StrokeNCT07014891
fNIRS-Driven Visual Feedback Training to Restore Walking After Stroke
A study testing Bobath Ball Training in people with Stroke, run by Shengjing Hospital at 1 site in China.
Trial summary
The objective of this clinical trial is to investigate whether intelligent visual feedback-based lower limb motor control training is more effective than conventional rehabilitation training in promoting walking ability recovery among stroke patients with hemiplegia. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Stroke
- What is being tested?
- Bobath Ball Training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- 15 Dec 2024to 3 Dec 2025
- 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
- 1: Vital signs are stable, with no severe cardiopulmonary diseases, making the patient suitable for exercise testing.
- 2: All patients are diagnosed with stroke by head CT or MRI, with clinical manifestations of unilateral limb hemiplegia.
- 3: The Brunnstrom stage of the lower limb is 3-5, quadriceps muscle strength is ≥ grade 3, modified Ashworth scale for the lower limb is < grade 2, and Hoffer walking scale is ≥ grade 2.
- 4: This is their first onset of the disease, with a disease course of ≤ 6 months, and the condition is stable.
- 5: Patients have no severe cognitive impairment or sensory aphasia, can understand and actively participate in the training program, and have provided informed consent by signing the consent form for this clinical study.
- 6: Age: 18-75 years old, no gender restrictions.
Who cannot join
- 1: Patients with tumors, tuberculosis, hematological diseases, or functional impairments of vital organs such as the heart or liver.
- 2: Those with lower limb musculoskeletal disorders, such as knee arthritis or lower limb fractures.
- 3: Individuals with severe abnormal muscle tone in the limbs or joint contracture deformities.
- 4: Patients experiencing severe pain that prevents them from tolerating physical activity.
- 5: Special populations, such as individuals with mental illnesses, breastfeeding women, or pregnant women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Rehabilitation Center of Shengjing Hospital, China Medical University
Shenyang, Liaoning, 110000
Xue Jiang, +86 189 4025 4064, jiangxueruby@163.com
Yan Chi, +86 15241806025, chiyan0726@163.com
About this study
Official title: A Study on Visual Feedback Motor Control Training Using Near-Infrared Spectroscopy (fNIRS) Brain Functional Imaging for Walking Function Recovery in Stroke Patients
The objective of this clinical trial is to investigate whether intelligent visual feedback-based lower limb motor control training is more effective than conventional rehabilitation training in promoting walking ability recovery among stroke patients with hemiplegia. The trial aims to address the primary question of the impact of intelligent visual feedback motor control training on the walking function of stroke patients with hemiplegia, and uses three-dimensional gait analysis for precise quantitative evaluation of therapeutic effects. Functional near-infrared spectroscopy (fNIRS) will be employed to explore patients' cerebral functional connectivity and cortical activation, and to analyze the correlation between fNIRS data and walking function scores (such as those from three-dimensional gait analysis), providing effective methods and a reliable reference basis for rehabilitation training of post-stroke hemiplegic patients.
Participants will be randomly divided into two groups: the experimental group receiving intelligent visual feedback motor control training, and the control group receiving Bobath ball training, 20 minutes per day, 5 days per week, for a total of four weeks. Before and after the treatment, indicators including fNIRS brain functional imaging, three-dimensional gait analysis, and Fugl-Meyer Assessment will be evaluated.
Read the detailed description
Stroke is an injury with a high disability rate, and in recent years, it has shown a trend of younger onset. Its common complication is hemiplegia of one side of the body, which affects the walking stability and coordination of patients and severely impairs their quality of life. Exploring treatment measures that can improve the walking function of stroke patients is of great significance. Clinical studies have found that the decline in knee joint control ability in hemiplegic patients is a key problem leading to the decline in walking function. Traditional training mostly uses manual operations by therapists, with limited effects. Moreover, the single - rehabilitation treatment takes a long time and has a high training intensity, resulting in most patients developing negative emotions such as irritability and anger during the training process, and having poor compliance with rehabilitation training.
