Clinical Research Directory

Immediate Effects of PETTLEP-Based AOMI on Upper Limb Kinematics in Stroke Survivors

The purpose of this study is to investigate the immediate effects of a mental practice technique, called Physical, Environment, Task, Timing, Learning, Emotion, Perspective (PETTLEP)-based Action Observation and Motor Imagery (AOMI), on arm movement in stroke survivors. Stroke often causes difficulty in moving the arm smoothly, leading patients to compensate by using their back or shoulder. In this study, participants will either receive a single session of the AOMI training (watching and mentally practicing a reach-to-grasp movement) or a control relaxation task. The researchers will use a smartphone-based motion capture system (OpenCap) to measure if the mental practice immediately improves the smoothness of the arm movement and reduces compensatory body movements.

GaitBetter: Motor and Cognitive Training for Gait Rehabilitation and Falls Prevention in Stroke Survivors.

In this research study, the investigators aim to test the usability and efficacy of the GaitBetter system for gait rehabilitation after stroke.

Effect of Transcutaneous Auricular Vagus Nerve Stimulation Application on Respiratory Functions in Stroke Patients

The purpose of this study is to evaluate the effectiveness of Transcutaneous Auricular Vagus Nerve Stimulation (TAVSS) in improving respiratory muscle strength and function in chronic stroke patients. It aims to explore TAVSS as a potential complementary approach in enhancing rehabilitation outcomes for this population.

rTMS Plus CCFES-mediated Functional Task Practice for Severe Stroke

This study is a necessary and important step in the development of a new therapy for upper limb functional recovery in patients with severe motor impairment. It is the first clinical trial of non-invasive brain stimulation (repetitive transcranial magnetic stimulation or rTMS) delivered to excite the undamaged hemisphere (specifically the contralesional higher motor cortices or cHMC) in stroke. Therefore, this study will determine whether the positive results obtained in our short-term pilot study can be made to last longer and produce functional benefits in severe patients with the application of brain stimulation in combination with long-term rehabilitation therapy. Rehabilitation therapy administered is called contralaterally controlled functional electrical stimulation (CCFES). Determining whether combining rTMS facilitating the cHMC with CCFES produces synergistic gains in functional abilities in severe patients is necessary for acceptance by the clinical community and to move this technology toward commercialization and widespread dissemination. The proposed study will determine whether the combination of rTMS facilitating the cHMC with CCFES produces greater improvements in upper extremity function in severe participants who are ≥6 months from stroke onset than the combination of rTMS facilitating the damaged hemisphere (specifically the ipsilesional primary motor cortex, iM1) and CCFES or the combination of sham rTMS and CCFES. The secondary purposes are to define which patients benefit most from the treatments, which may inform future device and treatment development and clinical translation, and to explore what distinct effects the three treatments have on the brain. To accomplish these purposes, we are conducting a clinical trial that enrolls severe stroke patients.

Upper Limb Nerve Cryoneurolysis is Non Inferior to the Usual Care and Has Therapeutic Add Value in Dealing With Shoulder Pain and Functional Problems Caused by Spasticity and Motor Impairment

This trial is part of the spastiCRYO clinical research project. The primary objective of this clinical trial is to test the hypothesis: "Upper limb nerve cryoneurolysis is non inferior to the usual care and has therapeutic add value in dealing with shoulder pain and functional problems caused by spasticity and motor impairment". It is a non-inferiority study on the referred topic, comparing the therapeutic effect (improvement in function and pain) of cryoneurolysis of selected nerves (lateral pectoral nerve and thoracodorsal nerve) with the usual care: intramuscular botulinum neurotoxin type A (BoNT-A) injection of pectoralis major, teres major and subscapularis muscles. The hypothesis is that cryoneurolysis is not inferior to the usual care in terms of magnitude of the therapeutic effect and might have a therapeutic add-value in terms of duration of that effect. Two secondary hypotheses are firstly, that cryoneurolysis is a safe procedure that can be deployed in a rehabilitation hospital setting with minimum requirements to perform mini-invasive procedures and secondly that selecting patients who might benefit from this treatment is straightforward. To test these hypotheses, the research team will gather, analyse and compare outcome measures data from the endpoints which are the changes along the trial duration in shoulder pain, upper limb function, involved muscles spasticity, shoulder range of motion (abduction and external rotation) level of impairment, and follow-up of potential adverse effects in two independent and equivalent groups of participants who have shoulder pain and functional limitations caused by spasticity and are in a stable phase of their condition. Participants in one group (cryoneurolysis arm) have one session of selected nerves ultrasound and neurostimulation guided cryoneurolysis and participants in the other group (BoNT-A arm) have one session of ultrasound and neurostimulation guided injection of BoNT-A in the pectoralis major, teres major and subscapularis. The participants of the two groups follow an upper limb analogous rehabilitation program for 24 weeks after each intervention. Longitudinal follow-up in the trial will take 24 weeks. In a real-world scenario, within 24 weeks the effect of Bont-A intramuscular injection has already waned, and the procedure should be repeated. Secondary objectives are to compare changes in upper limb sensory function and electroneuromyographic parameters with the intention to understand the cryoneurolysis mechanism of action and the reversibility of this mini-invasive intervention. Changes in quality-of-life dimension of participants is a secondary endpoint as well.

