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A clinical trial to evaluate the safety and efficacy of a rehabilitation training and evaluation system for the upper limb

A clinical trial to evaluate the safety and efficacy of a rehabilitation training and evaluation system for the upper limb

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000038676
Enrollment
Unknown
Registered
2020-09-28
Start date
2019-05-14
Completion date
Unknown
Last updated
2020-12-14

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

Conditions

Central nervous injury

Interventions

Experimental group:robot-assisted assessment and training
Control group:Dose matching routine rehabilitation therapy

Sponsors

Jing'an Branch, Huashan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18- 85 years; 2. Clinical diagnosis of CNS reported by computerized tomography (CT)or Magnetic Resonance Imaging (MRI) and with upper limb functional limitation; 3. Between 1 week and 2 years since CNS injury; 4. Able to provide consent to take part in the study and to comply with the requirements of the protocol.

Exclusion criteria

Exclusion criteria: 1. Severe cognitive impairment such as dementia, unilateral neglect, apraxia, etc. Folstein Mini Mental State Examination(MMSE)<= 9; 2. Other current significant impairment of the upper limb affected CNS injury, e.g. fixed contracture, frozen shoulder, severe arthritis, recent fracture and bleeding; 3. Inappropriate to receive treatment by the protocol suggested by clinicians or therapists; 4. Participants in other clinical trials within 3 months.

Design outcomes

Primary

MeasureTime frame
Fugl Meyer upper limb;

Secondary

MeasureTime frame
Fulg-Meyer hand and wrist;Fulg-Meyer lower limb;active range of motion (AROM) of shoulder, elbow and wrist;Modified Barthel Index;Muscular strength of biceps, triceps, wrist extensor and wrist flexor muscles (manual muscle test MMT);Satisfaction of the robot assisted assessment and training FLEXO-Arm1 system;

Countries

China

Contacts

Public ContactJie Jia

Jing'an Branch, Huashan Hospital, Fudan University

shannonjj@126.com+86 13611722357

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 16, 2026