NCT07455877

Effect of Interactive Games Based Hand Training on Hand Dexterity and Functional Outcome in Patients With Stroke

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 45 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This current study will be designed to determine the effect of smart tablets hand training applications on hand functions and functional outcome in patients with stroke. Tablet-based hand function training app with smart tablet exercises: Patients in the study group will receive 20 min of smart tablet active hand therapy. Patients in the study and control group will receive 30 min of conventional physical therapy program. This program consists of neurodevelopmental facilitation techniques organized specifically for each patient, range of motion exercises, strengthening exercises . It includes the following functional tasks (reaching, grasping, lifting and placing objects).

Detailed description

CHAPTER I INTRODUCTION Stroke is the third leading cause of disability in the world-wide due to brain tissue damage following ischemic or hemorrhagic lesions. Survivors present problems carrying out basic activities of daily living (BADLs) and instrumental activities of daily living (IADLs) and their perception of their functional outcome decreases. Impaired fine motor control of fingers is common after stroke, reducing the ability to grasp and manipulate objects and negatively impacting daily activities and functional outcome . Various rehabilitation approaches focusing on upper extremity motor rehabilitation, such as constraint induced movement training, task-oriented training, mental practice, and mirror therapy, have been widely applied in clinical practice, although effective to some extent, are often limited by therapist availability, treatment intensity, and patient motivation . Hand rehabilitation after a stroke is a long process, and motivation is crucial for the patient's outcome. The treatment outcome depends not only on the physical therapist's rehabilitation process but also on the patient's motivation for the training protocols .To make rehabilitation more appealing, game-based training protocols are incorporated into the training system Smart tablets have emerged as an innovative rehabilitation tool that combines visual feedback, gamification, and repetitive task-oriented exercises to promote motor learning. These devices provide flexible and engaging environments for home-based or clinical therapy and allow real-time monitoring of progress . The interactive nature of tablet-based applications helps stimulate neuroplasticity, especially when combined with conventional physiotherapy. Furthermore, technology-enhanced rehabilitation may improve motivation, adherence, and ultimately the functional outcome for stroke survivors and developed as an approach for hemiplegia rehabilitation in the upper extremities in recent decades . Meanwhile, smart tablet-based hand exercises delivers electrical currents to stimulate peripheral nerves, inducing muscle contractions that may enhance voluntary motor control and cortical reorganization . Statement of the problem: Is there a significant effect of interactive games based hand training on hand dexterity and functional outcome in patients with stroke? Purpose of the study: * To investigate the effectiveness of interactive games based hand training on increasing pinch grip strength in chronic stroke patients. * To investigate the effectiveness of interactive games based hand training on enhancing the functional outcome in chronic stroke patients. Significance of the study: Stroke is one of the leading causes of long-term disability worldwide, affecting millions of individuals annually . Among stroke survivors, approximately 80% experience upper limb impairments, with the hand being particularly affected. Decreased UL function is a common post-stroke impairment, restricting activities of daily living (ADL), with around 30% requiring assistance, and also negatively impacting functional outcome of hand for up to two-thirds of stroke patients . Delimitations This study will be delimited to the following aspects: 1. Forty chronic ischemic Stroke patients from both sexes 2. The age ranges from 45 to 65 3. Stroke duration between six months and two years. 4. The selected patients will be assigned randomly into to two equal groups. 5. Pinch grip strength measured by hand grip dynamometer 6. Degree of spasticity ranges from 1+ to 2 according to modified Ashworth scale. Basic Assumptions It will be assumed that: 1. Environmental aspects will be the same for all patients during the study. 2. The psycho-physiological factors will be the same for all subjects at testing procedures and treatment. 3. All patients will exert their maximum effort during assessment and treatment. 4. The studied sample will be carefully selected to represent the whole stroke patient's population. 5. All subjects will follow instructions. Hypothesis * There is no significant effect of smart tablet-based training on improving hand dexterity * There is no significant effect of smart tablet-based training on increasing pinch grip strength in stroke patients. * There is no significant effect of smart tablet-based training on enhancing functional outcome in stroke patients. CHAPTER II LITERATURE REVIEW This chapter will review the following items: 1. Stroke 2. Hand function and assessment 3. Stroke hand rehabilitation 4. Smart tablets hand training applications <!