Soft Rehabilitation Gloves as Assistive Technology: Enhancing Upper Limb Motor Function and Activities of Daily Living in Chronic Stroke-A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Kocaeli University
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Jebsen Taylor Hand Function Test
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
- •Those whose event date was more than 3 (three) months.
- •Individuals with upper limb and hand assessment of 3 or above according to the Brunnstrom Motor Assessment Scale.
- •Those with spasticity level of 2 and below in upper limb muscle groups according the Modified Ashworth Scale.
- •Individuals scoring 24 and above on the Standardized Mini-Mental Test.
Exclusion Criteria
- •Individuals with severe dystonia.
- •Those with severe soft tissue and/or joint contractures in the upper limbs.
- •Individuals with active reflex sympathetic dystrophy, active arthritis, fractures, circulatory disorders, or bone malignancies in the affected upper limbs.
- •Those with peripheral nerve injuries in the affected upper limb.
- •Individuals with cognitive or behavioral disorders that would hinder participation in the treatment program.
- •Those with aphasia and apraxia at a level that would hinder participation in the treatment program.
- •Individuals allergic to N Cloth and Lycra.
Arms & Interventions
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.
Intervention: Sybero SRGs (Device)
Control Group
Volunteers in the control group will receive standard diagnosis/treatment protocols, including occupational therapy activities, within the same period.
Intervention: Occupational therapy (Other)
Outcomes
Primary Outcomes
Jebsen Taylor Hand Function Test
Time Frame: Pre-treatment and Post-treatment (at the end of 3th week)
It is a test developed to assess the fine and gross motor functions of the hand in a standardized and objective manner. The functions of both hands were assessed using seven subtasks: writing, turning playing cards, picking up small objects, simulating eating, stacking checkers, picking up large light objects, and picking up large heavy objects. The completion time for each task was recorded separately. The tasks were performed using both hands. The test score was recorded as the time taken to complete the tasks. The seven subtasks in the test simulate activities that are commonly performed in daily life.
Goal Assessment Scale (GAS)-Light
Time Frame: Post-treatment (at the end of the 3 th week)
Functional goal attainment measurement (GAS) 5-Point Rating Scale Score Predicted Attainment (-2)Less than expected outcome (-1) Expected outcome after intervention (0)Much less than expected outcome (+1) Greater than expected outcome (+2) Much greater than expected outcome The GAS-light model is designed to assist clinicians in embedding GAS into their clinical reasoning, making GAS an integral part of the decision-making and review process, not a separate outcome measurement exercises. The fundamental differences between GAS-light and the original method are as follows: A pre-defined single scoring level, adjusted and fully documented for a zero score (i.e., a clear description of the intended level of success), all other levels are rated retrospectively. Both the individual and the treatment team are involved in both goal setting and evaluations.
Modified Frenchay Scale (MFS)
Time Frame: Pre-treatment and Post-treatment (at the end of 3th week)
The MFS is a scale used to assess patients' upper limb functions and IADL (such as drawing a straight line with a ruler, opening a jar lid, fastening a clothespin, and brushing hair, etc.). This scale consists of ten activities, four unilateral and six bilateral. The MFS was used to evaluate the IADL performance of patients with stroke before and after treatment. Scoring was done for each activity as 0 (no movement), 5 (task completed), and 10 (normal movement).
Secondary Outcomes
No secondary outcomes reported
Investigators
Tugba Gokbel
Assistant Prof, MD
Kocaeli University