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Cognitive Rehabilitation for Stroke-Related Cognitive Impairment

N/A

Recruiting

Led By Edward Taub, PhD

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with stroke > 1 year previously

Be older than 18 years old

Must not have

Patients with cognitive impairment due to a developmental disability, psychiatric disorder, or substance abuse or due to another type of brain injury, such a traumatic brain injury, or a progressive brain disease, such as Alzheimer's Dementia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from day 30 to day 60, i.e., from pre- to post-treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare two approaches to cognitive rehabilitation in adults with stroke and persistent mild to moderate cognitive impairment. One approach will add in-lab training on everyday activities and procedures to transfer improvements to daily life; the other approach will add in-lab training on relaxation, healthy nutrition, and healthy sleep with procedures to promote integration of lifestyle changes into everyday life. Both interventions will involve 35 hours of training. Testing will happen before and after treatment, and at 6- and 12-month follow-ups.

Who is the study for?

Adults over 40 with mild to moderate cognitive impairment from a stroke that happened more than a year ago. They need to be medically stable, able to follow instructions, and have adequate sight and hearing. A caregiver must be available, and they should be capable of traveling to the lab multiple times.

What is being tested?

The trial compares two cognitive rehabilitation methods for post-stroke patients: Constraint-Induced Cognitive Therapy (CICT) which includes in-lab training on daily activities, and Brain Fitness-Health Education Lifestyle Program (BF-HELP), focusing on relaxation and healthy lifestyle integration.

What are the potential side effects?

Since this study involves non-medical interventions like cognitive training games and lifestyle coaching rather than drugs or surgery, traditional side effects are not expected. However, participants may experience fatigue or frustration during the tasks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I had a stroke more than a year ago.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have cognitive issues due to a condition like Alzheimer's, brain injury, or substance abuse.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from day 30 to day 60, i.e., from pre- to post-treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from day 30 to day 60, i.e., from pre- to post-treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from day 30 to day 60, i.e., from pre- to post-treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Quality of Life in Neurological Disorders Measures (Neuro-QOL), Cognitive Function Scale

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: CICT without Follow-up Phone CallsExperimental Treatment4 Interventions

Participants in this group will receive 35 hours of training. Ten 1-hour sessions of SOPT will be scheduled in the home with training conducted independently by participants. Ten 2.5 hours of in-lab, face-to-face, therapist directed sessions will be scheduled. These sessions will feature a brief period of SOPT; the bulk of the sessions will be committed to (A) shaping on IADL and (B) the Cognitive Transfer Package. Training sessions will be permitted to be scheduled over 2-4 weeks. Family caregivers will receive training on how to best support participants in their therapeutic program. No follow-up phone calls will be made after treatment ends.

Group II: CICT with Follow-up Phone CallsExperimental Treatment5 Interventions

Participants in this group will receive 35 hours of training. Ten 1-hour sessions of SOPT will be scheduled in the home with training conducted independently by participants. Ten 2.5 hours of in-lab, face-to-face, therapist directed sessions will be scheduled. These sessions will feature a brief period of SOPT; the bulk of the sessions will be committed to (A) shaping on IADL and (B) the Cognitive Transfer Package. Training sessions will be permitted to be scheduled over 2-4 weeks. Family caregivers will receive training on how to best support participants in their therapeutic program. After treatment ends, four phone calls will be placed once-a-week for four weeks, then once-a-month for 11 months. The follow-up calls will target transition of any changes achieved during treatment into everyday life on a long-term basis.

Group III: BF-HELP with Follow-up Phone CallsActive Control5 Interventions

Participants in this group will receive 35 hours of training. Ten 1-hour sessions of SOPT will be scheduled in the home with training conducted independently by participants. Ten 2.5 hours of in-lab, face-to-face, therapist directed sessions will be scheduled. These sessions will feature a brief period of SOPT; the bulk of the sessions will be committed to (A) training on relaxation, healthy nutrition, and healthy sleep, and (B) the Healthy Lifestyle Transfer Package. Training sessions will be permitted to be scheduled over 2-4 weeks. Family caregivers will receive training on how to best support participants in their therapeutic program. After treatment ends, four phone calls will be placed once-a-week for four weeks, then once-a-month for 11 months. The follow-up calls will target transition of any changes achieved during treatment into everyday life on a long-term basis.

Group IV: BF-HELP without Follow-up Phone CallsActive Control5 Interventions

Participants in this group will receive 35 hours of training. Ten 1-hour sessions of SOPT will be scheduled in the home with training conducted independently by participants. Ten 2.5 hours of in-lab, face-to-face, therapist directed sessions will be scheduled. These sessions will feature a brief period of SOPT; the bulk of the sessions will be committed to (A) training on relaxation, healthy nutrition, and healthy sleep, and (B) the Healthy Lifestyle Transfer Package. Training sessions will be permitted to be scheduled over 2-4 weeks. Family caregivers will receive training on how to best support participants in their therapeutic program. No follow-up phone calls will be made after treatment ends.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Speed of Processing Training

2021

N/A

~360

0 / 2Eligibility criteria met