StrokeSTPANCT06790173
Effects of Strategy Training for Physical Activity (STPA) on the Post-stroke Executive Dysfunction
A study testing Strategy training for physical activity, Physical activity and Education in people with Stroke, run by Taipei Medical University at 5 sites in Taiwan.
Trial summary
The goal of this randomized controlled trial is to examine if combining strategy training and physical activity (STPA) works to improve executive function in community-dwelling adults with post-stroke cognitive impairment. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Stroke
- What is being tested?
- Strategy training for physical activity, Physical activity and Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 5 sitesTaiwan
- Study dates
- 3 Feb 2025to 31 Dec 2030
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 80 years old
- A diagnosis of stroke within the past 3 year
- Speaking Mandarin
- Montreal Cognitive Assessment (maximum=30) < 26
- 14 item-Executive Interview > 3
- Willing to provide informed consent
Who cannot join
- Modified Rankin Scale (mRS) = 5
- Any conditions that may impede the participation in the study, such as severe aphasia, postoperative immobilization, or major neuropsychiatric diseases.
- Pre-stroke mRS >1
- 6-level Saltin-Grimby Physical Activity Level Scale (SGPALS) = 5 or 6
- Participating in other interventional study concurrently
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Taiwan5 sites
Taipei Tzu Chi Hospital
New Taipei City, 231
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare
New Taipei City, 235
National Taiwan University Hospital
Taipei, 100
Taipei Medical University Hospital
Taipei, 110
Taipei Municipal Wanfang Hospital
Taipei, 116
About this study
Official title: Effects of Strategy Training for Physical Activity on Executive Functions in Stroke Survivors With Cognitive Impairments: a Phase II Randomized Controlled Trial
The goal of this randomized controlled trial is to examine if combining strategy training and physical activity (STPA) works to improve executive function in community-dwelling adults with post-stroke cognitive impairment. The main questions it aims to answer are:
- Does STPA and physical exercise alone lead to greater improvements in executive function among stroke survivors relative to the control intervention with education?
- Does STPA outperform physical exercise alone in the efficacy of executive functions?
- Do the effects of STPA on executive functions transfer to the global cognition, balance, and activity-participation outcomes?
- Do the effects of STPA persist for at least 6 months post-intervention?
Read more
Researchers will compare the efficacy of the STPA intervention against physical exercise alone or control intervention with education.
Participants will:
receive STPA, physical activity only, or an education program 2 to 3 sessions per week until finishing 12 sessions.
be assessed clinical outcomes at 5 times: pre-intervention, post-intervention, 3-month, 6-month, and 12-month follow-up.
Read the detailed description
Poststroke cognitive impairment is a prevalent consequence of stroke that significantly impacts multifaceted outcomes. Executive functions are particularly responsive to training among cognitive domains. Despite the accumulating literature supporting physical activity interventions, their effects have been observed to be small and time-limited. Incorporating a behavioral approach, such as strategy training, offers a promising avenue for promoting improvements in executive functions and related stroke outcomes. To the best of investigators' understanding, no study has examined whether combining strategy training with physical activity-oriented goals can ameliorate executive and cognitive functions in individuals with stroke.
This study aims to examine and compare the efficacy of STPA and physical activity alone on executive, cognitive, activity, and participation functions in people with poststroke cognitive impairments. This study addresses the following specific aims:
- Determine whether STPA in stroke patients with PSCI produces immediate improvements in executive functions that may generalize to improved global cognition, activity, or participation outcomes to a greater extent than a control intervention focused on stroke-related education;
- Examine the potential association between improvements in executive functions resulting from STPA and enhancements in activity and participation performance;
- Investigate the duration of therapeutic effects of STPA following the intervention;
To achieve these aims, a three-armed, parallel-design, randomized phase II clinical trial is designed and conducted. The investigators plan to recruit an expected sample of 120 adults with poststroke cognitive impairments from collaborative sites in northern Taiwan. Eligible participants are randomly assigned to one of the three intervention groups (STPA, physical activity, and education) at a 1:1:1 ratio. All participants should receive 12 sessions lasting 60 minutes over a maximum of 6 weeks. Primary outcomes for executive functions (Trail Making Test Part B and color-word condition of Stroop Color and Word Test) and secondary outcome measures, including Montreal Cognitive Assessment, processing speed (Trail Making Test Part A and word condition of Stroop Color and Word Test), Self-Regulation Skills Interview, Activity Measure for Post-Acute Care Outpatient Short Forms, Participation Measure-3 Domains, 4 Dimensions, Timed-Up and Go test, and Taiwan version of the International Physical Activity Questionnaire are administered at baseline (T1), post-intervention (T2), and 3-month (T3), 6-month (T4), and 12-month (T5) follow-ups. Data will be analyzed using constrained longitudinal data analysis and mixed-effects regression models. Additionally, qualitative in-depth interviews will be conducted with participants, caregivers, and therapists to understand their experiences, satisfaction, and their perceived effectiveness of the intervention. Transcribed data will be coded and analyzed with thematic analysis method.
