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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from day 30 to day 60, i.e., from pre- to post-treatment
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I had a stroke more than a year ago.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Quality of Life in Neurological Disorders Measures (Neuro-QOL), Cognitive Function Scale
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
2011
N/A
~340
Find a Location
Who is running the clinical trial?
National Institute on Aging (NIA)NIH
1,672 Previous Clinical Trials
28,018,543 Total Patients Enrolled
Posit ScienceUNKNOWN
University of Alabama at BirminghamLead Sponsor
1,590 Previous Clinical Trials
2,281,234 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am physically and mentally fit to participate in the study.You have some trouble with thinking and memory, as shown by a score of 10-26 on a test called the Montreal Cognitive Assessment.You live at home, not in a hospital or nursing facility.You have trouble with everyday tasks and scored 3 or below on the Cognitive Task Activity Log (CTAL).You need to have good eyesight and hearing to do the UFOV test.I can visit the lab multiple times.I can follow directions and remember information well enough to complete tests.I have cognitive issues due to a condition like Alzheimer's, brain injury, or substance abuse.I am 40 years or older and in stable health.I had a stroke more than a year ago.
Research Study Groups:
This trial has the following groups:- Group 1: BF-HELP with Follow-up Phone Calls
- Group 2: CICT without Follow-up Phone Calls
- Group 3: CICT with Follow-up Phone Calls
- Group 4: BF-HELP without Follow-up Phone Calls
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this investigation actively seeking new participants?
"Confirmed - this medical trial is still actively seeking participants, and the listing on clinicaltrials.gov was updated as recently as June 9th 2022. The initial post date for this study's advertisement was also 6/9/2022."
Answered by AI
How many volunteers are currently taking part in this experiment?
"Affirmative. The information on clinicaltrials.gov suggests that the trial which was posted in June 9th 2022 is still actively enrolling patients at this time. Currently, approximately 120 participants are being sought from a single medical site."
Answered by AI
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