StrokeNCT07725211
Task-Oriented Training Versus High-Intensity Gait Training in People With Chronic Stroke
A study testing Neurodevelopmental Treatment, High-Repetition Task-Oriented Training and High-Intensity Gait Training in people with Stroke and Hemiplegia, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to compare the effects of high-repetition task-oriented training and high-intensity gait training on walking capacity and functional mobility in individuals with chronic stroke. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stroke, Hemiplegia, Chronic Stroke
- What is being tested?
- Neurodevelopmental Treatment, High-Repetition Task-Oriented Training and High-Intensity Gait Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2026to 15 Dec 2026
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of first-ever unilateral stroke (ischemic or hemorrhagic) confirmed by clinical and/or radiological findings
- Time since stroke onset of at least 6 months (chronic phase)
- Age between 18 and 75 years
- Ability to walk at least 10 meters independently, with or without an assistive device
- Functional Ambulation Category (FAC) score of 3 or higher
- Sufficient cognitive ability to understand and follow instructions (Mini-Mental State Examination score ≥ 24)
- Willingness to participate and provision of written informed consent
Who cannot join
- Recurrent stroke or bilateral hemispheric involvement
- Unstable cardiovascular disease or other medical conditions contraindicating high-intensity exercise
- Severe lower extremity spasticity interfering with gait training (Modified Ashworth Scale score > 3)
- Orthopedic, rheumatological, or other neurological conditions affecting gait
- Severe visual or vestibular impairment
- Severe aphasia or cognitive impairment preventing participation in training or assessments
- Participation in another structured rehabilitation or exercise program during the study period
- Botulinum toxin injection to the lower extremity within the last 6 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Bingol State Hospital - City: Bingöl, Country: Türkiye (listede "Turkey" olarak geçebilir), Zip: 12000
Bingoel, Center, 12000
Samet Tatli, MD, +90 XXX XXX XX XX, drsamettatli@gmail.com
About this study
Official title: High-Repetition Task-Oriented Training Versus High-Intensity Gait Training for Lower Extremity Rehabilitation in Individuals With Chronic Stroke: An Assessor-Blinded Randomized Controlled Trial
The purpose of this study is to compare the effects of high-repetition task-oriented training and high-intensity gait training on walking capacity and functional mobility in individuals with chronic stroke.
Forty-five participants will be randomly assigned to one of three groups: (1) neurodevelopmental treatment (NDT) alone, (2) NDT combined with high-repetition task-oriented training, or (3) NDT combined with high-intensity gait training. All participants will receive treatment 3 days per week for 8 weeks (24 sessions in total). Walking capacity (6-Minute Walk Test) and functional mobility (Timed Up and Go Test, modified Dynamic Gait Index, 10-Meter Walk Test) will be assessed before and after the intervention by an assessor blinded to group allocation. The study hypothesizes that adding structured, intensity-based training approaches to conventional NDT will lead to greater improvements in walking capacity than NDT alone.
Read the detailed description
Stroke is a leading cause of long-term disability worldwide, and impaired walking capacity remains one of the most common and persistent limitations in the chronic phase. Although neurodevelopmental treatment (NDT) is widely used in clinical practice, current evidence emphasizes the role of training intensity and task-specific repetition in promoting locomotor recovery. However, comparative evidence regarding the relative effectiveness of high-repetition task-oriented training and high-intensity gait training as adjuncts to conventional therapy in chronic stroke is limited.
This study is designed as an assessor-blinded, three-arm, parallel-group randomized controlled trial. Forty-five individuals with chronic stroke will be randomly allocated in a 1:1:1 ratio to one of three groups (n=15 per group): (1) NDT alone, consisting of 45-minute sessions; (2) NDT combined with high-repetition task-oriented training; or (3) NDT combined with high-intensity gait training. In the combined groups, an additional 30 minutes of the respective training approach will be delivered in each session, resulting in approximately 75 minutes of total treatment time per session. All interventions will be delivered by a single experienced physiotherapist, 3 days per week for 8 weeks (24 sessions in total), at Bingöl State Hospital and the Faculty of Physiotherapy and Rehabilitation of Bingöl University.
The primary outcome is walking capacity assessed with the 6-Minute Walk Test. Secondary outcomes include the Timed Up and Go Test, the modified Dynamic Gait Index, and the 10-Meter Walk Test. All outcome measures will be administered at baseline and at the end of the 8-week intervention period by an independent assessor blinded to group allocation.
Data will be analyzed using repeated-measures analysis of variance to examine time-by-group interaction effects. The study is expected to provide comparative evidence to inform the selection of intensity-based adjunct training strategies in the rehabilitation of walking function in chronic stroke.
- Conditions
- Stroke, Hemiplegia, Chronic Stroke
- Being tested
- Neurodevelopmental Treatment, High-Repetition Task-Oriented Training, High-Intensity Gait Training
- Keywords
- Task-oriented training, High-intensity gait training, Neurodevelopmental treatment, Walking capacity, Gait rehabilitation, Functional mobility, 6-Minute Walk Test, Randomized controlled trial
- Medical subject headings
- Stroke, Hemiplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurodevelopmental TreatmentOther
Also called NDT
Conventional neurodevelopmental treatment delivered in 45-minute sessions, 3 days per week for 8 weeks, focusing on postural control, weight transfer, selective movement of the lower extremity, and facilitation of normal movement patterns. All sessions will be delivered by a single experienced physiotherapist.