- Conditions
- Stroke
- Being tested
- Strategy training for physical activity, Physical activity, Education
- Keywords
- Stroke, Executive function, Strategy training, Physical activity
- Medical subject headings
- Stroke, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strategy training for physical activityBehavioural
Also called STPA
STPA is a home-based rehabilitation that guides stroke participants to implement strategy training for addressing barriers to physical activity engagements. Participants learn and practice meta-cognitive strategies (to set a goal, to make a plan, to do the plan, to check the performance of the plan) throughout the intervention period.
Physical activityBehavioural
Also called PA
PA program consists of a warm-up for 5 minutes, an aerobic exercise program for 30-40 minutes, a multicomponent exercise program (resistance and balance training) for 10-20 minutes, and finally, a cooling down program for 5 minutes.
EducationOther
Stroke-related information and knowledge that includes stroke subtypes and their etiology, risk factors of primary and secondary stroke, healthy lifestyles, common sequala, and adaptive skills for impaired functions are provided.
| Study group | Role | What they receive |
|---|---|---|
| Strategy training for physical activity | Experimental | Trained therapists visit each participant for 60 minutes twice or thrice a week. The program consists of 12 therapist-guided sessions over a maximum of 6 weeks and includes the following active ingredients: knowledge of physical activity, self-selected activity-based goals, dynamic performance analysis, global strategy ("Goal-PlanDo-Check"), and guided discovery. Receives: Behavioral: Strategy training for physical activity |
| Physical activity | Active comparator | Participants assigned to the PA group receive a protocol of exercise program with 12, 1-hour sessions in total. Similar to STPA group, the frequency of intervention is twice or thrice a week. Receives: Behavioral: Physical activity |
| Education | Active comparator | Participants in this group receive a dose-matched educational intervention with 12 visits by well-trained research therapists through face-to-face talks. Sessions focus on instruction on general information regarding stroke and rehabilitation, and a summary of participants' condition and progression is provided for each visit. Receives: Other: Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trail-Making Test, Part B (TMT-B)
The TMT-B is a time-limited test (maximum 300 seconds) requiring participant to orderly trace stimuli that alternated between encircles numbers and characters as quickly and accurately as possible, with shorter time denoting better cognitive flexibility.
Measured: 5 time points: baseline (T1), from baseline to the end of intervention at 5-6 weeks (T2), from the end of intervention to 3-month(T3), to 6-month (T4), and to 12-month follow-up (T5)
Stroop Color and Word Test, color-word condition (SCWT-CW)
The Stroop Color and Word Test involves counting correct numbers according to a rule. In color-word condition, the word (e.g. "Red") is printed in a different color ink (e.g. green ink), while participants will require to name the color of ink, with greater correct responses denoting better inhibition.
Measured: 5 time points: baseline (T1), from baseline to the end of intervention at 5-6 weeks (T2), from the end of intervention to 3-month(T3), to 6-month (T4), and to 12-month follow-up (T5)
Secondary outcomes (8)
Montreal Cognitive Assessment (MoCA)
MoCA with 30 items evaluates the cognitive functions (range 0 to 30). This assessment covers domains such as visuospatial/executive skills, naming, memory, attention, language, abstraction, delayed recall, and orientation.
