessions focused on compensatory strategies), and three hours of weekly computer-based "homework" proctored by clinic staff who will be responsible for recording performance, and providing positive reinforcement of participation and effort.
行動：Informational Handout/Provider Visits
Provider based visits every three weeks and informational handout given to patient in regulation with current standard of care procedures.
行動：Cognitive Rehab
APT-III, Other standard individual and group interventions.
他の名前：
  • APT-III
実験的：Cognitive and Psychological Based Rehab
Arm 4: Integrated interdisciplinary cognitive rehabilitation combined with cognitive-behavioral psychotherapy. Individuals assigned to treatment arm 4 will receive 10 hours of individual and group treatment per week conducted by credentialed therapists and doctoral-level psychologists. The treatment components will include four hours of weekly 1 hr individual therapy sessions; 2 hrs of cognitive rehabilitation, 1 hr of cognitive rehab & 1 hr of individual psychotherapy targeting anxiety/combat stress symptoms including relaxation training & exposure therapy and cognitive-behavioral principles, 3 hrs of weekly group therapy & three hours of weekly "homework" including 30-mins relaxation training, 30-mins cognitive-behavioral psychotherapy homework, and 2 hrs of computerized cognitive rehabilitation exercises proctored by clinic staff.
行動：Informational Handout/Provider Visits
Provider based visits every three weeks and informational handout given to patient in regulation with current standard of care procedures.
行動：Cognitive Rehab
APT-III, Other standard individual and group interventions.
他の名前：
  • APT-III

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
Emotional Functioning
時間枠：Baseline

Symptom Checklist-90-Revised (SCL-90-R)

Global Severity Index and 9 subscales:

Somatization; Obsessive-Compulsive; Interpersonal Sensitivity; Depression; Anxiety; Hostility; Phobic Anxiety; Paranoid Ideation, and Psychoticism
Baseline
Cognitive Efficiency
時間枠：Baseline

Paced Auditory Serial Addition Test (PASAT)

  • correct trial 1
  • correct trial 2
  • correct trial 3
  • correct trial 4 Sum of trials 1-4
Baseline
Functional Behaviors
時間枠：Baseline
Key Behaviors Change Inventory (KBCI) Total score Inattention- raw & T-score Impulsivity- raw & T-score Unawareness of Problems - raw & T-score Apathy - raw & T-score Interpersonal Difficulties - raw & T-score Communication Problems - raw & T-score Somatic Difficulties - raw & T-score Emotional Adjustment - raw & T-score 64 individual items
Baseline
Emotional Functioning
時間枠：3 Weeks

Symptom Checklist-90-Revised (SCL-90-R)

Global Severity Index and 9 subscales:

Somatization; Obsessive-Compulsive; Interpersonal Sensitivity; Depression; Anxiety; Hostility; Phobic Anxiety; Paranoid Ideation, and Psychoticism
3 Weeks
Emotional Functioning
時間枠：6 Weeks

Symptom Checklist-90-Revised (SCL-90-R)

Global Severity Index and 9 subscales:

Somatization; Obsessive-Compulsive; Interpersonal Sensitivity; Depression; Anxiety; Hostility; Phobic Anxiety; Paranoid Ideation, and Psychoticism
6 Weeks
Emotional Functioning
時間枠：12 Weeks

Symptom Checklist-90-Revised (SCL-90-R)

Global Severity Index and 9 subscales:

Somatization; Obsessive-Compulsive; Interpersonal Sensitivity; Depression; Anxiety; Hostility; Phobic Anxiety; Paranoid Ideation, and Psychoticism
12 Weeks
Emotional Functioning
時間枠：18 Weeks

Symptom Checklist-90-Revised (SCL-90-R)

Global Severity Index and 9 subscales:

Somatization; Obsessive-Compulsive; Interpersonal Sensitivity; Depression; Anxiety; Hostility; Phobic Anxiety; Paranoid Ideation, and Psychoticism
18 Weeks
Cognitive Efficiency
時間枠：3 Weeks

