Is the Rehabilitation Robotic a Safe and Effective Choice for Stroke Patients?

NCT ID: NCT03290833

Last Updated: 2019-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-24
• Study Completion Date: 2019-06-09

Brief Summary

The effectiveness of robotic over conventional therapy is arguable and the best therapy strategy is still not clear. Basing on the existing evidence on motor learning and practice-induced neuroplasticity, the investigators plan to use an exoskeleton robotic hand to enhance the rehabilitation volume in the subacute stage of stroke patients. The robotic system allows intensive and customized training of hand and finger movements. The aim of this study is (1) to establish whether robot assisted therapy provides any additional motor recovery for the hand when administered during the subacute stage in a Chinese adult population diagnosed with stroke; (2) to evaluate the feasibility and efficacy of robot-assisted hand rehabilitation in improving arm function abilities in subacute hemiplegic patients.

Detailed Description

Introduction The number of incident strokes, prevalent stroke survivors, disability-adjusted life-years (DALYs) lost due to stroke, and stroke-related deaths is increasing in the word (1). Stroke is the most common cause of complex disability in Taiwan (2). After the acute phase of stroke, many patients are left with impairment of upper-limb movement (hemiparesis) because of the hand weakness and abnormal contractions. Motor recovery of the hand is the slowest and most difficult, leading to limited hand activities and occupational disability. Therefore, facilitating motor recovery of hand after stroke is crucial in stroke rehabilitation.

The mechanisms of recovery after stroke are multifactorial and the effect of rehabilitation programs is complex (3). Activity-dependent neural plasticity of the cortical maps adjacent to the lesion probably occurs, particularly during the acute period after stroke (4). In order to stimulate such plasticity, many new rehabilitation methods, including rehabilitation robots, have been developed according to the principles of motor learning (5). Robotic systems can provide repetitive, reproducible, interactive forms of physical therapy that can be quantified (6). The advantages of using robots in neuromotor rehabilitation includes favoring attention and reducing the effort of the patient during training (7), boosting motivation and adherence to treatment (8), as well as help in multi-sensory and sensorimotor integration (9). Some results are very promising, showing that robot-assisted therapy is safe and well tolerated and that it has a positive impact on muscle strength and function in the paretic arm (10-12). However, the quality of these evidence is still controversial and inconclusive. The effectiveness of robotic over conventional therapy is arguable and the best therapy strategy is still not clear. Furthermore, there is little understanding of the neurological mechanisms involved in functional recovery of the hand (13). In this study, the investigators hypothesize that the robot based assistance would outperform conventional therapy during the subacute stage of stroke.

Study objective

1. To establish whether robot assisted therapy provides any additional motor recovery for the hand when administered during the subacute stage in a Chinese adult population diagnosed with stroke.

2. To evaluate the feasibility and efficacy of robot-assisted hand rehabilitation in improving arm function abilities in subacute hemiplegic patients.

Conditions

Stroke

Study Design

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

Study Groups

Robotic

The experimental group will receive 30 minutes robotic training sessions, 3 times per week for a total of 30 sessions supervised by a research assistant. Immediately following this robot training, these subjects will receive schedule (1-hour sessions, 3 times/week, 30 total sessions) of conventional therapy from an occupational therapist.

Group Type: EXPERIMENTAL

Robotic

Intervention Type: DEVICE

Participants will be placed in the robot and practice common hand tasks involving single finger range of motion exercise, grasping, and pinching objects.

Conventional therapy

Intervention Type: OTHER

An occupational therapist will provide one-on-one individualized programs focused on arm and hand function. Treatment will include function-oriented specific tasks, such as reach, grasp, transport and release of various objects between different targets.

Conventional

In conventional therapy group, participants will receive an one-hour of one-on-one treatment (1-hour sessions, 3 times/week, 30 total sessions) from an occupational therapist, focusing on arm and hand function.

Group Type: ACTIVE_COMPARATOR

Conventional therapy

Intervention Type: OTHER

An occupational therapist will provide one-on-one individualized programs focused on arm and hand function. Treatment will include function-oriented specific tasks, such as reach, grasp, transport and release of various objects between different targets.

Interventions

Robotic

Participants will be placed in the robot and practice common hand tasks involving single finger range of motion exercise, grasping, and pinching objects.

Intervention Type: DEVICE

Conventional therapy

An occupational therapist will provide one-on-one individualized programs focused on arm and hand function. Treatment will include function-oriented specific tasks, such as reach, grasp, transport and release of various objects between different targets.

Intervention Type: OTHER

Other Intervention Names

Conventional therapy

Eligibility Criteria

Inclusion Criteria

• Adult patients (>20 years old) with a diagnosis of hemorrhagic or ischemic stroke and who experience severe upper extremity hemiparesis.

Exclusion Criteria

• severe pain and instability in the wrist of the affected arm, severe cognitive impairment, aphasia, hemispatial neglect, apraxia and joint contractures greater than 20 degrees in the affected hand.

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

Sponsors

Chung Yuan Christian University

UNKNOWN

Sponsor Role: collaborator

Ten-Chen General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chia-yu Hsu, MD

Role: PRINCIPAL_INVESTIGATOR

Ten-Chan General Hospital

Locations

Ten Chan General Hospital

Taoyuan, , Taiwan

Countries

Taiwan

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

TenChenGH

Identifier Type: -

Identifier Source: org_study_id