Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 12:43 PM
Study NCT ID:
NCT07434934
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-27
First Post:
2026-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Augmented Reality-Based Dual-Task Training in People With Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2028-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-19', 'studyFirstSubmitDate': '2026-02-10', 'studyFirstSubmitQcDate': '2026-02-19', 'lastUpdatePostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gait Velocity- single-task (BTS GAITLAB)', 'timeFrame': 'six weeks', 'description': 'Measured using BTS GAITLAB (Physiotherapy Laboratory, University of Sharjah) during walking under single-task condition (walking only). Report mean gait velocity across trials. Higher = faster walking.'}, {'measure': 'Gait velocity during dual-task walking (m/s)', 'timeFrame': '6 weeks', 'description': 'Measured using BTS GAITLAB during walking under dual-task cognitive condition. Report mean gait velocity across trials. Higher = faster walking under dual-task.'}], 'secondaryOutcomes': [{'measure': 'Balance - Berg Balance Scale (BBS)', 'timeFrame': 'Six weeks', 'description': 'Balance assessed using the Berg Balance Scale. Report total score (0-56). Higher = better balance.'}, {'measure': 'Activities-specific Balance Confidence (ABC) Scale score (0-100%)', 'timeFrame': '6 weeks', 'description': 'Balance confidence assessed using the ABC scale. Report total/mean percentage score (0-100%). Higher = greater confidence.'}, {'measure': 'Five Times Sit-to-Stand test time (seconds)', 'timeFrame': '6 weeks', 'description': 'Functional lower-limb performance assessed using five times chair sit-to-stand test. Report completion time in seconds. Lower = better.'}, {'measure': 'Functional Mobility Scale (FMS) rating', 'timeFrame': '6 weeks', 'description': 'Functional mobility assessed using the Functional Mobility Scale. Report FMS rating (per standard scoring). Higher = better mobility.'}, {'measure': 'Biodex Balance System stability index (unit per device output)', 'timeFrame': '6 weeks', 'description': 'Instrumented balance assessed using the Biodex Medical Balance System (Physiotherapy Laboratory, University of Sharjah). Report stability index as provided by the device. Interpret direction as per device metric (lower = better stability).'}, {'measure': 'Daily step count measured by FIBION (steps/day)', 'timeFrame': '6 weeks', 'description': 'Physical activity assessed using FIBION activity monitor worn 7 consecutive days / 24 h before and after intervention. Report mean daily step count over the monitoring period. Higher = more activity.'}, {'measure': 'Modified Physical Activity Scale (M-PAS) score', 'timeFrame': '6 weeks', 'description': 'Self-reported physical activity assessed using M-PAS. Report total score (per instrument scoring). Specify direction per scoring (higher = more activity).'}, {'measure': 'Falls Efficacy Scale-International (FES-I) total score', 'timeFrame': '6 weeks', 'description': 'Fall concern assessed using FES-I. Report total score (per instrument scoring). Higher = greater concern about falling (worse).'}, {'measure': 'Modified Fatigue Impact Scale (MFIS) total score', 'timeFrame': '6 weeks', 'description': 'Fatigue assessed using MFIS. Report total score (per instrument scoring). Higher = worse fatigue impact.'}, {'measure': 'Short Form-36 (SF-36) health-related quality of life score', 'timeFrame': '6 weeks', 'description': 'Quality of life assessed using SF-36. Report domain scores and/or Physical and Mental Component Summary scores (per SF-36 scoring). Higher = better health status.'}, {'measure': 'Hospital Anxiety and Depression Scale (HADS-A) score (0-21)', 'timeFrame': '6 weeks', 'description': 'Anxiety symptoms assessed using HADS Anxiety subscale. Report subscale score (0-21). Higher = worse anxiety symptoms.'}, {'measure': 'Hospital Anxiety and Depression Scale (HADS-D) score (0-21)', 'timeFrame': '6 weeks', 'description': 'Depressive symptoms assessed using HADS Depression subscale. Report subscale score (0-21). Higher = worse depressive symptoms.'}, {'measure': '6-Minute Walk Test distance (meters)', 'timeFrame': '6 weeks', 'description': 'Physical performance assessed using the 6-minute walking test. Report distance walked in meters. Higher = better walking endurance.'}, {'measure': 'Montreal Cognitive Assessment (MoCA) total score (0-30)', 'timeFrame': '6 weeks', 'description': 'Global cognitive function assessed using the MoCA. Report total score (0-30). Higher = better cognition.'}, {'measure': 'Symbol Digit Modalities Test (SDMT) score (correct responses)', 'timeFrame': '6 weeks', 'description': 'Processing speed assessed using SDMT (BICAMS component). Report total correct responses (per scoring). Higher = better.'