Ignite Creation Date:
2025-12-24 @ 4:19 PM
Ignite Modification Date:
2026-02-21 @ 6:44 PM
Study NCT ID:
NCT05615766
Status:
RECRUITING
Last Update Posted:
2025-09-04
First Post:
2022-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of a Robotic Exoskeleton for Upper Limb Rehabilitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 9}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-27', 'studyFirstSubmitDate': '2022-11-02', 'studyFirstSubmitQcDate': '2022-11-07', 'lastUpdatePostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0)', 'timeFrame': 'Change from baseline (week 1) at 6 weeks and 12 weeks', 'description': "The QUEST 2.0 evaluates a patient's satisfaction with various assistive technologies."}], 'primaryOutcomes': [{'measure': 'Spinal Cord Independence Measure version III (SCIM III)', 'timeFrame': 'Change from baseline (week 1) at 6 weeks', 'description': 'assesses performance in activities of daily living and mobility for individuals with spinal cord injury'}, {'measure': 'Spinal Cord Independence Measure version III (SCIM III)', 'timeFrame': 'Change from baseline (week 1) at 12 weeks', 'description': 'assesses performance in activities of daily living and mobility for individuals with spinal cord injury'}], 'secondaryOutcomes': [{'measure': 'The Graded Redefined Assessment of Strength, Sensation and Prehension (GRASSP).', 'timeFrame': 'Change from baseline (week 1) at 6 weeks and 12 weeks', 'description': 'The GRASSP is a clinical impairment measure for the upper limb for use after tetraplegia. The measure includes three domains which are important in describing hand function.'}, {'measure': 'The modified Ashworth scale', 'timeFrame': 'Change from baseline (week 1) at 6 weeks and 12 weeks', 'description': 'Ashworth scale is the most universally accepted clinical spasticity assessment tool used to measure the increase of muscle tone.'}, {'measure': 'Range of Motion', 'timeFrame': 'Change from baseline (week 1) at 6 weeks and 12 weeks', 'description': 'to assess the capability of a joint to go through its complete spectrum of movements'}, {'measure': 'Canadian Occupational Performance Measure (COPM)', 'timeFrame': 'Change from baseline (week 1) at 6 weeks and 12 weeks', 'description': "COPM assesses the patient's perceived occupational performance in the areas of selfcare, productivity, and leisure"}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Spinal Cord Injuries']}, 'descriptionModule': {'briefSummary': "Rehabilitation robotics has the potential to facilitate rehabilitation at home and empower people with spinal injuries to self-manage increasing their independence and improving their quality of life.\n\nThe objective of this study is to assess for the first time in the NHS the efficacy of a commercial robotic orthosis for upper limb rehabilitation in patients with spinal cord injury. The device is produced by Myomo (myomo.com) which is an American company. We will be assessing the wearable robotic orthosis also known as robotic exoskeleton in two different neuro-rehabilitation centres: National Spinal injuries Unit in Glasgow (Scotland) and The Robert Jones and Agnus Hunt Orthopaedic Hospital in Oswestry (England). The study will involve nine spinal cord injured tetraplegic inpatients in total.\n\nPatients will follow a twelve-week rehabilitation programme with three to four sessions per week in addition to their usual care and rehabilitation. Each session lasts for approximately 45 minutes. Participants arm function, range of motion, spasticity level will be measured before, half-way and at the end of the programme to assess change in these and other parameters. Training will focus on the dominant arm of the patient and compared to the other arm at every assessment stage.\n\nWe shall evaluate therapists' and patients' satisfaction with the commercial device in addition to assessing various clinical measures to evaluate the efficacy of using the robotic orthosis in rehabilitation and recovery of arm function."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18+ years.\n* The levels of C5 C6 Asia C/D would provide individuals with elbow and hand impairment and potentially functional shoulder movements. C7, C8 individuals could also benefit from the hand component of the device.\n* Some gross shoulder movement at start of the trial to enable changes at the elbow/hand, to have the greatest potential for functional change.\n* Preservation of hand sensation as base for motor restoration.\n* Some sitting balance would give the best opportunity for the arm to be released for functional upper limb activity.\n* EMG (muscle activity) evidence of active finger flexion, extension and elbow flexion extension Grade 1-2.\n* Minimal or No community functional use of upper limb at start of trial.\n* Spasticity MAS 1-3/5.'}, 'identificationModule': {'nctId': 'NCT05615766', 'acronym': 'Exo4UL', 'briefTitle': 'Assessment of a Robotic Exoskeleton for Upper Limb Rehabilitation', 'organization': {'class': 'OTHER', 'fullName': 'University of Liverpool'}, 'officialTitle': 'EXO4UL- Assessment of a Robotic Exoskeleton for Upper Limb Rehabilitation of Spinal Cord Injured Patients', 'orgStudyIdInfo': {'id': 'IRAS312522'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Device Intervention', 'description': 'The intervention group who will be undergoing rehabilitation using the robotic exoskeleton in addition to the assigned traditional rehabilitation programme on their dominant arm only.', 'interventionNames': ['Device: Experimental: Device Intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'the matched control group will be the same subjects undergoing traditional rehabilitation only on their non-dominant arm.'}], 'interventions': [{'name': 'Experimental: Device Intervention', 'type': 'DEVICE', 'otherNames': ['Robotic Rehabilitation'], 'description': 'The robotic rehabilitation programme using the MARK from Myomo (myomo.com) for the intervention group will last for 12 weeks with up to four sessions of rehabilitation per week, i.e. total of 48 sessions. Spinal cord injured inpatients in the study will have this intervention on their dominant arm in addition to the traditional rehabilitation programme assigned and standard care.', 'armGroupLabels': ['Device Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'HA7 4LP', 'city': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Emma Linley', 'role': 'CONTACT', 'email': 'LSCIResearch@nhs.net', 'phone': '020 3947 0100'}], 'facility': 'Royal National Orthopaedic Hospital (Stanmore)', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SY10 7AG', 'city': 'Oswestry', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Simon Pickard', 'role': 'CONTACT', 'email': 'simon.pickard1@nhs.net', 'phone': '01691 404000'}], 'facility': 'The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust', 'geoPoint': {'lat': 52.86195, 'lon': -3.05497}}], 'centralContacts': [{'name': 'Heba Lakany, PhD', 'role': 'CONTACT', 'email': 'heba.lakany@liverpool.ac.uk', 'phone': '+447737353181'}, {'name': 'Karen Wilding', 'role': 'CONTACT', 'email': 'sponsor@liverpool.ac.uk', 'phone': '+447717 863747'}], 'overallOfficials': [{'name': 'Heba Lakany, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Liverpool'}, {'name': 'Simon J Pickard', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Robert Jones and Agnes Hunt Orthopaedic Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Liverpool', 'class': 'OTHER'}, 'collaborators': [{'name': 'Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust', 'class': 'OTHER_GOV'}, {'name': 'The Queen Elizabeth National Spinal Injuries Unit, Scotland', 'class': 'UNKNOWN'}, {'name': 'Stoke Mandeville Spinal Research', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}