Effect of Customized Insoles on Gait in Post-Stroke Hemiparetic Individuals: A Randomized Controlled Trial

Abstract

Background: Insoles have been widely applied to many diseases, but stroke involves complex problems and there is a paucity of research on the application of insoles in stroke patients. Aim: To evaluate the effect of customized insoles on gait in patients with hemiplegia. Design: A randomized controlled trial. Setting: Rehabilitation department of a hospital. Population: A total of 50 stroke patients were randomized into an experimental group (n = 25) or a control group (n = 25). Methods: Both groups received conventional gait training, which was conducted five times a week, every 40 min for four weeks and patients in the experimental group were required to wear customized insoles for at least 1 h per day for four weeks. The primary outcome measure was the Tinetti Gait Scale (TGS) and the secondary outcome measures were the plantar pressure test, 6-min walking test (6MWT), lower extremity Fugl–Meyer assessment (FMA-LE), Berg Balance Scale (BBS), and the modified Barthel index (MBI). Results: Compared to the control group, there were significant increases in the experimental group after four weeks (p = 0.014) and at the four week follow-up (p = 0.001) in the change in TGS, weight-bearing on the involved side (p = 0.012) or forefoot (p = 0.028) when standing, weight-bearing on the involved side (p = 0.01 6) or forefoot (p = 0.043) when walking, early stance phase (p = 0.023) and mid stance phase (p = 0.013) on the involved side, FMA-LE (p = 0.029), BBS (p = 0.005), and MBI (p = 0.009), but there were no differences in the late stance phase (p = 0.472) on the involved side when walking or in the 6MWT (p = 0.069). Conclusions: Customized insoles had great efficacy in enhancing gait performance in stroke patients.

Effectiveness of Somatosensory Stimulation for the Lower Limb and Foot to Improve Balance and Gait after Stroke: A Systematic Review

“…Three studies [ 41 , 42 , 43 ] (total n = 45) involved manipulating the surface under the feet, altering mechanical alignment and proprioceptive input, via changes in surfaces [ 41 ] or wearing bespoke insoles [ 42 , 43 ]. Study samples ranged from 16 (just eight in the experimental group) [ 41 ] to 50 (25 in the experimental group) [ 43 ], with the third study [ 31 ] only including a total of 24 participants (12 in the experimental, insoles group). The mean difference ranged from 0.00 m/s (95% CI –0.18, 0.18; d = 0.000) [ 42 ] for mean velocity to 16.8 m (95% CI –1.95, 35.55; d = 0.527) [ 43 ] for the six-minute walk test.…”

“…Study samples ranged from 16 (just eight in the experimental group) [ 41 ] to 50 (25 in the experimental group) [ 43 ], with the third study [ 31 ] only including a total of 24 participants (12 in the experimental, insoles group). The mean difference ranged from 0.00 m/s (95% CI –0.18, 0.18; d = 0.000) [ 42 ] for mean velocity to 16.8 m (95% CI –1.95, 35.55; d = 0.527) [ 43 ] for the six-minute walk test.…”

“…The results of the three studies [ 41 , 42 , 43 ] that manipulated the surface under the feet, altering mechanical alignment and proprioceptive input via changes in surfaces, did not reach statistical significance; however, they may have resulted in a clinically important difference. The sample sizes were relatively small; further studies in this area of research are required.…”

“…( A ) Review of authors’ judgements for each domain within the ROB 2 tool. ( B ) Risk of bias assessment summary—collective risk of bias of all studies (%) using the ROB 2 tool [ 14 , 30 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 ].…”

Correlation analysis of balance function with plantar pressure distribution and gait parameters in patients with cerebral infarction in the basal ganglia region

“…In the present study, there was no obvious correlation between the BBS score and the stance phase, swing phase of the nonhemiplegic limbs, while the BBS score was negatively correlated with the stance and swing phases of the hemiplegic limbs and dual stance phase. Wang et al (2021) reported that as the pressure of hemiplegic forefoot in stroke-affected patients improved, the active dorsiflexion of the hemiplegic foot was promoted, the center of gravity was easier to move forward, the walking ability improved, and the balance ability improved. In et al (2017) improved the patient's knee extension ability, strengthened the contact area of the feet in the stance phase, and strengthened the dorsiflexion to reduce the time of the hemiplegic stance and swing phases, improve the patient's balance function, and improve their walking ability.…”