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Effects of RR and MT on Patient With Stroke

29. července 2012 aktualizováno: National Taiwan University Hospital

Randomized Trials of Robotic Rehabilitation, Mirror Therapy, and Dose-Matched Control Intervention for Upper-Limb Rehabilitation in Patients With Chronic Stroke: Comparative Efficacy and Clinimetric Study

The purpose of this proposal is 1) to compare the relative effects of the robotic rehabilitation (RR), mirror therapy (MT), and conventional intervention (CI), 2) to compare the effects of the combined therapy of the RR-Functional Electrical Stimulation (FES) and the RR-Placebo Intervention (PI), and 3) to identify the clinical predictors that will potentially influence the functional outcomes after interventions.

Přehled studie

Postavení

Neznámý

Podmínky

Intervence / Léčba

Detailní popis

Motor deficit of upper extremity is one of the prominent problems in patients with stroke. Looking for effective and efficient treatments to improve affected UE function is of great importance in the field of rehabilitation. Two emerging movement therapies in stroke rehabilitation are robotic rehabilitation (RR) and mirror therapy (MT). Scientific evidence for comparative effectiveness research of RR versus MT versus CI on functional outcomes (e.g., motor, muscle, sensory, and daily functions) in stroke patients is limited. In addition, studies showed FES induced some improvements in individual movements at the shoulder, elbow, wrist, and fingers or in muscle strength in patients with moderate-to-severe paresis. The combination therapy of the FES and training protocols may increase the benefits of standard rehabilitative treatments and may also facilitate motor learning. However, the combined training effects of the RR and FES on stroke patients have not been well studies in a larger sample yet. Specific objectives of this proposed research are as follows: First, The investigators will compare the efficacy of the RR, MT, and conventional rehabilitation. Secondly, the investigators will compare the efficacy of the RR-FES versus RR-PI on outcome measures. Thirdly, the investigators will identify the clinical predictors that will potentially influence the functional outcomes after interventions.

Typ studie

Intervenční

Zápis (Očekávaný)

100

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Tchaj-wan
      • Taipei City, Tchaj-wan
        • Nábor
        • National Taiwan University Hospital
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Keh-chung Lin, ScD

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

40 let až 75 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion Criteria:

  • Willing to provide the written informed consent
  • More than 6 months onset of unilateral stroke
  • An initial 25-56 or 18-50 scores on the UE subtest of the FMA
  • Sufficient cognitive ability (Mini Mental State Examination ≧ 24 points)
  • Without upper limb fracture within 3 months

Exclusion Criteria:

  • Recurrent of stroke or seizure episode during the intervention
  • Occurence of serious or continuous pain on affected upper-extremity
  • History of other neurological disease or severe orthopaedic condition

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Faktorové přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Robotic Rehabilitation with FES
Robotic rehabilitation combined Functional Electrical Stimulation (FES)
Behaviorální: Robotická rehabilitace s FES
Tato kombinovaná léčba RR-FES zahrnuje stejný protokol jako režim RR kromě toho, že pacienti dostávají FES současně s RR.
Ostatní jména:
  • RR-Functional Electrical Stimulation
  • RR combined Functional Electrical Stimulation
  • RR-FES
Experimentální: Mirror Therapy
Mirror Therapy (MT)
Behaviorální: Zrcadlová terapie
Tento protokol zahrnuje 1 hodinu zrcadlové terapie a 0,5 hodiny funkčního tréninku v relaci. Intenzita ošetření je 1,5 hodiny/den, 5 dní/týden, po dobu 4 týdnů. MT se zaměřuje na symetrické bimanuální pohyby a současné pozorování zrcadlové vizuální zpětné vazby odrážené nepostiženou horní končetinou.
Ostatní jména:
  • MT
Aktivní komparátor: Conventional Rehabilitation
Conventional Rehabilitation (CR) mainly focuses on occupational therapy training
Behaviorální: Konvenční rehabilitace
Účastníci v této skupině obdrží strukturovaný protokol založený na pracovní terapii, jako jsou neuro-vývojové techniky a přístup orientovaný na úkoly. Léčebná dávka je přizpůsobena skupinám RR a MT.
Ostatní jména:
  • ČT
  • Kontrolní léčba
  • ČR
Experimentální: Robotic Rehabilitation
Robotic Rehabilitation (RR)
Behaviorální: Robotic Rehabilitation
This protocol includes 5 to 10 min of warm-up, 1 hr of RR, and 15 to 20 min of functional activities training. The treatment intensity is 1.5 hours/day, 5days/week for 4 consecutive weeks. The RR session uses the robot-assisted arm trainer, Bi-Manu-Track (Reha-Stim Co., Berlin, Germany).
Ostatní jména:
  • RT
  • RR
  • Robotická terapie
Komparátor placeba: Robotic Rehabilitation with PI
Robotic rehabilitation with Placebo Intervention (RR-PI)
Behaviorální: Robotic Rehabilitation with PI
The RR-PI protocol is the same as the RR-FES protocol described above except that the surface electrodes are attached to the same target muscles on the affected UL but there is no output of electrical stimulation.
Ostatní jména:
  • Robotic Rehabilitation-PI
  • RR with Placebo Intervention
  • RR-PI

