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Task Oriented Training and Evaluation at Home (TOTE Home)

1. august 2016 oppdatert av: Veronica Rowe, Rowe, Veronica, M.D.

Objective: To determine the effectiveness of an upper extremity, task oriented training program delivered at home (TOTE Home) for people who are in the subacute recovery phase of a stroke.

Method: A single-subject AB series design with a follow-up to assess the effectiveness of TOTE Home which includes a maximum of 30, one hour sessions of training conducted in participants' homes. Repeated target measures of accelerometry and level of confidence to be analyzed throughout the study. Change scores from standardized assessments to be evaluated at baseline, post-intervention, and follow-up time periods.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Hemiparesis following a stroke frequently leads to "learned non-use" of the weaker arm and hand. Task oriented training has been suggested as a contemporary neurorehabilitation technique. A single-subject AB series design with a follow-up was conducted to assess the effectiveness of a task oriented training program administered in participants' homes. This intervention, Task Oriented Training at Home (TOTE Home), incorporated current experience-dependent plasticity aspects modeled after the Acquired Skill Acquisition Program (ASAP) protocol parameters and principles of task oriented training as suggested by Lang and Birkenmeier in 2014. Repeated measures of accelerometry and level of confidence on a priority task were analyzed with visual analysis of changes in level, trend, and slope. Change scores from standardized assessments for the upper extremity, Motor Activity Log, Stroke Impact Scale question of recovery, Functional Test for the Hemiparetic Upper Extremity, and Canadian Occupational Performance Measure were evaluated on data collected at baseline, post-intervention, and follow-up time periods.

Studietype

Intervensjonell

Registrering (Faktiske)

4

Fase

  • Ikke aktuelt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

21 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • upper extremity hemiparesis due to a stroke but met minimal movement criteria in the affected arm and hand (at least 10 degrees of active movement at the wrist, elbow, and shoulder movement, along with 10 degrees of active movement in the thumb and two other fingers)
  • minimal cognitive deficits as demonstrated by a 24 or higher on the Mini-Mental Status Exam
  • able to identify at least five specific tasks participants wish to achieve with their affected upper extremity. This was assessed with the Canadian Occupational Performance Measure (COPM)
  • at least 21 years of age
  • able to communicate in English
  • 3-12 months after their stroke which would classify them in the subacute level of recovery
  • all formal occupational therapy was completed.

Exclusion Criteria:

  • upper extremity pain that interfered with activities of daily living
  • requiring maximal assistance for mobility
  • arm or hand injury (unrelated to the stroke)
  • upper extremity amputations
  • inability to participate due to any illness, social or geographical reason, and any other diagnosis or limiting conditions that would affect participation

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Task Oriented Training

The intervention administered during each of the training sessions was modeled after the protocol outlined in Winstein et al. (2013) however implementation was in the participant's home setting and involved tasks in the participant's real world.

The manual entitled, "Upper-Extremity Task-Specific Training After Stroke or Disability" by Lang and Birkenmeier (2014) was also utilized to give a general overview of task specific training for the upper extremity and to help guide each activity the participant chose to work on.
Atferdsmessig: Task Oriented Treatment

The intervention administered during each of the training sessions was modeled after the protocol outlined in Winstein et al. (2013) however implementation was in the participant's home setting and involved tasks in the participant's real world.

The manual entitled, "Upper-Extremity Task-Specific Training After Stroke or Disability" by Lang and Birkenmeier (2014) was also utilized to give a general overview of task specific training for the upper extremity and to help guide each activity the participant chose to work on.

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Movement of the hemiparetic upper extremity as measured by accelerometry
Tidsramme: 24 hour recordings over 8 day periods
24 hour recordings over 8 day periods

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Rowe, Veronica, M.D.

Etterforskere

  • Studiestol: Marsha Neville, PhD, OT, Texas Woman's University

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juni 2015

Primær fullføring (Faktiske)

1. mars 2016

Studiet fullført (Faktiske)

1. mars 2016

Datoer for studieregistrering

Først innsendt

27. juli 2016

Først innsendt som oppfylte QC-kriteriene

1. august 2016

Først lagt ut (Anslag)

2. august 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

2. august 2016

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. august 2016

Sist bekreftet

1. juli 2016

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • TOTE Home 001

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

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