NCT05360017

Effectiveness and Safety of Single Lower Limb Rehabilitation Training Robot in Stroke Patients With Hemiplegia

A Clinical Trial to Evaluate the Effectiveness and Safety of Single Lower Limb Rehabilitation Training Robot in Lower Limb Motor Function Training of Stroke Patients With Hemiplegia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This trial is a multi center, randomized, controlled, excellent effect, open and loading trial design. The subjects are randomly assigned to the experimental group and the control group. The experimental group adopts litestepper single lower limb rehabilitation training robot walking training on the basis of routine rehabilitation management of stroke patients with hemiplegia, walking training once a day, 40 ± 5 minutes each time; The control group was treated with routine rehabilitation management of stroke patients with hemiplegia. The trial was an open design. Both researchers and subjects knew the treatment allocation and conducted three evaluations within 21 days to evaluate the effectiveness and safety of litestepper single lower limb rehabilitation training robot in the training of lower limb motor function of stroke patients with hemiplegia.

Detailed description

By collecting the movement gait information of the patient's healthy side limb, judging the patient's movement intention, analyzing and learning the gait characteristics of the patient's healthy side, so as to drive the movement of the single lower limb rehabilitation training robot and drive the patient's affected side limb to carry out the rehabilitation training suitable for the healthy side limb, which can enable the patient to complete the normal walking process and achieve the purpose of auxiliary rehabilitation. Through long-term walking rehabilitation, patients can gradually recover their normal walking gait.

Conditions

• Hemiplegia

Interventions

Type	Name	Description
DEVICE	litestepper single lower limb rehabilitation training robot	The experimental group adopts litestepper single lower limb rehabilitation training robot walking training on the basis of routine rehabilitation management of stroke patients with hemiplegia, walking training once a day, 40 ± 5 minutes each time; The control group was treated with routine rehabilitation management of stroke patients with hemiplegia. The trial was an open design. Both researchers and subjects knew the treatment allocation and conducted three evaluations within 21 days to evaluate the effectiveness and safety of litestepper single lower limb rehabilitation training robot in the training of lower limb motor function of stroke patients with hemiplegia.

Timeline

• Start date: 2021-12-02
• Primary completion: 2022-06-20
• Completion: 2022-06-20
• First posted: 2022-05-04
• Last updated: 2023-08-14

Locations

1 site across 1 country: China