Ignite Creation Date:
2025-12-24 @ 12:14 PM
Ignite Modification Date:
2025-12-26 @ 12:48 PM
Study NCT ID:
NCT02508961
Status:
COMPLETED
Last Update Posted:
2017-06-01
First Post:
2015-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
WEB-Based Physiotherapy for People With Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D009043', 'term': 'Motor Activity'}], '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'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-30', 'studyFirstSubmitDate': '2015-07-23', 'studyFirstSubmitQcDate': '2015-07-24', 'lastUpdatePostDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-07-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compliance to the exercise programme', 'timeFrame': '9 months', 'description': 'Number of completed exercise diary entries'}, {'measure': 'Two Minute Walk Test', 'timeFrame': '9 months'}], 'secondaryOutcomes': [{'measure': 'Timed 25 Foot Walk', 'timeFrame': '9 months'}, {'measure': 'Timed Up and Go', 'timeFrame': '9 months'}, {'measure': 'Berg Balance Scale', 'timeFrame': '9 months'}, {'measure': 'Physical Activity', 'timeFrame': '9 months', 'description': 'Measured using the activPAL physical activity monitor'}, {'measure': 'MS-Related Symptom Checklist', 'timeFrame': '9 months'}, {'measure': 'Multiple Sclerosis Impact Scale', 'timeFrame': '9 months'}, {'measure': 'Hospital Anxiety and Depression Scale', 'timeFrame': '9 months'}, {'measure': 'Health related quality of life', 'timeFrame': '9 months', 'description': 'EQ-5D'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Physical Activity', 'Exercise', 'Physiotherapy'], 'conditions': ['Multiple Sclerosis']}, 'referencesModule': {'references': [{'pmid': '30907159', 'type': 'DERIVED', 'citation': "Dennett R, Coulter E, Paul L, Freeman J. A qualitative exploration of the participants' experience of a web-based physiotherapy program for people with multiple sclerosis: Does it impact on the ability to increase and sustain engagement in physical activity? Disabil Rehabil. 2020 Oct;42(21):3007-3014. doi: 10.1080/09638288.2019.1582717. Epub 2019 Mar 23."}]}, 'descriptionModule': {'briefSummary': 'The study will be a pragmatic, single blind, randomised, controlled feasibility study, comparing 6 months of web-based physiotherapy plus usual care with usual care alone in pwMS. The study will recruit 90 pwMS from three UK Centres (30 from each centre); NHS Ayrshire and Arran, NHS Lothian, and Plymouth Hospitals NHS Trust.\n\nThe aim of this study is to assess the feasibility of a randomised controlled trial examining the effectiveness of a six-month web-based physiotherapy programme and usual care compared to usual care alone, in people moderately affected by MS and to gather essential information for the planning of a definitive trial, which would evaluate both clinical and cost effectiveness of the intervention.', 'detailedDescription': "Following baseline assessments, both groups will be given an appointment with the physiotherapist to agree shared goals and to devise an individualised exercise programme based upon their needs and treatment goals. Participants will then be randomised to one of two groups.\n\nParticipants randomised to the intervention group will receive their individualised exercise programme delivered via the web-based physio website. Participants will be asked to complete their exercise programme at least twice weekly. They will receive weekly standardised phone calls from the physiotherapist for the first two weeks of the programme. Every two weeks thereafter for the remainder of the 6 month intervention period the physiotherapist will review the exercise diary of each participant and remotely alter the participant's exercise programme as appropriate, by changing any combination of exercises, level of difficulty or number of repetitions. The number and type of exercises within the programme and duration to complete the exercise programme will be documented. Participants will be informed of any changes by standardised email.\n\nParticipants randomised to the control group will receive a print out exercise sheet of their individualised exercise programme. Participants will be asked to complete their exercise programme at least twice weekly. Compliance will be captured using a home exercise diary. Participants will also receive a weekly phone call from the physiotherapist for the first two weeks to check on progress."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A confirmed diagnosis of MS\n* Known to a MS consultant in NHS Ayrshire and Arran, Lothian or Plymouth Hospitals NHS Trust\n* EDSS of 4 - 6.5\n* Access to a personal computer/tablet or smart television with an email address and internet connection\n\nExclusion Criteria:\n\n* Currently taking part in regular exercise (two or more times per week) and/or a regular physiotherapy programme\n* Poor cognitive function as assessed by a Mini Mental State Examination Score (MMSE) \\<24\n* Any significant change in medication (within the last 3 months)\n* Relapse within 3 months requiring treatment\n* Other significant co-morbidities for which exercise is contra-indicated\n* Unwilling to be randomised to intervention/control group\n* Currently participating in another clinical trial (rehabilitation or pharmacological)'}, 'identificationModule': {'nctId': 'NCT02508961', 'acronym': 'WEB-PaMS', 'briefTitle': 'WEB-Based Physiotherapy for People With Multiple Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'University of Glasgow'}, 'officialTitle': 'WEB-Based Physiotherapy for People With Multiple Sclerosis', 'orgStudyIdInfo': {'id': '15/WS/0030'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Web-based physio', 'description': 'Participants receive an online individualised exercise programme to complete over the internet twice per week. Exercises can be a combination of aerobic, strengthening and balance exercises. Participants receive a weekly phone call from a physiotherapist for the first two weeks to check on progress. After this, every 2 weeks online exercise diaries are remotely monitored by a physiotherapist and exercise programmes progressed as appropriate.', 'interventionNames': ['Behavioral: Exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Print-out exercise programme', 'description': 'Participants receive printed exercise programme to complete twice per week. Exercises can be a combination of aerobic, strengthening and balance exercises. Participants receive a weekly phone call from a physiotherapist for the first two weeks to check on progress. Participants complete a paper exercise diary and after the first 2 weeks if they require a progression to their exercise programme they contact their physiotherapist.', 'interventionNames': ['Behavioral: Exercise']}], 'interventions': [{'name': 'Exercise', 'type': 'BEHAVIORAL', 'description': 'web-based physio exercise programme', 'armGroupLabels': ['Print-out exercise programme', 'Web-based physio']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'EH16 4SB', 'city': 'Edinburgh', 'country': 'United Kingdom', 'facility': 'Anne Rowling Regenerative Neurology Clinic', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}, {'zip': 'KA128SS', 'city': 'Irvine', 'country': 'United Kingdom', 'facility': 'Douglas Grant Rehabilitation Centre', 'geoPoint': {'lat': 55.6194, 'lon': -4.65508}}, {'zip': 'PL6 8BH', 'city': 'Plymouth', 'country': 'United Kingdom', 'facility': 'University of Plymouth', 'geoPoint': {'lat': 50.37153, 'lon': -4.14305}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Glasgow', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heatlh Service Ayrshire and Arran', 'class': 'OTHER_GOV'}, {'name': 'NHS Lothian', 'class': 'OTHER_GOV'}, {'name': 'University of Plymouth', 'class': 'OTHER'}, {'name': 'University Hospital Plymouth NHS Trust', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Dr Lorna Paul', 'investigatorAffiliation': 'University of Glasgow'}}}}