High-Repetition Task-Oriented TrainingOther
Also called HRTOT
Structured, task-specific lower extremity training performed at high repetition volumes for 30 minutes per session, in addition to neurodevelopmental treatment. Training includes functional tasks such as sit-to-stand, stepping, and weight-shifting activities, with the number of repetitions and task difficulty progressed individually based on participant performance.
High-Intensity Gait TrainingOther
Also called HIGT
Walking-based training performed for 30 minutes per session at high aerobic intensity, in addition to neurodevelopmental treatment. Training intensity will be progressively adjusted and monitored using target heart rate and ratings of perceived exertion.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Neurodevelopmental Treatment (NDT) | Active comparator | Participants will receive neurodevelopmental treatment alone, delivered in 45-minute sessions, 3 days per week for 8 weeks (24 sessions in total). Receives: Other: Neurodevelopmental Treatment |
| Group 2: NDT + High-Repetition Task-Oriented Training | Experimental | Participants will receive 45 minutes of neurodevelopmental treatment followed by 30 minutes of high-repetition task-oriented training targeting the lower extremity in each session (approximately 75 minutes in total), 3 days per week for 8 weeks (24 sessions in total). Receives: Other: High-Repetition Task-Oriented Training |
| Group 3: NDT + High-Intensity Gait Training | Experimental | Participants will receive 45 minutes of neurodevelopmental treatment followed by 30 minutes of high-intensity gait training in each session (approximately 75 minutes in total), 3 days per week for 8 weeks (24 sessions in total). Receives: Other: High-Intensity Gait Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-Minute Walk Test (6MWT)
The 6-Minute Walk Test measures the distance (in meters) a participant can walk in 6 minutes along a standardized walkway. Greater distance indicates better walking capacity. The test will be administered by an assessor blinded to group allocation.
Measured: 8 weeks
Secondary outcomes (2)
Modified Dynamic Gait Index (mDGI)
The modified Dynamic Gait Index evaluates the ability to modify gait in response to changing task demands across 8 tasks, each scored on three facets (time, level of assistance, and gait pattern). Total scores range from 0 to 64, with higher scores indicating better dynamic gait performance.
Measured: 8 weeks
10-Meter Walk Test (10MWT)
The 10-Meter Walk Test measures gait speed (in meters per second) over a 10-meter distance. Higher speed indicates better walking performance.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start15 Aug 2026 (estimated)
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Dec 2026 (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.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emrah Zirek, Bingol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07725211
- Sponsor's protocol ID
- BINGOL-FTR-2026-05-09
- Status last verified
- Jul 2026
- First submitted
- 21 Jul 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared publicly due to institutional data protection regulations and the terms of the ethics committee approval, which do not include consent for public data sharing. De-identified data may be made available from the principal investigator upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Repetition Task-Oriented Training Versus High-Intensity Gait Training for Lower Extremity Rehabilitation in Individuals With Chronic Stroke: An Assessor-Blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07725211
- Acronym / sponsor ID
- BINGOL-FTR-2026-05-09
- Conditions
- Stroke, Hemiplegia, Chronic Stroke
- Keywords
- Task-oriented training, High-intensity gait training, Neurodevelopmental treatment, Walking capacity, Gait rehabilitation, Functional mobility, 6-Minute Walk Test, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 15 Aug 2026 (estimated)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 24 Jul 2026 (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 purpose of this study is to compare the effects of high-repetition task-oriented training and high-intensity gait training on walking capacity and functional mobility in individuals with chronic stroke.
Forty-five participants will be randomly assigned to one of three groups: (1) neurodevelopmental treatment (NDT) alone, (2) NDT combined with high-repetition task-oriented training, or (3) NDT combined with high-intensity gait training. All participants will receive treatment 3 days per week for 8 weeks (24 sessions in total). Walking capacity (6-Minute Walk Test) and functional mobility (Timed Up and Go Test, modified Dynamic Gait Index, 10-Meter Walk Test) will be assessed before and after the intervention by an assessor blinded to group allocation. The study hypothesizes that adding structured, intensity-based training approaches to conventional NDT will lead to greater improvements in walking capacity than NDT alone.
Detailed description
Stroke is a leading cause of long-term disability worldwide, and impaired walking capacity remains one of the most common and persistent limitations in the chronic phase. Although neurodevelopmental treatment (NDT) is widely used in clinical practice, current evidence emphasizes the role of training intensity and task-specific repetition in promoting locomotor recovery. However, comparative evidence regarding the relative effectiveness of high-repetition task-oriented training and high-intensity gait training as adjuncts to conventional therapy in chronic stroke is limited.
