Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-27 @ 11:17 PM
Study NCT ID:
NCT07077460
Status:
RECRUITING
Last Update Posted:
2025-08-29
First Post:
2025-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Innovative Hand Rehabilitation System With Synchronized Contralateral Haptic Feedback
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Subjects would use their dominant hand to operate the hand training system (Tipr), and according to the game instructions prompted by the tablet screen, slowly press the corresponding finger to the evaluation system to reach the target force value. At the same time, the subjects were instructed to place their non-dominant hand behind the mirror device and place it on another hand training system (Tipr). When the dominant hand starts to execute the game instructions, the force exerted by the fingertips will be presented on the tablet in the form of a game task screen. At the same time, a mirror or other device that can provide a mirror will be used to project the mirrored game screen to the developing device on non-dominant hand side. At the same time, subjects would get the feedback from only mirror visual feedback or both mirror visual feedback and Graded-Pressure Haptic feedback device or no other feedback, respectively for each group, during performing the force control training.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-10-22', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-24', 'studyFirstSubmitDate': '2025-07-11', 'studyFirstSubmitQcDate': '2025-07-11', 'lastUpdatePostDateStruct': {'date': '2025-08-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hand Strength', 'timeFrame': 'Before and after intervention(test time:15 minutes)', 'description': 'Handgrip strength and pinch strength was measured respectively. JAMAR Grip Hand Dynamometer and JAMAR Hydraulic Pinch Gauge were used for the apparatus for force measurement. Pinch strength was divided into lateral pinch, tip pinch and tripod pinch. Each test will test for three times and get the average results.'}, {'measure': 'Purdue Pegboard Test (PPT)', 'timeFrame': 'Before and after intervention(total test time for all subtest: 10 minutes)', 'description': 'Assess the manual dexterity and coordination for one and both hands, including one hand, two hand and assembly subtest. ( Test for dominant hand and non-dominant hand). Each subtest test for three times.'}, {'measure': 'Minnesota Manual Dexterity Test (MMDT)', 'timeFrame': 'Before and after intervention(total test time for all subtests:25 minutes)', 'description': 'Assess the eye-hand coordination ability and manual dexterity. MMDT was divided into: Turning, Placing, One hand Turning and Placing, Two hand Turning and Placing, Displacing.'}, {'measure': 'Digit Independence (EN value)', 'timeFrame': 'Before and after intervention(test time:40 seconds for each digits)', 'description': 'The force independence of each digit is collected from the data during force tracking test in evaluation session. The parameter of force independence is an index of five digits overall enslaving presented as EN value. Dominant hand and non-dominant hand need to be evaluated.'}, {'measure': 'Force control ability', 'timeFrame': 'Before and after intervention(test time: 40 seconds for each digits)', 'description': 'Subjects will be asked to track the target force and presses task digit to fit the target line as accurately as possible. Dominant hand and non-dominant hand need to be evaluated.'}, {'measure': 'Oxygenated hemoglobin (HbO)', 'timeFrame': 'Before and after intervention(test time:40 minutes)', 'description': 'The Oxygenated hemoglobin (HbO) was measured while the participants play the game under both conditions'}], 'secondaryOutcomes': [{'measure': 'Maximum voluntary isometric contraction (MVIC)', 'timeFrame': 'Every time before the initiation of game(test time:1 seconds for each digit)', 'description': 'Maximum voluntary isometric contraction of each digit is measured for training reference'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Functional near infrared spectroscopy', 'Parameters of digit force independence', 'Mirror Visual Feedback', 'Hand Training System', 'Hand Dexterity', 'Synchronized contralateral haptic feedback'], 'conditions': ['Healthy Elderly']}, 'referencesModule': {'references': [{'pmid': '25653609', 'type': 'BACKGROUND', 'citation': 'Kim J, Muller KR, Chung YG, Chung SC, Park JY, Bulthoff HH, Kim SP. 