Efficacy of Assistive Soft Gloves in Chronic Stroke Rehabilitation

NCT ID: NCT07327151

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-01
• Study Completion Date: 2024-08-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Soft Rehabilitation Glove (SRG) Group

Volunteers in the research group, in addition to routine neurological rehabilitation programs, will receive rehabilitation using SRGs five days a week, totaling 15 sessions, with each session lasting 20 min.

Group Type: EXPERIMENTAL

Sybero SRGs

Intervention Type: DEVICE

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.

Control Group

Volunteers in the control group will receive standard diagnosis/treatment protocols, including occupational therapy activities, within the same period.

Group Type: ACTIVE_COMPARATOR

Occupational therapy

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Individuals aged 18 and above who have experienced cerebrovascular events confirmed by neuroimaging and are planned to be enrolled in a neurological rehabilitation treatment program.

2. Those whose event date was more than 3 (three) months.

3. Individuals with upper limb and hand assessment of 3 or above according to the Brunnstrom Motor Assessment Scale.

4. Those with spasticity level of 2 and below in upper limb muscle groups according the Modified Ashworth Scale.

5. Individuals scoring 24 and above on the Standardized Mini-Mental Test.

Exclusion Criteria

1. Individuals with severe dystonia.

2. Those with severe soft tissue and/or joint contractures in the upper limbs.

3. Individuals with active reflex sympathetic dystrophy, active arthritis, fractures, circulatory disorders, or bone malignancies in the affected upper limbs.

4. Those with peripheral nerve injuries in the affected upper limb.

5. Individuals with cognitive or behavioral disorders that would hinder participation in the treatment program.

6. Those with aphasia and apraxia at a level that would hinder participation in the treatment program.

7. Individuals allergic to N Cloth and Lycra.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kocaeli University

OTHER

Sponsor Role: lead

Responsible Party

Tugba Gokbel

Assistant Prof, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kocaeli University

Kocaeli, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

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Other Identifiers

KAEK/16.bI.05

Identifier Type: -

Identifier Source: org_study_id