Effects of RR and MT on Patient With Stroke
29 de julho de 2012 atualizado por: 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.
Visão geral do estudo
Status
Desconhecido
Condições
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Antecipado)
100
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Taipei City, Taiwan
- Recrutamento
- National Taiwan University Hospital
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Contato:
- Keh-chung Lin, ScD
- Número de telefone: 886-2-33668180
- E-mail: kehchunglin@ntu.edu.tw
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Investigador principal:
- Keh-chung Lin, ScD
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
40 anos a 75 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição fatorial
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Robotic Rehabilitation with FES
Robotic rehabilitation combined Functional Electrical Stimulation (FES)
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Este tratamento combinado RR-FES envolve o mesmo protocolo que o regime RR, exceto que os pacientes recebem FES simultaneamente com RR.
Outros nomes:
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Experimental: Mirror Therapy
Mirror Therapy (MT)
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Este protocolo inclui 1 hora de terapia de espelho e 0,5 hora de treinamento funcional em uma sessão.
A intensidade do tratamento é de 1,5 horas/dia, 5 dias/semana, durante 4 semanas.
O MT concentra-se em movimentos bimanuais simétricos e simultaneamente observando o feedback visual do espelho refletido pela extremidade superior não afetada.
Outros nomes:
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Comparador Ativo: Conventional Rehabilitation
Conventional Rehabilitation (CR) mainly focuses on occupational therapy training
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Os participantes deste grupo recebem um protocolo estruturado baseado em terapia ocupacional, como técnicas de neurodesenvolvimento e abordagem orientada para a tarefa.
A dose de tratamento é compatível com os grupos RR e MT.
Outros nomes:
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Experimental: Robotic Rehabilitation
Robotic Rehabilitation (RR)
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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).
Outros nomes:
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Comparador de Placebo: Robotic Rehabilitation with PI
Robotic rehabilitation with Placebo Intervention (RR-PI)
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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.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Fugl-Meyer Assessment (FMA)
Prazo: 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
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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).
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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
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Modified Ashworth Scale (MAS)
Prazo: 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
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The MAS is a 5-point ordinal scale to evaluate muscle tone of upper-extremity.
Higher score indicates a more severe hypertonia.
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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
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Functional independence measure (FIM)
Prazo: 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
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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.
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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
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Movement units (MU)
Prazo: Change from baseline in MU at 4 weeks
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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.
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Change from baseline in MU at 4 weeks
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Total displacement (TD)
Prazo: Change from baseline in TD at 4 weeks
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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.
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Change from baseline in TD at 4 weeks
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Percentage of peak velocity (PPV)
Prazo: Change from baseline in PPV at 4 weeks
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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.
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Change from baseline in PPV at 4 weeks
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Reaction time (RT)
Prazo: Change from baseline in RT at 4 weeks
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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.
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Change from baseline in RT at 4 weeks
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Action Research Arm Test (ARAT)
Prazo: 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
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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.
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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
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Medical Research Council scale (MRC)
Prazo: 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
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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.
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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
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MYOTON-3
Prazo: 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
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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.
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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
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Accelerometers
Prazo: 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
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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.
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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
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Peak velocity (PV)
Prazo: Change from baseline in PV at 4 weeks
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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.
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Change from baseline in PV at 4 weeks
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Trunk related Kinematic variables
Prazo: Change from baseline in trunk related kinematic variables at 4 weeks
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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.
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Change from baseline in trunk related kinematic variables at 4 weeks
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Motor Activity Log (MAL)
Prazo: 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
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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.
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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
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ABILHAND Questionnaire
Prazo: 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
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The ABILHAND is an inventory of 56 manual activities measuring the patient's perceived difficulty in daily activities.
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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
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Stroke Impact Scale Version 3.0 (SIS 3.0)
Prazo: 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
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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.
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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
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Nottingham Extended Activities of Daily Living Scale (NEADL)
Prazo: 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
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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.
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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
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revised Nottingham Sensory Assessment (rNSA)
Prazo: 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
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The rNSA examines the sensory function of the affected arm and includes tactile sensation, proprioception, and stereognosis subtests.
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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
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Fugl-Meyer Assessment-Sensory (FMA-S)
Prazo: 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
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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
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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
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8-OHdG: A Biomarker of Oxidative Stress
Prazo: 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
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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.
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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
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Multidimensional Fatigue Symptom Inventory (MFSI)
Prazo: 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
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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).
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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
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Keh-chung Lin, ScD, School of Occupational Therapy, College of Medicine, National Taiwan University
Publicações e links úteis
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Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de agosto de 2011
Conclusão Primária (Antecipado)
1 de julho de 2014
Conclusão do estudo (Antecipado)
1 de julho de 2014
Datas de inscrição no estudo
Enviado pela primeira vez
19 de julho de 2012
Enviado pela primeira vez que atendeu aos critérios de CQ
29 de julho de 2012
Primeira postagem (Estimativa)
1 de agosto de 2012
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
1 de agosto de 2012
Última atualização enviada que atendeu aos critérios de controle de qualidade
29 de julho de 2012
Última verificação
1 de julho de 2012
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 201012131RB
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