Examining Rehabilitation Training Methods (GUIDE)

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University of Pittsburgh

Status

Completed

Conditions

Directed Training
Guided Training

Treatments

Behavioral: Guided Training
Behavioral: Directed Training

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT02766400
R03HD073770-01 (U.S. NIH Grant/Contract)
UL1TR000005 (U.S. NIH Grant/Contract)
R01HD074693-02S1 (U.S. NIH Grant/Contract)
PRO12040383

Details and patient eligibility

About

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.

Enrollment

77 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

77 participants in 2 patient groups

Guided Training
Experimental group
Description:
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.
Treatment:
Behavioral: Guided Training
Directed Training
Active Comparator group
Description:
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.
Treatment:
Behavioral: Directed Training

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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