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Table 1 Data collection schedule on feasibility aspects and related uncertainties

From: A highly challenging balance training intervention for people with multiple sclerosis: a feasibility trial

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

  1. aPC1 to PC6 progression criteria no. 1 to no. 6, see under heading "Progression criteria" in text
  2. bAPDM APDM’s Mobility Lab™ a body-worn sensor technology for assessment of balance and gait
  3. cTrend in outcome response is reported in Results, Table 5