- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02559765
Access, Use and Opinions of Physiotherapy and Rehabilitation Services of People With Progressive MS in the UK.
Current Access to, Use and Perceived Efficacy of Physiotherapy and Rehabilitation Services by People With Progressive Multiple Sclerosis: a Survey of People With Progressive Multiple Sclerosis Via the UK MS Register.
Study Overview
Status
Conditions
Detailed Description
Multiple Sclerosis has three main forms: Relapsing Remitting MS (RRMS), Primary Progressive MS (PPMS) and Secondary Progressive MS (SPMS) as well as a rarer form called Progressive Relapsing MS (PRMS).
In cases of RRMS an individual will have periods of worsened symptoms followed by periods of remission. During remission the individual may make a full recovery or be left with some residual impairment. In both PPMS and SPMS an individual will have continuous worsening symptoms with a gradual increase in disability with little or no transient recovery. An individual with PRMS will have the continuous worsening of disability seen in both PPMS and SPMS coupled with occasional relapses as seen in RRMS.
Currently 15% of those with MS are diagnosed as PPMS, 5% are diagnosed with the rarer form of PRMS and approximately 80% are diagnosed with RRMS. However, approximately 65% of those with RRMS will go on to develop SPMS. This means that approximately 72% of all individuals with MS will be in a progressive phase of the disease at some point in their life.
Whilst there are disease modifying drugs available for those with RRMS there are currently limited pharmacological treatments available for those with the progressive forms of the disease. Physiotherapy and rehabilitation services are often used by people with progressive MS and access to these are part of the current NICE guidelines for the management of MS. Whilst physiotherapy and rehabilitation services are used by people with progressive MS there is currently no research investigating how many people with progressive MS use these services, who provides them, how they are delivered, how effective the recipient feels the treatment is and how they would like their service to be delivered. In addition the Progressive MS Alliance has highlighted progressive MS and symptom management and rehabilitation as an under-researched area.
The UK MS Register is funded by the MS Society and operated by the health informatics department within the College of Medicine at Swansea University. People with MS can sign up to the register and answer pre-set questionnaires online. The purpose of the Register is to be a longitudinal research database collecting routine data every three months as well as conducting individually commissioned cross sectional studies. It currently has over 11,000 members and over 2,200 of those registrants have a progressive form of MS. Not only is this is the first study with the UK MS register to focus on people with progressive forms of MS but also the first to focus on physiotherapy services.
This is a unique opportunity to access this patient group across a large geographical region and gain an insight into how physiotherapy and rehabilitation services are used, delivered and perceived. The outcome of this research has the potential to inform future physiotherapy interventions and rehabilitation guidelines.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Glasgow, United Kingdom, G12 8LL
- The University of Glasgow
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Have a form of progressive MS
- Be registered on the UK MS Register
Exclusion Criteria:
- Have relapsing remitting MS
- Be under 18 years of age
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants with access to physiotherapy for their MS. Questionnaire
Time Frame: three months
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Questionnaire has the following options: yes, no.
Participant may choose one.
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three months
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Number of participants that use physiotherapy for their MS. Questionnaire
Time Frame: three months
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Questionnaire has the following options: yes, no.
Participant may choose one.
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three months
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What is the participants' perceived efficacy of physiotherapy for their MS? Questionnaire
Time Frame: three months
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Nominal scale of: very harmful, harmful, neither harmful nor beneficial, beneficial, very beneficial Participant may choose one.
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three months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Most common referral process. Questionnaire
Time Frame: three months
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Participant may choose from the following options and choose more than one: Neurologist; GP; self-referral; MS nurse; other (please state); don't know
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three months
|
Most common provider of physiotherapy to the participant. Questionnaire
Time Frame: three months
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Participant may choose from the following options and choose more than one: NHS; private (self funded); private (insurance); charity; other (please state)
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three months
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Most common physiotherapy intervention received for participant's MS. Questionnaire
Time Frame: three months
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Participant may choose form the following options and choose more than one: exercises to do at home prescribed by a physiotherapist; exercises with a physiotherapist; functional electrical stimulation, transcutaneous electrical stimulation; tilt table; acupuncture; advice or education from a physiotherapist; other (please state)
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three months
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Most common pattern of physiotherapy appointments. Questionnaire
Time Frame: three months
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Participant may choose from the following options and choose only one: receiving physiotherapy sessions regularly; pattern varies depending on symptoms.
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three months
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Most common expected waiting time from referral to receiving physiotherapy appointment. Questionnaire
Time Frame: three months
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Participant may choose form the following options and choose only one: less than a week; 1 to 2 weeks; 2 or more weeks but less than 4 weeks; 4 or more weeks but less than 6 weeks; 6 or more weeks but less than 12 weeks; 12 or more weeks.
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three months
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Most common frequency of appointments. Questionnaire
Time Frame: three months
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Participant may choose form the following options and choose only one: once or more a week; once a fortnight; once every 1 to 3 months; twice a year; once a year or less
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three months
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Most common length of physiotherapy sessions. Questionnaire
Time Frame: three months
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Participant may choose form the following options and choose only one: up to half an hour; between half an hour and an hour; more than an hour.
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three months
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Most common number of people present at physiotherapy sessions. Questionnaire.
Time Frame: three months
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Participant may choose form the following options and choose more than one: one to one; 2- 4 people, 5 or more people; over the phone or internet.