The MRS - FS (Monitored Rehab Systems-Functional Squat) system is a horizontal squat weight - reduction device that simulates the human squatting motion. Patients can safely perform early lower - limb strength training in a lying - down position. The real - time electronic images presented by this system help correct abnormal postures of patients, strengthen motor control, and thus improve walking function. In addition, the gamified and task - oriented exercise training mode can evoke positive emotions, improve patients' compliance with rehabilitation training, and enhance the effectiveness of exercise training. Existing studies have confirmed that MRS - FS can effectively improve lower - limb function, provide real - time feedback, improve knee joint control ability, and correct hemiplegic gait. However, currently, there are relatively few randomized controlled trial studies in clinical applications for the rehabilitation treatment of stroke patients with hemiplegia. Therefore, the treatment plan and efficacy evaluation of this system for stroke patients with hemiplegia are the key points for further exploration in this study.
Research shows that the main mechanism of functional recovery after stroke is the plastic change of the central nervous system and the remodeling of brain function. Functional near - infrared spectroscopy (fNIRS) is a non - invasive, safe, and non - invasive imaging technique. It can accurately measure the changes in cerebral cortex activity by detecting the changes in blood oxygen levels in the cerebral cortex. Different from technologies such as X - ray and CT, fNIRS does not involve ionizing radiation. This study innovatively uses fNIRS to explore the brain functional connectivity and activation status that are affected by intelligent visual feedback motor control training on patients' walking function, and further observes the recovery of brain function. At the same time, three - dimensional gait analysis is used to accurately quantify gait characteristics, providing an effective treatment method for the rehabilitation training of stroke patients with hemiplegia.
Research process: According to the inclusion and exclusion criteria, if a patient meets the enrollment conditions of this trial and agrees to participate in this study, after signing the informed consent form, they will start to enter this study. The study period is 4 weeks. Assessments will be conducted before treatment and 4 weeks after treatment, including: near - infrared brain function imaging; three - dimensional gait analysis; Fugl - Meyer Assessment - Lower Extremity. The treatment of patients may include intelligent visual feedback motor control training / Bobath ball training. Treatment grouping: Subjects will be randomly grouped, and each subject has an equal probability of being assigned to any group. There are two groups in total: Group A: Intelligent visual feedback motor control training (MRS - FS); Group B: Bobath ball training.
- MRS - FS: The training includes six levels: random response, isometric contraction, random burst, control path, control position, and random deceleration. During the training process, the load of exercise training can be adjusted according to the patient's functional status and tolerance. It is carried out once a day, 20 minutes each time, 5 times a week, for a total of 4 weeks of treatment.
- Bobath ball: Specifically, it includes: ①In the supine position, the heel controls the ball to move back and forth; ② In the supine position, both feet step on the ball to perform a stepping motion, etc. It is carried out once a day, 20 minutes each time, 5 times a week, for a total of 4 weeks of treatment. For the randomized study: Patients may be randomly assigned (like flipping a coin) to Group A or Group B. Assessments will be carried out before treatment and 4 weeks after treatment.
- Conditions
- Stroke
- Being tested
- Intelligent Visual Feedback Motor Control Training, Bobath Ball Training
- Keywords
- stroke, visual feedback, Functional near-infrared spectroscopy, walking ability
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intelligent Visual Feedback Motor Control TrainingDevice
Patients receive motor control training using the intelligent training system (Monitored Rehab Systems B.V., 2031 CW Haarlem, The Netherlands). The Monitored Rehab Systems-Functional Squat is selected for lower - limb motor control training. The patient assumes a supine position, with both feet fixed at the correct position on the pushing - training board. The relative position of the patient can be displayed on the computer screen. The system represents the degree of joint flexion and extension and the duration of muscle contraction through the height, length, and size of images, while the speed of moving images reflects the speed of joint movement during exercise. Patients complete various simulated actions through interactive video games. During the training, the load of exercise training can be adjusted according to the patient's functional status and tolerance. The training is conducted once a day, 20 minutes per session, five times a week, for a total of four weeks.
