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Patient Targeted Upper Extremity Rehabilitation After Stroke (TARG)

5 agosto 2019 aggiornato da: VA Office of Research and Development

Patient-Targeted Upper Extremity Rehabilitation After Stroke

Each year in the US, approximately 795,000 people have a stroke, and the overwhelming majority of those who survive are unable to resume meaningful daily activities because of impaired movement in one arm/hand. This study will investigate the effects of a challenging 4-week physical rehabilitation therapy program that is targeted at specific movement impairments and systematically progressed to assure an ongoing "just right" level of rigor. The investigators anticipate that therapy targeted to address specific movement impairments will improve recovery of arm/hand movement in people who have had a stroke.

Panoramica dello studio

Stato

Completato

Condizioni

Descrizione dettagliata

The overwhelming majority of individuals who survive stroke have persistent upper extremity (UE) motor deficits which interfere with re-engagement in meaningful activities. While advances from neuroscience are spurring development of new rehabilitation strategies, the development of novel measurement methods has not kept pace. Currently, there is no comprehensive measurement framework to objectively quantify impairment, match a rehabilitation therapy program to a patient's impairment level, and measure specific therapy effects. Therefore there has not been a rehabilitation trial where a measurement framework is the basis for designing the treatment as well as defining the outcome. The investigators redesigned the Fugl-Meyer UE Assessment (FMA-UE) using item response theory Rasch analysis and developed a first of its kind measurement framework that locates a patient along a continuum of impairment and directs a personalized therapy program tailored to patients' specific impairments and ability levels. The purpose of this proposed research is to empirically test this framework.

The objective of this project is to empirically test the FMA-UE measurement framework.

This study hypothesizes that therapeutic task practice at the just-right challenge of difficulty will maximize post-stroke motor skill reacquisition. It is expected that "targeted task-practice", will increase UE motor ability because task goal difficulty will be matched and systematically progressed according to patients' initial and evolving levels of ability.

This is a single-blinded study with parallel arm design, stratified sampling and blocked randomization. 120 individuals with post-stroke UE hemiparesis will be enrolled; 40 participants per 3 UE impairment levels as defined by the investigators' measurement framework. Participants will engage in 12 sessions (3x/wk for 4 weeks, 2 hrs/session) of reach-to-grasp task-practice. Within each impairment level, subjects will be randomized to a treatment group; 20 to targeted task-practice and 20 to non-targeted task-practice. Targeted task-practice is personalized to patient-specific UE motor deficits with initial targets (goals) defined according to baseline measures and targets continually progressed after every 3 therapy sessions so that the goals match the patient's evolving level of ability. Non-targeted task practice is defined as a standard of care task-practice intervention intended to increase UE use but not alter specific impairments. Data analyses will include (1) ANOVA to test the effects of targeted vs. non-targeted therapy on UE motor ability, (2) multiple regression to model the relationship between therapy and movement adaptions occurring pre- to post-rehabilitation, and (3) growth mixture modeling to define responders and non-responders.

This project is significant because there is a pressing need for a comprehensive measurement framework to guide novel interventions designed to improve post-stroke UE motor function and define their effects.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

103

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

    • South Carolina
      • Charleston, South Carolina, Stati Uniti, 29401-5799
        • Ralph H. Johnson VA Medical Center, Charleston, SC

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 18 anni a 89 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

Individuals are eligible for this study if they have:

  • experienced a stroke at least 3 months prior that has resulted in unilateral hemiparesis.
  • exhibit voluntarily paretic arm shoulder flexion 30 degrees with simultaneous elbow extension 20 degrees.
  • impairment with overhead reach and wrist circumduction and fine motor dexterity.
  • passive range of motion in affected shoulder, elbow and wrist within 20 degrees of normal values.

