NCT07327151

Efficacy of Assistive Soft Gloves in Chronic Stroke Rehabilitation

Soft Rehabilitation Gloves as Assistive Technology: Enhancing Upper Limb Motor Function and Activities of Daily Living in Chronic Stroke-A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Kocaeli University · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

Stroke is a leading cause of disability, with hemiparesis affecting approximately 85% of survivors, particularly affecting the upper limbs, which play a critical role in the activities of daily living (ADLs). While robot-assisted rehabilitation (RAR) is gaining increasing attention owing to its capacity for intensive, repetitive, and task-specific training that promotes neuroplasticity, robot-assisted hand rehabilitation (RAHR) is not yet part of standard protocols and is understudied. This study investigated the effects of a soft rehabilitation glove (SRG) applied in addition to traditional neurorehabilitation on upper limb motor function and ADLs in individuals with chronic stroke.

Detailed description

This study aimed to investigate the effect of SRG, used in the treatment of stroke patients, on upper limb motor functions and ADLs. Stroke, the second most common cause of death in the community after heart disease, constitutes a significant health problem leading to disability in survivors. Hemiparesis, affecting approximately 85% of post-stroke patients, specifically targets the upper limbs. This rate was observed to be 40% in patients with chronic stroke. The majority of neurological motor recovery tends to occur within the first three months and can continue for up to six months, with functional improvement being prominent in the initial six months and potentially extending for up to one year. Problems arising after stroke include muscle weakness, loss of motor control, sensory disturbances, balance impairments, contractures, and changes in muscle tone. The fundamental goal of stroke rehabilitation is to enable stroke patients to achieve the maximum possible physical, functional, and psychosocial recovery within their limitations. Due to the more complex and delicately controlled anatomical structure of the upper limbs, post-stroke prognosis significantly influences ADLs. Therefore, upper limb rehabilitation is crucial for promoting independence in ADLs and improving quality of life (QoL). The number of studies on RAR has increased rapidly over the past decade. RAR contribute to the development of neuroplasticity in the brain owing to their high intensity, repetitiveness, task specificity, interactivity, and ability to objectively evaluate patient performance. The improvements correlated with motor abilities due to this development are crucial for enhancing functional performance. According to the literature, RAHR treatments applied to stroke patients significantly contribute to the improvement of upper-limb motor functions, strength, and motor control parameters after treatment. However, RAHR therapy has not yet been included in standard diagnosis/treatment protocols for hemiplegic individuals. As it is a relatively new concept introduced in the rehabilitation environment, its use is still being explored. Current research suggests the need for further studies to determine the effects of RAHR therapy on various components of stroke rehabilitation to provide higher-quality evidence. RAR treatments have been shown to stimulate neuroplastic changes through mirror neurons and consequently facilitate widespread cortical activation, which is essential for functional recovery after a stroke. Therefore, RAHR in stroke patients can contribute to functional improvement by enabling the application of goal-oriented tasks in enriched environments and ensuring high repetitions and intensity. This study aimed to investigate the impact of SRG therapy, applied in addition to routine neurological rehabilitation programs, on the affected upper limb motor functions and ADLs in hemiplegic volunteers.

Conditions

• Stroke

Interventions

Type	Name	Description
DEVICE	Sybero SRGs	Patients in this group received SRG (five days a week for a total of 15 sessions, each lasting 20 minutes) in addition to their routine neurological rehabilitation program (physiotherapy and occupational therapy). This device includes finger flexion and extension movements, grasping and releasing movements, and performing activities of daily living. Activities of daily living (such as eating, drinking, combing hair, opening jars, retrieving items from overhead shelves, carrying items, brushing teeth, and carrying bags) are determined based on the patients' functional status. The SRG is operated in passive mode, allowing finger flexion and extension movements. In mirror mode, a data glove was placed on the unaffected hand, and a SRG is placed on the affected hand. When the patient flexes their finger with the unaffected hand, signals from the data glove enables grasping of the paretic hand.
OTHER	Occupational therapy	Patients in this group received 20 min of occupational therapy (five days a week for a total of 15 sessions) in addition to their routine neurological rehabilitation program.

Timeline

• Start date: 2024-02-01
• Primary completion: 2024-08-30
• Completion: 2024-08-30
• First posted: 2026-01-08
• Last updated: 2026-01-13

Locations

1 site across 1 country: Turkey (Türkiye)