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One of the steps in this strategy, mirror therapy, has also been widely used in the clinical treatment of hemiplegic patients. Also, comparing with traditional rehabilitation treatments, mirror therapy can continuously provide cortical activation. Besides, several studies indicated that game-based interventions contribute to brain activation in the elderly due to their interest can improve users' motivation in the training program execution. In addition, force control training has positive effects on hand dexterity, and specific doses of motor control training not only improve motor function but also have positive effects on brain function.\n\nCurrently, hand function training primarily focuses on range of motion, strength, and hand function, although there is comparatively less emphasis on enhancing both force control and brain function. Moreover, studies related to mirror therapy has primarily focused on the execution of functional movements, but has not explored whether hand strength control training can achieve the same training effects on the affected or non-dominant side through the concept of mirror therapy. Furthermore, the effects of combining a hand strength control system with a synchronous contralateral clip-on force feedback device on brain activation and hand function have not yet been studied. Therefore, this study aimed to investigate the effects of integration a finger force control training system with synchronous contralateral force feedback and mirror visual feedback device on brain activation and hand function, aiming to develop a clinically applicable hand rehabilitation system. Additionally, visual feedback from force control training in our study is through the hints displayed virtually on the game interface of the tablet, which were represented as the height of the targets, not as typical as actual movement-based mirror therapy or task-based mirror therapy.\n\nTherefore, the purpose of the study is to understand the differences among training effects of integrating Graded-Pressure Haptic Device-TiPR closed-loop system and MVF; MVF and force control training, as well as isolated force control training, and to explore the training effects on hand strength, hand function and brain activation."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ranged from 20-80 years old\n* Without past medical history of musculoskeletal or neurological disorders that would affect muscle control ability or cause sensory abnormalities\n* Normal cognitive function to understand and follow the instructions\n* Able to understand Chinese, English, or Taiwanese language\n\nExclusion Criteria:\n\n* With a history of hand-related surgeries\n* With a history of neuromuscular diseases or degenerative arthritis\n* With a history of brain injury\n* With a history of taking psychiatric medications\n* Unable to understand instructions, or have cognitive impairments\n* With a history of physical disabilities (Loss of body parts) or taking relevant medications, including heart disease, peripheral arterial disease, respiratory system diseases, dialysis, unresolved upper extremity injury, or highly addicted to smoking or alcohol'}, 'identificationModule': {'nctId': 'NCT07077460', 'briefTitle': 'Innovative Hand Rehabilitation System With Synchronized Contralateral Haptic Feedback', 'organization': {'class': 'OTHER', 'fullName': 'National Cheng-Kung University Hospital'}, 'officialTitle': 'Innovative Hand Rehabilitation System With Synchronized Contralateral Haptic Feedback', 'orgStudyIdInfo': {'id': '113-162'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Mirror Visual Feedback Group', 'description': 'All the subjects were asked to use their dominant hands to operate the hand training system (TIPr) and place their non-dominant hands behind the mirror on the other hand training system (TIPr). According to the game instructions shown on the tablet screen, they should slowly press the evaluation system with the corresponding fingers to reach the target force value. When the dominant hand started to cooperate with the game instructions, the force exerted by the fingertips will be presented on the tablet, and the mirror would show the mirrored (reflected) image of force output level. The subjects were instructed to keep their eyes contacts on the reflected image from the mirror and simultaneously "imagine" that the non-dominant hand performing the same task as the dominant hand. Subjects was instructed not to move their non-dominant hand voluntarily.', 'interventionNames': ['Device: TIPr', 'Device: Mirror Visual Feedback Device']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non-Mirror Visual Feedback Group', 