Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 11:56 AM
Study NCT ID:
NCT07418905
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2026-02-20
First Post:
2024-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Technology-supported Motor Rehabilitation for People With Rett Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015518', 'term': 'Rett Syndrome'}], 'ancestors': [{'id': 'D038901', 'term': 'X-Linked Intellectual Disability'}, {'id': 'D008607', 'term': 'Intellectual Disability'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D040181', 'term': 'Genetic Diseases, X-Linked'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': "Customized gaming system used to improve purposeful arm use. Games are personalized based on what is motivating to the participant, so each session is personalizable. A variety of games will be available for the participant's choosing. The image or video game that the participant selected will then be projected onto the surface of a table and webcams directed at their body and programmed to detect the participant's movements will serve as the means to record what the participant is doing. Participants are typically engaged in stereotypies; such posturing will be counted as a STOP signal. As participants move their hands apart from each other or otherwise stop their unique stereotypy, the separation or reaching movements will be translated into key strokes that guide the games the participants are playing. The game play for each sessoin lasts for 15 minutes. The aim is to play at least 4 of these sessions over 7 days."}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 14}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-18', 'studyFirstSubmitDate': '2024-10-01', 'studyFirstSubmitQcDate': '2026-02-11', 'lastUpdatePostDateStruct': {'date': '2026-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Counts and timing of obligatory stereotypies', 'timeFrame': '60 min functional assessment periods: one just before start of intervention (baseline) and one at the end of intervention (post-intervention testing) Weekly data collection from intervention sessions: enrollment to end of intervention 26 weeks later.', 'description': 'We will collect two variables: the number of times the participant engages in her unique stereotypy and the length of time (in seconds) that the stereotypy occurs. Data will be collected from both weekly intervention sessions and the two functional assessments. Functional data will be collected from the movements made by the individual as well as from BEFORE and AFTER questionnaires to be completed by the caregivers of the participant.'}, {'measure': 'Timing and number of separations (ceasing stereotypies)', 'timeFrame': 'Two 60 minute assessment periods: one just before start of intervention (baseline) and one at the end of intervention (post-intervention testing). Data from intervention sessions will run from enrollment to end of intervention 26 weeks later.', 'description': 'Data will be collected from intervention sessions and the two functional assessments. Data will be in both the number of times each girls separates hands (counts) and timing (in seconds) to record how long hands remained apart. Functional data will be collected from the movements made by the individual as well as from BEFORE and AFTER questionnaires to be completed by the caregivers of the participant.'}, {'measure': 'Reaching data for number of reaches and amount of time reaching occurs', 'timeFrame': 'Two 60-minute assessment periods: one at baseline and one post final intervention session. Data from weekly intervention will be gathered from enrollment to 26 weeks later when intervention is complete.', 'description': 'Data will be collected from intervention sessions and the two functional reach assessments. Counts of the number of purposeful reaches and the extent of time (measured in seconds) the reach is maintained. Functional data will be collected from the movements made by the individual as well as from BEFORE and AFTER questionnaires to be completed by the caregivers of the participant.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['habilitation', 'recovery of function', 'purposeful arm use', 'gaming'], 'conditions': ['Rett Syndrome']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'McAmis NE, Foreman MH, Himmelrich MD, Diener PS and Engsberg JR. Development of a Method to Use a Color Tracker for Motor Therapy for Individuals with Rett Syndrome. SM J Pediatr. 2017; 2(2): 1012.'}, {'type': 'BACKGROUND', 'citation': 'Mraz KM, Amadio G, Diener P, Eisenberg G, Engsberg JR. Improving upper extremity motor skills in girls with rett syndrome using virtual reality. J of Intellect Disabil - Diagnosis and Treatment, 2016, 4(3):142-151.'}, {'type': 'BACKGROUND', 'citation': 'Mraz, K, Eisenberg G, Diener P, Amadio G, Foreman MH, Engsberg JR. The Effects of Virtual Reality on the Upper Extremity Skills of Girls with Rett Syndrome: A Single Case Study. J of Intellect Disabil- Diagnosis and Treatment. 2016, 4(3):152-9.'