Paced Auditory Serial Addition Test (PASAT)

  • correct trial 1
  • correct trial 2
  • correct trial 3
  • correct trial 4 Sum of trials 1-4
3 Weeks
Cognitive Efficiency
時間枠：6 Weeks

Paced Auditory Serial Addition Test (PASAT)

  • correct trial 1
  • correct trial 2
  • correct trial 3
  • correct trial 4 Sum of trials 1-4
6 Weeks
Cognitive Efficiency
時間枠：12 Weeks

Paced Auditory Serial Addition Test (PASAT)

  • correct trial 1
  • correct trial 2
  • correct trial 3
  • correct trial 4 Sum of trials 1-4
12 Weeks
Cognitive Efficiency
時間枠：18 Weeks

Paced Auditory Serial Addition Test (PASAT)

  • correct trial 1
  • correct trial 2
  • correct trial 3
  • correct trial 4 Sum of trials 1-4
18 Weeks
Functional Behaviors
時間枠：3 Weeks
Key Behaviors Change Inventory (KBCI) Total score Inattention- raw & T-score Impulsivity- raw & T-score Unawareness of Problems - raw & T-score Apathy - raw & T-score Interpersonal Difficulties - raw & T-score Communication Problems - raw & T-score Somatic Difficulties - raw & T-score Emotional Adjustment - raw & T-score 64 individual items
3 Weeks
Functional Behaviors
時間枠：6 Weeks
Key Behaviors Change Inventory (KBCI) Total score Inattention- raw & T-score Impulsivity- raw & T-score Unawareness of Problems - raw & T-score Apathy - raw & T-score Interpersonal Difficulties - raw & T-score Communication Problems - raw & T-score Somatic Difficulties - raw & T-score Emotional Adjustment - raw & T-score 64 individual items
6 Weeks
Functional Behaviors
時間枠：12 Weeks
Key Behaviors Change Inventory (KBCI) Total score Inattention- raw & T-score Impulsivity- raw & T-score Unawareness of Problems - raw & T-score Apathy - raw & T-score Interpersonal Difficulties - raw & T-score Communication Problems - raw & T-score Somatic Difficulties - raw & T-score Emotional Adjustment - raw & T-score 64 individual items
12 Weeks
Functional Behaviors
時間枠：18 Weeks
Key Behaviors Change Inventory (KBCI) Total score Inattention- raw & T-score Impulsivity- raw & T-score Unawareness of Problems - raw & T-score Apathy - raw & T-score Interpersonal Difficulties - raw & T-score Communication Problems - raw & T-score Somatic Difficulties - raw & T-score Emotional Adjustment - raw & T-score 64 individual items
18 Weeks

二次結果の測定

結果測定
メジャーの説明
時間枠
Fatigue
時間枠：Baseline
Fatigue Severity Scale (FSS) Total Raw scale 9 individual items
Baseline
Post-Concussive Symptoms
時間枠：Baseline
Neurobehavioral Symptom Inventory Total Raw scale 22 individual items
Baseline
Self Reported Quality of Life
時間枠：Baseline

World Health Organization Brief Quality of Life Scale (WHO-QOL-BREF) Total transformed score

Total score for each of the 5 subscale domains:

