- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT04927728
The Application of a Mental Practice Protocol in the Acute Inpatient Rehabilitation Setting
The Application of a Mental Practice Protocol to Increase the Functional Recovery of the Hemiparetic Upper Extremity in the Acute Inpatient Rehabilitation Setting
The purpose of this randomized controlled trial is to compare the effect of audio-guided mental practice (MP) and video-guided MP on the impairment and functional abilities of upper extremity (UE) hemiparesis following a stroke. Participants are recruited from Adventist Healthcare Rehabilitation Hospital. All participants must be less than one-month post-stroke with moderate UE hemiparesis. Eligible participants are randomly assigned to an experimental group, (MP or repetitive-task practice (RTP)), or the control group.
The MP groups will perform either audio-guided MP or video-guided MP, five days a week, with 20 repetitions of the following tasks: wiping a table, picking up a cup, brushing hair, and turning the pages of a book. The RTP group physically performed the same tasks. The control group received traditional stroke rehabilitation.
The investigators hypothesize that video MP will have greater improvements in UE impairments and functional abilities than audio MP, RTP, and/or traditional therapy.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Maryland
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Rockville, Maryland, Stati Uniti, 20850
- Adventist Healthcare Rehabilitation
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Primary diagnosis of stroke
- Less than one-month post-stroke
- Hemiparesis of one upper extremity
- Moderate upper extremity impairment
Exclusion Criteria:
- History of prior stroke
- Comorbidities (severe neurological, orthopedic, rheumatoid, or cardiac impairments)
- Severe spasticity
- Severe cognitive impairments
- Inability to perform mental imagery
- Severe aphasia based on speech therapist evaluation
- Low English proficiency
- Severe pain
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: Audio MP
Participants of the audio mental practice (MP) group will complete MP via audio-guided multisensory cues of one of four tasks: (1) wiping a table (2) picking up a cup (3) brushing hair and/or (4) turning the page of a book.
The assigned motor task is based upon the functional abilities of the patient.
MP will be performed followed by physical practice of the same task with a research therapist 3x/week and independent MP 2 days/week.
Each audio recording consists of 20 repetitions of the task.
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MP is the cognitive rehearsal of a motor task without physical movement, with the intent to improve motor performance.
Mental practice can be completed via audio or video recording, visual prompts, written instructions, self-initiated or recorded pictures.
Altri nomi:
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Sperimentale: Video MP
Participants of the video mental practice (MP) group will complete MP via video-guided multisensory cues of one of four tasks: (1) wiping a table (2) picking up a cup (3) brushing hair and/or (4) turning the page of a book.
The assigned motor task is based upon the functional abilities of the patient.
MP will be performed followed by physical practice of the same task with a research therapist 3x/week and independent MP 2 days/week.
Each audio recording consists of 20 repetitions of the task.
|
MP is the cognitive rehearsal of a motor task without physical movement, with the intent to improve motor performance.
Mental practice can be completed via audio or video recording, visual prompts, written instructions, self-initiated or recorded pictures.
Altri nomi:
|
Sperimentale: Repetitive-Task Practice
Participants of the repetitive-task practice group will complete repetitive practice of one of four tasks: (1) wiping a table (2) picking up a cup (3) brushing hair and/or (4) turning the page of a book.
The assigned motor task is based upon the functional abilities of the patient.
MP will be performed followed by physical practice of the same task with a research therapist 3x/week and independent MP 2 days/week.
Each participant completed at least 20 repetitions of the task.
|
Repetitive-Task Practice is the repetitive rehearsal of a motor task with the intent to improve motor performance.
Altri nomi:
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Comparatore attivo: Traditional Therapy
The control group received traditional occupational therapy stroke rehabilitation.
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Traditional therapy includes traditional interventions completed in occupational therapy for patients following a stroke.
These interventions include but are not limited to, range of motion, weight-bearing, massage, modalities, self-care training, and transfer training.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Fugl Meyer Assessment-Upper Extremity Portion (FMA-UE) (Measuring pre/post intervention change)
Lasso di tempo: Within 3 days of admission and within 3 days prior to discharge
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The Fugl Meyer Assessment-upper extremity(FMA-UE) portion will be administered to measure the impairment of the upper extremity.
Upper extremity movements are rated on 3-point ordinal scale where 0= unable to perform, 1= performs partially, 2= performs fully.
Cumulative scores range from 0-66 where a lower score indicates increased impairment.
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Within 3 days of admission and within 3 days prior to discharge
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Wolf Motor Function Test (WMFT) (Measuring pre/post intervention change)
Lasso di tempo: Within 3 days of admission and within 3 days prior to discharge
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The Wolf Motor Function Test (WMFT) is used to measure the functional abilities of the UE. 15 tasks are performed including six timed joint-segment movements and eight timed integrative functional movements.
Tasks are rated on a 6-point ordinal scale where 0= does not attempt to 5=movement appears to be normal.
Timed and functional ability scores are calculated to indicate the functional abilities of the UE.
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Within 3 days of admission and within 3 days prior to discharge
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Collaboratori e investigatori
Sponsor
Collaboratori
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Inizio studio (Effettivo)
Completamento primario (Effettivo)
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Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- AdventistHC
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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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