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StrokeNCT07148453

Effects of Mobile Application-Based Cognitive Training Along With Aerobic Training

A study testing Experimental Group in people with Stroke, run by Riphah International University at 1 site in Pakistan.

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

This randomized controlled trial will determine the effects of combining mobile application-based cognitive training with aerobic exercise on cognitive function and the effects of combining mobile application-based cognitive training with aerobic exercise on quality of life in post-stroke patients Read more about this study

Who is it for?
Ages 30 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Stroke
What is being tested?
Experimental Group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 sitePakistan
Study dates
20 Aug 2025to 20 Feb 2026
Phase
Interventional
Are there results?
None posted in the registry

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 30 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Both males and females
  • Patients aged 30-75 years
  • Spasticity grade (1 to 1+) based on the modified Ashworth scale (MAS)
  • Patients with CVA Education level: matriculation
  • at least Single-event stroke patients,
  • with a post-stroke duration of 3 to 18 months.
  • Mild to moderate cognitive impairment with a score between 10-25 on MOCA

Who cannot join

  • Patients with a history of recurrent stroke or hemiparesis caused by conditions other than stroke.
  • Patients with severe cardiovascular issues (e.g., unstable angina, severe coronary artery disease, or untreated congestive heart failure).
  • Patients with dementia, depression, visual or auditory impairments, and other neurological conditions (e.g., Multiple Sclerosis, Parkinson's disease) affecting cognition.
  • Individuals on medications known to affect cognitive function.
  • Patients with low educational levels (illiterate).

Trial locations and contacts

1 site in 1 country.

Pakistan1 site
  • Railway General Hospital

    Islamabad, Punjab Province, 44000

Other trials in Pakistan

About this study

Official title: Effects of Mobile Application-Based Cognitive Training Along With Aerobic Training on Cognitive Impairment and Quality of Life in Stroke

This randomized controlled trial will determine the effects of combining mobile application-based cognitive training with aerobic exercise on cognitive function and the effects of combining mobile application-based cognitive training with aerobic exercise on quality of life in post-stroke patients

Read the detailed description

The World Health Organization (WHO) defines stroke as a clinical syndrome marked by the rapid onset of symptoms indicating a focal or global disturbance in brain function. These symptoms last for more than 24 hours or result in death, with no identifiable cause other than a vascular origin. Data on stroke incidence and prevalence in Pakistan are limited, though numerous case series in the literature highlight notable variations in stroke epidemiology, risk factors, and subtypes within the population. The effects of stroke are vast, encompassing physical disability and mortality as well as profound psychological, social, and economic impacts.

Cognitive ability refers to thinking, making sound decisions, and interacting effectively with one's surroundings. When cognitive ability is impaired, it can affect concentration, memory, and learning. Intelligence, which reflects judgment, understanding, and reasoning skills, is often used to measure cognitive abilities in adapting to the environment. post-stroke cognitive impairment (PSCI) refers to cognitive difficulties that arise within 3 to 6 months after a stroke. These impairments may be linked directly to the stroke site, such as aphasia or memory issues, or result from damage to areas like the hippocampus, thalamus, and certain cortical regions. PSCI often overlaps with vascular cognitive impairment (VCI), displaying challenges in visuospatial, attentional, and executive functions. Although some researchers distinguish between early and delayed PSCI based on the timing of cognitive changes, there is no consistent definition, which has complicated PSCI research.

Mobile brain-training games like Lumosity and Peak aim to enhance cognitive skills, such as working memory and attention, through engaging, gamified tasks. These games use challenges and rewards to boost motivation and support learning. A user of the Lumosity app reported improvements in speed, attention, and memory after consistent use since 2011, with others who have experienced brain injuries such as coma, surgery, or concussion also noting positive effects. Brain-training apps like Lumosity and Peak promote cognitive enhancement through gamified tasks aimed at skills such as memory and attention. These claims have contributed to substantial market growth, with the brain-training app industry projected to exceed USD 44.43 billion by 2030.

Aerobic physical exercise (PE) is potentially significant in alleviating cognitive impairment after a stroke. Several neural mechanisms have been associated with the benefits of aerobic exercise on cognitive recovery. Additionally, aerobic exercise supports angiogenesis, reduces secondary injury, and minimizes neuronal damage, all of which contribute to improved cognitive outcomes following a stroke. Aerobic exercise sessions lasting more than 20 minutes are recommended, depending on the frequency and intensity of the exercise. It is also advisable to include warm-up and cool-down periods of 3 to 5 minutes.