}, {'measure': 'Hopkins Verbal Learning Test-II (HVLT-II) total recall score', 'timeFrame': '6 weeks', 'description': 'Verbal learning/memory assessed using HVLT-II (BICAMS component). Report total recall score (per scoring). Higher = better.'}, {'measure': 'Brief Visuospatial Memory Test-Revised (BVMT-R) total recall score', 'timeFrame': '6 weeks', 'description': 'Visuospatial memory assessed using BVMT-R (BICAMS). Report total recall score (per scoring). Higher = better memory.'}, {'measure': 'Stroop test interference score (per protocol)', 'timeFrame': '6 weeks', 'description': 'Inhibitory control assessed using the Stroop test. Report interference score. lower interference score = better'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dual task', 'rehabilitation', 'augmented reality', 'motor function'], 'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'Multiple Sclerosis (MS) is the most common NDD affecting young people worldwide. MS can seriously affect quality of life and hinder daily functional activities. Therefore, living with MS is a daunting task for both patients and their families. With the prediction of an increase in life expectancy, it is also expected that MS will pose major challenges to healthcare providers in the UAE and globally in terms of its clinical management and financial implications. This proposed project aims to develop structured AR scenarios that integrate dual-tasking exercises commonly used in MS physiotherapy, specifically designed to meet the needs of PwMS. The primary goal is to evaluate the feasibility, acceptability, and potential benefits of these AR scenarios as a rehabilitation tool for PwMS.', 'detailedDescription': "Among the most concerning aspects of MS are the presence of gait impairments, balance deficits, and cognitive dysfunction. These symptoms become even more pronounced under dual-task conditions. Dual tasks require individuals to perform cognitive and motor tasks simultaneously. The interaction between cognitive and motor functions is vital for daily activities. Any disruption in this connection can lead to significant disabilities, including an increased risk of falls, which can severely impact a person's quality of life. However, despite the clear evidence that PwMS struggle with dual-tasking, there are limited therapeutic interventions that effectively utilize the dual-task paradigm to mitigate its consequences. A systematic review conducted by Plummer et al highlighted the impact of traditional physiotherapy dual-task training and the lack of cognitive-motor interaction in older adults, which limits the availability of evidence-based recommendations. The lack of dual task interaction in traditional physiotherapy approaches has been identified as a contributing factor to the suboptimal outcomes in improving mobility, cognitive function, and consequently the fall risks. The integration between cognitive-motor interaction in rehabilitation is crucial to achieve better outcomes to reduce fall risk. To address this gap, a rehabilitation program that specifically targets cognitive-motor interactions is warranted.\n\nIn the last few years, the use of gaming technology has emerged in the neurorehabilitation field with advancements in technology. Gaming technology provides subjects with task-oriented training, repetitive practice with high intensity, multi-sensory feedback information, and motivation for endurance practice. It offers a more accessible and cost-effective intervention compared to traditional physical therapy. However, few studies have investigated the effects of dual-task training using virtual reality (VR) in people with Multiple Sclerosis (PwMS). A recent systematic review (currently under review) found that VR dual-task training has shown weak effects. This may be due to previous studies utilizing generic VR games that were not tailored to the specific impairments associated with MS. Additionally, the immersive nature of VR may induce cyber sickness, causing discomfort similar to motion sickness.