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A clinical study comparing the effectiveness and safety of NaturaGait and LOKOMAT® for improving lower limb walking function after brain injury.

Comparing NaturaGait and Lokomat® for the treatment of gait dysfunction.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600118603
Enrollment
Unknown
Registered
2026-02-09
Start date
2024-08-05
Completion date
Unknown
Last updated
2026-02-16

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

Conditions

Lower limb walking dysfunction after stroke.

Interventions

Trial group:NaturaGait training system, 40 minutes for each training session, 5 times a week, 20 times
Control group:The LOKOMAT training system is used for 40 minutes each time, 5 times a week, for 20 sessions

Sponsors

Shanghai Yangzhi rehabilitation hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.Age 18 to 80 years old, both men and women; 2.Head CT or MRI confirmed first stroke or brain injury, within 1 month of onset (early stage) or within 1 month to 1 year of onset (recovery stage); 3.The lesion is only in one cerebral hemisphere; 4.Accompanied by lateral limb disorders (Stage ? = 2, standing balance >= 1; 6.The Ashworth scale for the affected limb is 1-3; 7.The patient is able to comprehend and execute treatment directives (MMSE >= 21 points). They do not have a history of substance or alcohol dependence, nor do they have any concurrent cerebral anomalies or dysfunction. They also do not have severe hepatic or renal dysfunction or psychiatric disorders; 8.No history of epilepsy; 9.Signed informed consent for treatment.

Exclusion criteria

Exclusion criteria: 1.Age greater than 80 years; 2.History of two or more symptomatic strokes or prior history of brain injury, except TIA; 3.Patients with limb dysfunction due to osteoarticular disorders or other causes prior to or during the course of the disease; 4.Those with auditory comprehension impairment, visual impairment, hearing impairment, complete aphasia; cognitive dysfunction (MMSE < 21 points); 5.Those with other musculoskeletal or neurodegenerative disorders that affect the recovery of limb function; 6.Combined acute coronary events within 3 months before and after stroke onset; 7.Individuals who are unstable or unable to cooperate with active training; 8.History of major surgery a week ago; 9.Those with the following comorbid conditions: (1) severe hepatic and renal impairment (ALT, AST, TBiL, and Cr exceeding 50% of the upper limit of normal); (2) abnormal mental status; (3) comorbid malignancy, or history of malignancy; and (4) primary or secondary epilepsy; 10.Pregnant or lactating women.

Design outcomes

Primary

MeasureTime frame
Fugl-Meyer Assessment Score;

Secondary

MeasureTime frame
Berg Balance Scale;Modified Ashworth Scale;Modified Barthel Index;6-Minute Walk Distance;10-Meter Walk Speed;Timed Up and Go Test;Five-Repetition Sit-to-Stand Test;

Countries

China

Contacts

Public ContactJin lingjing

Shanghai Yangzhi rehabilitation hospital

lingjingjin@163.com+86 21 66111329

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 19, 2026