-- --> 1. Stroke: Stroke is a sudden disruption of blood flow to the brain, resulting in the loss of neurological function. It is classified into ischemic (due to a blockage) or hemorrhagic (due to bleeding), with ischemic strokes accounting for about 85% of all cases . The resulting neurological damage varies in severity depending on the location and extent of the brain lesion. Hemiparesis-weakness on one side of the body-is among the most prevalent complications and frequently impacts the upper extremity, limiting functional performance. The need for targeted rehabilitation, especially in the early stages of stroke recovery, is therefore urgent and well-documented in current clinical guidelines . Stroke remains one of the leading causes of adult disability globally, affecting approximately 80 million people worldwide , its affects approximately 15 million people globally each year, with nearly one-third experiencing long-term disability , with high rates of long-term physical, cognitive, and emotional impairments. Among stroke survivors, upper limb weakness is one of the most common and persistent deficits. Stroke is the second cause of mortality and the third cause of long-term disability worldwide with 33 million stroke survivors. A majority of patients with hemispheric stroke has limited use of the affected upper limb. In the first days after stroke onset, this concerns about 80% of the patients, while deficits in upper limb capacity persist at 6 months post stroke in 30%5 to 66%6 of the hemiplegic stroke patients. One year after stroke, upper limb deficits are accompanied by higher levels of anxiety and reduced self-reported well-being. Hence, improving upper limb capacity is a major therapeutic target in stroke rehabilitation. The impact of stroke on motor function, particularly in the upper limbs, affects an individual's ability to perform activities of daily living (ADLs), such as eating, dressing, and grooming negatively impacting independence. This impairment stems from damage to the corticospinal tract, which is crucial for voluntary motor control . Recovery is often incomplete, with only a fraction of patients regaining full function in the upper extremity without targeted rehabilitation. Consequently, enhancing motor recovery through evidence-based interventions remains a priority in stroke care Neuroplasticity-the brain's ability to reorganize itself by forming new neural connections-is the foundation of recovery after a stroke. Interventions that enhance neuroplasticity, such as task-specific training, motor learning, and stimulation techniques, have gained prominence. These interventions must be intensive, repetitive, and functionally relevant to maximize outcomes . Technologies like smart tablets and smart tablet-based hand exercises have emerged as promising tools to facilitate such recovery, particularly in chronic stroke patients who have plateaued with traditional methods. 2. Hand function and assessment: Common upper extremity (UE) impairments after stroke include paresis, loss of fractionated movement, abnormal muscle tone, and/or changes in somatosensation. These impairments are a result of direct damage to the primary motor cortex, the primary somatosensory cortex, secondary sensorimotor cortical areas, subcortical structures, and/or the corticospinal tract. The evaluation determines the presence and severity of each impairment and how the impairments are contributing to the loss of movement and function. The most common motor impairment seen after stroke is paresis. Paresis is a decreased ability to volitionally activate motor units and is caused by damage to the corticospinal system (the primary motor cortex, nonprime cortical motor areas, and the corticospinal tract) Clinically, paresis appears as weakness and results in slower, less accurate, and less efficient movements compared with those in neurologically intact individuals. A stroke will cause paresis on one side of the body, contralateral to the lesion brain. The hand is structured to be able to carry out the main actions of daily life. Functional limitations of the hand, precisely because of the role it plays, constitute the greatest disability in many neurological and orthopedic pathologies Numerous measures are readily available to clinicians for the evaluation of UE function after stroke. Action Research Arm Test (ARAT), Box and Blocks Test (BB), Chedoke Arm and Hand Activity Inventory (CAHAI), Jebsene Taylor Hand Function Test (JTT), Nine-Hole Peg Test, and the Wolf Motor Function Test (WMF) : Fugl-Meyer Assessment (FMA) - upper extremity section, ABILHAND, Sequential Occupational Dexterity Assessment (SODA) ,Sollerman Hand Function Test, Grip Ability Test (GAT), Purdue Pegboard Test and Crawford Small Parts Dexterity Test. The FMA-UL, which was widely used in studies on neurorehabilitation, was employed as one of the primary measurements in our present study to evaluate the motor impairment and recovery of upper limb. The FMA-UL (maximum: 66) applied a three-point ordinal scale from 0 to 2 to assess upper limb function, in which "0" represented "cannot perform," "1" represented "can perform partially," and "2" represented "can perform fully." A study indicated that FMA-UL ≤ 34 indicated severe to moderate motor impairment and FMA-UL ≥ 35 represented moderate-mild . In order to evaluate hand function recovery and further investigate the effect of treatments, the score of wrist and hand of the FMA (FMA-WH, maximum: 24) was also employed.. Hand function is a critical component of upper limb mobility and is essential for fine motor tasks. It includes grasping, manipulating objects, and coordinating finger movements-all of which are commonly impaired after a stroke. The loss of hand dexterity often leads to dependency and psychological distress . Restoring hand function is therefore a central goal in post-stroke rehabilitation, as it directly correlates with functional independence and community reintegration. In post-stroke individuals, impaired hand function is often characterized by decreased pinch grip strength, poor coordination, and abnormal muscle tone such as spasticity or flaccidity. These impairments directly hinder basic and instrumental activities of daily living (ADLs and IADLs), affecting both physical and psychosocial aspects of recovery. Restoration of hand function is a predictor of successful reintegration into daily life and is thus considered a key indicator in rehabilitation progress . Advanced technologies have enabled more accurate and quantitative assessments of hand performance. Electromyography (EMG), motion sensors, and force measurement tools are now integrated into rehabilitation settings to complement traditional scales like the ARAT or FMA-UE. These instruments allow for objective monitoring of muscle activation patterns and range of movement, which aids in customizing treatment plans and measuring subtle improvements . This data-driven approach enhances clinical decision-making and supports research on novel interventions like smart tablet and electrical stimulation therapies. 3. Stroke hand rehabilitation: Stroke rehabilitation is a dynamic and patient-centered process aimed at restoring function through repetitive, task-specific, and goal-oriented training. Conventional hand rehabilitation includes a range of techniques such as passive and active mobilization, mirror therapy, task-oriented exercises, and constraint-induced movement therapy . These interventions promote motor relearning and cortical reorganization, particularly when initiated early and delivered with sufficient intensity. Moreover, with traditional therapeutic tools it is difficult to train speed of motion and reaction time and almost impossible to objectively quantify performance for precise and objective evaluation and as well as for monitoring improvement. To overcome these challenges, researchers and clinicians are increasingly incorporating technology-assisted methods. Emerging evidence supports the integration of smart tablet devices, virtual reality, and electrical stimulation with conventional therapy to enhance outcomes . These multimodal approaches allow for higher repetition rates, real-time feedback, and individualized training, all of which are essential for driving neuroplasticity and improving functional hand use post-stroke. Effective hand rehabilitation requires early intervention, sustained intensity, and personalization based on patient capacity. Research supports the idea that task-specific and repetitive training leads to cortical reorganization and improved motor performance. Additionally, the integration of assistive technology, mirror therapy, and virtual reality into OT allows therapists to provide graded, engaging, and adaptable treatment sessions . For instance, a patient with right hemiparesis may be trained to use their affected hand to grasp a cup and bring it to their mouth using graded reach-and-grasp tasks supported by visual and verbal cues. This task-specific practice not only improves upper limb dexterity but also fosters confidence and autonomy in self-care. Occupational therapy serves as a critical link between motor recovery and real-life function, ensuring that gains in strength and coordination are translated into meaningful, everyday tasks . Moreover, the integration of multimodal rehabilitation approaches-combining cognitive, sensory, and motor components-has been shown to enhance outcomes. For example, mirror therapy and mental imagery, when paired with physical training, activate similar brain regions involved in movement planning and execution . Similarly, pairing physical therapy with smart tablet-based hand exercises or smart tablet devices can yield synergistic effects, enhancing motor relearning by simultaneously stimulating the muscles and the brain regions involved in movements. 