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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04927728
Other study ID # AdventistHC
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 28, 2019
Est. completion date November 25, 2020

Study information

Verified date June 2021
Source Adventist HealthCare
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date November 25, 2020
Est. primary completion date November 25, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Mental Practice
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.
Repetitive-Task Practice
Repetitive-Task Practice is the repetitive rehearsal of a motor task with the intent to improve motor performance.
Traditional Therapy
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.

Locations

Country Name City State
United States Adventist Healthcare Rehabilitation Rockville Maryland

Sponsors (2)

Lead Sponsor Collaborator
Adventist HealthCare Texas Woman's University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fugl Meyer Assessment-Upper Extremity Portion (FMA-UE) (Measuring pre/post intervention change) 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
Primary Wolf Motor Function Test (WMFT) (Measuring pre/post intervention change) 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
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