Progressive Multiple SclerosisNCT02559765
Access, Use and Opinions of Physiotherapy and Rehabilitation Services of People With Progressive MS in the UK.
An observational study of Progressive Multiple Sclerosis, run by University of Glasgow at 1 site in United Kingdom.
Trial summary
This survey will investigate the views of people with progressive MS in terms of physiotherapy services. In particular the study will examine the proportion of people with progressive MS on the MS register who use physiotherapy services, how worthwhile they think it is for them and how they would like their… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Progressive Multiple Sclerosis
- How many people
- 1,298 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2015to Nov 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People with progressive multiple sclerosis and registered on the UK MS Register
Who may be able to join
- Have a form of progressive MS
- Be registered on the UK MS Register
Who cannot join
- Have relapsing remitting MS
- Be under 18 years of age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
This survey will investigate the views of people with progressive MS in terms of physiotherapy services. In particular the study will examine the proportion of people with progressive MS on the MS register who use physiotherapy services, how worthwhile they think it is for them and how they would like their physiotherapy to be delivered. This survey will also explore how physiotherapy services for people with progressive MS varies across the UK and what other types of rehabilitation services are currently used by people with progressive MS.
Read the 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.
- Conditions
- Progressive Multiple Sclerosis
- Keywords
- physiotherapy, progressive multiple sclerosis, rehabilitation, rehabilitation services
- Medical subject headings
- Multiple Sclerosis, Chronic Progressive
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with access to physiotherapy for their MS. Questionnaire
Questionnaire has the following options: yes, no. Participant may choose one.
Measured: three months
Number of participants that use physiotherapy for their MS. Questionnaire
Questionnaire has the following options: yes, no. Participant may choose one.
Measured: three months
What is the participants' perceived efficacy of physiotherapy for their MS? Questionnaire
Nominal scale of: very harmful, harmful, neither harmful nor beneficial, beneficial, very beneficial Participant may choose one.
Measured: three months
Secondary outcomes (27)
Most common referral process. Questionnaire
Participant may choose from the following options and choose more than one: Neurologist; GP; self-referral; MS nurse; other (please state); don't know
Measured: three months
Most common provider of physiotherapy to the participant. Questionnaire
Participant may choose from the following options and choose more than one: NHS; private (self funded); private (insurance); charity; other (please state)
Measured: three months
Most common physiotherapy intervention received for participant's MS. Questionnaire
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)
Measured: three months
Most common pattern of physiotherapy appointments. Questionnaire
Participant may choose from the following options and choose only one: receiving physiotherapy sessions regularly; pattern varies depending on symptoms.
Measured: three months
Most common expected waiting time from referral to receiving physiotherapy appointment. Questionnaire
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.
Measured: three months
Most common frequency of appointments. Questionnaire
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
Measured: three months
Most common length of physiotherapy sessions. Questionnaire
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.
Measured: three months
Most common number of people present at physiotherapy sessions. Questionnaire.
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.
Measured: three months
Most common setting of receipt of physiotherapy. Questionnaire
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)
Measured: three months
Number of participants who think they need more physiotherapy than they currently receive. Questionnaire
Participant may choose form the following options and choose only one: yes; no; don't know
Measured: three months
Most common desired pattern of delivery of physiotherapy. Questionnaire
Participant may choose form the following options and choose only one: regularly; to vary depending on symptoms.
Measured: three months
Most common desired frequency of appointments. Questionnaire
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
Measured: three months
Most common desired length of physiotherapy appointments. Questionnaire
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.
Measured: three months
Most common desired setting for receiving physiotherapy. Questionnaire
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)
Measured: three months
Most common desired number of people present at physiotherapy sessions. Questionnaire.
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.
Measured: three months
Most common barriers to receiving physiotherapy. Questionnaire.
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)
Measured: three months
Number of participants who have access to MS specialist services. Questionnaire
Participant may choose from the following options and choose one: yes; no.
Measured: three months
Number of participants who are able to access MS specialist services as their needs change. Questionnaire
Participant may choose from the following options and choose one: yes; no.
Measured: three months
Most common health professional available as part of MS specialist services. Questionnaire
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)
Measured: three months
Most commonly used health professional available as part of MS specialist services. Questionnaire
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)
Measured: three months
Number of participants who are offered a regular review for their MS. Questionnaire
Participant may choose from the following options and choose one: yes; no; don't know
Measured: three months
Most common frequency of review. Questionnaire
Participant may choose from the following options and choose one: twice a year; once a year; less than once a year; don't know.
