Clinical trial NCT05841108: Effect of Task-oriented Training Assisted by Force Feedback Hand Rehabilitation Robot on Finger Function in Stroke Patients With Hemiplegia
Official title: Effect of Task-oriented Training Assisted by Force Feedback Hand Rehabilitation Robot on Finger Function in Stroke Patients With Hemiplegia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: Hand dysfunction
Force feedback hand rehabilitation robot
Task-oriented training
Neurorehabilitation
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
First posted: 2023-05-03
Enrollment: 44
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Over eighty percent of stroke patients experience finger-grasping dysfunction problems, compromising independence in daily life activities and quality of life. In routine training, task-oriented training is usually used for functional training of the hand, which may improve the finger grasping performance after stroke, whereby augmented therapy may lead to a better treatment outcome. Technology-supported training holds opportunities for increasing training intensity. However, most of the hand rehabilitation robots commonly used in the clinic are based on passive training mode and lacks the sensory feedback function of fingers, which is not conducive to patients completing more accurate grasping movements. The force feedback hand rehabilitation robot can make up for the above defects, but its clinical efficacy in stroke patients are not known to date. The aim of the present study was to investigate the effectiveness and added value of the force feedback hand rehabilitation robot combined with task-oriented training for stroke patients with hemiplegia.


Eligibility criteria: Inclusion Criteria:

* First-ever stroke
* Aged 20\~80 years old
* Post-stroke time≤6 months
* Clinically diagnosed with a central paresis of the right arm/hand (Brunnstrom stage of the affected upper limb≥II, Brunnstrom stage of the affected hand II\~V, Active flexion range of motion of the affected finger joint≥10°, MAS of affected upper limb and finger≤1+
* Sitting balance≥Level 2
* No serious depression and no visual impairment
* Cognitive and speech abilities sufficient to understand instructions and to provide informed consent

Exclusion Criteria:

* Severe additional neurological, orthopedic, or rheumatoid impairments before stroke which could interfere with task performance
* Sensory disturbance of fingers
* Severe joint pain caused by various reasons affects the functional activities of fingers
* Complicated with serious heart, lung, liver, kidney or infection
* Attending another study or therapy to improve arm-hand function

Primary outcomes:
measure: Fugl-Meyer motor function assessment-upper limb finger motor part
timeFrame: Change from baseline Fugl-Meyer motor function assessment-upper limb finger motor part score at 4 weeks
Secondary outcomes:
measure: Modified Ashworth scale (MAS)
timeFrame: Change from baseline Modified Ashworth scale outcome at 4 weeks
measure: Range of motion (ROM)
timeFrame: Change from baseline range of motion outcome at 4 weeks
measure: grip strength
timeFrame: Change from baseline grip strength at 4 weeks
measure: Brunnstrom recovery stages of hand (BRS-H)
timeFrame: Change from baseline brunnstrom recovery stages of hand at 4 weeks
measure: Barthel index (BI)
timeFrame: Change from baseline barthel index at 4 weeks
Other outcomes:
Locations:
city: Changchun
country: China
facility: First hospital of Jilin University
Study officials:
References: