- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Maryland
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Rockville, Maryland, États-Unis, 20850
- Adventist Healthcare Rehabilitation
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: 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.
Autres noms:
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Expérimental: 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.
Autres noms:
|
Expérimental: 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.
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Repetitive-Task Practice is the repetitive rehearsal of a motor task with the intent to improve motor performance.
Autres noms:
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Comparateur actif: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Fugl Meyer Assessment-Upper Extremity Portion (FMA-UE) (Measuring pre/post intervention change)
Délai: 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)
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- AdventistHC
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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