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Clinical study on the safety and feasibility of AiWalker-K for lower limb motor rehabilitation in children with cerebral palsy

Clinical study on the safety and feasibility of AiWalker-K for lower limb motor rehabilitation in children with cerebral palsy

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300067966
Enrollment
Unknown
Registered
2023-02-01
Start date
2023-02-01
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

cerebral palsy

Interventions

AR group:AiWalker-K training (A) and routine rehabilitation training (R)
RAR group:Routine rehabilitation training (R), AiWalker-K training (A) and routine rehabilitation training (R)

Sponsors

The Third Affiliated Hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 10 Years

Inclusion criteria

Inclusion criteria: 1. Meet the criteria for diagnosis and classification of cerebral palsy and GMFCS is II-IV; 2. The age is 3~10 years old; 3. The required height of the equipment is 80cm~150cm, and the weight is = 70kg; 4. Be able to reliably report pain, fear and discomfort, understand instructions and cooperate in completing training; 5. Those who have not received orthopedic surgery and botulinum toxin injection in the past 6 months; 6. If the anti-spasmodic drugs are taken orally, the drug use must be stable for at least 1 month before enrollment in the study; 7. Fully understand the content of the test, voluntarily participate in the test, and the guardian of the subject signs the informed consent in writing. When the subject has the ability to make consent, the subject also needs to sign the informed consent in person.

Exclusion criteria

Exclusion criteria: 1. Severe lower limb contracture; 2. Complications of heart, lung, liver and kidney; 3. Accompanied with severe epilepsy, genetic metabolic disease and severe skeletal system disease; 4. Combined visual, auditory and intellectual impairment; 5. Combined with acute or progressive nervous system disease; 6. Skin damage or infection at contact with equipment; 7. Inflammation of lower limbs and limitation of joint movement; 8. This study participated in other clinical trials of lower limb rehabilitation within 1 month before randomization; 9. Children who plan or expect to use new drugs, surgery and other antispasmodic treatment during the study period; 10. The researcher believes that there are other factors that are not suitable for children who participate in this study.

Design outcomes

Primary

MeasureTime frame
adverse event;Percentage increase in average heart rate;Changes in blood pressure;gross motor function measure GMFM;Pediatric Balance Scale;6 Minutes Walking Test;Physiological cost index;Edinburgh Visual Gait Score;

Countries

China

Contacts

Public ContactZhu Dengna

The Third Affiliated Hospital of Zhengzhou University

zhudengna@126.com+86 13838141626

Outcome results

None listed

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