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A prospective, parallel controlled clinical study evaluating the effectiveness and safety of lower limb rehabilitation exercise training assisted by lower limb rehabilitation training equipment

A prospective, parallel controlled clinical study evaluating the effectiveness and safety of lower limb rehabilitation exercise training assisted by lower limb rehabilitation training equipment

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400080467
Enrollment
Unknown
Registered
2024-01-30
Start date
2023-01-01
Completion date
Unknown
Last updated
2024-02-05

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

Conditions

Brain Damage

Interventions

Control group:Traditional methods of walking training can use walking aids or crutches to assist walking.
Test group:After wearing the equipment, perform walking training and use a walking aid or crutch to assist walking.

Sponsors

GUANGZHOU FIRST MUNICIPAL PEOPLE'S HOSPITAL
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: ? Subject age = 18 years old, regardless of gender; ? Need to undergo standing/walking training, as well as those with rehabilitation training needs and willingness; ? After the occurrence of brain injury, the vital signs are stable, and within one year, Brunstrom's motor function is at stage I or above; ? Height between 155cm and 180cm; ? Weight within 85kg; ? The cardiopulmonary indicators are stable.

Exclusion criteria

Exclusion criteria: ? Patients with unstable vital signs during the acute phase of the disease; ? Individuals with severe heart and lung diseases who are not suitable for active rehabilitation training; ? Malignant tumor with lower limb bone metastasis; ? Severe osteoporosis; ? Paraplegic individuals; ? Individuals who have participated in any clinical trials of drugs and/or medical devices within one month prior to enrollment; ? The researchers believe that there are any other factors that are not suitable for inclusion or that affect the participants' participation in the study.

Design outcomes

Primary

MeasureTime frame
Changes in walking ability before and after training?D1;

Secondary

MeasureTime frame
Changes in walking ability before and after wearing?D2;Changes in Berg Balance Scale Scores;Device performance;

Countries

China

Contacts

Public ContactLan Yue

GUANGZHOU FIRST MUNICIPAL PEOPLE'S HOSPITAL

bluemooning@163.com+86 189 8899 1916

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026