4. Smart tablets hand training applications : Tablet-based hand training applications represents a technological advancement in stroke rehabilitation, providing structured, repetitive, and high-intensity training, which are essential components of neuroplasticity. Devices such as exoskeleton gloves and hand smart tablets assist patients in executing controlled hand movements, even in the absence of voluntary muscle strength . These smart tablets can be adjusted based on the patient's functional level, offering both passive and active-assistive movements to facilitate recovery. Clinical trials have demonstrated that smart tablets hand training applications can significantly improve hand function, particularly when used as an adjunct to conventional therapy. For instance, a study found that patients who received tablet-based hand training applications showed greater improvements in upper limb function compared to those receiving only traditional rehabilitation. Furthermore, smart tablet devices enhance patient engagement through interactive tasks and real-time performance feedback, which may increase motivation and adherence to therapy regimens. Recent developments in smart tablets hand training applications also emphasize the importance of patient engagement through gamification and biofeedback. Interactive systems that track performance and provide visual or auditory feedback have been associated with increased motivation and better adherence to rehabilitation programs . The user swipes, taps or pinches the screen with their fingers to perform game-like activities, which is more naturalistic than operating a mouse or using a computer keyboard . CHAPTER III SUBJECTS, MATERIALS AND METHODS This current study will be designed to determine the effect of smart tablets hand training applications on hand functions and functional outcome in patients with stroke. This study will be carried out at private clinic specialized in neurorehabilitation. Study design: Randomized controlled trial. A. Subjects selection: Forty chronic ischemic stroke patients from both sexes will be enrolled in this study. Patients will be diagnosed as stroke patients based on careful clinical evaluation by the neurologist and magnetic resonance imaging (MRI) of the brain. The patients will be recruited from private clinics specializing in neurorehabilitation. On approval to participate in the study, all subjects will sign an informed consent form after receiving full information on the purpose of study, procedure, possible benefits, privacy and use of data, and their rights to withdraw from the study whenever they want Appendix (1). Patients who fulfill diagnostic criteria for stroke will be randomly assigned into two equal groups (study and control groups). • Study group (GA): This group will receive smart tablet hand training applications for 20 minutes in addition to 30 minutes of conventional physical therapy program in the form of prolonged stretch, active upper extremity exercises, balance, gait training and hand function. Hand function training includes the following activities: turning cards, transfer cubes, grasping rubber ball, picking up coins. Sessions will be conducted three times per week for six weeks (18 sessions) with a total session duration ranging from 50 to 60 minutes. * Control group (GB): This group will receive the same conventional physical therapy program in the form of for prolonged stretch, active upper extremity exercises, balance, gait training and hand function. Hand function training includes the following activities: turning cards, transfer cubes, grasping rubber ball, picking up coins. The sessions will be conducted three times per week for six weeks (18 sessions) with a total session duration ranging from 50 to 60 minutes. Sample size: total sample size is 40 subjects (20 in each group). The sample size was calculated using the G\*Power software . Inclusion criteria: <!-- --> 1. Forty chronic ischemic stroke patients from both sexes. 2. Their ages will range from 45 - 65 years old. 3. Stroke duration between six months and two years. 4. Spasticity grade of the upper limb is from 1+to 2 according to the Modified Ashworth scale. 5. MMSE score \> 24 to ensure adequate cognitive function for following instructions. 6. Patients with at least 20° of wrist flexion/extension and at least 10° of finger flexion and extension of the paretic limb. 7. Brunnstrom stages ≥ 4 were included 8. Medically stable patients. Exclusion Criteria: 1. Other neurological disorders (e.g.: Multiple sclerosis, Parkinsonism…etc). 2. Visual, auditory, and cognitive deficits. 3. Patients with psychological or sever cognitive disorders. 4. Patients with musculoskeletal problems (deformity or contracture). 5. Medically unstable and uncooperative patients. Study outcome measures: 1. Power and Pinch grip strength by hand dynamometer. 2. Hand dexterity by Purdue peg board test. 3. Wolf Motor Function Test 4. Fugl-Meyer Assessment (FMA) B. Instrumentations: For assessment: - 1\. Fugl-Meyer Assessment (FMA) - upper extremity section of physical performance upper extremity hand section. Total score of hand section =14. The FMA-UL applied a three-point ordinal scale from 0 to 2 to assess upper limb function, in which "0" represented "cannot perform," "1" represented "can perform partially," and "2" represented "can perform fully." . 2\. Pinch pinch grip strength by hand dynamometer. Maximal pinch grip strength is easy to measure and is commonly used in clinical practice to quantify weakness and recovery following a stroke. The reliability of maximal pinch grip strength measurements has been demonstrated both in asymptomatic and symptomatic subjects. Studies have also shown that maximal pinch grip strength measurements are reliable in subjects with hemiparesis . 