Responsiveness of the Mini-Balance Evaluation System Test in Type 2 Diabetic Patients with Peripheral Neuropathy

Figures & data

Figure 1 Study procedure.

Box 1 The Foot Care Programme

Foot examination every day during putting on and taking off the socks and shoes using small handheld mirror (inspection of feet, including toes, looking for areas of redness or other lesions such as a blister, cut, scratch or ulcer)

2. Wear comfortable footwear and not to rub against any areas of the feet (not too tight shoes, shoes that have rough edges, uneven seams)

3. Examine the shoe daily for cracks, stones and nails that can damage the feet

4. Avoid walking barefoot indoors and outdoors (avoid also walking barefoot in socks without footwear, or in thin-sole standard slippers)

5. Protect the feet from sunburn by using sunscreen with a high sun protection factor and/or covering the feet in strong sunlight

6. Avoid using corn-removing plasters or blades (avoid using chemical agents or plasters to remove calluses or corns, use emollients to lubricate dry skin, and cut toenails straight across, file the edges with a nail file)

7. Wash the feet carefully every day and dry with a soft towel between the toes where infections may occur, such as athlete’s foot (tinea pedis)

8. Moisturize the feet after drying

9. Access the local podiatry service for expert foot care if required

Box 2 The Balance Exercises Programme

Stance on heel/ toes

2. Tandem stance

3. One leg stance

4. Toe walking

5. Heel walking

6. Tandem walking

7. Functional strength

8. Endurance exercises (sitting to standing and step-up)

Table 1 Baseline Characteristics of the Sample

Characteristics	Overall (n = 48)
Gender; n (%)
Male	3 (6.3)
Female	45 (93.8)
Age (years); mean ± SD	59.04 ± 7.53
Weight (kg); mean ± SD	57.67 ± 10.34
Height (m); mean ± SD	1.55 ± 0.07
BMI (kg/m^2); mean ± SD	23.86 ± 4.13
Marital status; n (%)
Single	8 (16.7)
Married	17 (35.4)
Divorce	2 (4.2)
Widowed	21 (43.8)
Education; n (%)
Primary	12 (25.0)
Secondary	19 (39.6)
Higher/Graduate	17 (35.4)
Occupation; n (%)
Unemployed	34 (70.8)
Employed ^a	14 (29.2)
Smoking or ever smoked; n (%)
Yes	2 (4.2)
No	46 (95.8)
Drinking Alcohol; n (%)
Yes	2 (4.2)
No	46 (95.8)
Duration (years); mean ± SD	10.58 ± 3.76
Fasting blood glucose level (mg/dl); mean ± SD	148.52 ± 33.23
HbA1C (mg/dl); mean ± SD	8.21 ± 1.75
MNSI Questionnaires; mean ± SD	5.02 ± 2.04
MNSI Physical assessment; mean ± SD	3.09 ± 0.67
Number of prescribed drugs (tablets); mean ± SD	3.23 ± 1.10
Comorbidities; n (%)
Yes^b	42 (87.5)
No	6 (12.5)
History of foot ulcer but no ulcer at present; n (%)
Yes	1 (2.1)
No	47 (97.9)

Notes: ^aGovernment, business, worker, etc. ^bHypertension, heart disease, etc.

Abbreviations: DM, diabetic mellitus; BMI, body mass index; MNSI, Michigan Neuropathy Screening Instrument; SD, standard deviation.

Table 2 Results of the Mini-BESTest and the Global Rating of Change (GRC) Scale at Baseline and Post-Intervention

