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

NCT ID: NCT05841108

Last Updated: 2023-05-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-04
• Study Completion Date: 2023-11-10

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

experimental group

Group Type: EXPERIMENTAL

force feedback rehabilitation robot (SEM™ Glove)

Intervention Type: DEVICE

In the experimental group, the therapists were asked to illustrate and demonstrate the motor points of the cylindrical grasping and spherical grasping movements, and the patients were instructed to imitate them with nonparalytic hand, while the latter patients wore SEM™ Glove were used for task-oriented training, such as inserting pegs, grasping a ball into a barrel, and drinking water exercises. The difficulty of task-oriented training can be adjusted according to the patient's actual condition, such as changing the shape, weight, size of the target or changing the distance, duration, and so on during training

control group

Group Type: ACTIVE_COMPARATOR

assisted by a therapist

Intervention Type: OTHER

The control group received task-oriented training assisted by a therapist to complete the same task as the experimental group. Therapists need to instruct patients to try to grasp items and give appropriate assistance to guarantee their completion of the grasping task. If finger extension is weak, the therapist assists the patient in extension of the digits before grasping the items, and if the finger flexion angle does not meet the grasp function needs, it should assist in flexion finger movements

Interventions

force feedback rehabilitation robot (SEM™ Glove)

In the experimental group, the therapists were asked to illustrate and demonstrate the motor points of the cylindrical grasping and spherical grasping movements, and the patients were instructed to imitate them with nonparalytic hand, while the latter patients wore SEM™ Glove were used for task-oriented training, such as inserting pegs, grasping a ball into a barrel, and drinking water exercises. The difficulty of task-oriented training can be adjusted according to the patient's actual condition, such as changing the shape, weight, size of the target or changing the distance, duration, and so on during training

Intervention Type: DEVICE

assisted by a therapist

The control group received task-oriented training assisted by a therapist to complete the same task as the experimental group. Therapists need to instruct patients to try to grasp items and give appropriate assistance to guarantee their completion of the grasping task. If finger extension is weak, the therapist assists the patient in extension of the digits before grasping the items, and if the finger flexion angle does not meet the grasp function needs, it should assist in flexion finger movements

Intervention Type: OTHER

Other Intervention Names

SEM™ Glove

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Hospital of Jilin University

OTHER

Sponsor Role: lead

Responsible Party

Zhenlan li

department director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

First hospital of Jilin University

Changchun, , China

Site Status: RECRUITING

Countries

China

Central Contacts

zhenlan li

Role: CONTACT

zhenlan@jlu.edu.cn

15943053720

Facility Contacts

zhenlan li

Role: primary

zhenlan@jlu.edu.cn

15943053720

References

Li Y, Lian Y, Chen X, Zhang H, Xu G, Duan H, Xie X, Li Z. Effect of task-oriented training assisted by force feedback hand rehabilitation robot on finger grasping function in stroke patients with hemiplegia: a randomised controlled trial. J Neuroeng Rehabil. 2024 May 14;21(1):77. doi: 10.1186/s12984-024-01372-3.

Reference Type: DERIVED

PMID: 38745227 (View on PubMed)

Other Identifiers

20220101

Identifier Type: -

Identifier Source: org_study_id