Examining Rehabilitation Training Methods

NCT02766400 | Completed Results DMC

• 4 other identifiers: PRO12040383R03HD073770-01R01HD074693-02S1UL1TR000005
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Guided Training; Directed Training

Keywords

Stroke; Rehabilitation; Cognition; Disability; Intervention

Outcome Measures

Primary Outcomes (1)

• Differences in Independence With Activities of Daily Living (Functional Independence Measure) Between Groups Over Time

  Differences between groups in mean independence scores (computed from Functional Independence Measure total scores) over time. The Functional Independence Measure contains 18 items with a total score ranging from 18-126 is obtained (18=complete dependence/total assistance with basic self-care and mobility activities; 126=complete independence with basic self-care and mobility activities). Total scores were calculated for each participant at baseline, discharge, month 3, month 6, and month 12, and mean total scores for each group were calculated at each time point. Differences in mean scores were examined between groups over time with mixed model analyses.

  Baseline, rehab discharge, month 3, month 6, month 12

Study Arms (2)

Guided Training

EXPERIMENTAL

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.

Behavioral: Guided Training

Directed Training

ACTIVE COMPARATOR

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.

Behavioral: Directed Training

Interventions

Guided Training BEHAVIORAL

Also known as: Strategy Training

Guided Training

Directed Training BEHAVIORAL

Also known as: Direct Skill Training

Directed Training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Pittsburgh: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

Related Publications (2)

• 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.

  PMID: 29552996 DERIVED

• 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.

  PMID: 27794487 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Limitations and Caveats

Both interventions were offered in addition to usual care (comprised mostly of direct skill training). This may have minimized the overall effect of guided training.

Results Point of Contact

• Title: Elizabeth R. Skidmore, PhD, OTR/L, FAOTA
• Organization: University of Pittsburgh

skidmore@pitt.edu

(412) 383-6617

Study Officials

• Elizabeth R Skidmore, PhD, OTR/L

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 3, 2016
• First Posted: May 9, 2016
• Study Start: August 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: July 1, 2015
• Last Updated: January 9, 2020
• Results First Posted: October 20, 2016

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)