Measured: three months
Most common health professional who carries out review. Questionnaire
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)
Measured: three months
Most common setting of review. Questionnaire
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)
Measured: three months
Most common disease modifying therapy taken in past. Questionnaire
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
Measured: three months
Most common disease modifying therapy being taken. Questionnaire
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
Measured: three months
Most commonly used complimentary therapy used for MS. Questionnaire
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)
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2015 (estimated)
- Study startAug 2015
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Progressive Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,298 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Glasgow
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Ayrshire and Arran, AKM
- Responsible party
- Principal investigator, Evan Campbell, University of Glasgow
- Investigators
- Evan Campbell, MRes, Principal investigator, The University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02559765
- Sponsor's protocol ID
- 200140102
- Status last verified
- May 2016
- First submitted
- 21 Sep 2015
- Last updated
- 13 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT02559765
- Acronym / sponsor ID
- 200140102
- Conditions
- Progressive Multiple Sclerosis
- Keywords
- physiotherapy, progressive multiple sclerosis, rehabilitation, rehabilitation services
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,298 participants (actual)
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Collaborators
- NHS Ayrshire and Arran, AKM
- Study start
- Aug 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 24 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This survey will investigate the views of people with progressive MS in terms of physiotherapy services. In particular the study will examine the proportion of people with progressive MS on the MS register who use physiotherapy services, how worthwhile they think it is for them and how they would like their physiotherapy to be delivered. This survey will also explore how physiotherapy services for people with progressive MS varies across the UK and what other types of rehabilitation services are currently used by people with progressive MS.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People with progressive multiple sclerosis and registered on the UK MS Register
Key inclusion criteria (2 listed)
- Have a form of progressive MS
- Be registered on the UK MS Register
Key exclusion criteria (2 listed)
- Have relapsing remitting MS
- Be under 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants with access to physiotherapy for their MS. Questionnaire
Time frame: three months
Questionnaire has the following options: yes, no. Participant may choose one.
Number of participants that use physiotherapy for their MS. Questionnaire
Time frame: three months
Questionnaire has the following options: yes, no. Participant may choose one.
What is the participants' perceived efficacy of physiotherapy for their MS? Questionnaire
Time frame: three months
Nominal scale of: very harmful, harmful, neither harmful nor beneficial, beneficial, very beneficial Participant may choose one.
27 secondary outcomes
Most common referral process. Questionnaire
Time frame: three months
Most common provider of physiotherapy to the participant. Questionnaire
Time frame: three months
Most common physiotherapy intervention received for participant's MS. Questionnaire
Time frame: three months
Most common pattern of physiotherapy appointments. Questionnaire
Time frame: three months
Most common expected waiting time from referral to receiving physiotherapy appointment. Questionnaire
Time frame: three months
Most common frequency of appointments. Questionnaire
Time frame: three months
Most common length of physiotherapy sessions. Questionnaire
Time frame: three months
Most common number of people present at physiotherapy sessions. Questionnaire.
Time frame: three months
Most common setting of receipt of physiotherapy. Questionnaire
Time frame: three months
Number of participants who think they need more physiotherapy than they currently receive. Questionnaire
Time frame: three months
Most common desired pattern of delivery of physiotherapy. Questionnaire
Time frame: three months
Most common desired frequency of appointments. Questionnaire
Time frame: three months
Most common desired length of physiotherapy appointments. Questionnaire
Time frame: three months
Most common desired setting for receiving physiotherapy. Questionnaire
Time frame: three months
Most common desired number of people present at physiotherapy sessions. Questionnaire.
Time frame: three months
Most common barriers to receiving physiotherapy. Questionnaire.
Time frame: three months
Number of participants who have access to MS specialist services. Questionnaire
Time frame: three months
Number of participants who are able to access MS specialist services as their needs change. Questionnaire
Time frame: three months
Most common health professional available as part of MS specialist services. Questionnaire
Time frame: three months
Most commonly used health professional available as part of MS specialist services. Questionnaire
Time frame: three months
Number of participants who are offered a regular review for their MS. Questionnaire
Time frame: three months
Most common frequency of review. Questionnaire
Time frame: three months
Most common health professional who carries out review. Questionnaire
Time frame: three months
Most common setting of review. Questionnaire
Time frame: three months
Most common disease modifying therapy taken in past. Questionnaire
Time frame: three months
Most common disease modifying therapy being taken. Questionnaire
Time frame: three months
Most commonly used complimentary therapy used for MS. Questionnaire
Time frame: three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evan Campbell, MRes principal investigator
The University of Glasgow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Progressive Multiple Sclerosis, run by University of Glasgow at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with access to physiotherapy for their MS. Questionnaire (time frame: three months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2016.