Combined Mirror Therapy and Soft Robotic Glove for Hand Recovery After Stroke

Post-stroke hemiplegia frequently results in impaired upper limb function, which significantly affects independence and quality of life. Various rehabilitation approaches have been developed to improve motor recovery, including mirror therapy and robotic-assisted training. Mirror therapy uses visual feedback to stimulate neural plasticity and enhance motor recovery, while soft robotic gloves assist repetitive hand movements and facilitate functional training. This randomized controlled trial aims to investigate the effect of combining mirror therapy with a soft robotic glove on hand function recovery in patients with post-stroke hemiplegia. Participants will be randomly assigned to different intervention groups receiving mirror therapy, soft robotic glove training, combined therapy, or conventional rehabilitation. The primary outcome will assess improvement in upper limb motor function using validated clinical assessment tools. Secondary outcomes will evaluate functional hand performance and activities of daily living. The findings of this study may contribute to improving rehabilitation strategies for stroke survivors and provide evidence for integrating innovative rehabilitation technologies into clinical practice.

The Effect of Blood Flow Restriction Training Combined With Transcranial Magnetic Stimulation on Limb Function in Hemiplegic Patients After Stroke

This randomized controlled trial aims to evaluate whether combining blood flow restriction training (BFRT) with repetitive transcranial magnetic stimulation (rTMS) improves limb function in stroke patients with hemiplegia. A total of 69 participants will be randomly assigned to three groups: conventional rehabilitation alone (control group), conventional rehabilitation plus rTMS, or conventional rehabilitation plus BFRT combined with rTMS. The intervention period is 4 weeks, with assessments conducted at baseline and at the end of treatment. The primary outcome is the change in upper extremity Fugl-Meyer Assessment (FMA-UE) score, which measures motor function recovery. Secondary outcomes include Wolf Motor Function Test, Modified Barthel Index for daily activities, Berg Balance Scale, and safety parameters such as coagulation markers and adverse events. This study will help determine whether this combined approach offers a more effective rehabilitation strategy for stroke survivors.

Mirror vs Virtual Reality Therapy for Upper Extremity Function in Hemiplegic Patients

Upper extremity impairment in hemiplegic patients significantly impacts daily activities and reduces quality of life. Although traditional rehabilitation methods can help, some patients experience limited progress. Recently, modern techniques such as mirror therapy and virtual reality (VR) have emerged, demonstrating promising results in motor skill improvement. This study aims to directly compare the acute effects of mirror therapy and VR therapy on upper limb motor function in hemiplegic patients. Forty-two participants aged 18-75 with hemiplegia due to stroke (6-12 months post-stroke) will be randomly assigned to either mirror therapy or VR therapy. The evaluation includes motor function (Fugl-Meyer Assessment), spasticity (Modified Ashworth Scale), activities of daily living (Barthel Index), fine motor skills (Box and Block Test), proprioception, and reaction time. The goal is to identify the effectiveness of the mirror therapy and VR therapy on motor function, spasticity control, proprioception, daily activity performance, and reaction times, contributing valuable insights to clinical rehabilitation practices.

Exergame vs Balance Training in Hemiplegia

Hemiplegia rehabilitation is a long and demanding process, but with the right approach and patience, it is possible to regain lost functions and improve quality of life. Balance plays a critical role in helping stroke survivors regain independence. This randomized controlled study aims to compare the effects of balance exercises and video-based exergame training, in addition to conventional physiotherapy, on lower extremity functionality, balance, gait, daily living activities, quality of life, and fear of falling in patients with hemiplegia following stroke. A minimum of 30 eligible participants will be randomly assigned to two groups: Group 1 (Balance Exercise Group): Conventional physiotherapy plus balance exercises. Group 2 (Exergame Group): Conventional physiotherapy plus video-based exergame sessions using the Nintendo Switch Ring Fit Adventure. Both interventions will be conducted twice a week for four weeks under the supervision of a physiotherapist. Assessments will be performed before and after the intervention using standardized scales.

