SUMS: Standing up in people with multiple sclerosis
| ISRCTN | ISRCTN69614598 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN69614598 |
| IRAS number | 163803 |
| Secondary identifying numbers | CPMS 18999, IRAS 163803 |
- Submission date
- 03/02/2016
- Registration date
- 03/02/2016
- Last edited
- 17/08/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English Summary
Background and study aims
Multiple sclerosis (MS) is one of the most common diseases of the central nervous system (brain and spinal cord). Healthy nerves are coated in a fatty casing (myelin sheath) which helps messages to travel quickly and smoothly along nerves. When a person is suffering from MS, the immune system, which normally helps to protect against infection, attacks the myelin sheath, stripping it from the nerves (demyelination). This demyelination means that messages cannot travel along the nerves effectively causing a range of disabilities, such as walking problems and immobility. Being able to stand upright is highly valued by most people, both mentally and physically. Standing frames are commonly used by people with spinal cord injury (SCI) who are unable to stand unaided. These frames provide support to enable even severely disabled patients to stand safely. Regular use has been shown to reduce complications of immobility (such as pressure sores and muscle wasting) and boost feelings of wellbeing. Many people with MS develop severe walking problems and so spend much of their day sitting down. The associated complications impact on quality of life and result in increased healthcare needs. These problems can be minimised if physical activity is increased, however without easy access to a frame, people must travel to a rehabilitation/MS centre to stand which can be both expensive and time consuming. Using a standing frame at home may offer a solution which reduces the economic and social costs for the patient and NHS. The aim of this study is to test the effectiveness of a home-based standing programme with a frame in people who are severely disabled by their MS.
Who can participate?
Adults with MS who require assistance to walk more than 20 metres or who are restricted to a bed or wheelchair.
What does the study involve?
Participants are randomly allocated to one of two groups. Participants in the first group receive two, home-based, hour-long therapy sessions, during which time they are taught how to use the standing frame, followed by six 15-minute telephone consultations. The participants are encouraged to stand in the frame for 30 minutes, three times a week. In order to offer further support, participants are given user-friendly information leaflets and DVDs. Participants in the second group continue to receive usual care. At the start of the study and then again after 20 and 36 weeks, participants in both groups complete a number of questionnaires and assessments in order to test if their motor (movement) abilities and quality of life have improved.
What are the possible benefits and risks of participating?
Participants may benefit from an increased level of physical activity and improvements to movement and mood as a result of regularly standing in the frame. Risks of taking part are small but some participants may experience some increased fatigue, muscle stiffness or soreness because muscles that may not have been moved in a long time are being used.
Where is the study run from?
Peninsula Allied Health Centre (Plymouth University) and at least 30 other health centres catering for people with MS across Devon, Cornwall and East Anglia (UK)
When is the study starting and how long is it expected to run for?
