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

NCT05841108 | Unknown

• 1 other identifier: 20220101
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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

Keywords

Hand dysfunction; Force feedback hand rehabilitation robot; Task-oriented training; Neurorehabilitation

Outcome Measures

Primary Outcomes (1)

• Fugl-Meyer motor function assessment-upper limb finger motor part

  Fugl-meyer motor function assessment-upper limb (FMA-UL) has been found a reliable and valid test for the assessment of arm hand function in stroke patients. The maximum score of on the FMA-UL is 66 points. This study used FMA-UL finger motor part , with a total score of 14 points.

  Change from baseline Fugl-Meyer motor function assessment-upper limb finger motor part score at 4 weeks

Secondary Outcomes (5)

• Modified Ashworth scale (MAS)

  Change from baseline Modified Ashworth scale outcome at 4 weeks

• Range of motion (ROM)

  Change from baseline range of motion outcome at 4 weeks

• grip strength

  Change from baseline grip strength at 4 weeks

• Brunnstrom recovery stages of hand (BRS-H)

  Change from baseline brunnstrom recovery stages of hand at 4 weeks

• Barthel index (BI)

  Change from baseline barthel index at 4 weeks

Study Arms (2)

experimental group

EXPERIMENTAL

Device: force feedback rehabilitation robot (SEM™ Glove)

control group

ACTIVE COMPARATOR

Other: assisted by a therapist

Interventions

force feedback rehabilitation robot (SEM™ Glove) 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

Also known as: SEM™ Glove

experimental group

assisted by a therapist 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

control group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Hospital of Jilin University: lead

Study Sites (1)

First hospital of Jilin University

Changchun, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 38745227 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

zhenlan li

CONTACT

15943053720; zhenlan@jlu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: department director

Study Record Dates

• First Submitted: February 14, 2023
• First Posted: May 3, 2023
• Study Start: May 4, 2023
• Primary Completion: November 10, 2023
• Study Completion: November 10, 2023
• Last Updated: May 6, 2023

Record last verified: 2023-05

Locations

CN (1)