Effects of end-effector type lower limb rehabilitation robot-assisted gait training in patients with subacute stroke

Not Applicable

Completed

• Conditions: Diseases of the circulatory system

• Registration Number: KCT0005373
• Lead Sponsor: Asan Medical Center

Brief Summary

Methods: Forty-nine stroke patients were randomly assigned to 2 treatment groups: a 30-minute end-effector lower limb rehabilitation robot training plus 1.5-hour conventional physiotherapy (robot group; n = 26), or a 2-hour conventional physiotherapy (control group; n = 23). All patients received 5 treatments weekly for 4 weeks. The functional ambulatory category was the primary outcome and the motricity index, Fugl Meyer assessment-lower extremity, rivermead mobility index, 10 meter walk test, Berg balance scale, and modified Barthel index were secondary outcomes. Results: All outcome measures significantly improved in both groups after training (P > .05). The robot group improved more in FAC than the control group (P = .005). Conclusions: Compared with conventional physiotherapy alone, end-effector lower limb robot-assisted gait training with conventional physiotherapy improved subacute stroke patients walking ability.

Detailed Description

Not available

Study Timeline

• Study Completion: 2021-12-13
• Results First Posted: 2023-10-20
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

Age = 19 years
- Within 3 months of stroke onset
- Hemiparesis
- Functional Ambulatory Category (FAC) score = 3 and Trunk Control Test = 49
- Ability to participate in the robot-assisted gait training
- Previously independent walker

Exclusion Criteria

- Severe cognitive disorders(MMSE <10) or aphasia that impeded communication
- Severe lower extremity musculoskeletal disease
- Severe lower extremity contracture that limits range of motion
- Fractures, open wound, or unhealed ulcers
- Body weight > 135kg, height > 195cm
- Difficulty in robot-assisted gait treatment due to serious medical conditions such as cardiovascular or lung disease
- Risk of compression fracture due to severe osteoporosis
- Other neurological disorders affecting the lower extremities (eg Parkinson disease, multiple sclerosis, etc.)
- In case the researcher judges that participation in this study is inappropriate

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Functional Ambulatory Category

Secondary Outcome Measures

Name	Time	Method
Motricity index-Lower Extremity;Fugl Meyer Assessment-Lower Extremity;Rivermead Mobility Index;10 Meter Walk Test;Berg balance score;Modified Barthel Index