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Fugl-Meyer Assessment (FMA)
Časové okno: Change from baseline in FMA at 4 weeks, change from baseline in FMA at 8 weeks, change from baseline in FMA at 16 weeks, change from baseline in FMA at 28 weeks
The upper-extremity subscale of the FMA contains 33 items to assess motor impairment. Each item is scored on a 3-point ordinal scale (0-cannot perform, 1-performs partially, 2-performs fully and correctly).
Change from baseline in FMA at 4 weeks, change from baseline in FMA at 8 weeks, change from baseline in FMA at 16 weeks, change from baseline in FMA at 28 weeks
Modified Ashworth Scale (MAS)
Časové okno: Change from baseline in MAS at 4 weeks, change from baseline in MAS at 8 weeks, change from baseline in MAS at 16 weeks, change from baseline in MAS at 28 weeks
The MAS is a 5-point ordinal scale to evaluate muscle tone of upper-extremity. Higher score indicates a more severe hypertonia.
Change from baseline in MAS at 4 weeks, change from baseline in MAS at 8 weeks, change from baseline in MAS at 16 weeks, change from baseline in MAS at 28 weeks
Functional independence measure (FIM)
Časové okno: Change from baseline in FIM at 4 weeks, change from baseline in FIM at 8 weeks, change from baseline in FIM at 16 weeks, change from baseline in FIM at 28 weeks
The FIM consists of 18 items grouped into 6 subscales measuring self-care, sphincter control, transfer, locomotion, communication, and social cognition ability. Each item is rated from 1 to 7 based on the required level of assistance to perform the tasks.
Change from baseline in FIM at 4 weeks, change from baseline in FIM at 8 weeks, change from baseline in FIM at 16 weeks, change from baseline in FIM at 28 weeks
Movement units (MU)
Časové okno: Change from baseline in MU at 4 weeks
The parameter of movement units is collected by a 7-camera motion analysis system (VICON MX 3-D, Oxford Metrics Inc., Oxford, UK) from unilateral and bilateral reaching tasks of pressing the desk bell. One acceleration phase and one deceleration phase constitute a MU. The number of MU indicates the movement smoothness.
Change from baseline in MU at 4 weeks
Total displacement (TD)
Časové okno: Change from baseline in TD at 4 weeks
The TD is collected by a 7-camera motion analysis system (VICON MX 3-D, Oxford Metrics Inc., Oxford, UK) from unilateral and bilateral reaching tasks of pressing the desk bell. TD refers to the path of a hand shifting in three-dimensional space and is a measurement of trajectory smoothness.
Change from baseline in TD at 4 weeks
Percentage of peak velocity (PPV)
Časové okno: Change from baseline in PPV at 4 weeks
PPV is collected by a 7-camera motion analysis system (VICON MX 3-D, Oxford Metrics Inc., Oxford, UK) from unilateral and bilateral reaching tasks of pressing the desk bell. PPV indicates the percentage of acceleration phase among the whole movement process. It is an outcome measurement of pre-motor planning ability.
Change from baseline in PPV at 4 weeks
Reaction time (RT)
Časové okno: Change from baseline in RT at 4 weeks
The reaction time is collected by a 7-camera motion analysis system (VICON MX 3-D, Oxford Metrics Inc., Oxford, UK) from unilateral and bilateral reaching tasks of pressing the desk bell. RT is the time required to prepare a motor response toward an external signal and indicates speed of motor planning.
Change from baseline in RT at 4 weeks
Action Research Arm Test (ARAT)