Bobath Ball TrainingDevice
Bobath Ball Training Specific operations include: ① In the supine position, the heel controls the ball to move back and forth; ② In the supine position, both feet step on the ball to perform stepping movements, etc. The training is conducted 1 session daily, 20 minutes per session, 5 days per week, for a total of 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Intelligent Visual Feedback Motor Control Training | Experimental | Patients receive motor control training using the Intelligent Visual Feedback Motor Control Training System (Monitored Rehab Systems B.V., 2031 CW Haarlem, The Netherlands), with the Monitored Rehab Systems-Functional Squat selected for training. The patient is in a supine position, with both feet fixed at the correct position on the pushing training board. The relative position of the patient is displayed on the computer screen. The system uses the height, length, and size of images to represent the degree of joint flexion/extension and the duration of muscle contraction, while the speed of moving images reflects the speed of joint movement and muscle contraction during exercise. Patients complete various simulated actions through interactive video games. The load of exercise training can be adjusted according to the patient's functional status and tolerance. The training is conducted once a day, 20 minutes each time, 5 times a week, for a total of 4 weeks. Receives: Device: Intelligent Visual Feedback Motor Control Training |
| Bobath Ball Training | Active comparator | Bobath Ball Training Specific operations include: ① In the supine position, the heel controls the ball to move back and forth; ② In the supine position, both feet step on the ball to perform stepping movements, etc. The training is conducted 1 session daily, 20 minutes per session, 5 days per week, for a total of 4 weeks. Receives: Device: Bobath Ball Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional near-infrared spectroscopy
Near-infrared Brain Functional Imaging：The testing areas cover the bilateral prefrontal lobes, motor areas, occipital lobes, and other brain regions. Within 1 week before treatment initiation, a physician will collect resting-state and task-state fNIRS data from enrolled patients.Resting-State Data Collection：The patient is fitted with an fNIRS measurement headcap. In a quiet, comfortable environment, they are instructed to sit, relax, keep eyes closed (without falling asleep), and data are collected for 5 minutes.Task-State Data Collection：A walking paradigm is set up. The test includes a 10-second preparatory phase where the patient stands at rest, followed by the task phase:Upon the command "Please start walking," the subject alternates stepping for 30 seconds.At the command "Stop," they cease walking and stand in place to rest for 30 seconds.
This "walk-rest" cycle is repeated 4 times.Identical data collection will be completed within 1 week after treatment concludes.
Measured: Baseline, 4-weeks treatment
Three-Dimensional Gait
- Gait spatiotemporal parameters
- Lower limb joint angles
- Lower limb joint moments
- Ground reaction forces etc.
Measured: Baseline, 4-weeks treatment
Secondary outcomes (1)
Fugl Meyer Assessment
The Fugl-Meyer Assessment (FMA) is used to evaluate the lower limb motor function and coordination of research subjects. Modified from the Brunnstrom evaluation method, this scale is divided into two parts: upper limb and lower limb motor function assessment, with only the lower limb subscale (FMA-LE) applied in this study. The FMA-LE consists of 17 items, each graded into three levels (0 points = unable to perform; 1 point = partially performed; 2 points = fully performed), with a total score ranging from 0 to 34. A higher score indicates better lower limb motor function.
Measured: Baseline, 4-weeks treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start15 Dec 2024
- Primary completion3 Dec 2025 (estimated)
- Study completion3 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- 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
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shengjing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xue Jiang, Shengjing Hospital
- Investigators
- Xue Jiang, Study chair, Shengjing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07014891
- Sponsor's protocol ID
- 2024PS1843K
- Status last verified
- Jun 2025
- First submitted
- 3 Jun 2025
- Last updated
- 24 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study data will be made available under reasonable request after publication. Data will include de-identified participant data and the data dictionary. Requests can be submitted to the corresponding author. Request will be analyzed and ethical and legal implications of data sharing will be considered. Data will be shared after consent of study participants
Publications
Ferrari M, Quaresima V. A brief review on the history of human functional near-infrared spectroscopy (fNIRS) development and fields of application. Neuroimage. 2012 Nov 1;63(2):921-35. doi: 10.1016/j.neuroimage.2012.03.049. Epub 2012 Mar 28.