Exclusion Criteria:

Individuals are not eligible for this study if they have:

  • a lesion in the brainstem or cerebellum.
  • another neurological disease that may impair motor skills (e.g., Parkinson's Disease).
  • pain in the affected upper extremity that would limit participation in the study intervention.
  • difficulty understanding and following 3-step directions.
  • difficulty sitting independently without postural support.
  • an orthopedic condition or impaired corrected vision that alters the kinematics of reaching.
  • are unable to travel to and remain in Charleston SC for the duration of the 4-week study.

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: Targeted Task Practice
Targeted task practice is defined as a therapy program aimed at patient-specific upper extremity motor impairment levels and systematically progressed to assure an ongoing "just right" match between task-difficulty and patient-ability. Participants attended occupational therapy 3 times per week for 4 weeks. Each therapy session was 2 hours in length.
Similar to stroke rehabilitation occupational therapy.
Altri nomi:
  • Task Practice
Comparatore attivo: Non-Targeted Task Practice
Non-targeted task practice is a standard of care treatment consisting of task practice with no guidance from the measurement framework to systematically address specific upper extremity motor impairment levels or progress rehabilitation therapy. Participants attended occupational therapy 3 times per week for 4 weeks. Each therapy session was 2 hours in length.
Similar to stroke rehabilitation occupational therapy.
Altri nomi:
  • Task Practice

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Fugl-Meyer Assessment of the Upper Extremity
Lasso di tempo: participants will be followed for the duration of the 4-week rehabilitation treatment, an expected average of 4 weeks.
The Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) is a stroke rehabilitation assessment of arm/hand movement impairment. It is traditionally scored by assigning 30 items assessing voluntary arm/hand movements and 3 items assessing reflexes an ordinal rating (0=unable, 1=partial, 2=near normal), then summing the ratings to obtain a general statement of ability. Instead of this traditional scoring method, the investigators will eliminate the reflex items, thus reporting the aggregate score possible from 0/60 to 60/60 points. Higher scores indicate greater levels of arm movement ability.
participants will be followed for the duration of the 4-week rehabilitation treatment, an expected average of 4 weeks.
Wolf Motor Function Test
Lasso di tempo: participants will be followed for the duration of the 4-week rehabilitation treatment, an expected average of 4 weeks.
The Wolf Motor Function Test is an assessment of arm movement function. Subjects are timed (seconds) as they complete 15 functional movements with the paretic arm. The average time required to complete an item is reported in seconds so that lower scores (quicker completion times) indicate greater functional movement skills. Post-intervention averages were compared to baseline averages so a reduction in timed averages indicates improved movement function.
participants will be followed for the duration of the 4-week rehabilitation treatment, an expected average of 4 weeks.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Surface Electromyographic (sEMG) Analysis of Functional Arm Muscle Activations
Lasso di tempo: participants will be followed for the duration of the 4-week rehabilitation treatment, an expected average of 4 weeks.
sEMG analysis is an objective method to study muscle coordination during functional arm movements. Subjects will be fitted with sensors on the skin placed over 8 arm/shoulder muscles on both arms. The sensors will detect the muscle activity of these muscles during functional reaching movements. sEMG data will be recorded with a 16-channel wireless Motion Labs EMG system and processed with custom ORBIS software.
participants will be followed for the duration of the 4-week rehabilitation treatment, an expected average of 4 weeks.

Collaboratori e investigatori

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

Investigatori

  • Investigatore principale: Michelle L. Woodbury, PhD, Ralph H. Johnson VA Medical Center, Charleston, SC

Pubblicazioni e link utili

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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)

1 marzo 2013

Completamento primario (Effettivo)

31 marzo 2017

Completamento dello studio (Effettivo)

31 marzo 2017

Date di iscrizione allo studio

Primo inviato

11 marzo 2013

Primo inviato che soddisfa i criteri di controllo qualità

21 marzo 2013

Primo Inserito (Stima)

27 marzo 2013

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

8 agosto 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

5 agosto 2019

Ultimo verificato

1 agosto 2019

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

Indeciso

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

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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