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Effects of RR and MT on Patient With Stroke

29 luglio 2012 aggiornato da: 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.

Panoramica dello studio

Stato

Sconosciuto

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Anticipato)

100

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Taiwan
      • Taipei City, Taiwan
        • Reclutamento
        • National Taiwan University Hospital
        • Contatto:
        • Investigatore principale:
          • Keh-chung Lin, ScD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 40 anni a 75 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione fattoriale
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Robotic Rehabilitation with FES
Robotic rehabilitation combined Functional Electrical Stimulation (FES)
Comportamentale: Riabilitazione robotica con FES
Questo trattamento combinato RR-FES prevede lo stesso protocollo del regime RR, tranne per il fatto che i pazienti ricevono FES in concomitanza con RR.
Altri nomi:
  • RR-Functional Electrical Stimulation
  • RR combined Functional Electrical Stimulation
  • RR-FES
Sperimentale: Mirror Therapy
Mirror Therapy (MT)
Comportamentale: Terapia dello specchio
Questo protocollo include 1 ora di terapia dello specchio e 0,5 ore di allenamento funzionale in una sessione. L'intensità del trattamento è di 1,5 ore/giorno, 5 giorni/settimana, per 4 settimane. MT si concentra su movimenti bimanuali simmetrici e contemporaneamente sull'osservazione del feedback visivo speculare riflesso dall'estremità superiore non interessata.
Altri nomi:
  • MT
Comparatore attivo: Conventional Rehabilitation
Conventional Rehabilitation (CR) mainly focuses on occupational therapy training
Comportamentale: Riabilitazione convenzionale
I partecipanti a questo gruppo ricevono un protocollo strutturato basato sulla terapia occupazionale come tecniche di neuro-sviluppo e approccio orientato al compito. La dose di trattamento è abbinata ai gruppi RR e MT.
Altri nomi:
  • CT
  • Trattamento di controllo
  • CR
Sperimentale: Robotic Rehabilitation
Robotic Rehabilitation (RR)
Comportamentale: 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).
Altri nomi:
  • RT
  • RR
  • Terapia robotica
Comparatore placebo: Robotic Rehabilitation with PI
Robotic rehabilitation with Placebo Intervention (RR-PI)
Comportamentale: 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.
Altri nomi:
  • Robotic Rehabilitation-PI
  • RR with Placebo Intervention
  • RR-PI

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Fugl-Meyer Assessment (FMA)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Motor Activity Log (MAL)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

National Taiwan University Hospital

Investigatori

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

Pubblicazioni e link utili

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Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 agosto 2011

Completamento primario (Anticipato)

1 luglio 2014

Completamento dello studio (Anticipato)

1 luglio 2014

Date di iscrizione allo studio

Primo inviato

19 luglio 2012

Primo inviato che soddisfa i criteri di controllo qualità

29 luglio 2012

Primo Inserito (Stima)

1 agosto 2012

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

1 agosto 2012

Ultimo aggiornamento inviato che soddisfa i criteri QC

29 luglio 2012

Ultimo verificato

1 luglio 2012

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 201012131RB

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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