Background
From randomized trial to routine care
Rationale for trial design
Study aims
-
Aim I: to test the effectiveness of the adapted balance training program on balance, gait and physical activity in people with PD in real-life clinical settings.
-
Aim II: to conduct a process evaluation of the effectiveness-implementation study by gathering information on the implementation process at the various clinical settings.
-
Aim III: to determine barriers and facilitators that affect implementation of the program in these settings.
Methods
Description of the HiBalance program
Adaptation of the HiBalance program to clinical settings
Program feature | HiBalance-RCT (Efficacy phase) | HiBalance-clinical setting (Effectiveness/Implementation phase) |
---|---|---|
Inclusion criteria | Idiopathic Parkinson’s disease | Idiopathic Parkinson’s disease |
Hoehn & Yahr score of 2 or 3 | Hoehn & Yahr score of 2 or 3 | |
Able to walk independently indoors without an aid | Able to walk independently indoors without an aid | |
Mini-Mental State examination score > 24 points | Cognitively capable of following instructions in a group setting | |
Age ≥60 years | All Ages | |
Core components | Individually adapted, highly challenging and progressive balance training in 3 blocks with progressively integrated dual-task training | Individually adapted, highly challenging and progressive balance training in 3 blocks with progressively integrated dual-task training |
Dose | 30 h of group training (3 x 1 h sessions/week x 10 weeks) | 20 h of group training (2 x 1 h sessions/week x 10 weeks) 10 h home exercise program (1 h/week x 10 weeks) |
Providers | Physical therapist PhD students (site responsible) and clinicians | Physical therapist clinicians |
Sites | 2 sites, one university hospital | 4–6 clinical sites/primary care clinics |
Outcome evaluation | ||
Performance-based
| ||
Balance performance | Mini-BESTest score | Mini-BESTest score |
Modified figure of eight test | ||
Physical activity level | Steps per day measured by accelerometer | Steps per day measured by accelerometer |
Self-reported
| ||
Fear of falling/balance confidence | Falls Efficacy Scale-International (FES-I) (A measure of concerns about falling) | Activities-specific balance confidence scale (ABC scale) (A measure of balance confidence) |
Activities of daily living | Unified Parkinson’s Disease Rating Scale (UPDRS)- ADL component | |
Self-rated health Walking Evaluation method | SF-36/PDQ-39 PDQ-39 Randomized controlled trial | EQ-5D-3 L Walking impact scale (Walk 12G) Non-randomized controlled design |
Study setting
Study phases
Outcome evaluation of the intervention (Aim I)
Study participants
Data collection
Outcome measures
Data analysis
Process evaluation of the implementation (Aim II)
Research question relating to aim II
Assessment of process outcomes
Process outcomesa
| Targeted groups | Method of data collection |
---|---|---|
Fidelity
| Patient training diaries/attendance Physical therapist trainers sessions plans | Assessment of group training protocols Focus group interviews |
Dose
| Physical therapist trainers (dose provided) Participants with PD (dose received) | Assessment of group training protocols Assessment of attendance at group training/home training protocols |
Recruitment
| Physical therapist trainers | Study logs and focus group interviews |
Reach
| Participants with PD | Study logs |
Barriers and facilitatorsb
| Targeted groups | Method of data collection |
Knowledge and beliefs about the program
Relative advantage of the program Need for adaptability of the program Self-efficacy to train patients according to the programs core components Perceived complexity/difficulty of implementing the program in everyday practice | Physical therapist trainers | Focus group interviews |
Patients need and resources
Knowledge and beliefs about the balance program Perceived complexity of performing the training | Participants with PD | Structured questionnaire |