Feasibility aspect | Assessments | ||||
---|---|---|---|---|---|
Baseline | Post block | Follow-up | |||
A | B | C | |||
Recruitment process and rates on inclusion and retention | |||||
Eligibility screening process (PC1)a and inclusion rate (PC2)a | X | ||||
Retention rate (PC3)a | X | X | X | X | |
Study procedures | |||||
Information and communication accuracy | X | ||||
Inclusion and exclusion assessment | X | ||||
Assessment on demography and clinical characteristics | X | ||||
Acceptability of time required for assessment procedures | X | X | |||
Blood-sampling procedures | X | ||||
Attitude towards long-term follow-up assessments | X | ||||
Intervention delivery | |||||
Training session time of day and weekly frequency | X | ||||
Duration of training session | X | ||||
Individual adjustment of: | |||||
Exercises related to intervention progression | X | X | X | ||
Level of challenge across the progression blocks | X | X | X | ||
Exercises related to disability level and variation in daily capacity | X | X | X | ||
Monitoring of level of challenge | X | X | X | ||
Group training despite divergence in level of overall MS disability | X | ||||
Individual balance exercises | X | ||||
Safety in training | X | ||||
Home exercise program as substitute for group training session | X | ||||
Individual effort required for participation | X | ||||
Motivation in training | X | ||||
Attendance at training sessions (PC4)a | X | ||||
Perceived intervention effect on balance control | X | ||||
Willingness to recommend the training (PC5)a | X | ||||
Potential outcome measures | |||||
Primary outcome: | |||||
Primary outcome suitability of the Mini-BESTestc (PC6)a | X | X | |||
Secondary outcomes: | |||||
10-Meter Walk Testc | X | X | |||
2-Minute Walk Testc | X | X | |||
APDMb Gait analysis (spatial and temporal gait parameters) | X | X | |||
APDMb Sway test | X | X | |||
Six Spot Step Testc | X | X | |||
Multiple Sclerosis Walking Scalec | X | X | |||
Falls Efficacy Scale Internationalc | X | X | |||
Frenchay Activities Index | X | X | |||
Multiple Sclerosis Impact Scale-29c | X | X | |||
Modified Fatigue Impact Scalec | X | X | |||
Hospital Anxiety and Depression Scale | X | X | |||
EuroQol-5D (Index and Visual Analog Scalec) | X | X | |||
Life Satisfaction Scale | X | X | |||
Acceptance of Chronic Health Condition Scale | X | X | |||
Trail Making Testc | X | X | |||
Ray Auditory Verbal Learning Testc | X | X | |||
Symbol Digit Modalities Testc | X | X | |||
Immunological markers in blood | X | X |