Topic: Neurological disorders
Conditions
Interventions
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 ti
Sponsors
Plymouth Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Motor function is measured using the Amended Motor Club Assessment at baseline, 20 and 36 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
England, United Kingdom
Contacts
Public ContactJennifer Freeman
Outcome results
None listed