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Effect of Task-oriented Training Assisted by Force Feedback Hand Rehabilitation Robot on Finger Function in Stroke Patients With Hemiplegia

J

Jilin University

Status

Enrolling

Conditions

Stroke

Treatments

Other: assisted by a therapist
Device: force feedback rehabilitation robot (SEM™ Glove)

Study type

Interventional

Funder types

Other

Identifiers

NCT05841108
20220101

Details and patient eligibility

About

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.

Enrollment

44 estimated patients

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

44 participants in 2 patient groups

experimental group
Experimental group
Treatment:
Device: force feedback rehabilitation robot (SEM™ Glove)
control group
Active Comparator group
Treatment:
Other: assisted by a therapist

Trial contacts and locations

1

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Central trial contact

zhenlan li

Data sourced from clinicaltrials.gov

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