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A clinical trial evaluates the effectiveness and safety of "the development of medical robotic products and navigation systems for intelligent limb rehabilitation training and real-time functional assessment" in upper limb movement for stroke hemiplegia patients

A clinical trial evaluates the effectiveness and safety of "the development of medical robotic products and navigation systems for intelligent limb rehabilitation training and real-time functional assessment" in upper limb movement for stroke hemiplegia patients

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078581
Enrollment
Unknown
Registered
2023-12-13
Start date
2023-12-01
Completion date
Unknown
Last updated
2023-12-19

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

Conditions

Stroke

Interventions

Experimental group: "Upper Limb Rehabilitation Training System" training and fundamental rehabilitation programs
Control group:Traditional occupational therapy and fundamental rehabilitation programs

Sponsors

Zhejiang Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: ?Understand the entire process of the trial, voluntarily participate, and sign the informed consent form. ?Age =18 and =85 years, both genders accepted. ?Stable vital signs, stable condition, tolerant to low-intensity seated training. ?Weight =100kg, height 1.50m to 1.90m. ?Diagnosed with stroke hemiplegia, including ischemic and hemorrhagic strokes, with a duration of =six months post-onset. ?Level one of sitting balance, able to use the "upper limb rehabilitation training system" with the assistance of medical staff. ?No significant restriction in passive range of motion for shoulder, elbow, and wrist joints.

Exclusion criteria

Exclusion criteria: ?Severe limitations in joint range of motion restricting upper limb movements. ?Skin damage or infection at sites of contact between the upper limb and the robot during wear. ?Unstable angina, severe arrhythmia, or other significant history of heart disease. ?History of severe chronic obstructive pulmonary disease. ?Other contraindications or complications that may affect upper limb training. ?Pregnant, planning pregnancy, or lactating women. ?Participation in any clinical trial within the month prior to selection. ?Other situations as determined by the researcher that deem the individual ineligible to participate in the clinical trial.

Design outcomes

Primary

MeasureTime frame
Score of Fugl-Meyer Assessment (FMA) Upper Extremity section ;Wolf Motor Function Test (WMFT);

Secondary

MeasureTime frame
The score of the Modified Barthel Index (MBI);

Countries

China

Contacts

Public ContactJian LIN

Zhejiang Hospital

18072807831@189.cn+86 571 8737 7411

Outcome results

None listed

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