Overall Functioning Physical Capacity Psychological Social Relationships Environment
Baseline
Neuropsychological Status
時間枠：Baseline
Neuropsychological Global Composite Score Average normative t-score of: [CVLT-2 sum trials 1-5, D-KEFS Verbal Fluency total score, Trail Making Test - part B only, WAIS-IV Processing Speed, Working, CVLT- 2 Trial 1, CVLT-2 Trial 2, CVLT- 2 Trial 3, CVLT-2 Trial 4, CVLT-2 Trial 5, CVLT-2 Total Trials 1-5, CVLT-2 Total Trials 1-5 (T-score), CVLT-2 List B, SDFR, SDCR, LDFR, LDCR, total perseverations,total intrusions CVLT-2 LD recognition hits CVLT-2 LD recognition FP errors Trails part A, Trails part B, Trails part A, Trails part B, WAIS-IV Processing Speed Index, WAIS-IV Symbol Search
Baseline
Self Reported Alcohol Use Behaviors
時間枠：Baseline
Alcohol Use Disorders Identification Test (AUDIT) Summary Socre; 10 individual items
Baseline
Post-Traumatic Stress Symptomatology
時間枠：18 Weeks
Post-Traumatic Stress Checklist-Military Form (PCL-M) Total Raw Socre 17 items
18 Weeks
Self Reported Headache Disability
時間枠：Baseline
Headache Impact Test-6 (HIT-6) Total Weighted Score
Baseline
Health Related (Cognition) Locus of Control
時間枠：Baseline
Multidimensional Health Locus of Control Scale (MHLCS-Form C) Internal subscale-total raw Chance subscale-total raw Powerful others subscale-total raw Doctors subscale-total raw Other people subscale-total raw
Baseline
Perceived Self-Efficacy (Cognition)
時間枠：Baseline
Self-Efficacy for Symptom Management Scale SEsx total SEsocial subscale SEemotional subscale SEcognitvie subscale 13 individual items
Baseline
Attribution of Cognitive Symptoms
時間枠：Baseline
Cognitive Symptom Attribution Scale 7 individual items
Baseline
Therapist-Rated Patient Engagement in Treatment
時間枠：Week 6 of treatment
Rehabilitation Intensity of Therapy Scale (RITS) Weekly average rating (weeks 1-6)
Week 6 of treatment
Post-Concussive Symptoms
時間枠：6 Weeks
Neurobehavioral Symptom Inventory (NSI) Total Raw scale 22 individual items
6 Weeks
Post-Concussive Symptoms
時間枠：12 weeks
Neurobehavioral Symptom Inventory (NSI) Total Raw scale 22 individual items
12 weeks
Post-Concussive Symptoms
時間枠：18 weeks
Neurobehavioral Symptom Inventory (NSI) Total Raw scale 22 individual items
18 weeks
Fatigue
時間枠：6 weeks
Fatigue Severity Scale (FSS) Total Raw scale 9 individual items
6 weeks
Fatigue
時間枠：12 Weeks
Fatigue Severity Scale (FSS) Total Raw scale 9 individual items
12 Weeks
Fatigue
時間枠：18 Weeks
Fatigue Severity Scale (FSS) Total Raw scale 9 individual items
18 Weeks
Change in Healthcare Utilization
時間枠：30 days prior to Baseline and 6 months post Baseline
Summed total number of appointments 30 days prior to study enrollment and summed total number of appointments for 30 days between 5 and 6 months post-treatment.
30 days prior to Baseline and 6 months post Baseline
Self Reported Quality of Life
時間枠：6 weeks

World Health Organization Brief Quality of Life Scale (WHO-QOL-BREF) Total transformed score

Total score for each of the 5 subscale domains:

Overall Functioning Physical Capacity Psychological Social Relationships Environment
6 weeks
Self Reported Quality of Life
時間枠：12 weeks

World Health Organization Brief Quality of Life Scale (WHO-QOL-BREF) Total transformed score

Total score for each of the 5 subscale domains:

Overall Functioning Physical Capacity Psychological Social Relationships Environment
12 weeks
Self Reported Quality of Life
時間枠：18 weeks

World Health Organization Brief Quality of Life Scale (WHO-QOL-BREF) Total transformed score

Total score for each of the 5 subscale domains:

