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StrokeNCT05162781

Transferring Speed of Processing Gains to Everyday Cognitive Tasks After Stroke

A study testing Speed of Processing Training, Instrumental Activities of Daily Living In-lab Training and Cognitive Transfer Packagke in people with Stroke and Cognitive Dysfunction, run by University of Alabama at Birmingham at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study will compare two approaches to cognitive rehabilitation in adults with stroke with persistent, mild to moderate, cognitive impairment. Both approaches will feature a web-based computer "game" that trains cognitive processing speed, i.e., how quickly individuals process information that they receive through… Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Stroke, Cognitive Dysfunction
What is being tested?
Speed of Processing Training, Instrumental Activities of Daily Living In-lab Training and Cognitive Transfer Packagke
Could I receive a placebo?
No, everyone receives an active treatment
How many people
82 participants
Where
1 siteUnited States
Study dates
9 Jun 2022to 28 Feb 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

Other trials in United States

About this study

This study will compare two approaches to cognitive rehabilitation in adults with stroke with persistent, mild to moderate, cognitive impairment. Both approaches will feature a web-based computer "game" that trains cognitive processing speed, i.e., how quickly individuals process information that they receive through their senses. This training is termed Speed of Processing Training (SOPT). One approach will add (A) in-lab training on everyday activities with important cognitive components and (B) procedures designed to transfer improvements in cognition from the treatment setting to everyday life. This approach is termed Constraint-Induced Cognitive Therapy (CICT). The other approach will add (A) in-lab training on relaxation, healthy nutrition, and healthy sleep and (B) procedures designed to promote integration of these lifestyle changes into everyday life. This approach is termed Brain Fitness-Heath Education Lifestyle Program (BF-HELP).

Both CICT and BF-HELP will involve 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 in-lab training on the target behaviors and the procedures designed to promote transfer of therapeutic gains to daily life; The set of the latter procedures is termed the Transfer Package. To accommodate the demands of participants' other activities, training sessions will be permitted to be scheduled as tightly as every weekday over 2 weeks or as loosely as every other weekday or so over 4 weeks. Family caregivers in both groups will also receive training on how to best support participants in their therapeutic program.

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The study will also test if there is an advantage to placing follow-up phone calls after treatment ends. The purpose of the calls will be to support transition of any behavioral changes achieved during treatment into everyday life on a long-term basis.

Participants will be randomly assigned to the interventions.

Testing will happen one month before treatment, one day before treatment, one day afterwards, and 6-months afterwards. Outcomes measured will include cognitive processing speed, cognitive function on laboratory tests, and spontaneous performance of everyday activities with important cognitive components in daily life.

Being tested
Speed of Processing Training, Instrumental Activities of Daily Living In-lab Training, Cognitive Transfer Packagke, Family Caregiver Coaching, Follow-up Phone Calls
Keywords
stroke, cognitive dysfunction, cognitive processing speed, IADL
Medical subject headings
Stroke, Cognitive Dysfunction

What participants receive

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

  • Speed of Processing TrainingBehavioural

    Also called SOPT

    This training component targets cognitive processing speed, i.e., how quickly individuals process information that they receive through their senses. Cognitive processing speed is thought to be a basic capacity of the brain that underlies several other cognitive functions. Training is implemented using a web-based computer "game", in which participants are required to fixate on a target at the center of the screen and identify targets in the periphery. The game is made progressively more difficult, in small increments, as participants gain mastery by increasing the speed at which targets are presented and increasing the number of distractors.

  • Instrumental Activities of Daily Living In-lab TrainingBehavioural

    Also called IADL In-lab Training

    The training component is thought to bridge SOPT training, which targets a basic cognitive capacity, and IADL performance in daily life. This training component will involve repeated trials in which participants will practice carrying out simulated IADL tasks in the lab under the supervision of the trainer. The training will follow shaping principles, i.e., task requirements will be made progressively more challenging, in small increments, as participants gain mastery. Frequent, positive feedback will be provided.

  • Cognitive Transfer PackagkeBehavioural

    This training component is designed to transfer improvements in cognition from the treatment setting to everyday life. Elements of this package include negotiating a behavioral contract about the roles of the participant and family caregiver in the treatment, monitoring behavior outside the lab, and assigning performance of IADL as homework.

  • Family Caregiver CoachingBehavioural

    One or more family members of the participant will receive coaching on how to best support the participant in carrying out the in-home components of the intervention.