PubMed 22510258Lin CH, Chou LW, Luo HJ, Tsai PY, Lieu FK, Chiang SL, Sung WH. Effects of Computer-Aided Interlimb Force Coupling Training on Paretic Hand and Arm Motor Control following Chronic Stroke: A Randomized Controlled Trial. PLoS One. 2015 Jul 20;10(7):e0131048. doi: 10.1371/journal.pone.0131048. eCollection 2015.
PubMed 26193492Takahashi MTC, Balardin JB, Bazan PR, Boasquevisque DS, Amaro Junior E, Conforto AB. Effect of transcranial direct current stimulation in the initial weeks post-stroke: a pilot randomized study. Einstein (Sao Paulo). 2024 Jun 24;22:eAO0450. doi: 10.31744/einstein_journal/2024AO0450. eCollection 2024.
PubMed 38922218Cohen EJ, Quarta E, Bravi R, Granato A, Minciacchi D. Neural plasticity and network remodeling: From concepts to pathology. Neuroscience. 2017 Mar 6;344:326-345. doi: 10.1016/j.neuroscience.2016.12.048. Epub 2017 Jan 7.
PubMed 28069532Schnautz LS. Critical Care Nursing Clinics of North America. Cardiovascular disease in women. Preface. Crit Care Nurs Clin North Am. 2008 Sep;20(3):xi-xii. doi: 10.1016/j.ccell.2008.03.015. No abstract available.
PubMed 18644505Jarvis HL, Brown SJ, Price M, Butterworth C, Groenevelt R, Jackson K, Walker L, Rees N, Clayton A, Reeves ND. Return to Employment After Stroke in Young Adults: How Important Is the Speed and Energy Cost of Walking? Stroke. 2019 Nov;50(11):3198-3204. doi: 10.1161/STROKEAHA.119.025614. Epub 2019 Sep 26.
PubMed 31554503
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on Visual Feedback Motor Control Training Using Near-Infrared Spectroscopy (fNIRS) Brain Functional Imaging for Walking Function Recovery in Stroke Patients
- ClinicalTrials.gov ID
- NCT07014891
- Acronym / sponsor ID
- 2024PS1843K
- Conditions
- Stroke
- Keywords
- stroke, visual feedback, Functional near-infrared spectroscopy, walking ability
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Shengjing HospitalUniversity, hospital or other
- Study start
- 15 Dec 2024 (actual)
- Primary completion
- 3 Dec 2025 (estimated)
- Study completion
- 3 Dec 2025 (estimated)
- First posted
- 11 Jun 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 objective of this clinical trial is to investigate whether intelligent visual feedback-based lower limb motor control training is more effective than conventional rehabilitation training in promoting walking ability recovery among stroke patients with hemiplegia. The trial aims to address the primary question of the impact of intelligent visual feedback motor control training on the walking function of stroke patients with hemiplegia, and uses three-dimensional gait analysis for precise quantitative evaluation of therapeutic effects. Functional near-infrared spectroscopy (fNIRS) will be employed to explore patients' cerebral functional connectivity and cortical activation, and to analyze the correlation between fNIRS data and walking function scores (such as those from three-dimensional gait analysis), providing effective methods and a reliable reference basis for rehabilitation training of post-stroke hemiplegic patients.
Participants will be randomly divided into two groups: the experimental group receiving intelligent visual feedback motor control training, and the control group receiving Bobath ball training, 20 minutes per day, 5 days per week, for a total of four weeks. Before and after the treatment, indicators including fNIRS brain functional imaging, three-dimensional gait analysis, and Fugl-Meyer Assessment will be evaluated.