Measured: 5 time points: baseline (T1), from baseline to the end of intervention at 5-6 weeks (T2), from the end of intervention to 3-month(T3), to 6-month (T4), and to 12-month follow-up (T5)
Trail-Making Test, Part A (TMT-A)
The TMT-A requires participant to orderly trace the numeral stimuli as quickly and accurately as possible, and shorter time to complete represent better performance (maximum 300 seconds)
Measured: 5 time points: baseline (T1), from baseline to the end of intervention at 5-6 weeks (T2), from the end of intervention to 3-month(T3), to 6-month (T4), and to 12-month follow-up (T5)
Stroop Color and Word Test, color condition (SCWT-C)
The SCET-C asks participant to correctly answer the color ink in accordance with word on the cards, and greater correct responses denoting better performance.
Measured: 5 time points: baseline (T1), from baseline to the end of intervention at 5-6 weeks (T2), from the end of intervention to 3-month(T3), to 6-month (T4), and to 12-month follow-up (T5)
Self-Regulation Skills Interview
This assessment comprises six standardized questions indicating three factors: awareness, readiness to change, and strategy behavior.
Measured: 5 time points: baseline (T1), from baseline to the end of intervention at 5-6 weeks (T2), from the end of intervention to 3-month(T3), to 6-month (T4), and to 12-month follow-up (T5)
Activity Measure for Post-Acute Care (AM-PAC) Outpatient Short Forms
The AM-PAC measures the difficulty is performing three activity domains: Basic Mobility (18 activities), Daily Activity (15 activities), and Applied Cognition (19 activities) on a 4-point scale. In this trial, Applied Cognition domain is viewed as a secondary outcome.
Measured: 5 time points: baseline (T1), from baseline to the end of intervention at 5-6 weeks (T2), from the end of intervention to 3-month(T3), to 6-month (T4), and to 12-month follow-up (T5)
Participation Measure-3 Domains, 4 Dimensions (PM-3D4D)
PM-3D4D consists of 24 items for evaluating three domains of participation, which are community, productivity, and social. Participants will be asked to rate all items on the four distinct dimensions: (1) diversity, (2) frequency, (3) desire for change, and (4) perceived difficulty.
Measured: 5 time points: baseline (T1), from baseline to the end of intervention at 5-6 weeks (T2), from the end of intervention to 3-month(T3), to 6-month (T4), and to 12-month follow-up (T5)
Time-Up and Go test (TUG)
During the test, participants are asked to complete a serous of tasks: standing up from a chair, walking straight for 3 meters, turning around, walking back to the chair, and sitting down. The time to complete is recorded.
Measured: 5 time points: baseline (T1), from baseline to the end of intervention at 5-6 weeks (T2), from the end of intervention to 3-month(T3), to 6-month (T4), and to 12-month follow-up (T5)
International Physical Activity Questionnaire (IPAQ) short form
IPAQ is used to calculate MET-minute per week based on participants' self-report physical activity durations on walking, moderate exercise, and vigorous exercise in the nearest 7 days.
Measured: 5 time points: baseline (T1), from baseline to the end of intervention at 5-6 weeks (T2), from the end of intervention to 3-month(T3), to 6-month (T4), and to 12-month follow-up (T5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start3 Feb 2025
- Primary completion1 Jun 2029 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe 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
- Model description
- The allocation ratio is 1:1:1.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Feng-Hang Chang, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06790173
- Sponsor's protocol ID
- N202405115
- Acronym
- STPA
- Status last verified
- Apr 2025
- First submitted
- 17 Jan 2025
- Last updated
- 11 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Strategy Training for Physical Activity on Executive Functions in Stroke Survivors With Cognitive Impairments: a Phase II Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06790173
- Acronym / sponsor ID
- STPA / N202405115
- Conditions
- Stroke
- Keywords
- Stroke, Executive function, Strategy training, Physical activity
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- 1 Jun 2029 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 23 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this randomized controlled trial is to examine if combining strategy training and physical activity (STPA) works to improve executive function in community-dwelling adults with post-stroke cognitive impairment. The main questions it aims to answer are:
- Does STPA and physical exercise alone lead to greater improvements in executive function among stroke survivors relative to the control intervention with education?
- Does STPA outperform physical exercise alone in the efficacy of executive functions?
- Do the effects of STPA on executive functions transfer to the global cognition, balance, and activity-participation outcomes?
- Do the effects of STPA persist for at least 6 months post-intervention?
Researchers will compare the efficacy of the STPA intervention against physical exercise alone or control intervention with education.
Participants will:
receive STPA, physical activity only, or an education program 2 to 3 sessions per week until finishing 12 sessions.
be assessed clinical outcomes at 5 times: pre-intervention, post-intervention, 3-month, 6-month, and 12-month follow-up.