Validity and Reliability of the Hypertonia Assessment Tool (HAT) in Stroke Patients

In this study, the validity and reliability of the Hypertonia Assessment Tool (HAT), which has previously been validated in the pediatric cerebral palsy (CP) population, will be evaluated in adult individuals who have experienced a stroke. The HAT is a specific clinical instrument designed to differentiate subtypes of hypertonia, including spasticity, dystonia, and rigidity. Accurate classification of hypertonia subtypes following stroke is crucial for guiding rehabilitation strategies. However, the HAT has not yet been validated in the adult post-stroke population. This study will be conducted at the Physical Medicine and Rehabilitation Clinic of SBU Fatih Sultan Mehmet Training and Research Hospital. The study aims to evaluate the validity and reliability of the HAT for use in adults with stroke.

Repetitive Transcranial Magnetic Stimulation Combined With Motor Rehabilitation Improves Motor and Functional Outcomes After Ischemic Stroke

Ischemic stroke is a leading cause of long-term motor disability, frequently resulting in hemiplegia and limitations in daily activities and quality of life. Motor rehabilitation is a fundamental component of post-stroke care across all stages of recovery; however, functional outcomes may vary, particularly in patients with persistent motor impairment. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive brain stimulation technique that has been used as an adjunct to rehabilitation to modulate cortical excitability and potentially support motor recovery. The purpose of this study is to evaluate the effects of low-frequency rTMS combined with conventional motor rehabilitation compared with sham rTMS combined with conventional motor rehabilitation in patients with first-ever ischemic stroke during the acute, subacute, and chronic stages. Motor function, balance, functional mobility, activities of daily living, and stroke-specific quality of life will be assessed at baseline, after the intervention, and at 3-month and 6-month follow-up.

Investigation of the Effects of Vestibular Rehabilitation and Dynamic Neuromuscular

This study will aim to investigate the effects of vestibular rehabilitation, dynamic neuromuscular stabilization (DNS), and conservative rehabilitation exercises on balance and mobility in hemiplegic patients, and to compare the exercise programs with one another. Evaluation tools include the Brunnstrom Motor Staging, Fugl-Meyer Upper Extremity Motor Function Scale, Modified Ashworth Scale, Mini-Mental State Examination, Berg Balance Scale, Stroke Impact Scale, and Timed Up and Go test.

Pelvic-Restricted vs. Pelvic-Free Robot-Assisted Gait Training in Stroke Patients

This randomized controlled clinical trial aims to compare the effects of pelvic-free versus pelvic-restricted robot-assisted gait training (RAGT) on gait pattern, balance, and fear of falling in stroke patients. Stroke survivors often experience gait impairments, reduced balance, and fear of falling, which limit independence and quality of life. Conventional physiotherapy requires high intensity and repetition but is restricted by therapist capacity. Robotic gait systems provide intensive, repetitive, and safe training; however, most limit pelvic motion, potentially disrupting natural gait patterns and balance strategies. A total of 36 participants with chronic stroke (≥6 months post-stroke, age ≥18 years, hemiplegic gait disorder, Functional Ambulation Category ≥2) will be randomized into two groups: (1) pelvic-free RAGT plus conventional rehabilitation, or (2) pelvic-restricted RAGT plus conventional rehabilitation. Interventions will consist of 8 RAGT sessions (twice weekly) and 20 conventional rehabilitation sessions (five times weekly) over 4 weeks. Primary outcomes include gait analysis parameters (gait speed, step length, cadence, temporal symmetry index) and clinical measures such as the Berg Balance Scale, Functional Ambulation Category, Motricity Index (lower limb), and Falls Efficacy Scale-International. Assessments will be performed at baseline and after 4 weeks of treatment. The study hypothesizes that pelvic-free RAGT will improve gait symmetry, balance, and reduce fear of falling more effectively than pelvic-restricted training. Results are expected to provide evidence supporting the integration of pelvic-free robotic gait systems into post-stroke rehabilitation to enhance functional recovery and patient confidence

Comparison of the Effectiveness of TENS and TENS + NMES Treatment in Stroke Patients With Shoulder Pain

In this study, the effects of Transcutaneous Electrical Nerve Stimulation (TENS) and Neuromuscular Electrical Stimulation (TENS + NMES) applied in addition to TENS on pain, shoulder joint range of motion and upper extremity functions will be comparatively evaluated in stroke patients with hemiplegic shoulder pain. In this direction, in the study; The effectiveness of both treatment approaches on the severity of hemiplegic shoulder pain, their contribution to shoulder functionality and daily living activities will be examined; It will be investigated whether NMES application added to TENS provides an additional clinical benefit compared to TENS.

