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A randomized controlled study of the effectiveness of exoskeleton robot-based target walking speed and walking time training on walking function and cerebral cortical activation in stroke patients

A randomized controlled study of the effectiveness of exoskeleton robot-based target walking speed and walking time training on walking function and cerebral cortical activation in stroke patients

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400080118
Enrollment
Unknown
Registered
2024-01-22
Start date
2024-01-29
Completion date
Unknown
Last updated
2024-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

stroke

Interventions

Exoskeleton Robotics Routine Training Group:Lower limb exoskeleton robotics training was performed 15 times, 5 times per week for 3 weeks of intervention. Walking speed was 0.2 m/s for 30 minutes per
Exoskeleton Robotics Target Speed Walking Training Group:week for 3 weeks of intervention. Walking speed was 0.5 m/s for 30 minutes per intervention.
Exoskeleton Robotics Target Time Walking Training Group:week for 3 weeks of intervention. Walking speed was 0.2 m/s for 60 minutes per intervention.
Exoskeleton Robotics Target Speed Walking+Target Time Walking Training Group:week for 3 weeks of intervention. Walking speed was 0.5 m/s for 60 minutes per intervention.

Sponsors

Shanghai Yangzhi Rehabilitation Hospital (Shanghai Sunshine Rehabilitation Center)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Meet the diagnostic criteria for stroke in the Diagnostic Points of Various Cerebrovascular Diseases revised by the Fourth National Academic Conference on Cerebrovascular Diseases; (2) The first diagnosis of stroke, including cerebral infarction and cerebral hemorrhage, is confirmed by cranial CT or MRI imaging, and the duration of the disease is between 2 weeks and 6 months after the onset of the disease; (3) Vital signs are stable, condition is stabilized, hemiplegia after stroke, and gait disturbance exists; (4) Age 18 - 80 years old, gender is not limited, weight = 100kg; (5) Modified Ashworth classification of muscle tone = grade 2; (6) Functional Ambulation Scale (FAC) = grade 2 (grade 2: patient walks with continuous or intermittent support from 1 person), and can walk independently = 15 meters; (7) Good cognitive function, can understand and actively participate in the training program, agree and sign the informed consent;

Exclusion criteria

Exclusion criteria: (1) Severe restriction of joint range of motion limiting walking motion; (2) Unhealed fractures or osteoporosis; (3) Skin injury or infection of the lower limbs and robot wearing parts; (4) Unstable angina pectoris, severe arrhythmia and other heart diseases; (5) Severe chronic obstructive pulmonary disease; (6) Untreated deep vein thrombosis; (7) Participation in other clinical trials during the same period;

Design outcomes

Primary

MeasureTime frame
10-meter walk test;cortical activation index;

Secondary

MeasureTime frame
6-minute walk test;Timed Up and Go Test;functionalambulation category scale;Fugl-Meyer assessment scale;Rivermead Mobility Index;Berg Balance Scale;Spatio-temporal parameters of gait;Plantar pressure parameters;

Countries

China

Contacts

Public ContactQi Qi

Shanghai Yangzhi Rehabilitation Hospital (Shanghai Sunshine Rehabilitation Center)

qibuqi133@163.com+86 133 1162 6715

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 21, 2026