Detailed description
Poststroke cognitive impairment is a prevalent consequence of stroke that significantly impacts multifaceted outcomes. Executive functions are particularly responsive to training among cognitive domains. Despite the accumulating literature supporting physical activity interventions, their effects have been observed to be small and time-limited. Incorporating a behavioral approach, such as strategy training, offers a promising avenue for promoting improvements in executive functions and related stroke outcomes. To the best of investigators' understanding, no study has examined whether combining strategy training with physical activity-oriented goals can ameliorate executive and cognitive functions in individuals with stroke.
This study aims to examine and compare the efficacy of STPA and physical activity alone on executive, cognitive, activity, and participation functions in people with poststroke cognitive impairments. This study addresses the following specific aims:
- Determine whether STPA in stroke patients with PSCI produces immediate improvements in executive functions that may generalize to improved global cognition, activity, or participation outcomes to a greater extent than a control intervention focused on stroke-related education;
- Examine the potential association between improvements in executive functions resulting from STPA and enhancements in activity and participation performance;
- Investigate the duration of therapeutic effects of STPA following the intervention;
To achieve these aims, a three-armed, parallel-design, randomized phase II clinical trial is designed and conducted. The investigators plan to recruit an expected sample of 120 adults with poststroke cognitive impairments from collaborative sites in northern Taiwan. Eligible participants are randomly assigned to one of the three intervention groups (STPA, physical activity, and education) at a 1:1:1 ratio. All participants should receive 12 sessions lasting 60 minutes over a maximum of 6 weeks. Primary outcomes for executive functions (Trail Making Test Part B and color-word condition of Stroop Color and Word Test) and secondary outcome measures, including Montreal Cognitive Assessment, processing speed (Trail Making Test Part A and word condition of Stroop Color and Word Test), Self-Regulation Skills Interview, Activity Measure for Post-Acute Care Outpatient Short Forms, Participation Measure-3 Domains, 4 Dimensions, Timed-Up and Go test, and Taiwan version of the International Physical Activity Questionnaire are administered at baseline (T1), post-intervention (T2), and 3-month (T3), 6-month (T4), and 12-month (T5) follow-ups. Data will be analyzed using constrained longitudinal data analysis and mixed-effects regression models. Additionally, qualitative in-depth interviews will be conducted with participants, caregivers, and therapists to understand their experiences, satisfaction, and their perceived effectiveness of the intervention. Transcribed data will be coded and analyzed with thematic analysis method.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- The allocation ratio is 1:1:1.
| Arm | Type | Receives |
|---|---|---|
| Strategy training for physical activity | Experimental | Behavioral: Strategy training for physical activityTrained therapists visit each participant for 60 minutes twice or thrice a week. The program consists of 12 therapist-guided sessions over a maximum of 6 weeks and includes the following active ingredients: knowledge of physical activity, self-selected activity-based goals, dynamic performance analysis, global strategy ("Goal-PlanDo-Check"), and guided discovery. |
| Physical activity | Active comparator | Behavioral: Physical activityParticipants assigned to the PA group receive a protocol of exercise program with 12, 1-hour sessions in total. Similar to STPA group, the frequency of intervention is twice or thrice a week. |
| Education | Active comparator | Other: EducationParticipants in this group receive a dose-matched educational intervention with 12 visits by well-trained research therapists through face-to-face talks. Sessions focus on instruction on general information regarding stroke and rehabilitation, and a summary of participants' condition and progression is provided for each visit. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 to 80 years old
- A diagnosis of stroke within the past 3 year
- Speaking Mandarin
- Montreal Cognitive Assessment (maximum=30) < 26
- 14 item-Executive Interview > 3
Key exclusion criteria (5 listed)
- Modified Rankin Scale (mRS) = 5
- Any conditions that may impede the participation in the study, such as severe aphasia, postoperative immobilization, or major neuropsychiatric diseases.