'description': 'All the subjects were asked to use their dominant hands to operate the hand training system (TIPr) and place their non-dominant hands behind the mirror on the other hand training system. According to the game instructions shown on the tablet screen, they should slowly press the evaluation system with the corresponding fingers to reach the target force value. When the dominant hand starts to cooperate with the game instructions, the force exerted by the fingertips will be presented on the tablet. Different from MVF group, the mirror would be covered. The subjects were instructed to keep their eyes contact on the tablet and imagine the non-dominant hand performing the same task as the dominant hand without mirror visual feedback. Subjects was instructed not to move their non-dominant hand voluntarily.', 'interventionNames': ['Device: TIPr', 'Device: Mirror Visual Feedback Device(Blocked mirror)']}, {'type': 'EXPERIMENTAL', 'label': 'Output-Dependent Cutaneous Pressure Tactile plus Mirror Visual Feedback Group', 'description': 'All the subjects were asked to use their dominant hands to operate the hand training system (TIPr) and place their non-dominant hands behind the mirror on the other hand training system (TIPr). Moreover, graded cutaneous pressure feedback, delivered via a novel Graded-Pressure Haptic Device would be applied on non-dominant fingers. When the dominant hand started to play the game, the force exerted by the fingertips will be presented on the tablet, and the mirror would show the mirrored image of force output level. Subjects were instructed to keep their eyes contacts on the mirrored-image and simultaneously "imagine" that the non-dominant hand performing the same task as the dominant hand. At the same time, subjects would additionally received force pulses on the non-dominant fingertip in synchrony with the TiPR game\'s force output (matched amplitude) to add tactile feedback. Subjects was instructed not to move their non-dominant hand voluntarily.', 'interventionNames': ['Device: TIPr', 'Device: Mirror Visual Feedback Device', 'Device: Graded-Pressure Haptic Device (Passive press-feedback cushion)']}], 'interventions': [{'name': 'TIPr', 'type': 'DEVICE', 'description': 'TIPr is a second-generation device, which is originated from Pressing Evaluation and Training System (PETs), developed by NCKU Motion Analysis Lab. This 2nd generation device is a home-based training device, which equipped with single-axis force sensors and displayed visual feedback through a tablet advantages.', 'armGroupLabels': ['Mirror Visual Feedback Group', 'Non-Mirror Visual Feedback Group', 'Output-Dependent Cutaneous Pressure Tactile plus Mirror Visual Feedback Group']}, {'name': 'Mirror Visual Feedback Device', 'type': 'DEVICE', 'description': 'A box with two compartments through a partition with two mirrors installed on each side, which is applied in Mirror therapy.', 'armGroupLabels': ['Mirror Visual Feedback Group', 'Output-Dependent Cutaneous Pressure Tactile plus Mirror Visual Feedback Group']}, {'name': 'Mirror Visual Feedback Device(Blocked mirror)', 'type': 'DEVICE', 'description': 'Different from Mirror Visual Feedback Device in MVF group, the mirror was blocked by black curtain or paperboard.', 'armGroupLabels': ['Non-Mirror Visual Feedback Group']}, {'name': 'Graded-Pressure Haptic Device (Passive press-feedback cushion)', 'type': 'DEVICE', 'description': "A passive press-feedback cushion (Graded-Pressure Haptic Device) would deliver force pulses to the subjects' non-dominant fingertips in synchrony with the TiPR game's force output (matched amplitude)", 'armGroupLabels': ['Output-Dependent Cutaneous Pressure Tactile plus Mirror Visual Feedback Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '701', 'city': 'Tainan', 'state': 'Taiwan', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Fong-Chin Su, PHD', 'role': 'CONTACT', 'email': 'fcsu@ncku.edu.tw', 'phone': '06-2757575', 'phoneExt': '63422'}], 'facility': 'National Cheng Kung University', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}], 'centralContacts': [{'name': 'Fong-Chin Su, PHD', 'role': 'CONTACT', 'email': 'fcsu@ncku.edu.tw', 'phone': '06-2757575', 'phoneExt': '63422'}], 'overallOfficials': [{'name': 'Fong-Chin Su, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chair Professor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cheng-Kung University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chair Professor', 'investigatorFullName': 'Fong Chin Su', 'investigatorAffiliation': 'National Cheng-Kung University Hospital'}}}}