Detailed description
Stroke is an injury with a high disability rate, and in recent years, it has shown a trend of younger onset. Its common complication is hemiplegia of one side of the body, which affects the walking stability and coordination of patients and severely impairs their quality of life. Exploring treatment measures that can improve the walking function of stroke patients is of great significance. Clinical studies have found that the decline in knee joint control ability in hemiplegic patients is a key problem leading to the decline in walking function. Traditional training mostly uses manual operations by therapists, with limited effects. Moreover, the single - rehabilitation treatment takes a long time and has a high training intensity, resulting in most patients developing negative emotions such as irritability and anger during the training process, and having poor compliance with rehabilitation training.
The MRS - FS (Monitored Rehab Systems-Functional Squat) system is a horizontal squat weight - reduction device that simulates the human squatting motion. Patients can safely perform early lower - limb strength training in a lying - down position. The real - time electronic images presented by this system help correct abnormal postures of patients, strengthen motor control, and thus improve walking function. In addition, the gamified and task - oriented exercise training mode can evoke positive emotions, improve patients' compliance with rehabilitation training, and enhance the effectiveness of exercise training. Existing studies have confirmed that MRS - FS can effectively improve lower - limb function, provide real - time feedback, improve knee joint control ability, and correct hemiplegic gait. However, currently, there are relatively few randomized controlled trial studies in clinical applications for the rehabilitation treatment of stroke patients with hemiplegia. Therefore, the treatment plan and efficacy evaluation of this system for stroke patients with hemiplegia are the key points for further exploration in this study.
Research shows that the main mechanism of functional recovery after stroke is the plastic change of the central nervous system and the remodeling of brain function. Functional near - infrared spectroscopy (fNIRS) is a non - invasive, safe, and non - invasive imaging technique. It can accurately measure the changes in cerebral cortex activity by detecting the changes in blood oxygen levels in the cerebral cortex. Different from technologies such as X - ray and CT, fNIRS does not involve ionizing radiation. This study innovatively uses fNIRS to explore the brain functional connectivity and activation status that are affected by intelligent visual feedback motor control training on patients' walking function, and further observes the recovery of brain function. At the same time, three - dimensional gait analysis is used to accurately quantify gait characteristics, providing an effective treatment method for the rehabilitation training of stroke patients with hemiplegia.
Research process: According to the inclusion and exclusion criteria, if a patient meets the enrollment conditions of this trial and agrees to participate in this study, after signing the informed consent form, they will start to enter this study. The study period is 4 weeks. Assessments will be conducted before treatment and 4 weeks after treatment, including: near - infrared brain function imaging; three - dimensional gait analysis; Fugl - Meyer Assessment - Lower Extremity. The treatment of patients may include intelligent visual feedback motor control training / Bobath ball training. Treatment grouping: Subjects will be randomly grouped, and each subject has an equal probability of being assigned to any group. There are two groups in total: Group A: Intelligent visual feedback motor control training (MRS - FS); Group B: Bobath ball training.
- MRS - FS: The training includes six levels: random response, isometric contraction, random burst, control path, control position, and random deceleration. During the training process, the load of exercise training can be adjusted according to the patient's functional status and tolerance. It is carried out once a day, 20 minutes each time, 5 times a week, for a total of 4 weeks of treatment.
