Examining Rehabilitation Training Methods

NCT ID: NCT02766400

Last Updated: 2020-01-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2015-07-31

Brief Summary

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Individuals with cognitive impairments after stroke sustain significant disability in their daily tasks, and account for a significant proportion of stroke-related healthcare costs. This loss of independence is costly because individuals with stroke-related cognitive impairments require more rehabilitation and more resources to support their living, whether in institutional or community settings. The proposed study examines the effects of directed and guided training on the recovery of independence with daily activities in adults with stroke-related cognitive impairments in acute rehabilitation. The investigators predict that patients in both groups will demonstrate significant improvement in independence with daily activities in the first 12 months after rehabilitation admission, but that patients who receive guided training will demonstrate significantly more improvements than patients who received directed training.

Detailed Description

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Conditions

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Guided Training Directed Training

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Guided Training

Guided training is a rehabilitation training approach that maximizes the expertise of the patient, by teaching patients to identify and prioritize activities, identify barriers to performing activities, generate their own strategies for addressing these barriers, and apply this process through iterative practice. Guided training equips patients with "practical" skills that have the potential to generalize beyond activities addressed during the intervention program to novel problematic activities that arise after the intervention program, thereby promoting long-term independence.

Group Type EXPERIMENTAL

Guided Training

Intervention Type BEHAVIORAL

Directed Training

Directed training is a rehabilitation approach that maximizes the expertise of the rehabilitation practitioner. Rehabilitation practitioners identify and prioritize problematic activities, identify barriers to performing these activities, generate strategies to address these barriers and instruct patients in these strategies, and repeat the process with a variety of problematic activities identified during the rehabilitation program. Directed training promotes independence with training activities, however the benefits of direct training are likely to be activity-specific (i.e., only promote improvement on the trained activity) and not generalizable to other daily activities. This therapist-directed approach is currently the method used most frequently in acute rehabilitation.

Group Type ACTIVE_COMPARATOR

Directed Training

Intervention Type BEHAVIORAL

Interventions

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Guided Training

Intervention Type BEHAVIORAL

Directed Training

Intervention Type BEHAVIORAL

Other Intervention Names

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Strategy Training Direct Skill Training

Eligibility Criteria

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Inclusion Criteria

* primary diagnosis of acute stroke
* admission to acute inpatient rehabilitation
* impairment in cognitive functions (as indicated by 14-item Executive Interview ≥ 3)

Exclusion Criteria

* diagnosis of dementia in the medical record
* inability to follow two-step commands 80% of the time
* severe aphasia (score of 0 or 1 on the Boston Diagnostic Aphasia Examination 3rd Edition Severity Rating Scale)
* current untreated major depressive, bipolar, or psychotic disorder (PRIME-MD)
* drug or alcohol abuse within 3 months (Mini-International Neuropsychiatric Interview)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Elizabeth R. Skidmore, PhD, OTR/L

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elizabeth R Skidmore, PhD, OTR/L

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

References

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Kringle EA, Terhorst L, Butters MA, Skidmore ER. Clinical Predictors of Engagement in Inpatient Rehabilitation Among Stroke Survivors With Cognitive Deficits: An Exploratory Study. J Int Neuropsychol Soc. 2018 Jul;24(6):572-583. doi: 10.1017/S1355617718000085. Epub 2018 Mar 19.

Reference Type DERIVED
PMID: 29552996 (View on PubMed)

Skidmore ER, Butters M, Whyte E, Grattan E, Shen J, Terhorst L. Guided Training Relative to Direct Skill Training for Individuals With Cognitive Impairments After Stroke: A Pilot Randomized Trial. Arch Phys Med Rehabil. 2017 Apr;98(4):673-680. doi: 10.1016/j.apmr.2016.10.004. Epub 2016 Oct 26.

Reference Type DERIVED
PMID: 27794487 (View on PubMed)

Other Identifiers

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R03HD073770-01

Identifier Type: NIH

Identifier Source: secondary_id

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R01HD074693-02S1

Identifier Type: NIH

Identifier Source: secondary_id

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UL1TR000005

Identifier Type: NIH

Identifier Source: secondary_id

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PRO12040383

Identifier Type: -

Identifier Source: org_study_id

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