  • Follow-up Phone CallsBehavioural

    After treatment ends, four phone calls will be placed once-a-week for four weeks, then once-a-month for 5 months. The follow-up calls will target transition of any changes achieved during treatment into everyday life on a long-term basis after.

  • Healthy Lifestyle In-lab TrainingBehavioural

    This training component is designed to promote lifestyle changes that support brain fitness. Participants will receive education and coaching in the lab on relaxation, healthy nutrition, and healthy sleep.

  • Healthy Lifestyle Transfer PackageBehavioural

    This training component is designed to support integration into everyday life of the lifestyle changes training in the lab. Elements of this package include negotiating a behavioral contract about the roles of the participant and family caregiver in the treatment, monitoring behavior outside the lab, and assigning relaxation exercises, for example, as homework.

Study groups in NCT05162781
Study groupRoleWhat they receive
CICT with Follow-up Phone CallsExperimentalParticipants 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 5 months. The follow-up calls will target transition of any changes achieved during treatment into everyday life on a long-term basis.
Receives: Behavioral: Speed of Processing Training; Behavioral: Instrumental Activities of Daily Living In-lab Training; Behavioral: Cognitive Transfer Packagke; Behavioral: Family Caregiver Coaching; Behavioral: Follow-up Phone Calls
CICT without Follow-up Phone CallsExperimentalParticipants 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.
Receives: Behavioral: Speed of Processing Training; Behavioral: Instrumental Activities of Daily Living In-lab Training; Behavioral: Cognitive Transfer Packagke; Behavioral: Family Caregiver Coaching
BF-HELP with Follow-up Phone CallsActive comparatorParticipants 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 5 months. The follow-up calls will target transition of any changes achieved during treatment into everyday life on a long-term basis.
Receives: Behavioral: Speed of Processing Training; Behavioral: Family Caregiver Coaching; Behavioral: Follow-up Phone Calls; Behavioral: Healthy Lifestyle In-lab Training; Behavioral: Healthy Lifestyle Transfer Package
BF-HELP without Follow-up Phone CallsActive comparatorParticipants 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.
Receives: Behavioral: Speed of Processing Training; Behavioral: Family Caregiver Coaching; Behavioral: Follow-up Phone Calls; Behavioral: Healthy Lifestyle In-lab Training; Behavioral: Healthy Lifestyle Transfer Package

What is being measured

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

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

    The Neuro-QOL assesses function in daily life in several domains; it is a widely used, validated, transdiagnostic, self-report measure. The development and use of the Neuro-QOL is supported by the National Institutes of Health. The component of the Neuro-QOL that assessed cognitive function will be used here. Items are rated by respondents using a five-point scale: 1 = not at all, 5 = very much. Higher scores indicate better function.

    Measured: Change from Day 30 to Day 60, i.e., from Pre- to Post-treatment

Timeline

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

  1. First posted17 Dec 2021
  2. Study start9 Jun 2022
  3. Primary completion14 Sep 2026
  4. Study completion28 Feb 2027 (estimated)

Resources

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
Model description
Half of the participants will receive CICT, which consists of SOPT, IADL training in the lab, and a Transfer Package targeting IADL performance outside it. The other half will receive BF-HELP, which consists of SOPT, in-lab training on relaxation, nutrition, and sleep hygiene, and a Transfer Package targeting implementation of these lifestyle changes outside it. Half of the CICT group will receive 9 follow-up phone calls over the course of six months. The other CICT participants will receive none. The same will apply to the BF-HELP group. The phone calls will support integration of the behavioral changes targeted during treatment to everyday life afterwards. For all participants, outcome testing will take place one month before treatment (Baseline 1), one day before treatment (Baseline 2 aka Pre-treatment), one day afterwards (Post-treatment), and 6-months afterwards (6-month Follow-up). Randomization will take place after Baseline 2.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
82 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05162781
Sponsor's protocol ID
IRB-300008211
Other IDs
1R01AG070049-01A1
Status last verified
Oct 2026
First submitted
19 Nov 2021
Last updated
29 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Speed of Processing Training, Instrumental Activities of Daily Living In-lab Training and Cognitive Transfer Packagke in people with Stroke and Cognitive Dysfunction, run by University of Alabama at Birmingham 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 0 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 29 Oct 2026. 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?

This study is still under way. Results are not available in the source record yet.

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?

Quality of Life in Neurological Disorders Measures (Neuro-QOL), Cognitive Function Scale (time frame: Change from Day 30 to Day 60, i.e., from Pre- to Post-treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 29 Oct 2026.

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