\n\nIn contrast to VR, Augmented Reality (AR) technology is emerging as a promising alternative in the field of rehabilitation. The use of AR in neurological rehabilitation has significantly expanded, offering a unique advantage by seamlessly combining motor and cognitive tasks. In AR, users interact with real environments enhanced by virtual objects relevant to daily activities, enabling effective motor-cognitive training with immediate feedback in a safe, controlled setting, crucial for improving rehabilitation outcomes. AR is also less overwhelming compared to other gaming technologies, as it does not provide a fully immersive experience, making it easier for patients who struggle with intense visual and sensory stimulation. Additionally, the flexibility of AR allows patients to engage in therapy at home, easily integrating it with everyday activities. This rehabilitation approach enhances the enjoyment of therapy, providing an interactive experience, which can improve long-term adherence, a vital factor for managing a progressive disease like MS, where maintaining function throughout all stages is essential. This project aims to support people with Long Term Neurological Conditions (LTNC) with complex needs as per MS to maintain mobility and cognitive function has potential to reduce dependence on residential services and acute hospital care. This proposed project also aligns with the National Multiple Sclerosis Society priorities and objectives which emphasize advancing innovative and emerging treatments that can slow and reverse MS. It has an important role to play in developing seamless programs for the management of people with LTNCs that focus on early intervention with better use of technology approaches in rehabilitation that can also form a sustainable resource to patient's self-management in the future."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Neurologist-confirmed diagnosis of MS according to the revised McDonald criteria and PDDS score of ≤6\n* Age above 18 years;\n* Affected by relapsing remitting and secondary progressive MS\n* Successful completion of Physical Activity Readiness Questionnaire (PAR-Q)\n* Presence of mild/moderate cognitive impairment (Montreal Cognitive Assessment - MoCA \\>18)\n* Ambulatory for indoor and outdoor mobility with or without an assistive device but without physical assistance\n\nExclusion Criteria:\n\n* Acute illness or injury that would prevent safe participation in an exercise program\n* Presence of any other neurological conditions (e.g., stroke),\n* Presence of severe psychiatric illness other than anxiety or depression\n* According to the Diagnostic and Statistical Manual of Mental Disorders, 5th -Edition (DSM- V),\n* Presence of disabling sensory alterations (i.e. auditory and visual disturbances)\n* Relapse in the 3 months before enrollment\n* Current engagement in 3 days a week or more of moderate/vigorous exercise'}, 'identificationModule': {'nctId': 'NCT07434934', 'acronym': 'MS', 'briefTitle': 'Augmented Reality-Based Dual-Task Training in People With Multiple Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'University of Sharjah'}, 'officialTitle': 'Development of Augmented Reality-Based Dual-Task Training to Enhance Cognitive and Motor Function in People With Multiple Sclerosis', 'orgStudyIdInfo': {'id': 'REC-24-12-22-01-F'}, 'secondaryIdInfos': [{'id': '133128', 'type': 'OTHER_GRANT', 'domain': 'National Multiple Sclerosis Society'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Augmented Reality', 'description': 'The participants in the experimental group will be asked to make 3 visits per week for a total of 18 sessions over the intervention period (6-week). Each session is expected to last between 40 minutes to one hour.', 'interventionNames': ['Other: Augmented Reality Exercises']}, {'type': 'NO_INTERVENTION', 'label': 'Home-based exercises', 'description': 'Home exercise control group will include the same exercises as in the intervention group except that they will perform at home for the same parameters without the utility of AR.'}], 'interventions': [{'name': 'Augmented Reality Exercises', 'type': 'OTHER', 'otherNames': ['AR dual task'], 'description': 'All participants in the experimental group will then be given a tutorial on how to perform the proposed exercises based on AR and they will be asked to familiarise themselves with the system. While the participants in the control group will be given a leaflet of physical exercises and they will be instructed by a physical therapist on the correct performance of these exercises', 'armGroupLabels': ['Augmented Reality']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27272', 'city': 'Sharjah city', 'state': 'Emirate of Sharjah', 'country': 'United Arab Emirates', 'contacts': [{'name': 'Alham Al Sharman, Associate Prof', 'role': 'CONTACT', 'email': 'aal-sharman@sharjah.ac.ae', 'phone': '00971563103259'}], 'facility': 'Alham Al Sharman', 'geoPoint': {'lat': 25.3342, 'lon': 55.41221}}], 'centralContacts': [{'name': 'Alham Al Sharman, Associate Prof', 'role': 'CONTACT', 'email': 'aal-sharman@sharjah.ac.ae', 'phone': '00971563103259'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sharjah', 'class': 'OTHER'}, 'collaborators': [{'name': 'Qatar University', 'class': 'OTHER'}, {'name': 'University College Cork', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Alham Al-Sharman', 'investigatorAffiliation': 'University of Sharjah'}}}}