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The Effects of Mirror Therapy on Upper Extremity in Stroke Patients

3 novembre 2015 aggiornato da: Taipei Medical University Hospital
The purpose of this study is to compare treatment efficacy of mirror therapy (MT), mirror therapy combining mesh glove (MG+MT) stimulation, and controlled treatment (CT) in people with stroke.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

55% to 75% of people after stroke have a paretic arm that causes motor impairment. Among novel rehabilitation interventions, MT was found to be beneficial and comparatively low-cost. MT reduced motor impairment possibly in part of recruiting the premotor cortex or balancing the neural activation within the primary motor cortex toward the affected hemisphere. However, the benefits in certain aspects of outcomes are under debate. Another treatment, MG, can be used to normalize muscle tone, suppress muscle spasticity, enhance residual volitional activity of hand and arm, or even increasing walking speed. In addition, providing MG stimulation might result in plastic changes in the primary motor cortex, and induced a long-lasting modulated effect on motor cortical excitability. The possible mechanism of brain plasticity underlying MG is collective with the mechanism behind the MT. Adding MG to MT might augment the cortical reorganization. In sum, combining MT with MG may supplement the disadvantage or uncertain effects of MT and broaden the benefited outcomes.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

60

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
      • New Taipei City, Taiwan, 23561
        • Shuang-Ho Hospital, Taipei Medical University

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 20 anni a 75 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • The onset duration more than 3 months
  • Demonstration of Brunnstrom stage equal to or above stage III of the affected upper extremity
  • No serious cognitive deficits (a score of more than 24 on the Mini Mental State Exam)
  • No serious visual and visual-perception impairments
  • No concurrent participation in other drug or rehabilitation research
  • No serious attention deficits
  • No excessive spasticity in any of the joints of the affected UL exclusion criteria

Exclusion Criteria:

  • Exhibit physician determined major medical problems or poor physical conditions that would interfere with participation
  • Excessive pain in any joint that might limit participation

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: Mirror therapy
mirror box training with or without sham mesh glove stimulation
Comportamentale: Mirror box training
This protocol includes 1 hour mirror therapy and 0.5 hour functional training in a session. The treatment intensity is 1.5 hours/day, 5 days/week, for 4 weeks. MT focuses on symmetrical bimanual movements and simultaneously observing the visual feedback of the unaffected upper extremity reflected by the mirror.
Altri nomi:
  • MT
Sperimentale: Mirror therapy + Mesh glove stimulation
Mirror therapy combined with mesh glove stimulation
Comportamentale: Mirror box training
This protocol includes 1 hour mirror therapy and 0.5 hour functional training in a session. The treatment intensity is 1.5 hours/day, 5 days/week, for 4 weeks. MT focuses on symmetrical bimanual movements and simultaneously observing the visual feedback of the unaffected upper extremity reflected by the mirror.
Altri nomi:
  • MT
Altro: mesh glove stimulation
The MG is a two-channel electrical stimulator providing synchronous or reciprocal sensory stimulation with variant amplitudes.
Altri nomi:
  • M.G
Comparatore attivo: Controlled intervention
conventional interventions
Comportamentale: conventional intervention
Participants in this group receive a structured protocol based on occupational therapy such as neuro-developmental techniques and task-oriented approach
Altri nomi:
  • CI

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Fugl-Meyer Assessment (FMA)
Lasso di tempo: Baseline, change from baseline in FMA at 4 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). The sub-score of a proximal shoulder/elbow (0-42) and a distal hand/wrist (0-24) will be also calculated to investigate the treatment effects on separate upper extremity elements.
Baseline, change from baseline in FMA at 4 weeks, change from baseline in FMA at 16 weeks, change from baseline in FMA at 28 weeks
Wolf Motor Function Test (WMFT)
Lasso di tempo: Baseline, change from baseline in WMFT at 4 weeks, change from baseline in WMFT at 16 weeks, change from baseline in WMFT at 28 weeks
  • The WMFT composed of 3 parts: Time, Functional ability, and Strength
  • Includes 15 function-based tasks and 2 strength based tasks
  • Performance time is referred to as WMFT-TIME
  • Functional ability is referred to as WMFT-FAS
  • Items 1-6 involve timed functional tasks, items 7-14 are measures of strength, and the remaining 9 items consist of analyzing movement quality when completing various tasks.
  • Examiner should test the less affected upper extremity followed by the most affected side.
  • Uses a 6-point ordinal scale
  • "0" = "does not attempt with the involved arm" to
  • "5" = "arm does participate; movement appears to be normal."
  • Maximum score is 75
  • Lower scores are indicative of lower functioning levels
  • WMFT-TIME allows 120 seconds per task
Baseline, change from baseline in WMFT at 4 weeks, change from baseline in WMFT at 16 weeks, change from baseline in WMFT at 28 weeks
Accelerometers
Lasso di tempo: Baseline, change from baseline in accelerometers at 4 weeks, change from baseline in accelerometers at 16 weeks, change from baseline in accelerometers at 28 weeks
The accelerometers are used to provide a direct and objective measure of the amount of the impaired arm movement outside the laboratory. 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. A "threshold-filter" will be applied to the raw recordings to obtain an accurate measure of the duration of arm movement.
Baseline, change from baseline in accelerometers at 4 weeks, change from baseline in accelerometers at 16 weeks, change from baseline in accelerometers at 28 weeks
revised Nottingham Sensory Assessment (rNSA)
Lasso di tempo: Baseline, change from baseline in rNSA at 4 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 (0=Absent, 1=Impaired, 2=Normal), proprioception (0=Absent, 1=Appreciation of movement sense, 2=Direction of movement sense, 3=Joint position sense), and stereognosis (0=Absent, 1=Impaired, 2=Normal) subtests.
Baseline, change from baseline in rNSA at 4 weeks, change from baseline in rNSA at 16 weeks, change from baseline in rNSA at 28 weeks