This study evaluates the combined impact of the Lumosity brain-training app and aerobic exercise on cognitive function and quality of life (QoL) in older stroke survivors. Traditional methods typically independently implement cognitive rehabilitation and aerobic training, with limited evidence supporting their combined application. This research aims to demonstrate whether combining these methods yields superior cognitive and functional recovery outcomes. Given the limited research on the use of commercial brain training games specifically for stroke survivors, this study seeks to fill a gap in the literature. Previous research has primarily focused on healthy populations, leaving a need for more targeted investigations in stroke rehabilitation. By assessing Lumosity's impact on cognitive recovery, this study will provide valuable insights into the potential of brain training apps for post-stroke rehabilitation. Furthermore, aerobic exercise has demonstrated significant potential in supporting cognitive recovery after stroke, promoting neural plasticity, enhancing neurogenesis, and improving blood flow to affected brain regions. These mechanisms contribute to better cognitive and functional outcomes. This study will explore the combined benefits of cognitive training and aerobic exercise, investigating whether this integrated approach can offer a more effective, accessible, and low-cost strategy for delaying cognitive decline, improving QoL, and supporting long-term recovery in stroke survivors. If successful, this combined approach could pave the way for scalable, novel interventions that empower stroke survivors in their cognitive rehabilitation and overall recovery process.

Conditions
Stroke
Being tested
Experimental Group, Control Group
Keywords
Stroke rehabilitation, cognitive impairment, Lumosity, brain training games
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.

  • Experimental GroupOther

    The experimental group will receive training through a smartphone-based brain training program using the Lumosity app, as well as aerobic exercise on a bicycle ergometer for 18 sessions other days for 6 weeks, 3 times per week, every session for 40 minutes (20 minutes aerobic training on a stationary bicycle ergometer followed by 20 minutes for Lumosity training application on the smartphone).

  • Control GroupOther

    The control group will participate in aerobic training on a bicycle ergometer as well as mental exercises for 18 sessions every other day for 6 weeks, 3 sessions/week, each for 40 minutes

Study groups in NCT07148453
Study groupRoleWhat they receive
Lumosity-based cognitive training + aerobic exerciseExperimentalThe experimental group will receive training through a smartphone-based brain training program using the Lumosity app, as well as aerobic exercise on a bicycle ergometer for 18 sessions other days for 6 weeks, 3 times per week, every session for 40 minutes (20 minutes aerobic training on a stationary bicycle ergometer followed by 20 minutes for Lumosity training application on the smartphone).
Receives: Other: Experimental Group
Aerobics + Traditional mental exercisesActive comparatorThe control group will participate in aerobic training on a bicycle ergometer as well as mental exercises for 18 sessions every other day for 6 weeks, 3 sessions/week, each for 40 minutes.
Receives: Other: Control Group

What is being measured

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

  1. Montreal Cognitive Assessment

    Brief cognitive function assessment tool consisting of 12 items. Visuospatial, executive functioning, short-term memory, attention/concentration/Working memory, Language and orientation.

    Normal Cognition= 26-30 Cognitive impairment: Mild=18-25, Moderate=10-17, Severe= under 10

    Measured: 6 weeks

  2. Trail Making Test A and B

    Measure the cognitive function executive. In part A the patient draws lines to join numbered circles (1-25) to connect them in ascending order. In part B, the patient connects the circles alternating between numbers (1-13) and letters (A-L). Trail A; Average; 29 Sec Deficient; >78 sec Rule of Thumb Most in 90 sec Trail B; Average; 75 sec Deficient; >273 sec. Rule of Thumb Most in 3min

    Measured: 6 weeks

  3. 6-Minute Walk Test (6MWT)

    Submaximal exercise test that assesses aerobic capacity and endurance by measuring the distance an individual can walk on a flat, hard surface in a period of 6 minutes. It reflects functional exercise performance and cardiovascular fitness. Commonly used in stroke rehabilitation to evaluate improvements in mobility and endurance.

    Measured: 6 weeks

  4. Stroke Specific Quality of Life scale (SS-QOL)

    The self-reported questionnaire consists of 49 items across 12 domains. Mobility, Mood, Self-care, Cognition, Social roles, Upper extremity function, work, sleep, family roles, personality, Vision, and strength. Scoring based on a Likert scale ranging from 1-5.

    Measured: 6 weeks

Timeline

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

  1. First posted29 Aug 2025
  2. Study start20 Aug 2025
  3. Primary completion20 Feb 2026
  4. Study completion20 Feb 2026

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
Masking
Single blind
Who is masked
Participant
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07148453
Sponsor's protocol ID
02165/ Umber un Nisa
Status last verified
Mar 2026
First submitted
24 Aug 2025
Last updated
30 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Experimental Group in people with Stroke, run by Riphah International University at 1 site in Pakistan.

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 7 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 30 Mar 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 Pakistan. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Montreal Cognitive Assessment (time frame: 6 weeks). The study lists 4 primary outcomes in all. 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 30 Mar 2026.

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