This study is designed as an assessor-blinded, three-arm, parallel-group randomized controlled trial. Forty-five individuals with chronic stroke will be randomly allocated in a 1:1:1 ratio to one of three groups (n=15 per group): (1) NDT alone, consisting of 45-minute sessions; (2) NDT combined with high-repetition task-oriented training; or (3) NDT combined with high-intensity gait training. In the combined groups, an additional 30 minutes of the respective training approach will be delivered in each session, resulting in approximately 75 minutes of total treatment time per session. All interventions will be delivered by a single experienced physiotherapist, 3 days per week for 8 weeks (24 sessions in total), at Bingöl State Hospital and the Faculty of Physiotherapy and Rehabilitation of Bingöl University.
The primary outcome is walking capacity assessed with the 6-Minute Walk Test. Secondary outcomes include the Timed Up and Go Test, the modified Dynamic Gait Index, and the 10-Meter Walk Test. All outcome measures will be administered at baseline and at the end of the 8-week intervention period by an independent assessor blinded to group allocation.
Data will be analyzed using repeated-measures analysis of variance to examine time-by-group interaction effects. The study is expected to provide comparative evidence to inform the selection of intensity-based adjunct training strategies in the rehabilitation of walking function in chronic stroke.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: Neurodevelopmental Treatment (NDT) | Active comparator | Other: Neurodevelopmental TreatmentParticipants will receive neurodevelopmental treatment alone, delivered in 45-minute sessions, 3 days per week for 8 weeks (24 sessions in total). |
| Group 2: NDT + High-Repetition Task-Oriented Training | Experimental | Other: High-Repetition Task-Oriented TrainingParticipants will receive 45 minutes of neurodevelopmental treatment followed by 30 minutes of high-repetition task-oriented training targeting the lower extremity in each session (approximately 75 minutes in total), 3 days per week for 8 weeks (24 sessions in total). |
| Group 3: NDT + High-Intensity Gait Training | Experimental | Other: High-Intensity Gait TrainingParticipants will receive 45 minutes of neurodevelopmental treatment followed by 30 minutes of high-intensity gait training in each session (approximately 75 minutes in total), 3 days per week for 8 weeks (24 sessions in total). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of first-ever unilateral stroke (ischemic or hemorrhagic) confirmed by clinical and/or radiological findings
- Time since stroke onset of at least 6 months (chronic phase)
- Age between 18 and 75 years
- Ability to walk at least 10 meters independently, with or without an assistive device
- Functional Ambulation Category (FAC) score of 3 or higher
Key exclusion criteria (8 listed)
- Recurrent stroke or bilateral hemispheric involvement
- Unstable cardiovascular disease or other medical conditions contraindicating high-intensity exercise
- Severe lower extremity spasticity interfering with gait training (Modified Ashworth Scale score > 3)
- Orthopedic, rheumatological, or other neurological conditions affecting gait
- Severe visual or vestibular impairment
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 |
|---|---|---|
| Neurodevelopmental TreatmentAlso: NDTConventional neurodevelopmental treatment delivered in 45-minute sessions, 3 days per week for 8 weeks, focusing on postural control, weight transfer, selective movement of the lower extremity, and facilitation of normal movement patterns. All sessions will be delivered by a single experienced physiotherapist. | Other | Group 1: Neurodevelopmental Treatment (NDT) |
| High-Repetition Task-Oriented TrainingAlso: HRTOTStructured, task-specific lower extremity training performed at high repetition volumes for 30 minutes per session, in addition to neurodevelopmental treatment. Training includes functional tasks such as sit-to-stand, stepping, and weight-shifting activities, with the number of repetitions and task difficulty progressed individually based on participant performance. | Other | Group 2: NDT + High-Repetition Task-Oriented Training |
| High-Intensity Gait TrainingAlso: HIGTWalking-based training performed for 30 minutes per session at high aerobic intensity, in addition to neurodevelopmental treatment. Training intensity will be progressively adjusted and monitored using target heart rate and ratings of perceived exertion. | Other | Group 3: NDT + High-Intensity Gait Training |
Primary outcome
6-Minute Walk Test (6MWT)
Time frame: 8 weeks
The 6-Minute Walk Test measures the distance (in meters) a participant can walk in 6 minutes along a standardized walkway. Greater distance indicates better walking capacity. The test will be administered by an assessor blinded to group allocation.
2 secondary outcomes
Modified Dynamic Gait Index (mDGI)
Time frame: 8 weeks
10-Meter Walk Test (10MWT)
Time frame: 8 weeks
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 24 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared publicly due to institutional data protection regulations and the terms of the ethics committee approval, which do not include consent for public data sharing. De-identified data may be made available from the principal investigator upon reasonable request.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurodevelopmental Treatment, High-Repetition Task-Oriented Training and High-Intensity Gait Training in people with Stroke and Hemiplegia, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
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 8 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: opening soon, as of the sponsor's last update on 24 Jul 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 Turkey (Türkiye). 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?
Contact Emrah Zirek, Ph. D. (+904262160012, zireke@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-Minute Walk Test (6MWT) (time frame: 8 weeks). 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 24 Jul 2026.