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Kinematic analyses
Lasso di tempo: Baseline, change from baseline in kinematic parameters at 4 weeks
A 7-camera motion-analysis system (VICON MX, Oxford Metrics Inc., Oxford, UK) was used. The variables of reaction time (second), movement time (second), total displacement (mm), peak velocity (mm/second), percentage of peak velocity, joint recruitments (degree), and maximum shoulder and elbow cross-correlation were collected.
Baseline, change from baseline in kinematic parameters at 4 weeks
Motor Activity Log (MAL)
Lasso di tempo: Baseline, change from baseline in MAL at 4 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.
Baseline, change from baseline in MAL at 4 weeks, change from baseline in MAL at 16 weeks, change from baseline in MAL at 28 weeks
Semmes-Weinstein monofilaments
Lasso di tempo: Baseline, change from baseline in Semmes-Weistein monofilaments at 4 weeks, change from baseline in Semmes-Weistein monofilaments at 16 weeks, change from baseline in Semmes-Weistein monofilaments at 28 weeks
The Semmes-Weinstein monofilaments is used for measuring diminishing and returning cutaneous sensation.A nylon 'string' is specifically calibrated in stiffness to represent a baseline level of sensation that can be considered 'the line' between having neuropathy and having normal sensation.
Baseline, change from baseline in Semmes-Weistein monofilaments at 4 weeks, change from baseline in Semmes-Weistein monofilaments at 16 weeks, change from baseline in Semmes-Weistein monofilaments at 28 weeks
Functional Independence Measure (FIM)
Lasso di tempo: Baseline, change from baseline in FIM at 4 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. Each item is rated from 1 to 7 (max. score 126) based on the required level of assistance to perform the tasks.
Baseline, change from baseline in FIM at 4 weeks, change from baseline in FIM at 16 weeks, change from baseline in FIM at 28 weeks
Stroke Impact Scale version 3.0 (SIS 3.0)
Lasso di tempo: Baseline, change from baseline in SIS at 4 weeks, change from baseline in SIS at 16 weeks, change from baseline in SIS at 28 weeks
The SIS 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.
Baseline, change from baseline in SIS at 4 weeks, change from baseline in SIS at 16 weeks, change from baseline in SIS at 28 weeks
8-OHdG
Lasso di tempo: Baseline, change from baseline in 8-OHDG at 4 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 will be collected in the centrifugal tubes before and after rehabilitation interventions. The samples will be 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), will be used to determine the urinary 8-OHdG levels.
Baseline, change from baseline in 8-OHDG at 4 weeks, change from baseline in 8-OHDG at 16 weeks, change from baseline in 8-OHDG at 28 weeks

Collaboratori e investigatori

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

Sponsor

Taipei Medical University Hospital

Investigatori

  • Investigatore principale: Keh-chung Lin, ScD, School of Occupational Therapy, College of Medicine, National Taiwan University
  • Investigatore principale: Tsan-hon Liou, PhD, Shuang-Ho Hospital, Taipei Medical University
  • Investigatore principale: Ching-yi Wu, ScD, Department of Occupational Therapy, College of Medicine, Chang Gung University

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 settembre 2010

Completamento primario (Effettivo)

1 maggio 2014

Completamento dello studio (Effettivo)

1 maggio 2014

Date di iscrizione allo studio

Primo inviato

27 luglio 2012

Primo inviato che soddisfa i criteri di controllo qualità

2 agosto 2012

Primo Inserito (Stima)

3 agosto 2012

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

5 novembre 2015

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 novembre 2015

Ultimo verificato

1 novembre 2012

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CRC-09-10-08

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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