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Evaluation of Robot Assisted Neuro-Rehabilitation (SRT3)

17 ottobre 2019 aggiornato da: VA Office of Research and Development

Evaluation of Robot Assisted Neuro-rehabilitation

Robotic devices are capable of providing therapy to the arm of patients with weakness due to stroke. Robotic therapy improves some aspects of stroke related arm weakness, but the use of the weak arm for real life situations often remains limited. The goal of this study is to determine the best way to use robotic devices and functional task training to improve the use of the stroke affected arm for real life situations. A secondary goal of this study is to determine how or if specific areas of the brain are excited before and after training. The use of a safe and painless magnetic field directed at the brain called transcranial magnetic stimulation (TMS) will be used at set intervals to gain a better understanding of brain activity during recovery.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

After obtaining informed consent, participants will undergo 3 sessions of baseline testing using upper extremity motor assessments of the shoulder, elbow, wrist, thumb and grip. Upper extremity kinematic and strength testing will be performed with the rehabilitation robots in measurement mode. The rehabilitation robot modules include the wrist, the planar (shoulder-elbow), and alternating wrist and shoulder-elbow robot. These robotic devices are cleared for marketing as a registered medical device under U.S. FDA regulations and are listed with the FDA both as an evaluation devices and as therapy devices.

Patients will be randomized to receive 12 weeks of robotic therapy sessions or 12 weeks of robot therapy combined with transition to task therapy. Study interventions will occur 3 times a week for 12 weeks. Robot therapy will consist of a progression through three robot modules: wrist, planar, and alternating wrist and shoulder-elbow robot. The progression will be sequential with four weeks of training on each robotic device. All participants will complete a motor activity log during this intervention phase.

TMS is being used for physiological measurement and evaluations will be conducted with each participant at baseline, week one, week five, eight, and final. TMS will also occur during the follow-up on week twenty-four.

Disability and depression questionnaires, upper extremity measures and evaluations of functional performance will be conducted during the study at baseline, and at training completion (visit 36). Patients will return twelve weeks after the end of the training period to determine whether any observed improvements persist.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

59

Fase

  • Fase 2
  • Fase 1

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

  • Stati Uniti
    • Maryland
      • Baltimore, Maryland, Stati Uniti, 21201
        • Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

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

21 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Clinically defined, unilateral, hemiparetic stroke with radiologic exclusion of other possible diagnoses
  • Adequate language, and cognitive function to participate in training, testing, and informed consent process
  • The study arm of the participant will present with moderate to severe dysfunction based on Fugl-Meyer Motor Assessment range of 7 to 38
  • Stroke onset greater than 6 months for ischemic stroke and greater than 1 year for hemorrhagic stroke
  • Men or women over 21 years of age

Exclusion Criteria:

  • Seizures or treatment with anticonvulsant medications within the last 10 years (This criteria does not preclude participation in the study, but does preclude participation in the TMS testing)
  • Treatment with any medications known to interfere with brain stimulation: any medication with central nervous system depressant activity, including, but not limited to benzodiazepines, barbiturates, and neuroleptics (This criteria does not preclude participation in the study, but does preclude participation in the TMS testing)
  • Serious complicating medical conditions, contractures or orthopedic problems in the study arm limiting the range of joint movement for the study positions
  • Visual loss such that the participant cannot see the test patterns on the monitor of the training robot computer
  • Botox injection to the study arm within 3 months of enrollment or during the study period
  • Any change in the exercise regime involving the study arm. This includes starting any new exercise or discontinuing any current exercise regimen

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 parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Robot Therapy
12 weeks of robotic therapy
Comportamentale: Robot Therapy
Robot assisted arm exercise for 60 minutes progressing each month through three robot modules: wrist, planar, and alternating sessions on the wrist and planar robot 3x/week for 12 weeks.
Altri nomi:
  • Upper extremity (UE) robot-assisted exercise
Comparatore attivo: Transition to Task Training
12 weeks of task specific practice combined with robotic therapy
Comportamentale: Transition to Task Training
Robot therapy as described for 45 minutes and 15 minutes of task specific arm exercise using the hemiparetic arm 3x/week for 12 weeks.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Fugl-Meyer Motor Upper Extremity Assessment
Lasso di tempo: Baseline, 12 week, and 24 week retention
This is a stroke-specific measure of impairment of the upper extremity that has been shown to be valid and reliable with high inter-rater and test-retest reliability. It provides a direct-observational assessment of volitional movement and motor impairment related to reflexes, sensation, and abnormal synergies. Each item on the FM is rated on a three-point ordinal scale (0 = cannot perform, 1 = performs partially, 2 = performs fully). The scale ranges from 0-66 with higher scores representing less motor impairment.
Baseline, 12 week, and 24 week retention

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Motor Cortex Excitability Via Transcranial Magnetic Stimulation (TMS)
Lasso di tempo: week 12
week 12
Wolf Motor Function Test (WMFT)
Lasso di tempo: Baseline, 12 week, and 24 week retention
The Wolf Motor Function Test (WMFT) examines UE function based on task performance time, quality of movement, and ability to hold a weight. Functional use and speed of movement are based on fifteen timed activities and two strength activities. It has high inter-rater reliability, internal consistency, and test-retest reliability. Timed tasks that cannot be completed default to a time score of 120 seconds. Faster times or a lower score in seconds represent better function. Improvement is represented by a decreased time to complete the tasks therefore a negative change score from baseline to follow-up indicates improvement.
Baseline, 12 week, and 24 week retention
Stroke Impact Scale: Hand Subscale
Lasso di tempo: Baseline, 12 week and 24 week retention
The Stroke Impact Scale (SIS) is a self-report structured interview consisting of eight domains designed to assess changes in impairment, disabilities, and handicap following stroke that contribute to quality of life. It has been tested and found to be reliable, valid, and sensitive to change in the stroke population. There are four physical domains that that can be analyzed separately. The hand domain was analyzed for this study and the scores for this domain range from 0-100. Higher scores indicate greater function.
Baseline, 12 week and 24 week retention

Collaboratori e investigatori

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

Sponsor

VA Office of Research and Development

Collaboratori

Massachusetts Institute of Technology
University of Maryland, College Park

Investigatori

  • Investigatore principale: Christopher T. Bever, MD, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

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 (Effettivo)

27 aprile 2011

Completamento primario (Effettivo)

16 gennaio 2015

Completamento dello studio (Effettivo)

30 gennaio 2015

Date di iscrizione allo studio

Primo inviato

24 novembre 2010

Primo inviato che soddisfa i criteri di controllo qualità

1 dicembre 2010

Primo Inserito (Stima)

3 dicembre 2010

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

30 ottobre 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

17 ottobre 2019

Ultimo verificato

1 ottobre 2019

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • B6935-R

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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