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

September 12, 2019 updated by: Ten-Chen General Hospital
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
34

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taoyuan City, Taiwan
        • Ten Chan General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: 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.
Device: Robotic
Participants will be placed in the robot and practice common hand tasks involving single finger range of motion exercise, grasping, and pinching objects.
Other Names:
  • Conventional therapy
Other: 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.
ACTIVE_COMPARATOR: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Fugl-Meyer score
Time Frame: Change from baseline to 10 weeks
The investigators used FMA scale to evaluate sensorimotor recovery of patients with particular attention to the hand and wrist section (maximum score=24) to assess the functional capacity of the affected hand.
Change from baseline to 10 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Motricity Index (MI) scale
Time Frame: Change from baseline to 10 weeks
The Motricity Index was used to measure strength in upper and lower extremities after stroke. The weighted score based on the ordinal 6 point scale of Medical Research Council was used to measure maximal isometric muscle strength.
Change from baseline to 10 weeks
Change in Functional Independence Measure scale (FIM)
Time Frame: Change from baseline to 10 weeks
The investigators used FIM to assess the degree of independence and need-of-assistance in basic activities of daily living at enrolment and at the end of the study. FIM is an 18-item ordinal scale rated from 1 (total dependence) to 7 (total independence) per item; 13 items of this scale, the sub-scale Motor- FIM, were used to evaluate motor disability.
Change from baseline to 10 weeks
Change in Visual analogue scale (VAS)
Time Frame: Change from baseline to 10 weeks
The investigators used VAS (0 extremely simple- 10 extremely difficult) to access the feasibility of the device in terms of the number of patients who completed the program.
Change from baseline to 10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ten-Chen General Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Chung Yuan Christian University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Chia-yu Hsu, MD, Ten-Chan General hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 24, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 9, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 9, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 7, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 20, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 25, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 13, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 12, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TenChenGH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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