ICF-Based Effects of PNF and Kinesio Taping on Hand Function in Hemiplegic Stroke

This clinical trial aims to compare the effects of kinesio taping and PNF on hemiplegic hand functions. In addition, the effects of these applications on body structure, activity, and participation will be examined. The main questions it aims to answer are: Do kinesio taping and PNF applications have different effects on hemiplegic hand function? Are kinesio taping and PNF applications effective in body structure, activity, and participation? The researchers will compare the advantages of kinesio taping and PNF applications over each other. Participants: Kinesio taping and/or PNF applications will be applied 3 days a week for 8 weeks. Tests will be performed on the first and last day of the study to evaluate hand functions.

The Effect of Robot-Assisted Gait Training With or Without Plantar Pressure Summary Feedback: Impact on Gait Symmetry and Balance in Hemiplegic Patients

The goal of this randomized, single-blind clinical trial is to learn whether a 4-week Lokomat-based gait training program with plantar pressure feedback can improve gait symmetry and balance in adult patients with chronic hemiplegic stroke. The main questions it aims to answer are: Does Lokomat training with plantar pressure feedback improve spatiotemporal gait symmetry, as measured with the GAITRite system, more than Lokomat training without plantar pressure feedback? Does this intervention lead to greater improvements in balance and walking speed, assessed by the Berg Balance Scale (BBS) and the 10-Meter Walk Test (10MWT), compared with conventional Lokomat training? Researchers will compare a group receiving Lokomat training with both real-time feedback and additional summary plantar pressure feedback to a group receiving Lokomat training with real-time feedback only, to see if adding plantar pressure feedback results in superior gains in gait symmetry, balance, and walking ability. Participants will be adult inpatients with chronic hemiplegic stroke. They will be randomly assigned to one of the two training groups and will receive Lokomat-based gait training three times per week for 30 minutes per session over four weeks. Before and after the intervention period, participants will undergo gait analysis using the GAITRite walkway and clinical assessments including the BBS and 10MWT.

Postural Kinesio Taping in Stroke Rehabilitation

Stroke often leads to postural asymmetry and impaired trunk control, which negatively affect mobility, balance, coordination, and activities of daily living. These impairments increase the risk of falls and reduce functional independence during the rehabilitation process. The purpose of this randomized controlled trial is to investigate the effects of posture-oriented kinesio taping, applied in addition to standard neurological rehabilitation, on functional outcomes in patients with stroke. Participants will be randomly assigned to either an intervention group receiving kinesio taping plus standard rehabilitation or a control group receiving standard rehabilitation alone. Functional outcomes including trunk control, postural stability, balance, mobility, and activities of daily living will be assessed using validated clinical scales at baseline and after the intervention period. The findings of this study are expected to provide evidence regarding the clinical effectiveness of posture-oriented kinesio taping as a non-invasive and easily applicable adjunct treatment in stroke rehabilitation.

Evaluation of the Effectiveness of Pericapsular Nerve Group Block in Hemiplegic Shoulder Pain

Hemiplegic shoulder pain (HSP) is a common and clinically significant complication after stroke that negatively affects rehabilitation outcomes. It is associated with shoulder subluxation, capsular contracture, spasticity, and central pain mechanisms, leading to pain, limited range of motion, and reduced quality of life. The suprascapular nerve (SSN) block has been shown to be effective for shoulder pain management; however, the glenohumeral joint (GHJ) receives innervation from multiple nerves including the axillary, subscapular, and lateral pectoral nerves. The recently described pericapsular/periarticular nerve group (PENG) block targets these articular branches and may provide analgesia with minimal motor impairment. This study aims to evaluate the effects of adding an ultrasound-guided PENG block to conventional physical therapy in patients with post-stroke hemiplegic shoulder pain, focusing on pain intensity, range of motion, and quality of life outcomes.