Measurements	Overall (n = 48)
Mini-BESTest; mean ± SD/ medium (min:max)
Baseline	17.02 ± 1.64 / 17 (14:20)
Post-intervention	23.42 ± 2.34 / 24 (18:27)
Changed score post-intervention; mean ± SD (95% CI)	6.40 ± 1.48 (5.96–6.83)*
≥ 5; n (%)	41 (85.42)
< 5; n (%)	7 (14.58)
Floor and ceiling effects (n = 48); n (%)
Floor effect at baseline (score: 14)	4 (8.33)
Floor effect post-intervention (score:18)	1 (2.08)
Ceiling effect at baseline (score: 20)	1 (2.08)
Ceiling effect post-intervention (score: 27)	3 (6.25)
GRC; mean ± SD/ medium (min:max)
Patient GRC	3.73 ± 0.45 / 4 (3:4)
Therapist GRC	3.04 ± 0.50 / 3 (2:4)
Average GRC value of both patients and therapist	3.39 ± 0.42 / 3.5 (2.5:4)
Mean GRC > 3; n (%)	35 (72.92)
Mean GRC ≤ 3; n (%)	13 (27.08)

Note: *Statistically significant (p < 0.001).

Abbreviations: CI, confidence interval; GRC, global rating change; max, maximum; min, minimum; Mini-BESTest, Mini-Balance Evaluation System Test; SD, standard deviation.

Table 3 Reliability and Responsiveness Indexes for Mini-BESTest

Measurements	Overall (n = 48)
Test-retest reliability of Mini-BESTest (n = 14); 95%(CI)	0.80 (0.48–0.93)^a*
Responsiveness: distribution-based methods
Change score (Post - Pre) (n = 48); 95% (CI)	6.40 (5.96–6.83)^b*
ES; 95% (CI)	3.9 (3.01–4.77)^b
SRM	4.32
SEM	0.73^a
MDC95	2.03^a
Responsiveness: anchor-based methods
The change of the GRC; using of the average GRC
GRC ≤ 3 (n = 13); mean ± SD	5.15 ± 1.46
GRC >3 (n = 35); mean ± SD	6.86 ± 1.21
Mean Difference; 95% (CI)	1.70 (0.86–2.54)*
Pearson r; (95% CI)
Patient GRC/Therapist GRC	0.52 (0.28–0.70)*
Average GRC/Mini-BESTest change score	0.63 (0.42–0.77)*
AUC	0.81 (0.65–0.98)*
Mini-BESTest and GRC
Mini-BESTest ≥ 5 and GRC > 3; n (%)	34 (70.83)
Mini-BESTest < 5 and GRC ≤ 3; n (%)	6 (12.50)
Mini-BESTest < 5 and GRC > 3; n (%)	1 (2.08)
Mini-BESTest ≥ 5 and GRC ≤ 3; n (%)	7 (14.58)
Sensitivity (%)	97.14
Specificity (%)	46.15

Notes: ^aData from the first 14 subjects. ^bData from all the participants (n = 48). *Statistically significant (p < 0.001).

Abbreviations: AUC, area under the receiver operating curve; ES, effect size; GRC, global rating change; MDC, minimum detectable change; SEM, standard error measurement; SRM, standard response mean.

Figure 2 Comparison of mean Mini-BESTest scores between at baseline (white box) and after intervention (gray box).

Table 4 Cut-off Value of the Mini-BESTest Change Scores According to the GRC Scores ≤3 versus >3

Cutpoint	Sensitivity	Specificity	Correctly Classification	LR+	LR-
≥ 4	100.00%	0.00%	72.92%	1.0000
≥ 5	97.14%	46.15%	83.33%	1.8041	0.0619
≥ 6	88.57%	69.23%	83.33%	2.8786	0.1651
≥ 7	62.86%	84.62%	68.75%	4.0857	0.4390
≥ 8	25.71%	84.62%	41.67%	1.6714	0.8779
≥ 9	11.43%	100.00%	35.42%		0.8857
> 9	0.00%	100.00%	27.08%		1.0000

Abbreviation: LR, likelihood ratio.

Figure 3 Receiver operating characteristic curve (ROC) using the Mini-BESTest cut-off score (≥ 5) (in the blue circle) to distinguish the improvement of patients by Global Rating of Change (GRC) scale; patients who improved (GRC > 3) from those who did not improve (GRC ≤ 3) with the area under the curve (AUC) (0.81 (95% CI: [0.65–0.98]).