Effects of Upper Limb Motor and Robotic Training Over Neuroplasticity and Function Capacity (NARLE1)
Effects of Upper Limb Motor Training and Upper Limb Robotic Training Over Neuroplasticity and Function Capacity: A Single-blind Randomized Clinical Trial With Patients With Stroke Sequelae
調査の概要
詳細な説明
The trial is being carried out in the Institute of Physical Medicine and Rehabilitation of the University of São Paulo since February 2012. The investigators are including patients with clinical diagnosis of Ischemic or hemorrhagic stroke.
The patients are being randomized in blocks of four, six and eight, in two arms: ICT: patients are undergoing 60 minutes physiotherapy and occupational therapy twice a week for ten consecutive weeks. Other therapeutic services as phonoaudiology, psychology, nutrition, physical conditioning are prescribed upon the patients' medical demands. After the 10 weeks, the patients are undergoing two whole weeks of daily ICT as to reach 90% of the time under constraint, including weekends. During this last period, no other therapeutic service is offered, but the occupational therapy under ICT. Patients are not allowed to undergo robotic therapy.
Robotic therapy: patients are undergoing robotic occupational therapy for 60 minutes, three times a week for twelve consecutive weeks. All other therapeutic services are prescribed upon the patients' medical demands. Patients are not allowed to undergo ICT.
The investigator and the raters are blind to treatment.
The evaluations are done prior to the beginning of the treatment and at the end of it. The follow up assessments are done at 3 and 12 months after the end of the treatment.
The sample size was estimated to be 62 patients in each arm, a total size of 124 patients
研究の種類
入学 (実際)
段階
- フェーズ2
連絡先と場所
研究場所
-
-
-
Sao Paulo、ブラジル、04116-040
- Centro de Pesquisa Clínica do Instituto de Medicina Física e Reabilitação do HCFMUSP
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Clinical diagnosis of stroke;
- Patients from 6 months after stroke up to 36 months after stroke;
- Clinically stable;
- Upper limb Brunnstrom scale III or IV;
- Brunnstrom scale above V if clinician supports patients will benefit from treatment;
- Minimum wrist extension of 20°, and minimum of 10° of metacarpophalangeal active extension.
- Signed Informed Consent Form;
Exclusion Criteria:
- Mini-Mental score lower than 20 points;
- Previous multiple strokes;
- Bone diseases and articulation injuries ;
- Presence of psychological disturbances capable of diminishing adherence;
- Articulation pain within the range of motion proposed by the therapies;
- Participation in another study protocol for upper limbs therapies.
- Previous treatment with robotic assisted therapies.
研究計画
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：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Induced Constraint Therapy - ICT
Physical rehabilitation with Induced Constraint Therapy as part of the occupational therapy.
Standard Occupational Therapy two times a week for ten weeks, followed by two whole weeks of Induced Constraint Therapy.
|
Standard Occupational Therapy two times a week for ten weeks, followed by two whole weeks of Induced Constraint Therapy.
他の名前：
|
|
実験的：Robotic occupational therapy
Physical rehabilitation with Robotic occupational therapy.
Robotic Occupational Therapy three times a week for twelve weeks.
|
Robotic Occupational Therapy three times a week for twelve weeks.
他の名前：
|
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 |
|---|---|---|
|
Change on Motor Function assessed by Wolf Motor Function scale
時間枠：Baseline and 12 weeks
|
Change from baseline in Wolf Motor Function scale.
|
Baseline and 12 weeks
|
|
Change on Motor Function assessed by Fugl Meyer scale
時間枠：Baseline and 12 weeks
|
Change from baseline in Fugl Meyer scale.
|
Baseline and 12 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change on Motor Function assessed by Wolf Motor Function scale
時間枠：Baseline, 3 months and 12 months
|
Multiple changes from baseline in Wolf Motor Function scale.
|
Baseline, 3 months and 12 months
|
|
Change on Motor Function assessed by Fugl Meyer scale
時間枠：Baseline, 3 months and 12 months
|
Multiple changes from baseline in Fugl Meyer scale.
|
Baseline, 3 months and 12 months
|
|
Change on Motor Function assessed by Robotic scale
時間枠：Baseline, 3 months and 12 months
|
Multiple changes from baseline in robotic scale.
|
Baseline, 3 months and 12 months
|
|
Change on Function ability and quality of movement assessed by Arm Motor Ability Test (AMAT)
時間枠：Baseline, 12 weeks, 3 months and 12 months
|
Multiple changes from baseline in AMAT scale.
|
Baseline, 12 weeks, 3 months and 12 months
|
|
Change on Functional Independence Measure (FIM) as assessed by FIM scale
時間枠：Baseline, 12 weeks, 3 months and 12 months
|
Multiple changes from baseline in FIM scale.
|
Baseline, 12 weeks, 3 months and 12 months
|
|
Change on Quality of life assessed by Stroke Impact Scale (SIS)
時間枠：Baseline, 12 weeks, 3 months and 12 months
|
Multiple changes from baseline in SIS.
|
Baseline, 12 weeks, 3 months and 12 months
|
|
Change on Kinematic variables assessed by InMotion robots
時間枠：Baseline, 12 weeks, 3 months and 12 months
|
Multiple motion changes from baseline in the Kinematic variables assessed by InMotion robots.
|
Baseline, 12 weeks, 3 months and 12 months
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Psychological Evaluation assessed by Perceived Stress Scale (PSS-10)
時間枠：Baseline, 12 weeks, 3 months and 12 months
|
Multiple changes from baseline in PSS-10.
|
Baseline, 12 weeks, 3 months and 12 months
|
|
Neuroplasticity as assessed by Brain Derived Neurotrophic Factor (BDNF)
時間枠：Baseline, 12 weeks, 3 months and 12 months
|
Multiple changes from baseline in BDNF.
|
Baseline, 12 weeks, 3 months and 12 months
|
|
Corticospinal excitability as assessed by transcranial magnetic stimulation (TMS)
時間枠：Baseline, 12 weeks, 3 months and 12 months
|
Multiple changes from baseline in TMS.
|
Baseline, 12 weeks, 3 months and 12 months
|
|
Neurologic evaluation as assessed by electroencephalography
時間枠：Baseline, 12 weeks, 3 months and 12 months
|
Multiple changes from baseline in electroencephalography.
|
Baseline, 12 weeks, 3 months and 12 months
|
協力者と研究者
捜査官
- 主任研究者：Linamara Rizzo Battistella, Md PhD、University of Sao Paulo
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 0910.0.015.000-11
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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。