Upper limb dysfunction caused by central nervous system injury
Conditions
Interventions
Treatment Group:The upper limb exoskeleton rehabilitation training system shall be utilized with the following modes selectable based on clinical indications:
(1) Active Rehabilitation Mode
(2) Passive Rehabilitation Mode
(3) Mirror Therapy Mode
(4) Resistance Training Mode.
Training parameters: 30 minutes/session, 1 session/day, 5 sessions/week.
Control group:Conventional upper limb rehabilitation training. Perform the following training for 30 minutes each time, once a day, 5 times a week:
(1) Elbow and hand muscle strength training
(2) Elbow and hand endurance training
(3) Elbow and hand joint range of motion training.
Sponsors
Second Affiliated Hospital of Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: (1) Age between 18 and 85 years old, inclusive, regardless of gender; (2) Central nervous system injury confirmed by CT or MRI (either first occurrence or previous occurrence without residual upper limb dysfunction), accompanied by current upper limb dysfunction; (3) Brunnstrom motor function stage of the affected upper limb >= II; (4) Clinically stable condition with ability to cooperate with treatment and evaluations; (5) Signed written informed consent form.
Exclusion criteria
Exclusion criteria: (1) Presence of skeletal, articular, or muscular disorders affecting the affected upper limb (e.g., fractures, shoulder subluxation, pain) or other contraindications/complications interfering with functional training; (2) Open wounds or infections in skin areas contacting the rehabilitation device on the affected upper limb; (3) Severe cardiopulmonary or systemic comorbidities rendering patients unable to tolerate rehabilitation training; (4) Severe visual, auditory, cognitive, or communication impairments hindering rehabilitation participation; (5) Active psychiatric disorders or epileptic status; (6) Planned pregnancy within 6 months, or current pregnancy/lactation (female participants); (7) Participation in other clinical trials within the preceding 3 months; (8) Investigator-determined ineligibility for study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fugl-Meyer upper limb motor function assessment scale score on day 21 of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Fugl-Meyer upper limb motor function assessment scale score on day 10 of treatment;Modified Barthel Index score;Modified Ashworth spasticity scale score;Equipment performance evaluation; | — |
Countries
China
Contacts
Public ContactXiong Bing
Second Affiliated Hospital of Zhejiang University School of Medicine
Outcome results
None listed