- Bobath ball: Specifically, it includes: ①In the supine position, the heel controls the ball to move back and forth; ② In the supine position, both feet step on the ball to perform a stepping motion, etc. It is carried out once a day, 20 minutes each time, 5 times a week, for a total of 4 weeks of treatment. For the randomized study: Patients may be randomly assigned (like flipping a coin) to Group A or Group B. Assessments will be carried out before treatment and 4 weeks after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intelligent Visual Feedback Motor Control Training | Experimental | Device: Intelligent Visual Feedback Motor Control TrainingPatients receive motor control training using the Intelligent Visual Feedback Motor Control Training System (Monitored Rehab Systems B.V., 2031 CW Haarlem, The Netherlands), with the Monitored Rehab Systems-Functional Squat selected for training. The patient is in a supine position, with both feet fixed at the correct position on the pushing training board. The relative position of the patient is displayed on the computer screen. The system uses the height, length, and size of images to represent the degree of joint flexion/extension and the duration of muscle contraction, while the speed of moving images reflects the speed of joint movement and muscle contraction during exercise. Patients complete various simulated actions through interactive video games. The load of exercise training can be adjusted according to the patient's functional status and tolerance. The training is conducted once a day, 20 minutes each time, 5 times a week, for a total of 4 weeks. |
| Bobath Ball Training | Active comparator | Device: Bobath Ball TrainingBobath Ball Training Specific operations include: ① In the supine position, the heel controls the ball to move back and forth; ② In the supine position, both feet step on the ball to perform stepping movements, etc. The training is conducted 1 session daily, 20 minutes per session, 5 days per week, for a total of 4 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 1: Vital signs are stable, with no severe cardiopulmonary diseases, making the patient suitable for exercise testing.
- 2: All patients are diagnosed with stroke by head CT or MRI, with clinical manifestations of unilateral limb hemiplegia.
- 3: The Brunnstrom stage of the lower limb is 3-5, quadriceps muscle strength is ≥ grade 3, modified Ashworth scale for the lower limb is < grade 2, and Hoffer walking scale is ≥ grade 2.
- 4: This is their first onset of the disease, with a disease course of ≤ 6 months, and the condition is stable.
- 5: Patients have no severe cognitive impairment or sensory aphasia, can understand and actively participate in the training program, and have provided informed consent by signing the consent form for this clinical study.
Key exclusion criteria (5 listed)
- 1: Patients with tumors, tuberculosis, hematological diseases, or functional impairments of vital organs such as the heart or liver.
- 2: Those with lower limb musculoskeletal disorders, such as knee arthritis or lower limb fractures.
- 3: Individuals with severe abnormal muscle tone in the limbs or joint contracture deformities.
- 4: Patients experiencing severe pain that prevents them from tolerating physical activity.
- 5: Special populations, such as individuals with mental illnesses, breastfeeding women, or pregnant women.
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 |
|---|---|---|
| Intelligent Visual Feedback Motor Control TrainingPatients receive motor control training using the intelligent training system (Monitored Rehab Systems B.V., 2031 CW Haarlem, The Netherlands). The Monitored Rehab Systems-Functional Squat is selected for lower - limb motor control training. The patient assumes a supine position, with both feet fixed at the correct position on the pushing - training board. The relative position of the patient can be displayed on the computer screen. The system represents the degree of joint flexion and extension and the duration of muscle contraction through the height, length, and size of images, while the speed of moving images reflects the speed of joint movement during exercise. Patients complete various simulated actions through interactive video games. During the training, the load of exercise training can be adjusted according to the patient's functional status and tolerance. The training is conducted once a day, 20 minutes per session, five times a week, for a total of four weeks. | Device | Intelligent Visual Feedback Motor Control Training |
| Bobath Ball TrainingBobath Ball Training Specific operations include: ① In the supine position, the heel controls the ball to move back and forth; ② In the supine position, both feet step on the ball to perform stepping movements, etc. The training is conducted 1 session daily, 20 minutes per session, 5 days per week, for a total of 4 weeks. | Device | Bobath Ball Training |
Primary outcome
Functional near-infrared spectroscopy
Time frame: Baseline, 4-weeks treatment
Near-infrared Brain Functional Imaging：The testing areas cover the bilateral prefrontal lobes, motor areas, occipital lobes, and other brain regions. Within 1 week before treatment initiation, a physician will collect resting-state and task-state fNIRS data from enrolled patients.Resting-State Data Collection：The patient is fitted with an fNIRS measurement headcap. In a quiet, comfortable environment, they are instructed to sit, relax, keep eyes closed (without falling asleep), and data are collected for 5 minutes.Task-State Data Collection：A walking paradigm is set up. The test includes a 10-second preparatory phase where the patient stands at rest, followed by the task phase:Upon the command "Please start walking," the subject alternates stepping for 30 seconds.At the command "Stop," they cease walking and stand in place to rest for 30 seconds. This "walk-rest" cycle is repeated 4 times.Identical data collection will be completed within 1 week after treatment concludes.
