Mechanical peripheral stimulation for the treatment of gait disorders in patients with Parkinson’s disease: a multi-centre, double-blind, crossover randomized controlled trial

Table 1 Clinical characteristics of participants with PD at baseline (T1)

Variables	SHAM (n = 38)	Gondola^® (n = 36)	p value
Sex, n male/female (%)	20/18 (52.6/47.4)	19/17 (52.8/47.2)	1.000
Age (years)	70.2 ± 10.3	69.2 ± 7.3	0.437
BMI (kg/m²)	27.8 ± 4.7	27.7 ± 4.0	0.896
MoCA (0–30)	24.7 ± 2.8	24.0 ± 2.8	0.301
MDS-UPDRS I (phase OFF,0–52 points)	13.8 ± 5.1	12.7 ± 6.4	0.903
MDS-UPDRS II (phase OFF, 0–52 points)	18.6 ± 7.4	18.4 ± 7.8	0.821
MDS-UPDRS III (phase OFF, 0–132 points)	52.8 ± 15.8	51.9 ± 14.9	0.595
MDS-UPDRS IV (phase OFF, 0–24 points)	5.2 ± 2.6	4.9 ± 2.6	0.504
H&Y stage, n (%)
− 2	7 (18.4)	6 (16.7)	0.438
− 2.5	6 (15.8)	5 (13.9)
− 3	16 (42.1)	21 (58.3)
− 4	9 (23.7)	4 (11.1)
FOG-Q (0–24)	10.6 ± 4.7	11.3 ± 4.9	0.504
Mini-BESTest (0–28)	14.8 ± 5.2	15.3 ± 4.5	0.580

The values are the means ± SDs, except for sex and H&Y score (number of patients followed by percentage). For statistical analysis, an unpaired t test was used. A p value < 0.05 was considered toindicate statistical significance. BMI body mass index, MoCA Montreal Cognitive Assessment, MDS-UPDRS Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (part I–Nonmotor aspects of experiences of daily living; part II–Motor aspects of experiences of daily living; part III–Motor examination; part IV- Motor complications), H&Y Hoehn and Yahr (2 = Bilateral involvement without impairment of balance; 2.5 = Mild bilateral disease with recovery on pull test; 3 = Mild to moderate bilateral disease; some postural instability; physically independent; 4 = Severe disability; still able to walk or stand unassisted); FOG-Q Freezing Of Gait–Questionnaire, Mini-BESTest Mini-Balance Evaluation Systems Test

ISSN: 1743-0003