September 2015 to March 2017
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Dr Jennifer Freeman
jenny.freeman@plymouth.ac.uk
Contact information
Public
Peninsula Allied Health Centre
Plymouth University
Derriford Road
Plymouth
PL6 8BH
United Kingdom
| Phone | +44 1752 588835 |
|---|---|
| jenny.freeman@plymouth.ac.uk |
Study information
| Study design | Randomised; Interventional; Design type: Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A multi-centre randomised controlled trial to assess the effectiveness and cost effectiveness of a home-based self-management standing frame programme plus usual care versus usual care in people with progressive multiple sclerosis (MS) who have severely impaired balance and mobility |
| Study acronym | SUMS |
| Study hypothesis | The aim of this study is to investigate the clinical and cost effectiveness of a home-based self management standing programme in people who are severely physically impaired with multiple sclerosis (MS). |
| Ethics approval(s) | NRES Committee South West – Frenchay, 13/05/2015, ref: 15/SW/0088 |
| Condition | Topic: Neurological disorders; Subtopic: Neurological (all Subtopics); Disease: Multiple Sclerosis |
| Intervention | Participants are randomly allocated to one of two groups. Intervention group: Participants will be asked to stand in an Oswestry standing frame for 30 minutes three times per week for a total of 16 weeks during a 20 week period. This method of supported standing, uses a robust wooden frame to provide support through the use of straps at the knees, hips and ankles (www.oswestry-frames.co.uk). The treating physiotherapist will teach the participant and carer safe use of the standing frame over 2 face-to-face sessions in the participant’s home (~60 minutes/session). They will be taught exercises, stretches and balance activities to undertake using the frame. To complement this and optimise adherence, an information booklet and DVD will provide advice on how to intensify the programme, a detailed description/schema of the exercises, advice on safety issues, and “frequently asked questions”. To further optimise adherence these face-to-face sessions will be supported by weekly telephone support (~15 minutes) for 4 weeks, and then monthly for the following 2 months. Calls will focus on facilitating individuals to set and achieve personal targets. As is routine clinical practice, the therapist’s contact name and telephone number will be provided should any queries arise. Individuals may take up to four weeks to become re-accustomed to an upright position. A 20 week period has therefore been allocated for achieving the desired intensity of standing activity as participants will not have been used to prolonged standing and may fatigue. This further allows for time when the participant is unable to use the frame (illness, holidays, etc.), as highlighted by our user discussion groups. Control group: Participants receive usual physiotherapy care only. Although usual care varies between individuals, it rarely involves regular physiotherapy intervention either within the community or hospital. Intervention is generally limited to a few visits, typically reacting to presenting problems (e.g. practising transfer skills, providing mobility aids) rather than promoting long-term preventative self-management.. Participants in both groups are followed up at 20 and 36 weeks. |
| Intervention type | Other |
| Primary outcome measure | Motor function is measured using the Amended Motor Club Assessment at baseline, 20 and 36 weeks. |
| Secondary outcome measures | 1. Bowel and Bladder Control is measured using the self report Bladder and Bowel Control Scales at baseline, 20 and 36 weeks 2. Falls frequency is determined at baseline, 20 and 36 weeks 3. Knee extensor strength is measured using dynanometry at baseline, 20 and 36 weeks 4. Length of hip flexors are measured using goniometry at baseline, 20 and 36 weeks 5. Quality-adjusted life-years (QALY) are measured at baseline, 20 and 36 weeks 6. Quality of Life is measured using the 29-item MS Impact Scale and the EURoQOL 5D-5L at baseline, 20 and 36 weeks 7. Respiratory capacity is measured using spirometry to measure forced expiratory volume (FEV) at baseline, 20 and 36 weeks 8. Sitting balance is measured using the Modified Functional Reach in Sitting at baseline, 20 and 36 weeks 9. Spasm Frequency is measured using the Penn Spasm Frequency Scale at baseline, 20 and 36 weeks |
| Overall study start date | 01/01/2015 |
