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Table 1 Intervention chart

From: Feasibility of a specific task-oriented training versus its combination with manual therapy on balance and mobility in people post stroke at the chronic stage: study protocol for a pilot randomised controlled trial

Item no.

Item description

1 Brief name

Group A

Group B

Group C

Upper ankle joint manual therapy (MT) and task-oriented mobility and balance training (TOT)

Task-oriented mobility and balance training (TOT)

Control group: no intervention

2 Why

To evaluate the feasibility of the methods of a larger trial and explore the preliminary effects of a specific TOT versus its combination with talocrural MT on balance, mobility, ankle range of motion (ROM), number of falls and health-related quality of life in people post stroke.

3 What materials

- Information sheet on study procedures

- Information booklet on home-based TOT programme

- Exercise diary including a compliance checklist

4 What procedures

- Usual care

- TOT introduction: in lay language; description of the principles

- Supervised TOT performance

- Home-based TOT

 

- MT introduction: in lay language; description of the principles

- MT performance of the talocrural joint

- Home-based ankle mobilising exercise

  

5 Who provides

The intervention will be provided by a trained physiotherapist who holds a Master’s degree in musculoskeletal physiotherapy and is studying for another Master’s degree in neurological physiotherapy

 

6 How

- TOT and MT introduction and performance: individually and depending on the group patients will be allocated to

- Home-based training: individually

 

7 Where

- TOT and MT introduction and performance: at Outpatient therapy centre “Kinema”, Germany

- Home-based training: At patients’ homes

 
 

17 minutes, 6 times a week, for 4 weeks

8 When and how much

15 min MT plus 30 min TOT, 2 times per week, for 4 weeks

45 min TOT, 2 times per week, for 4 weeks

 

20 min home-based training, 4 times per week, for 4 weeks; on the supervised intervention-free days

 

9 Tailoring

Same intervention for all patients

Same intervention for all patients

No intervention

10 Modifications

No modifications

No modifications

No modifications

11 How well planned

- Intervention adherence and compliance will be assessed using a patient diary, during appointments and at post-intervention

- Recording in excel sheets will be performed by the instructing researcher (physiotherapist)

- The process will be supervised by the academic supervisor.

12 How well actual

- Adherence rates will be reported as median (range) times per week and percentage (95% confidence interval): face-to-face and home-based training

- Compliance will be presented narratively (exercise types and order; number of repetitions; problems and deviations from protocol with reasons or explanations)