Guided TrainingGUIDENCT02766400

Examining Rehabilitation Training Methods

A study testing Guided Training and Directed Training in people with Guided Training and Directed Training, run by University of Pittsburgh at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Guided Training, Directed Training
What is being tested?: Guided Training and Directed Training
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 77 participants
Where: 1 siteUnited States
Study dates: Aug 2012to Jul 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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 locations and contacts

1 site in 1 country.

United States1 site

University of Pittsburgh
Pittsburgh, Pennsylvania, 15260

Other trials in United States

About this study

Official title: Guided Versus Directed Training in Acute Stroke Rehabilitation

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
Being tested: Guided Training, Directed Training
Keywords: Stroke, Rehabilitation, Cognition, Disability, Intervention
Medical subject headings: Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Guided TrainingBehavioural
Also called Strategy Training
Directed TrainingBehavioural
Also called Direct Skill Training

Study groups in NCT02766400
Study group	Role	What they receive
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. Receives: 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. Receives: Behavioral: Directed Training

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline, rehab discharge, month 3, month 6, month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2012Jul 2015

First posted9 May 2016 (estimated)
Study startAug 2012
Primary completionDec 2014
Study completionJul 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Guided TrainingStudies of the same condition, open and under way.
More trials run by University of PittsburghThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 77 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02766400
Sponsor's protocol ID: PRO12040383
Other IDs: R03HD073770-01, R01HD074693-02S1, UL1TR000005
Acronym: GUIDE
Status last verified: Jan 2020
First submitted: 3 May 2016
Last updated: 9 Jan 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No: At present, there is no plan to share data.

Publications

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.
PubMed 29552996
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.
PubMed 27794487

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitation
AI-Guided Multi-Electrode Transcutaneous Spinal Cord Stimulation for Gait Rehabilitation in People With Spinal Cord Injury or Stroke
Spinal Cord Injuries (SCI)
Not yet recruiting
Feasibility Pilot of Remote Mindfulness Training Across Multiple Sites (REFORM Pilot)
Psychological Stress
Not yet recruiting
Effects of Motor Control Exercises With and Without Pressure Biofeedback in Recurrent Low Back Pain (MCE)
Low Back Pain
Recruiting
Behavioral Intervention and Guided Stepping Training Early Post-Stroke
Stroke
Not yet recruiting
EFFECT OF COMBINED VIRTUAL REALITY-GUIDED BREATHING AND AEROBIC TRAINING ON VENTILATORY FUNCTION IN PATIENTS WITH COPD
Chronic Obstructive Lung Disease

All Guided Training trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Guided Versus Directed Training in Acute Stroke Rehabilitation
ClinicalTrials.gov ID: NCT02766400
Acronym / sponsor ID: GUIDE / PRO12040383
Conditions: Guided Training, Directed Training
Keywords: Stroke, Rehabilitation, Cognition, Disability, Intervention
Study type: Interventional
Recruitment status: Completed
Enrolment: 77 participants (actual)
Lead sponsor: University of PittsburghUniversity, hospital or other
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study start: Aug 2012
Primary completion: Dec 2014 (actual)
Study completion: Jul 2015 (actual)
First posted: 9 May 2016 (estimated)
Results: Posted 20 Oct 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Guided Training	Experimental	Behavioral: Guided TrainingGuided 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.
Directed Training	Active comparator	Behavioral: Directed TrainingDirected 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (5 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Guided TrainingAlso: Strategy Training	Behavioural	Guided Training
Directed TrainingAlso: Direct Skill Training	Behavioural	Directed Training

Primary outcome

Differences in Independence With Activities of Daily Living (Functional Independence Measure) Between Groups Over Time
Time frame: Baseline, rehab discharge, month 3, month 6, month 12
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.

Results and safety

Results posted to the registry on 20 Oct 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Guided Training	21	19
Directed Training	22	20

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

Time frame: Baseline, rehab discharge, month 3, month 6, month 12. Mean (Standard Error). Unit: units on a scale

Measure	Guided Training n = 21	Directed Training n = 22
Baseline Scores	67.33 (3.21)	67.32 (3.91)
Discharge Scores	86.86 (3.08)	89.05 (4.41)
Month 3 Scores	105.32 (4.94)	102.55 (5.41)
Month 6 Scores	107.68 (3.45)	100.52 (5.35)
Month 12 Scores	108.47 (4.34)	100.25 (5.12)

Guided Training vs Directed Training: Cohen's d effect size at 12 months: 0.53 (95% CI -0.12 to 1.19), p <0.001, Linear mixed models

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Guided Training	0 of 21 (0%)	0 of 21 (0%)	Not reported
Directed Training	0 of 22 (0%)	0 of 22 (0%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29552996Kringle 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.
Derived from this study: PubMed 27794487Skidmore 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.
Individual participant dataSharing planned: No. At present, there is no plan to share data.

Related trials for Guided Training

Enrolling by invitation
AI-Guided Multi-Electrode Transcutaneous Spinal Cord Stimulation for Gait Rehabilitation in People With Spinal Cord Injury or Stroke
Spinal Cord Injuries (SCI)
Not yet recruiting
Feasibility Pilot of Remote Mindfulness Training Across Multiple Sites (REFORM Pilot)
Psychological Stress
Not yet recruiting
Effects of Motor Control Exercises With and Without Pressure Biofeedback in Recurrent Low Back Pain (MCE)
Low Back Pain
Recruiting
Behavioral Intervention and Guided Stepping Training Early Post-Stroke
Stroke
Not yet recruiting
EFFECT OF COMBINED VIRTUAL REALITY-GUIDED BREATHING AND AEROBIC TRAINING ON VENTILATORY FUNCTION IN PATIENTS WITH COPD
Chronic Obstructive Lung Disease

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Elizabeth R Skidmore, PhD, OTR/L principal investigator

University of Pittsburgh

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Guided Training and Directed Training in people with Guided Training and Directed Training, run by University of Pittsburgh at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Differences in Independence With Activities of Daily Living (Functional Independence Measure) Between Groups Over Time (time frame: Baseline, rehab discharge, month 3, month 6, month 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02766400, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2020.