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The Application of a Mental Practice Protocol in the Acute Inpatient Rehabilitation Setting

9. juni 2021 oppdatert av: Adventist HealthCare

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.

Studieoversikt

Studietype

Intervensjonell

Registrering (Faktiske)

18

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Maryland
      • Rockville, Maryland, Forente stater, 20850
        • Adventist Healthcare Rehabilitation

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

18 år til 80 år (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

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: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
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.
Andre navn:
  • Mentale bilder
  • Motor Imagery
Eksperimentell: 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.
Andre navn:
  • Mentale bilder
  • Motor Imagery
Eksperimentell: 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.
Andre navn:
  • Repetitive-Task Specific Practice
Aktiv komparator: Traditional Therapy
The control group received traditional occupational therapy stroke rehabilitation.
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Fugl Meyer Assessment-Upper Extremity Portion (FMA-UE) (Measuring pre/post intervention change)
Tidsramme: Within 3 days of admission and within 3 days prior to discharge
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.
Within 3 days of admission and within 3 days prior to discharge
Wolf Motor Function Test (WMFT) (Measuring pre/post intervention change)
Tidsramme: Within 3 days of admission and within 3 days prior to discharge
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.
Within 3 days of admission and within 3 days prior to discharge

Samarbeidspartnere og etterforskere

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Samarbeidspartnere

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 (Faktiske)

28. januar 2019

Primær fullføring (Faktiske)

25. november 2020

Studiet fullført (Faktiske)

25. november 2020

Datoer for studieregistrering

Først innsendt

1. juni 2021

Først innsendt som oppfylte QC-kriteriene

9. juni 2021

Først lagt ut (Faktiske)

16. juni 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

16. juni 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

9. juni 2021

Sist bekreftet

1. juni 2021

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • AdventistHC

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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