Task Oriented Training and Evaluation at Home (TOTE Home)
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.
Panoramica dello studio
Descrizione dettagliata
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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. |
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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Movement of the hemiparetic upper extremity as measured by accelerometry
Lasso di tempo: 24 hour recordings over 8 day periods
|
24 hour recordings over 8 day periods
|
Collaboratori e investigatori
Sponsor
Investigatori
- Cattedra di studio: Marsha Neville, PhD, OT, Texas Woman's University
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- TOTE Home 001
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
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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