Overall Functioning Physical Capacity Psychological Social Relationships Environment
18 weeks
Neuropsychological Status
時間枠：6 Weeks
Neuropsychological Global Composite Score Average normative t-score of: [CVLT-2 sum trials 1-5, D-KEFS Verbal Fluency total score, Trail Making Test - part B only, WAIS-IV Processing Speed, Working, CVLT- 2 Trial 1, CVLT-2 Trial 2, CVLT- 2 Trial 3, CVLT-2 Trial 4, CVLT-2 Trial 5, CVLT-2 Total Trials 1-5, CVLT-2 Total Trials 1-5 (T-score), CVLT-2 List B, SDFR, SDCR, LDFR, LDCR, total perseverations,total intrusions CVLT-2 LD recognition hits CVLT-2 LD recognition FP errors Trails part A, Trails part B, Trails part A, Trails part B, WAIS-IV Processing Speed Index, WAIS-IV Symbol Search
6 Weeks
Neuropsychological Status
時間枠：12 Weeks
Neuropsychological Global Composite Score Average normative t-score of: [CVLT-2 sum trials 1-5, D-KEFS Verbal Fluency total score, Trail Making Test - part B only, WAIS-IV Processing Speed, Working, CVLT- 2 Trial 1, CVLT-2 Trial 2, CVLT- 2 Trial 3, CVLT-2 Trial 4, CVLT-2 Trial 5, CVLT-2 Total Trials 1-5, CVLT-2 Total Trials 1-5 (T-score), CVLT-2 List B, SDFR, SDCR, LDFR, LDCR, total perseverations,total intrusions CVLT-2 LD recognition hits CVLT-2 LD recognition FP errors Trails part A, Trails part B, Trails part A, Trails part B, WAIS-IV Processing Speed Index, WAIS-IV Symbol Search
12 Weeks
Neuropsychological Status
時間枠：18 Weeks
Neuropsychological Global Composite Score Average normative t-score of: [CVLT-2 sum trials 1-5, D-KEFS Verbal Fluency total score, Trail Making Test - part B only, WAIS-IV Processing Speed, Working, CVLT- 2 Trial 1, CVLT-2 Trial 2, CVLT- 2 Trial 3, CVLT-2 Trial 4, CVLT-2 Trial 5, CVLT-2 Total Trials 1-5, CVLT-2 Total Trials 1-5 (T-score), CVLT-2 List B, SDFR, SDCR, LDFR, LDCR, total perseverations,total intrusions CVLT-2 LD recognition hits CVLT-2 LD recognition FP errors Trails part A, Trails part B, Trails part A, Trails part B, WAIS-IV Processing Speed Index, WAIS-IV Symbol Search
18 Weeks
Self Reported Alcohol Use Behaviors
時間枠：6 weeks
Alcohol Use Disorders Identification Test (AUDIT) Summary Socre; 10 individual items
6 weeks
Self Reported Alcohol Use Behaviors
時間枠：12 weeks
Alcohol Use Disorders Identification Test (AUDIT) Summary Socre; 10 individual items
12 weeks
Self Reported Alcohol Use Behaviors
時間枠：18 weeks
Alcohol Use Disorders Identification Test (AUDIT) Summary Socre; 10 individual items
18 weeks
Post-Traumatic Stress Symptomatology
時間枠：6 weeks
Post-Traumatic Stress Checklist-Military Form (PCL-M) Total Raw Socre 17 items
6 weeks
Post-Traumatic Stress Symptomatology
時間枠：Baseline
Post-Traumatic Stress Checkilist-Military Form (PCL-M) Total Raw Socre 17 items
Baseline
Post-Traumatic Stress Symptomatology
時間枠：12 Weeks
Post-Traumatic Stress Checklist-Military Form (PCL-M) Total Raw Socre 17 items
12 Weeks
Self Reported Headache Disability
時間枠：6 weeks
Headache Impact Test-6 (HIT-6) Total Weighted Score
6 weeks
Self Reported Headache Disability
時間枠：12 weeks
Headache Impact Test-6 (HIT-6) Total Weighted Score
12 weeks
Self Reported Headache Disability
時間枠：18 Weeks
Headache Impact Test-6 (HIT-6) Total Weighted Score
18 Weeks
Health Related (Cognition) Locus of Control
時間枠：6 weeks