Časové okno: Change from baseline in ARAT at 4 weeks, change from baseline in ARAT at 8 weeks, change from baseline in ARAT at 16 weeks, change from baseline in ARAT at 28 weeks
The ARAT assesses the ability to handle objects with 19 items divided into 4 subscales of grasp, grip, pinch, and gross movement by 4-level ordinal scale. Higher the score, better the performance.
Change from baseline in ARAT at 4 weeks, change from baseline in ARAT at 8 weeks, change from baseline in ARAT at 16 weeks, change from baseline in ARAT at 28 weeks
Medical Research Council scale (MRC)
Časové okno: Change from baseline in MRC at 4 weeks, change from baseline in MRC at 8 weeks, change from baseline in MRC at 16 weeks, change from baseline in MRC at 28 weeks
The MRC scale assesses muscle power with scores ranging from 0 (no contraction) to 5 (normal power). The muscle strength of shoulder flexors/abductors, elbow flexors/extensors, wrist flexors/extensors, and finger extensors are graded.
Change from baseline in MRC at 4 weeks, change from baseline in MRC at 8 weeks, change from baseline in MRC at 16 weeks, change from baseline in MRC at 28 weeks
MYOTON-3
Časové okno: Change from baseline in MYOTON-3 at 4 weeks, change from baseline in MYOTON-3 at 8 weeks, change from baseline in MYOTON-3 at 16 weeks, change from baseline in MYOTON-3 at 28 weeks
MYOTON-3 is used to assess muscle tone of the affected upper limb. There are three measurement parameters in the MYOTON-3: F - Frequency, Hz, characterizing muscle tone; D - Decrement, characterizing muscle elasticity; and S - Stiffness, N/m, characterizing muscle stiffness.
Change from baseline in MYOTON-3 at 4 weeks, change from baseline in MYOTON-3 at 8 weeks, change from baseline in MYOTON-3 at 16 weeks, change from baseline in MYOTON-3 at 28 weeks
Accelerometers
Časové okno: Change from baseline in accelerometers at 4 weeks, change from baseline in accelerometers at 8 weeks, change from baseline in accelerometers at 16 weeks, change from baseline in accelerometers at 28 weeks
Accelerometers are used to provide a direct and objective measure of the amount of the impaired arm movement outside the laboratory. In this project, acceleration is sampled at 10 Hz and summed over a user- specified epoch. The recording epoch in this study is 2 seconds; recording capacity is approximately 72 hours.
Change from baseline in accelerometers at 4 weeks, change from baseline in accelerometers at 8 weeks, change from baseline in accelerometers at 16 weeks, change from baseline in accelerometers at 28 weeks
Peak velocity (PV)
Časové okno: Change from baseline in PV at 4 weeks
PPV is collected by a 7-camera motion analysis system (VICON MX 3-D, Oxford Metrics Inc., Oxford, UK) from unilateral and bilateral reaching tasks of pressing the desk bell. PV corresponds to the changeover from the acceleration to the deceleration phase and is related to the force produced.
Change from baseline in PV at 4 weeks
Trunk related Kinematic variables
Časové okno: Change from baseline in trunk related kinematic variables at 4 weeks
The parameter of movement units is collected by a 7-camera motion analysis system (VICON MX 3-D, Oxford Metrics Inc., Oxford, UK) from unilateral and bilateral reaching tasks of pressing the desk bell. These parameters include trunk displacement, trunk flexion angular change, trunk-arm delay, shoulder flexion & trunk flexion correlation, and elbow extension & trunk flexion correlation. These variables indicate the degree of trunk compensatory movement and interjoint coordination.
Change from baseline in trunk related kinematic variables at 4 weeks

