Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2026-01-04 @ 8:35 PM
Study NCT ID:
NCT02898558
Status:
COMPLETED
Last Update Posted:
2017-11-30
First Post:
2016-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Body Representation in Movement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-28', 'studyFirstSubmitDate': '2016-09-08', 'studyFirstSubmitQcDate': '2016-09-12', 'lastUpdatePostDateStruct': {'date': '2017-11-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Action Research Arm test', 'timeFrame': 'Baseline, immediately after the training (two weeks) and after one month', 'description': '19 item measure of motor control (i.e. (grasp, grip, pinch, and gross arm movement). Max score is 57'}], 'secondaryOutcomes': [{'measure': 'Rivermead Assessment of Somatosensory Performance', 'timeFrame': 'Baseline, immediately after the training (two weeks) and after one month', 'description': 'Battery designed to test somatosensory functions, comprising of 7 subtests (sharp/dull discrimination, surface pressure touch, surface localization, sensory extinction, two-point discrimination, temperature discrimination, proprioception movement and direction discrimination). Max score for each subtest is 60, except for sensory extinction (max is 12) and two-point discrimination (fail or pass).'}, {'measure': 'Grip strength', 'timeFrame': 'Baseline, immediately after the training (two weeks) and after one month', 'description': "A grip dynamometer measures participants' grip strength"}, {'measure': 'Finger tapping', 'timeFrame': 'Baseline, immediately after the training (two weeks) and after one month', 'description': "Electronic tapping test measures participants' tapping rate of the index finger"}, {'measure': 'Reach and grasping', 'timeFrame': 'Baseline, immediately after the training (two weeks) and after one month', 'description': 'Motion tracking equipment used to measure participants kinematic parameters (movement time, peak velocity, grip aperture, etc.) when reaching and grasping 3 objects, for a total of 30 movements.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke']}, 'referencesModule': {'references': [{'pmid': '11516950', 'type': 'BACKGROUND', 'citation': 'Kennett S, Taylor-Clarke M, Haggard P. Noninformative vision improves the spatial resolution of touch in humans. Curr Biol. 2001 Aug 7;11(15):1188-91. doi: 10.1016/s0960-9822(01)00327-x.'}, {'pmid': '14966526', 'type': 'BACKGROUND', 'citation': 'Taylor-Clarke M, Jacobsen P, Haggard P. Keeping the world a constant size: object constancy in human touch. Nat Neurosci. 2004 Mar;7(3):219-20. doi: 10.1038/nn1199. Epub 2004 Feb 15.'}, {'pmid': '21303990', 'type': 'BACKGROUND', 'citation': 'Mancini F, Longo MR, Kammers MP, Haggard P. Visual distortion of body size modulates pain perception. Psychol Sci. 2011 Mar;22(3):325-30. doi: 10.1177/0956797611398496. Epub 2011 Feb 8.'}, {'pmid': '17704352', 'type': 'BACKGROUND', 'citation': 'Yozbatiran N, Der-Yeghiaian L, Cramer SC. A standardized approach to performing the action research arm test. Neurorehabil Neural Repair. 2008 Jan-Feb;22(1):78-90. doi: 10.1177/1545968307305353. Epub 2007 Aug 17.'}, {'pmid': '12194623', 'type': 'BACKGROUND', 'citation': 'Winward CE, Halligan PW, Wade DT. The Rivermead Assessment of Somatosensory Performance (RASP): standardization and reliability data. Clin Rehabil. 2002 Aug;16(5):523-33. doi: 10.1191/0269215502cr522oa.'}]}, 'descriptionModule': {'briefSummary': "This study explores the possible implications of the increase in perceived body size for rehabilitation of motor functions. In a recent study we have tested if motor abilities of patients with stroke improve wearing magnifying lenses, showing that a beneficial effect of magnifying lenses can be observed in some patients. In the present study, we will identify 12 patients from this cohort who demonstrated an improvement greater than 10% in one or two motor task when wearing magnifying glasses. These participants will be invited to take part in a clinical study in which they will undergo a training phase: subjects will wear magnifying lenses at home for 30 minutes daily for 14 days while completing a jigsaw puzzle; a log will be kept to document participation. Participants' performance on different motor tasks will be assessed before, immediately after and 1 month after the training session. Standardized measures of motor performance will include the the Action Research Arm test and the Rivermead Assessment of Somatosensory Performance (RASP). In addition, participants will undergo grip strength, finger tapping tasks and a reaching and grasping task. We expect the repeated use of magnifying lenses to generate an improvement of patients' performance across tasks and this effect to be persistent in time.", 'detailedDescription': "Altering the apparent size of a body part with magnifying changes tactile acuity, tactile distance judgments and pain perception.\n\nIn a recent study we have tested if motor abilities (grip strength, finger tapping and reaching and grasping) of patients with stroke improve wearing magnifying lenses. The results of this study showed that a beneficial effect of magnifying lenses on movement can be observed in some patients with stroke. The present study aims at following up these results and investigating the possible use of magnifying lenses in the rehabilitation to improve motor controls of stroke patients.\n\nTo pursuit this aim, we will identify 12 patients in our previous study cohort who demonstrated an improvement greater than 10% in the grip strength or finger tapping task when wearing magnifying glasses. These participants will be invited to take part in the present clinical study in which they will undergo a training phase: subjects will wear magnifying lenses at home for 30 minutes daily for 14 days while completing a jigsaw puzzle; a log will be kept to document participation. Participants' performance on different motor tasks will be assessed before, immediately after and 1 month after the training session. Standardized measures of motor performance will include the the Action Research Arm test and the Rivermead Assessment of Somatosensory Performance (RASP). In addition, participants will undergo grip strength (6 trials), finger tapping tasks (6 trials) and a reaching and grasping task, inn which they will be asked to reach and grasp 3 different objects (30 trials). We expect the repeated use of magnifying lenses to generate an improvement of patients' performance across task and this effect to be persistent in time."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients suffering from stroke who showed an improvement with magnifying lenses in our previous study.\n\nExclusion Criteria:\n\n* Patients suffering from stroke who did not show an improvement with magnifying lenses in our previous study.'}, 'identificationModule': {'nctId': 'NCT02898558', 'briefTitle': 'Effect of Body Representation in Movement', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Effect of Body Representation in Movement', 'orgStudyIdInfo': {'id': '702940'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Magnification hand size', 'description': 'magnifying lenses used for 30 minutes daily for 14 days while completing a jigsaw puzzle', 'interventionNames': ['Behavioral: Magnification hand size', 'Device: magnifying lenses']}], 'interventions': [{'name': 'Magnification hand size', 'type': 'BEHAVIORAL', 'description': 'Participants will use magnifying lenses while completing a jigsaw puzzle for 30 min a day for 14 days.', 'armGroupLabels': ['Magnification hand size']}, {'name': 'magnifying lenses', 'type': 'DEVICE', 'armGroupLabels': ['Magnification hand size']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Branch Coslett, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}, {'name': 'Steven Jax, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'MOSS S.p.A.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'collaborators': [{'name': 'Moss Rehabilitation Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}