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three months
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Most common setting of receipt of physiotherapy. Questionnaire
Time Frame: three months
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Participant may choose form the following options and choose more than one: at home; in a hospital or clinic; in a community centre; in a charity centre; other (please state)
|
three months
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Number of participants who think they need more physiotherapy than they currently receive. Questionnaire
Time Frame: three months
|
Participant may choose form the following options and choose only one: yes; no; don't know
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three months
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Most common desired pattern of delivery of physiotherapy. Questionnaire
Time Frame: three months
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Participant may choose form the following options and choose only one: regularly; to vary depending on symptoms.
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three months
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Most common desired frequency of appointments. Questionnaire
Time Frame: three months
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Participant may choose form the following options and choose only one: once or more a week; once a fortnight; once every 1 to 3 months; twice a year; once a year or less
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three months
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Most common desired length of physiotherapy appointments. Questionnaire
Time Frame: three months
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Participant may choose form the following options and choose one: up to half an hour; between half an hour and an hour; more than an hour.
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three months
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Most common desired setting for receiving physiotherapy. Questionnaire
Time Frame: three months
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Participant may choose form the following options and choose one: at home; in a hospital or clinic; in a community centre; in a charity centre; other (please state)
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three months
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Most common desired number of people present at physiotherapy sessions. Questionnaire.
Time Frame: three months
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Participant may choose form the following options and choose one: one to one; 2- 4 people, 5 or more people; over the phone or internet.
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three months
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Most common barriers to receiving physiotherapy. Questionnaire.
Time Frame: three months
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Participant may choose form the following options and choose more than one then rate their most severe from 1-3: Pain; fear of falling; bladder or bowels problems; fatigue; depression; anxiety/panic attacks; difficulty with walking; difficulty with wheelchair transfers; transport problems; distance to travel; lack of suitable parking; lack of time; family commitments; work commitments; cost; need someone to come with me; personal issues with physiotherapist; problems being referred to physiotherapy; physiotherapy is not available; physiotherapy will not be beneficial for me; there is nothing that makes it difficult for me to receive physiotherapy; other (please state)
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three months
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Number of participants who have access to MS specialist services. Questionnaire
Time Frame: three months
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Participant may choose from the following options and choose one: yes; no.
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three months
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Number of participants who are able to access MS specialist services as their needs change. Questionnaire
Time Frame: three months
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Participant may choose from the following options and choose one: yes; no.
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three months
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Most common health professional available as part of MS specialist services. Questionnaire
Time Frame: three months
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Participant may choose from the following options and choose more than one: Occupational therapist; Social worker; MS specialist nurse; Continence nurse; Nurse: other (please state); Psychologist; GP; MS specialist Doctor/Neurologist; Doctor: other (please state); Speech and language therapist; Dietician; Orthotist; Other (please state)
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three months
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Most commonly used health professional available as part of MS specialist services. Questionnaire
Time Frame: three months
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Participant may choose from the following options and choose more than one: Occupational therapist; Social worker; MS specialist nurse; Continence nurse; Nurse: other (please state); Psychologist; GP; MS specialist Doctor/Neurologist; Doctor: other (please state); Speech and language therapist; Dietician; Orthotist; Other (please state)
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three months
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Number of participants who are offered a regular review for their MS. Questionnaire
Time Frame: three months
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Participant may choose from the following options and choose one: yes; no; don't know
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three months
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Most common frequency of review. Questionnaire
Time Frame: three months
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Participant may choose from the following options and choose one: twice a year; once a year; less than once a year; don't know.
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three months
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Most common health professional who carries out review. Questionnaire
Time Frame: three months
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Participant may choose from the following options and choose one: MS specialist Doctor/Neurologist; GP; Nurse; Physiotherapist; Occupational therapist; The person who does my review can vary; Other (please state)
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three months
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Most common setting of review. Questionnaire
Time Frame: three months
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Participant may choose from the following options and choose one: at home; in a hospital or clinic; in a community centre; GP surgery; other (please state)
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three months
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Most common disease modifying therapy taken in past. Questionnaire
Time Frame: three months
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Participant may choose from the following options and choose one: Beta-interferon (Rebif, Avonex, Betaferon); Glatiramer acetate (Copaxone); Dimethyl fumarate (Tecfidera); Teriflunomide (Aubagio); Natalizumab (Tysabri, Antigren); Fingolimod (Gilenya, Novartis); Mitoxantrone (novantrone); Alemtuzumab (Lemtrada); I have never taken any of these medications
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three months
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Most common disease modifying therapy being taken. Questionnaire
Time Frame: three months
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Participant may choose from the following options and choose one: Beta-interferon (Rebif, Avonex, Betaferon); Glatiramer acetate (Copaxone); Dimethyl fumarate (Tecfidera); Teriflunomide (Aubagio); Natalizumab (Tysabri, Antigren); Fingolimod (Gilenya, Novartis); Mitoxantrone (novantrone); Alemtuzumab (Lemtrada); • I do not currently take any of these medications
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three months
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Most commonly used complimentary therapy used for MS. Questionnaire
Time Frame: three months
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Participant may choose from the following options and choose more than one: Massage; Reflexology; Osteopathy or chiropractic; Magnet field therapy; The Alexander technique; Acupuncture or acupressure; Hyperbaric oxygen therapy; Reiki; Aromatherapy Relaxation or meditation; Homeopathy or herbal medicine; Other (please state)
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three months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Evan Campbell, MRes, The University of Glasgow
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 200140102
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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