Multidimensional Health Locus of Control Scale (MHLCS-Form C) Internal subscale-total raw Chance subscale-total raw Powerful others subscale-total raw Doctors subscale-total raw Other people subscale-total raw
6 weeks
Health Related (Cognition) Locus of Control
時間枠：12 weeks
Multidimensional Health Locus of Control Scale (MHLCS-Form C) Internal subscale-total raw Chance subscale-total raw Powerful others subscale-total raw Doctors subscale-total raw Other people subscale-total raw
12 weeks
Health Related (Cognition) Locus of Control
時間枠：18 weeks
Multidimensional Health Locus of Control Scale (MHLCS-Form C) Internal subscale-total raw Chance subscale-total raw Powerful others subscale-total raw Doctors subscale-total raw Other people subscale-total raw
18 weeks
Perceived Self-Efficacy (Cognition)
時間枠：6 weeks
Self-Efficacy for Symptom Management Scale SEsx total SEsocial subscale SEemotional subscale SEcognitvie subscale 13 individual items
6 weeks
Perceived Self-Efficacy (Cognition)
時間枠：12 weeks
Self-Efficacy for Symptom Management Scale SEsx total SEsocial subscale SEemotional subscale SEcognitvie subscale 13 individual items
12 weeks
Perceived Self-Efficacy (Cognition)
時間枠：18 weeks
Self-Efficacy for Symptom Management Scale SEsx total SEsocial subscale SEemotional subscale SEcognitvie subscale 13 individual items
18 weeks
Attribution of Cognitive Symptoms
時間枠：6 weeks
Cognitive Symptom Attribution Scale 7 individual items
6 weeks
Attribution of Cognitive Symptoms
時間枠：12 weeks
Cognitive Symptom Attribution Scale 7 individual items
12 weeks
Attribution of Cognitive Symptoms
時間枠：18 weeks
Cognitive Symptom Attribution Scale 7 individual items
18 weeks
Therapist-Rated Patient Engagement in Treatment
時間枠：Week 1 of Treatment
Rehabilitation Intensity of Therapy Scale (RITS) Weekly average rating (weeks 1-6)
Week 1 of Treatment
Therapist-Rated Patient Engagement in Treatment
時間枠：Week 2 of treatment
Rehabilitation Intensity of Therapy Scale (RITS) Weekly average rating (weeks 1-6)
Week 2 of treatment
Therapist-Rated Patient Engagement in Treatment
時間枠：Week 3 of treatment
Rehabilitation Intensity of Therapy Scale (RITS) Weekly average rating (weeks 1-6)
Week 3 of treatment
Therapist-Rated Patient Engagement in Treatment
時間枠：Week 4 of treatment
Rehabilitation Intensity of Therapy Scale (RITS) Weekly average rating (weeks 1-6)
Week 4 of treatment
Therapist-Rated Patient Engagement in Treatment
時間枠：Week 5 of treatment
Rehabilitation Intensity of Therapy Scale (RITS) Weekly average rating (weeks 1-6)
Week 5 of treatment

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。

スポンサー

Brooke Army Medical Center

協力者

Henry M. Jackson Foundation for the Advancement of Military Medicine
The Defense and Veterans Brain Injury Center

捜査官

  • 主任研究者：Amy O Bowles, MD、BAMC

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

便利なリンク

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

2011年6月1日

一次修了 (実際)

2014年6月1日

研究の完了 (実際)

2014年8月1日

試験登録日

最初に提出

2011年4月15日

QC基準を満たした最初の提出物

2011年4月20日

最初の投稿 (見積もり)

2011年4月21日

学習記録の更新

投稿された最後の更新 (見積もり)

2015年2月9日

QC基準を満たした最後の更新が送信されました

2015年2月6日

最終確認日

2015年2月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • C.2010.199

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。

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