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Motor Activity Log (MAL)
Časové okno: Change from baseline in MAL at 4 weeks, change from baseline in MAL at 8 weeks, change from baseline in MAL at 16 weeks, change from baseline in MAL at 28 weeks
The MAL is a semi-structured interview of patients to assess the amount of use (AOU) and quality of movement (QOM) of the affected upper extremity in 30 important daily activities using a 6-point ordinal scale. Higher scores indicate superior amount and quality of use in affected upper extremity.
Change from baseline in MAL at 4 weeks, change from baseline in MAL at 8 weeks, change from baseline in MAL at 16 weeks, change from baseline in MAL at 28 weeks
ABILHAND Questionnaire
Časové okno: Change from baseline in ABILHAND at 4 weeks, change from baseline in ABILHAND at 8 weeks, change from baseline in ABILHAND at 16 weeks, change from baseline in ABILHAND at 28 weeks
The ABILHAND is an inventory of 56 manual activities measuring the patient's perceived difficulty in daily activities.
Change from baseline in ABILHAND at 4 weeks, change from baseline in ABILHAND at 8 weeks, change from baseline in ABILHAND at 16 weeks, change from baseline in ABILHAND at 28 weeks
Stroke Impact Scale Version 3.0 (SIS 3.0)
Časové okno: Change from baseline in SIS at 4 weeks, change from baseline in SIS at 8 weeks, change from baseline in SIS at 16 weeks, change from baseline in SIS at 28 weeks
The SIS 3.0 is a stroke-specific instrument of health-related quality of life and contains 59 items measuring 8 domains. Items are rated on a 5-point Likert scale with lower scores indicate greater difficulty in task completion during the past week. Aggregate scores, ranges from 0 to 100, are generated for each domain.
Change from baseline in SIS at 4 weeks, change from baseline in SIS at 8 weeks, change from baseline in SIS at 16 weeks, change from baseline in SIS at 28 weeks
Nottingham Extended Activities of Daily Living Scale (NEADL)
Časové okno: Change from baseline in NEADL at 4 weeks, change from baseline in NEADL at 8 weeks, change from baseline in NEADL at 16 weeks, change from baseline in NEADL at 28 weeks
The NEADL consists of 22 activity items, scoring on the basis of the required level of assistance. The range of total score is 0-66, and higher score representing better function.
Change from baseline in NEADL at 4 weeks, change from baseline in NEADL at 8 weeks, change from baseline in NEADL at 16 weeks, change from baseline in NEADL at 28 weeks
revised Nottingham Sensory Assessment (rNSA)
Časové okno: Change from baseline in rNSA at 4 weeks, change from baseline in rNSA at 8 weeks, change from baseline in rNSA at 16 weeks, change from baseline in rNSA at 28 weeks
The rNSA examines the sensory function of the affected arm and includes tactile sensation, proprioception, and stereognosis subtests.
Change from baseline in rNSA at 4 weeks, change from baseline in rNSA at 8 weeks, change from baseline in rNSA at 16 weeks, change from baseline in rNSA at 28 weeks
Fugl-Meyer Assessment-Sensory (FMA-S)
Časové okno: Change from baseline in FMA-S at 4 weeks, change from baseline in FMA-S at 8 weeks, change from baseline in FMA-S at 16 weeks, change from baseline in FMA-S at 28 weeks
The FMA-S contains 12 three-point items, four for light touch and eight for position sense. The total score ranges from 0 to 24. The sensation for light touch will be estimated subjectively. The patient will be asked whether he or she feels that light touches on both arms and the palmar surface of the hands give the same qualitative and quantitative impressions. The position sense of the joints will involve tests for interphalangeal joint of the thumb, the wrist, the elbow, and the shoulder joint
Change from baseline in FMA-S at 4 weeks, change from baseline in FMA-S at 8 weeks, change from baseline in FMA-S at 16 weeks, change from baseline in FMA-S at 28 weeks
8-OHdG: A Biomarker of Oxidative Stress
Časové okno: Change from baseline in 8-OHdG at 4 weeks, change from baseline in 8-OHdG at 8 weeks, change from baseline in 8-OHdG at 16 weeks, change from baseline in 8-OHdG at 28 weeks
Urinary 8-OHdG is a stable and integral biomarker of oxidative DNA damage. About 10 mL to 15 mL urine samples of the patients are collected in the centrifugal tubes before and after rehabilitation interventions. The samples is transported with dry ice under 4°C and preserved in a -80°C refrigerator before analysis. A highly sensitive and selective method, using isotope- dilution liquid chromatography with tandem mass spectrometry (LC/MS/MS), is used to determine the urinary 8-OHdG levels.
Change from baseline in 8-OHdG at 4 weeks, change from baseline in 8-OHdG at 8 weeks, change from baseline in 8-OHdG at 16 weeks, change from baseline in 8-OHdG at 28 weeks
Multidimensional Fatigue Symptom Inventory (MFSI)
Časové okno: Change from baseline in MFSI at 4 weeks, change from baseline in MFSI at 8 weeks, change from baseline in MFSI at 16 weeks, change from baseline in MFSI at 28 weeks
The general subscale of the MFSI is used to measure general fatigue of the patients. It includes 6 items with a total score ranging from 0 (not at all) to 24 (extremely).
Change from baseline in MFSI at 4 weeks, change from baseline in MFSI at 8 weeks, change from baseline in MFSI at 16 weeks, change from baseline in MFSI at 28 weeks

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

National Taiwan University Hospital

Vyšetřovatelé

  • Vrchní vyšetřovatel: Keh-chung Lin, ScD, School of Occupational Therapy, College of Medicine, National Taiwan University

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

1. srpna 2011

Primární dokončení (Očekávaný)

1. července 2014

Dokončení studie (Očekávaný)

1. července 2014

Termíny zápisu do studia

První předloženo

19. července 2012

První předloženo, které splnilo kritéria kontroly kvality

29. července 2012

První zveřejněno (Odhad)

1. srpna 2012

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Odhad)

1. srpna 2012

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

29. července 2012

Naposledy ověřeno

1. července 2012

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 201012131RB

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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