3\. Purdue Pegboard Test: The Purdue Pegboard Test (PPT) is a reliable and widely used assessment tool for evaluating fine motor dexterity and bimanual coordination, making it highly relevant in stroke rehabilitation. It consists of a board with holes into which metal pegs are inserted by the patient. It also comes with washers and collars to be placed on the pins . The test measures movements, coordination and speed of hand and finger dexterity. In the test procedures, the patient is first asked to use the non-affected hand to properly insert as many pins as possible in the holes. Then, the same procedure is repeated for the affected hand. In the final stage the patient is given 60 sec to place the pins, washers and collars using both hands. 5\. Wolf Motor Function Test (WMFT): * This test is used to quantitatively assess the upper extremity motor ability through timed and functional tasks in individuals with stroke. It includes 15 tasks divided into functional activities and strength-based assessments. * The tasks are scored based on performance time (measured in seconds) and functional ability (using a 6-point ordinal scale). * The test has shown high reliability and validity in assessing recovery of upper limb motor function post-stroke. For treatment: - 1- Tablet-based hand function training app Smart tablet apps will include interactive tasks such as tracing shapes, tapping sequences, drag-and-drop puzzles, and timed motor tasks designed to stimulate fine hand movements. Sessions will be supervised and progressed based on patient performance. Apps will provide visual and auditory feedback to enhance user engagement. Tablet Application Description: 1. Dexteria Dexteria is designed to improve fine motor skills and hand readiness for writing in both children and adults. It's widely used in pediatric occupational therapy but can also benefit adults recovering from hand injuries or neurological conditions. Dexteria offers a set of therapeutic hand exercises that take advantage of the multi-touch interface of tablets and smartphones. These exercises help build strength, control, and coordination in the fingers and hands. Main Features: Finger Tap Exercises: Improve individual finger isolation and motor control. Pinch Exercises: Strengthen finger and hand muscles through coordinated pinch movements. Tracing Letters and Shapes: Enhance handwriting skills and visual-motor integration. Procedures: 1. Tablet-based hand function training app with smart tablet exercises: Patients in the study group will receive 20 min of smart tablet active hand therapy. 2. Selected physical therapy program: Patients in the study and control group will receive 30 min of conventional physical therapy program. This program consists of neurodevelopmental facilitation techniques organized specifically for each patient, range of motion exercises, strengthening exercises . It includes the following functional tasks (reaching, grasping, lifting and placing objects). Each of these tasks was performed for 5 repetitions. These tasks were performed with the participant seating and objects placed over the table of suitable height, provided participants had sufficient movement in their affected UL to attempt the functional tasks. For those participants who did not have sufficient movement in their affected UL to practice such tasks, the therapist will assist the participant by guiding the limb through the tasks with the help of manual contact. The difficulty level of practiced tasks will increase gradually, with the goal being set just above the patient's ability level to perform. Difficulty level was progressed by increasing the distance between participant and object and by decreasing the shape of the object. Rest intervals were given whenever required for the total of 5 minutes in one treatment session . The sessions will be three times per week for six weeks (18 sessions). Statistical procedures: The collected data will be statistically analyzed using: • Descriptive statistics (mean and standard deviations). • Shapiro-Wilk test for analysis of data normality will be used. * Inferential statistics; unpaired t-test will be used to compare between subjects characteristics of the two groups. * Repeated measures MANOVA will be used to compare all dependent variables within and between groups. * Statistical analysis will be conducted using SPSS for Windows, version 20 (SPSS, Inc., Chicago, IL). Statistical significance will be set at the (p\< 0.05).

Conditions

• Chronic Stroke Patients

Interventions

Type	Name	Description
OTHER	interactive games	smart tablets hand training applications
OTHER	conventional physical therapy	prolonged stretch, active upper extremity exercises, balance, gait training and hand function. Hand function training includes the following activities: turning cards, transfer cubes, grasping rubber ball, picking up coins

Timeline

• Start date: 2026-03-01
• Primary completion: 2026-07-01
• Completion: 2026-07-25
• First posted: 2026-03-06
• Last updated: 2026-03-09