- Pre-stroke mRS >1
- 6-level Saltin-Grimby Physical Activity Level Scale (SGPALS) = 5 or 6
- Participating in other interventional study concurrently
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 |
|---|---|---|
| Strategy training for physical activityAlso: STPASTPA is a home-based rehabilitation that guides stroke participants to implement strategy training for addressing barriers to physical activity engagements. Participants learn and practice meta-cognitive strategies (to set a goal, to make a plan, to do the plan, to check the performance of the plan) throughout the intervention period. | Behavioural | Strategy training for physical activity |
| Physical activityAlso: PAPA program consists of a warm-up for 5 minutes, an aerobic exercise program for 30-40 minutes, a multicomponent exercise program (resistance and balance training) for 10-20 minutes, and finally, a cooling down program for 5 minutes. | Behavioural | Physical activity |
| EducationStroke-related information and knowledge that includes stroke subtypes and their etiology, risk factors of primary and secondary stroke, healthy lifestyles, common sequala, and adaptive skills for impaired functions are provided. | Other | Education |
Primary outcome
Trail-Making Test, Part B (TMT-B)
Time frame: 5 time points: baseline (T1), from baseline to the end of intervention at 5-6 weeks (T2), from the end of intervention to 3-month(T3), to 6-month (T4), and to 12-month follow-up (T5)
The TMT-B is a time-limited test (maximum 300 seconds) requiring participant to orderly trace stimuli that alternated between encircles numbers and characters as quickly and accurately as possible, with shorter time denoting better cognitive flexibility.
Stroop Color and Word Test, color-word condition (SCWT-CW)
Time frame: 5 time points: baseline (T1), from baseline to the end of intervention at 5-6 weeks (T2), from the end of intervention to 3-month(T3), to 6-month (T4), and to 12-month follow-up (T5)
The Stroop Color and Word Test involves counting correct numbers according to a rule. In color-word condition, the word (e.g. "Red") is printed in a different color ink (e.g. green ink), while participants will require to name the color of ink, with greater correct responses denoting better inhibition.
8 secondary outcomes
Montreal Cognitive Assessment (MoCA)
Time frame: 5 time points: baseline (T1), from baseline to the end of intervention at 5-6 weeks (T2), from the end of intervention to 3-month(T3), to 6-month (T4), and to 12-month follow-up (T5)
Trail-Making Test, Part A (TMT-A)
Time frame: 5 time points: baseline (T1), from baseline to the end of intervention at 5-6 weeks (T2), from the end of intervention to 3-month(T3), to 6-month (T4), and to 12-month follow-up (T5)
Stroop Color and Word Test, color condition (SCWT-C)
Time frame: 5 time points: baseline (T1), from baseline to the end of intervention at 5-6 weeks (T2), from the end of intervention to 3-month(T3), to 6-month (T4), and to 12-month follow-up (T5)
Self-Regulation Skills Interview
Time frame: 5 time points: baseline (T1), from baseline to the end of intervention at 5-6 weeks (T2), from the end of intervention to 3-month(T3), to 6-month (T4), and to 12-month follow-up (T5)
Activity Measure for Post-Acute Care (AM-PAC) Outpatient Short Forms
Time frame: 5 time points: baseline (T1), from baseline to the end of intervention at 5-6 weeks (T2), from the end of intervention to 3-month(T3), to 6-month (T4), and to 12-month follow-up (T5)
Participation Measure-3 Domains, 4 Dimensions (PM-3D4D)
Time frame: 5 time points: baseline (T1), from baseline to the end of intervention at 5-6 weeks (T2), from the end of intervention to 3-month(T3), to 6-month (T4), and to 12-month follow-up (T5)
Time-Up and Go test (TUG)
Time frame: 5 time points: baseline (T1), from baseline to the end of intervention at 5-6 weeks (T2), from the end of intervention to 3-month(T3), to 6-month (T4), and to 12-month follow-up (T5)
International Physical Activity Questionnaire (IPAQ) short form
Time frame: 5 time points: baseline (T1), from baseline to the end of intervention at 5-6 weeks (T2), from the end of intervention to 3-month(T3), to 6-month (T4), and to 12-month follow-up (T5)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strategy training for physical activity, Physical activity and Education in people with Stroke, run by Taipei Medical University at 5 sites in Taiwan.
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 6 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: enrolling by invitation, as of the sponsor's last update on 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Taiwan. 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?
Trail-Making Test, Part B (TMT-B) (time frame: 5 time points: baseline (T1), from baseline to the end of intervention at 5-6 weeks (T2), from the end of intervention to 3-month(T3), to 6-month (T4), and to 12-month follow-up (T5)). The study lists 2 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 11 Apr 2025.