| Overall study end date | 31/03/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 140; UK Sample Size: 140; Description: 70 people will be randomly allocated to the usual care group and 70 to the standing frame plus usual care group. |
| Total final enrolment | 140 |
| Participant inclusion criteria | 1. Individuals diagnosed with primary or secondary progressive MS according to McDonald’s criteria 2. Aged 18 years or over 3.Willing and able to consent to participate 4. Scoring 6.5-8.0 on the Expanded Disability Status Scale (EDSS), i.e. people who “require bilateral assistance to walk 20 metres or less” to those “restricted to bed or wheelchair” 5. Ability of the home / family to accommodate the standing frame 6. Able to get into a standing frame independently or with assistance from a carer 7. Agreement of another person (e.g. carer) should assistance be necessary for the standing programme 8. Willing and able to travel to local assessment centres for blinded outcomes assessment |
| Participant exclusion criteria | 1. Any recent changes in disease modifying therapies (more specifically if they have ever had Campath, are within past 6 months of ceasing Nataluzimab, or are within 3 months of ceasing any other MS disease modifying drug) 2. Have relapsed/received steroid treatment within the last month 3. Are currently, or during the past 6 months have undertaken a regular standing frame programme(more than once a week) 4. Have a history of osteoporotic-related fractures 5. Have comorbidities which contraindicate standing in the frame (e.g. foot ulceration, uncontrolled epilepsy) or likely to impact on the trial (e.g. chronic jaundice, heart disease, age related multiple co-morbidities) 6. Currently participating in another clinical trial (rehabilitation or pharmacological) |
| Recruitment start date | 01/09/2015 |
| Recruitment end date | 31/03/2017 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Derriford Road
Plymouth
PL6 8BH
United Kingdom
Bodmin Business Centre
Bodmin
PL31 1AQ
United Kingdom
Newquay
TR7 1RQ
United Kingdom
Treliske
Truro
TR1 3LJ
United Kingdom
Redruth
TR15 3ER
United Kingdom
Liskeard
PL14 3XD
United Kingdom
Newton Abbot
TQ12 2TS
United Kingdom
Paignton
TQ3 3AG
United Kingdom
Coronation Road
Totnes
TQ9 5GH
United Kingdom
Mansion House Street
Dartmouth
TQ6 9BD
United Kingdom
200 Mount Gould Road
Plymouth
PL4 7PY
United Kingdom
Puslinch Farm
Yealmpton
PL8 2NN
United Kingdom
Bideford
EX39 3AG
United Kingdom
St Brannock's Park Road
Ilfracombe
EX34 8JF
United Kingdom
Chard Road
Axminster
EX13 5DU
United Kingdom
Tiverton
EX16 6NT
United Kingdom
Clyst Heath
Exeter
EX2 7EY
United Kingdom
Exeter
EX2 6DW
United Kingdom
Exeter
EX2 8TU
United Kingdom
Abbey Rise
Whitchurch Road
Tavistock
PL19 9AS
United Kingdom
Swaffham
PE37 7HL
United Kingdom
Dereham
NR19 2EX
United Kingdom
Wymondham
NR18 0AR
United Kingdom
High Kelling
Holt
NR25 6QA
United Kingdom
North Walsham
NR28 9AP
United Kingdom
Norwich
NR6 6BB
United Kingdom
Norwich
NR2 3TU
United Kingdom
Bury St Edmunds
IP32 7BT
United Kingdom
Newmarket
CB8 7JG
United Kingdom
Lowestoft
NR33 0AZ
United Kingdom
Stowmarket
IP3 9GJ
United Kingdom
Felixstowe
IP11 7HJ
United Kingdom
Sponsor information
Hospital/treatment centre
Neurology
The John Bull Building
Derriford Hospital
16 Research Way Derriford
Plymouth
PL6 8BU
England
United Kingdom
"ROR" |
https://ror.org/05x3jck08 |
|---|
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/05/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | 1. Planned dissemination of results via journal articles, newsletters, conference presentations, user discussion groups, and the study website. 2. Planned publication in MS lay newsletters and magazines (e.g. MS Trust “Open Door” and MS Society “Research Matters” newsletters) 3. Planned presentation at national and international conferences |
| IPD sharing plan | - |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2019 | 16/07/2019 | Yes | No |
| Results article | qualitative results | 28/10/2020 | 30/10/2020 | Yes | No |
| Protocol article | 05/05/2016 | 17/08/2022 | Yes | No | |
| Statistical Analysis Plan | version 1 | 17/01/2018 | 17/08/2022 | No | No |
| HRA research summary | 28/06/2023 | No | No |
Additional files
Editorial Notes
17/08/2022: Publication reference and statistical analysis plan added.
30/10/2020: Publication reference added.
16/07/2019: Publication reference and total final enrolment added.
05/02/2016: Verified study information with principal investigator.
