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Table 2 Primary dependent study variables and their measurement instruments

From: Efficacy and efficiency of a new therapeutic approach based on activity-oriented proprioceptive antiedema therapy (TAPA) for edema reduction and improved occupational performance in the rehabilitation of breast cancer-related arm lymphedema in women: a controlled, randomized clinical trial

PRIMARY DEPENDENT VARIABLES

MEASUREMENT INSTRUMENTS/INTERPRETATION OF RESULTS

- Treatment adherence:

- yes/no

Calculation of the percentage of treatment compliance for therapeutic adherence. PC = number of activities performed by patient/number of activities prescribed by the therapist *100. If PC is equal to or over 80%, it is considered that there was good treatment adherence. If less, no.

 

-Physical state of the limb (inspection and palpation of the affected area). Photographs will be taken of the limb [42].

- Skin hydration:

- Skin lesions:

- Nail lesions: Yes / no

- Induration / Fibrosis: Yes / no

- Pitting edema: Yes / no

- Stemmer: Yes / no

Normal/ dry/sweating

Yes / no

Yes / no

Yes / no

Yes / no

Yes / no

 

-Visual analogue scale (VAS), where 0 is no pain, heaviness or tension and 10 is maximum pain, heaviness or tension.

- Pain:

- Heaviness:

- Tension:

VAS 0–10

VAS 0–10

VAS 0–10

- Shoulder joint rotation:

Degrees with goniometer:

Flexion___/Abduction___/External rotation___

 

-Volume, through circometry (manual measurement of perimeters of the limbs with a tape measure, the value of the volume is approximate and volume is calculated using the Kuhnke formula Vol = (C1 2 + C2 2 + … Cn 2)/ π)) [43,44,45].

- Degree of lymphedema (according to % of volumetric):

_Grade 1 or mild: difference in circometry less than 4 cm (in volume 10–25%) with respect to the healthy arm.

_Grade 2 or moderate: difference in circometry between 4 and 6 cm (in volume 25–50%) with respect to the healthy arm.

- Volumetric %:

- Difference in volume in % between both extremities:

- Volumetric in ml:

Vol = __%

D = __%

Vol = __ml

*an edema reduction of 150 ml over the basal value is required in order to be considered clinically relevant

- Function of the upper limb/activity performance.

- Value of Quick Disabilities of the Arm, Shoulder and Hand (Quick DASH) [21], with transcultural, reliability, validity and sensitivity adaptation to changes of its extended version in 2006 [46, 47].

- Quick DASH value = __% (the result is calculated as a percentage, the higher the obtained result, the greater the disability or symptom)

- Treatment costs

Sum of expenses:

-Prescription of compression garment:

Yes (specify type and cost ______________) / NO

- Type of bandaging used:

proprioceptive / multi-layer (number of rolls used per price of each of the same)

- Total number of treatment hours with therapist:

5/10/other (which:___) (number of hours used per professional hour price)