Multiple Sclerosis (MS) Nervous System Diseases
Conditions
Interventions
Randomisation lists will be generated using block randomisation with random variable block length, stratified by site and multiple sclerosis type, and a 1:1 randomisation ratio. Lists will be produced
Sponsors
University of Liverpool
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: People with multiple sclerosis (MS): 1 Adults with primary progressive, secondary progressive or relapsing-remitting multiple sclerosis. 2. Expanded disability status scale score =4.0 and =6.5. 4= Significant disability, self-sufficient and up and about some 12 hours a day. Able to walk without aid or rest for 500m. 6.5= Requires two walking aids to walk about 20m without resting). Carers or people who help look after people with MS who were involved in the study: - This includes provision of informal or formal care, assistance with activities related to the study including attendance of hospital visits, use of the surface neuromuscular electrical stimulation device, recording of information related to healthcare visits, physical activity or exercise. Healthcare practitioners and staff involved in the study: - Healthcare practitioners and staff (clinical and non-clinical) who were involved in the set-up or delivery of the study.
Exclusion criteria
Exclusion criteria: People with Multiple Sclerosis: 1. Clinically isolated syndrome. 2. People with multiple sclerosis in an active relapse or <8-weeks since a relapse. 3. Lower-limb peripheral nerve injury. 4. Fixed lower-limb contractures. 5. Contraindications to surface neuromuscular electrical stimulation i.e. 5.1. Pregnancy 5.2. Uncontrolled Epilepsy 5.3. Any of the following in the lower limbs: i) Peripheral nerve injury ii) Unstable fractures or orthopaedic condition affecting the lower limb iii) Cancer (malignancy) in the areas of the electrode placement iv) Skin infection / devitalised skin at the electrode placement site 6. Unable to apply and control surface neuromuscular electrical stimulation device or braces independently or with carer assistance. 7. Other co-morbidities that could affect mobility/additional underlying condition e.g. stroke. Cardiac pacemaker/history of cardiac problems will not be a reason for exclusion but recruitment will be subject to cardiologist approval. Carers of people with MS who were involved in the randomised controlled trial: 1. Carers of people who help look after people with MS but were not involved in the study will not be eligible. Healthcare practitioners and staff involved in the study: 1. Healthcare practitioners or staff not involved in setting up or delivering the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| As this is an acceptability and feasibility study there is no primary outcome measure. An objective of this study is to collect data on candidate outcome measures to determine the primary outcome for the future trial and enable sample size calculations based on this. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Levels of functional disability measured using Expanded disability status scale (EDSS) at screening, 3 and 6 months. 2. Disease and demographic characteristics at baseline (age, sex, ethnicity, height, weight, disease subtype, years since diagnosis, annual relapse rate). 3. Number of relapses (total). 4. Level of impairment measured using type and number of walking aids used 5. Muscle function/balance measured using Timed up and Go (TUG) at baseline, 3 and 6 months. 6. Exercise tolerance measured using 2 minute walk test (2MWT) at baseline, 3 and 6 months. 7. Spasm frequency measured using Penn spasm frequency scale (PSFS) at baseline, 3 and 6 months. 8. Quality of life measured using Multiple Sclerosis Impact Scale (MSIS- 29) at baseline, 3 and 6 months. 9. Energy and drive (fatigue) measured using the fatigue severity scale (FSS) at baseline, 3 and 6 months. 10. Impact of fatigue on cognitive, physical and psychosocial function measured using Modified Fatigue Impact Scale – 5-item version (MFIS-5) at baseline, 3 and 6 months. 11. Measure of disability measured using World Health Organization Disability Assessment Schedule 2.0 - 36 version (WHODAS 2.0) at baseline, 3 and 6 months. 12. Health-related quality of life measured using European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) at baseline, 3 and 6 months. 13. Health resources and accessed measured using the Modular resource-use measure (ModRUM) at 3 and 6 months. 14. Lower limb pain measured using a numerical rating scale (lower limb pain) at baseline, 3 and 6 months. 15. Muscle stiffness measured using the Modified Ashworth Scale (MAS) at baseline, 3 and 6 months. 16. Lower limb range of movement ROM (Knee and ankle) measured at baseline, 3 and 6 months. 17. Lower limb strength measured using MRC Oxford strength assessment (Knee and ankle) measured at baseline, 3 and 6 months. | — |
Countries
England, United Kingdom
Contacts
Public ContactFraser Philp
Outcome results
None listed