Efficacy of Assistive Soft Gloves in Chronic Stroke Rehabilitation

NCT07327151 | Completed

• 1 other identifier: KAEK/16.bI.05
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Outcome Measures

Primary Outcomes (3)

• Goal Assessment Scale (GAS)-Light

  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.

  Post-treatment (at the end of the 3 th week)

• Modified Frenchay Scale (MFS)

  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).

  Pre-treatment and Post-treatment (at the end of 3th week)

• Jebsen Taylor Hand Function Test

  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.

  Pre-treatment and Post-treatment (at the end of 3th week)

Other Outcomes (1)

• Assessment of Hand and Finger Grip Strength a Hand Dynamometer

  Pre-treatment and post-treatment (at the end of 3th week)

Study Arms (2)

Soft Rehabilitation Glove (SRG) Group

EXPERIMENTAL

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.

Device: Sybero SRGs

Control Group

ACTIVE COMPARATOR

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

Other: Occupational therapy

Interventions

Sybero SRGs 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.

Soft Rehabilitation Glove (SRG) Group

Occupational therapy 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.

Control Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kocaeli University: lead

Study Sites (1)

Kocaeli University

Kocaeli, Turkey (Türkiye)

Location

Related Publications (12)

• Stein J. Robotics in rehabilitation: technology as destiny. Am J Phys Med Rehabil. 2012 Nov;91(11 Suppl 3):S199-203. doi: 10.1097/PHM.0b013e31826bcbbd.

  PMID: 23080036 RESULT

• Maciejasz P, Eschweiler J, Gerlach-Hahn K, Jansen-Troy A, Leonhardt S. A survey on robotic devices for upper limb rehabilitation. J Neuroeng Rehabil. 2014 Jan 9;11:3. doi: 10.1186/1743-0003-11-3.

  PMID: 24401110 RESULT

• Balasubramanian S, Klein J, Burdet E. Robot-assisted rehabilitation of hand function. Curr Opin Neurol. 2010 Dec;23(6):661-70. doi: 10.1097/WCO.0b013e32833e99a4.

  PMID: 20852421 RESULT

• Prange GB, Jannink MJ, Groothuis-Oudshoorn CG, Hermens HJ, Ijzerman MJ. Systematic review of the effect of robot-aided therapy on recovery of the hemiparetic arm after stroke. J Rehabil Res Dev. 2006 Mar-Apr;43(2):171-84. doi: 10.1682/jrrd.2005.04.0076.

  PMID: 16847784 RESULT

• Timmermans AA, Seelen HA, Willmann RD, Kingma H. Technology-assisted training of arm-hand skills in stroke: concepts on reacquisition of motor control and therapist guidelines for rehabilitation technology design. J Neuroeng Rehabil. 2009 Jan 20;6:1. doi: 10.1186/1743-0003-6-1.

  PMID: 19154570 RESULT

• Vanoglio F, Bernocchi P, Mule C, Garofali F, Mora C, Taveggia G, Scalvini S, Luisa A. Feasibility and efficacy of a robotic device for hand rehabilitation in hemiplegic stroke patients: a randomized pilot controlled study. Clin Rehabil. 2017 Mar;31(3):351-360. doi: 10.1177/0269215516642606. Epub 2016 Jul 10.

  PMID: 27056250 RESULT

• Hsieh YW, Wu CY, Liao WW, Lin KC, Wu KY, Lee CY. Effects of treatment intensity in upper limb robot-assisted therapy for chronic stroke: a pilot randomized controlled trial. Neurorehabil Neural Repair. 2011 Jul-Aug;25(6):503-11. doi: 10.1177/1545968310394871. Epub 2011 Mar 24.

  PMID: 21436390 RESULT

• Zbytniewska M, Kanzler CM, Jordan L, Salzmann C, Liepert J, Lambercy O, Gassert R. Reliable and valid robot-assisted assessments of hand proprioceptive, motor and sensorimotor impairments after stroke. J Neuroeng Rehabil. 2021 Jul 16;18(1):115. doi: 10.1186/s12984-021-00904-5.

  PMID: 34271954 RESULT

• Park S, Fraser M, Weber LM, Meeker C, Bishop L, Geller D, Stein J, Ciocarlie M. User-Driven Functional Movement Training With a Wearable Hand Robot After Stroke. IEEE Trans Neural Syst Rehabil Eng. 2020 Oct;28(10):2265-2275. doi: 10.1109/TNSRE.2020.3021691. Epub 2020 Sep 4.

  PMID: 32886611 RESULT

• Radder B, Prange-Lasonder GB, Kottink AIR, Holmberg J, Sletta K, van Dijk M, Meyer T, Melendez-Calderon A, Buurke JH, Rietman JS. Home rehabilitation supported by a wearable soft-robotic device for improving hand function in older adults: A pilot randomized controlled trial. PLoS One. 2019 Aug 6;14(8):e0220544. doi: 10.1371/journal.pone.0220544. eCollection 2019.

  PMID: 31386685 RESULT

• Liao WW, Wu CY, Hsieh YW, Lin KC, Chang WY. Effects of robot-assisted upper limb rehabilitation on daily function and real-world arm activity in patients with chronic stroke: a randomized controlled trial. Clin Rehabil. 2012 Feb;26(2):111-20. doi: 10.1177/0269215511416383. Epub 2011 Aug 12.

  PMID: 21840917 RESULT

• Villafane JH, Taveggia G, Galeri S, Bissolotti L, Mulle C, Imperio G, Valdes K, Borboni A, Negrini S. Efficacy of Short-Term Robot-Assisted Rehabilitation in Patients With Hand Paralysis After Stroke: A Randomized Clinical Trial. Hand (N Y). 2018 Jan;13(1):95-102. doi: 10.1177/1558944717692096. Epub 2017 Feb 16.

  PMID: 28719996 RESULT

MeSH Terms

Conditions

Stroke

Interventions

Occupational Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Prof, MD

Study Record Dates

• First Submitted: December 24, 2025
• First Posted: January 8, 2026
• Study Start: February 1, 2024
• Primary Completion: August 30, 2024
• Study Completion: August 30, 2024
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)