Three-Dimensional Gait
Time frame: Baseline, 4-weeks treatment
* Gait spatiotemporal parameters * Lower limb joint angles * Lower limb joint moments * Ground reaction forces etc.
1 secondary outcome
Fugl Meyer Assessment
Time frame: Baseline, 4-weeks treatment
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 Jun 2025.
- Results publication: PubMed 22510258Ferrari M, Quaresima V. A brief review on the history of human functional near-infrared spectroscopy (fNIRS) development and fields of application. Neuroimage. 2012 Nov 1;63(2):921-35. doi: 10.1016/j.neuroimage.2012.03.049. Epub 2012 Mar 28.
- Results publication: PubMed 26193492Lin CH, Chou LW, Luo HJ, Tsai PY, Lieu FK, Chiang SL, Sung WH. Effects of Computer-Aided Interlimb Force Coupling Training on Paretic Hand and Arm Motor Control following Chronic Stroke: A Randomized Controlled Trial. PLoS One. 2015 Jul 20;10(7):e0131048. doi: 10.1371/journal.pone.0131048. eCollection 2015.
- Results publication: PubMed 38922218Takahashi MTC, Balardin JB, Bazan PR, Boasquevisque DS, Amaro Junior E, Conforto AB. Effect of transcranial direct current stimulation in the initial weeks post-stroke: a pilot randomized study. Einstein (Sao Paulo). 2024 Jun 24;22:eAO0450. doi: 10.31744/einstein_journal/2024AO0450. eCollection 2024.
- Results publication: PubMed 28069532Cohen EJ, Quarta E, Bravi R, Granato A, Minciacchi D. Neural plasticity and network remodeling: From concepts to pathology. Neuroscience. 2017 Mar 6;344:326-345. doi: 10.1016/j.neuroscience.2016.12.048. Epub 2017 Jan 7.
- Results publication: PubMed 18644505Schnautz LS. Critical Care Nursing Clinics of North America. Cardiovascular disease in women. Preface. Crit Care Nurs Clin North Am. 2008 Sep;20(3):xi-xii. doi: 10.1016/j.ccell.2008.03.015. No abstract available.
- Results publication: PubMed 31554503Jarvis HL, Brown SJ, Price M, Butterworth C, Groenevelt R, Jackson K, Walker L, Rees N, Clayton A, Reeves ND. Return to Employment After Stroke in Young Adults: How Important Is the Speed and Energy Cost of Walking? Stroke. 2019 Nov;50(11):3198-3204. doi: 10.1161/STROKEAHA.119.025614. Epub 2019 Sep 26.
- Individual participant dataSharing planned: Yes. Study data will be made available under reasonable request after publication. Data will include de-identified participant data and the data dictionary. Requests can be submitted to the corresponding author. Request will be analyzed and ethical and legal implications of data sharing will be considered. Data will be shared after consent of study participants
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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.
Xue Jiang study chair
Shengjing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bobath Ball Training in people with Stroke, run by Shengjing Hospital at 1 site in China.
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: looking for participants now, as of the sponsor's last update on 24 Jun 2025. 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 China. 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 Xue Jiang (+8618940254064, jiangxueruby@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional near-infrared spectroscopy (time frame: Baseline, 4-weeks treatment). 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?
On the ClinicalTrials.gov record for NCT07014891, which also lists 6 linked publications.
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 Jun 2025.