Investigation of the Effectiveness of Flossing in Hemiplegic Patients With Shoulder Pain

This study aims to contribute to clinical practice by investigating the effectiveness of flossband application on range of motion, functionality, pain and sleep quality in hemiplegic patients with shoulder pain.

sTMS Combined With CIMT and taVNS In Infants With Hemiplegia

Preterm and term infants with brain injury frequently have delayed motor skills, and one hand and arm may become stronger than the other, which can signal early cerebral palsy. A new treatment, transcutaneous vagus nerve stimulation (taVNS), boosts specific brain circuits and may improve function when paired with intensive motor activities. This study will test taVNS-paired constraint induced movement therapy in infants who have greater weakness on one side and determine if a single pulse of transcranial brain stimulation over the motor area can cause a measurable movement of the hand or thumb, and indicate which infants can benefit from 40h taVNS-paired CIMT.

Effects of Intermittent Theta Burst Stimulation (iTBS) on Motor Recovery of Lower Extremity in Chronic Stroke Patients

This study aims to evaluate the effects and clinical feasibility of non-invasive brain stimulation protocols, specifically intermittent Theta Burst Stimulation, as part of rehabilitation interventions for motor recovery of lower extremity in the chronic phase after stroke. It also seeks to explore the underlying mechanisms by investigating changes of functional and structural brain networks.

Effects of Intermitted Theta Burst Stimulation (iTBS) on Motor Recovery of Upper Extremity in Chronic Stroke Patients

This study aims to evaluate the effects and clinical feasibility of non-invasive brain stimulation protocols, specifically intermittent Theta Burst Stimulation, as part of rehabilitation interventions for motor recovery of upper extremity in the chronic phase after stroke. It also seeks to explore the underlying mechanisms by investigating changes of functional and structural brain networks.

Botulinum Toxin Applications in Hemiplegic Patients

This retrospective study will be conducted by reviewing the medical records of hemiplegic patients who received botulinum toxin treatment between 2017 and 2020 at the Physical Medicine and Rehabilitation outpatient clinic of Istanbul Physical Medicine and Rehabilitation Training and Research Hospital. A total of 35 hemiplegic patients who underwent botulinum toxin injection and had at least two follow-up records (with a 6-month interval) will be included. Sociodemographic and clinical data, stroke-related characteristics, botulinum toxin dosage, injected muscle groups, medications, and comorbidities will be recorded. Functional assessments, including the Functional Independence Measure (FIM) and Brunnstrom stage, as well as spasticity evaluations using the Modified Ashworth Scale and the Global Spasticity Index, will be obtained from patient files.

CUped: An Approach to Motor Recovery Post-Stroke, Not Compensation

The goal of lower limb rehabilitation after stroke is recovery of independent walking at home and in the community. Few stroke survivors achieve this goal. Suboptimal outcomes are due to the serious and intransigent nature of movement impairments caused by stroke and the scarcity of feasible and effective therapies that restore movement lost to stroke. Our team has developed a novel exercise intervention called CUped (pronounced cupid, like the Roman god) to address barriers to recovery and improve walking after stroke. CUped is so called because it compels use of the paretic limb during a movement that resembles pedaling. This project will examine safety, acceptability, and tolerance to CUped, characterize its therapeutic effects, and identify dose-response relationships. Results will provide preliminary data for an R01 to support a randomized controlled trial (RCT). CUped is designed to help stroke survivors recover lower limb movement lost to stroke, thereby improving walking. It is intended to be used as an adjunct to gait training. CUped uses a robotic technology that eliminates compensatory movements that interfere with recovery, compels use of the paretic lower limb, and targets 3 key movement impairments caused by stroke: decreased muscle output from the paretic limb, inappropriate paretic muscle timing, and abnormal interlimb coordination. Exercise is done in sitting which enables high repetition practice. Like walking, CUped requires continuous, reciprocal use of both lower limbs; effects are likely to transfer to walking. The risk-reward profile of this proposal is ideal for an R21, which is an NIH funding opportunity intended to encourage exploratory/developmental research by providing support for the early and conceptual stages of project development. CUped is a novel therapy grounded in a physiologic premise and based on prior observations from our laboratory. The investigators have pilot data suggesting that CUped fulfills its design specifications, and this study will be the first to test its therapeutic effects. In this Stage 1 rehabilitation trial, The investigators will support or quickly refute the hypothesis that CUped is safe, acceptable, and capable of eliciting a therapeutic response in stroke survivors. The investigators will also examine tolerance to CUped and dose-response effects. If our hypotheses are supported, the investigators will be poised to run an RCT to isolate the effects of CUped and compare them to standard care. Future work will investigate physiologic mechanisms underlying the effects of CUped.