}]}, 'descriptionModule': {'briefSummary': 'This study focuses on improving purposeful arm use while simultaneously reducing engagement in stereotypies. It is typically expected that the training period for this study will last about 6 months. The first half of the training periods will be devoted to learning to separate hands to stop the stereotypies that interfere with arm and hand use. In this first half, participants will also need to learn to keep arms apart in order to be actively involved in the chosen game. The second half of the training period will be devoted to learning to stop stereotypies and reach for targets that are intended to start game play. When not touching the targets, the software will interpret that the game should stop and wait for the next target to be touched.', 'detailedDescription': 'Baseline measurements taken at start of study. Training occurs for separation tasks for the first 13 weeks, with four 15-min sessions running per week. To gradually improve in ability to control gaming with arms/hands, each participant has the option of trying 13 levels or challenges on the extent of separation (how far apart hands can be taken.) Training occurs for the final 13 weeks for reaching tasks. Here, the participant must separate hands and reach for a defined target in order to initiate game play. These sessions will also last 15 minutes each and four sessions will be required per week.\n\nAt the conclusion of the 26 weeks of training, the measurements of functional arm/hand use, and other behavioral measurements taken at Baseline will be repeated and compared to Baseline to assist in determining the success of the gaming used to train purposeful and functional arm use.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '4 Years', 'genderBased': True, 'genderDescription': 'female', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* dx of Rett syndrome\n* functional range of motion of both arms\n* no seizures or seizures managed with medication\n* understanding cause and effect\n* midline stereotypies\n\nExclusion Criteria:\n\n* no competing orthopedic or neuromuscular diagnosis that impacts shoulder movements'}, 'identificationModule': {'nctId': 'NCT07418905', 'acronym': 'TeMoRett', 'briefTitle': 'Technology-supported Motor Rehabilitation for People With Rett Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Georgetown University'}, 'officialTitle': 'Technology-supported Motor Rehabilitation for People With Rett Syndrome (TeMoRett) Sub-project: Psychophysiological Personalization of the Technology-supported Motor Rehabilitation for People With Rett Syndrome', 'orgStudyIdInfo': {'id': '13GW0488B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gaming system', 'description': "The study will involve several sequential phases: pre-intervention testing, cause-and-effect training/intervention, and a post-intervention testing phase. The aim is to learn to control stereotypies and learn to interact with their environment to increase independent play skills. Training will take place using telemedicine methods. The game consists of computer generated games developed by the researchers specifically for the needs of individuals with dyspraxia. The images or video that the participant will watch will be projected to the table. The participant's hand movements to stop their stereotypies will be detected as the Start signal for the game to begin. When hands return to their stereotypy, the computer camera will detect that as the Stop signal and the game will pause until hands are detected separated from each other again.", 'interventionNames': ['Behavioral: computer gaming']}], 'interventions': [{'name': 'computer gaming', 'type': 'BEHAVIORAL', 'description': 'Investigators will personalize gaming sessions based on the motivators and interests of each participant. During each intervention session, the participant will be encouraged to initiate voluntary hand separations in order to activate or control the gaming activity.', 'armGroupLabels': ['Gaming system']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20814', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'Georgetown University School of Medicine', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}], 'overallOfficials': [{'name': 'Pamela Diener, PhD,MS,OT/L', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Georgetown University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Publications resulting from the study will be the means by which the outcomes of the study and details of participants within in (coded to maintain confidentiality) be disseminated.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Georgetown University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fraunhofer Heinrich Hertz Institut (HHI)', 'class': 'UNKNOWN'}, {'name': 'Max-Planck-Institute for Cognition', 'class': 'UNKNOWN'}, {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, {'name': 'Rett Syndrome of Germany', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Co-Principal Investigator', 'investigatorFullName': 'Pamela Diener', 'investigatorAffiliation': 'Georgetown University'}}}}