Unilateral vs. Bilateral Approaches to Hybrid Stroke Rehabilitation

July 6, 2016 updated by: Chang Gung Memorial Hospital
The aim of the project is to compare the effects of unilateral hybrid therapy [unilateral robot-assisted therapy (RT)] + unilateral arm training (UAT)] and bilateral hybrid therapy [bilateral RT + bilateral arm training (BAT)] on motor function, daily function, mobility, life quality, and motor control strategy in stroke patients.

Study Overview

Status

Status

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

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.

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 (Anticipated)

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.
72

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
      • Kwei-Shan, Tao-Yuan, Taiwan, 333
        • Not yet recruiting
        • Chang Gung Memorial Hospital
      • New Taipei City, Taiwan
        • Recruiting
        • Taipei Hospital, Ministry of Health and Welfare
    • Toayuan county
      • Kwei-shan, Toayuan county, Taiwan, 333
        • Not yet recruiting
        • Lo-Sheng Sanatorium and Hospital
        • Contact:

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

16 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. ≥3 months onset from a first-ever unilateral stroke;
  2. minimal motor criteria to receive CIT (i.e., ≥10º wrist extension and ≥ 10º extension at the thumb and any two other digits);
  3. an initial FMA-UE score of 10 to 56, indicating mild to moderate and moderate to severe upper extremity motor impairment;
  4. no excessive spasticity in any of the joints of the affected arm (shoulder, elbow, wrist, and fingers);
  5. able to follow instructions and perform the study tasks (Mini Mental State Examination ≥ 22);
  6. without upper extremity fracture within 3 months;
  7. no participation in any rehabilitation experiments or drug studies during the study period; and (8) willing to provide written informed consent.

Exclusion Criteria:

  1. acute inflammatory disease;
  2. major health problems or poor physical condition that might limit participation; and (3) attend any other study in recent 3 months.

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 Assignment
  • Masking: Single

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: Unilateral Hybrid Intervention Group
Participants will receive 6 weeks of bilateral RT training using the BMT and UAT training in each session.
Procedure: Unilateral Hybrid Intervention
For the unilateral RT training, participants will practice with their affected arms following a unilateral training protocol of BMT for 45 minutes (Yang, et al., 2012). For the UAT training, participants will receive training of the affected UL in functional tasks with behavioral shaping for 45 minutes (Lin, Wu, et al., 2009).
Experimental: Bilateral Hybrid Intervention Group
Participants will receive 6 weeks of bilateral RT training using the BMT and BAT training in each session.
Procedure: Bilateral Hybrid Intervention
For the bilateral RT training, patients will focus on training involving both arms using the BMT robot for 45 minutes. During the 45 minutes BAT training, participants will receive training in tasks focusing on bilateral symmetric or alternating movements of both ULs.
Experimental: Robot-Assisted Training Group
Participants will receive 6 weeks of RT training using the BMT in each session.
Procedure: Robot-Assisted Training
The RT intervention will be matched in duration and intensity with the hybrid interventions. Participants in the RT group will practice on the BMT with bilateral protocols for 90 minutes. The tasks will be tailored according to the level

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
Time Frame
Change scores of Fugl-Meyer assessment(FMA)
Time Frame: baseline, 3 weeks, 6 weeks, 18 weeks
baseline, 3 weeks, 6 weeks, 18 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
Time Frame
Wolf Motor Function Test (WMFT)
Time Frame: baseline, 6 weeks
baseline, 6 weeks
Change scores of Box and block test (BBT)
Time Frame: baseline, 3 weeks, 6 weeks, 18 weeks
baseline, 3 weeks, 6 weeks, 18 weeks
Change scores of Action research arm test (ARAT)
Time Frame: baseline, 3 weeks, 6 weeks
baseline, 3 weeks, 6 weeks
Change scores of Medical Research Council scale (MRC)
Time Frame: baseline, 3 weeks, 6 weeks
baseline, 3 weeks, 6 weeks
Change scores of Modified Ashworth scale (MAS)
Time Frame: baseline, 3 weeks, 6 weeks
baseline, 3 weeks, 6 weeks
Change scores of Myoton
Time Frame: baseline, 6 weeks
baseline, 6 weeks
Change scores of Chedoke Arm and Hand Activity Inventory (CAHAI)
Time Frame: baseline, 6 weeks
baseline, 6 weeks
Change scores of Functional independent measure (FIM)
Time Frame: baseline, 3 weeks, 6 weeks
baseline, 3 weeks, 6 weeks
Change scores of Stroke Impact Scale (SIS 3.0 version)
Time Frame: baseline, 3 weeks, 6 weeks, 18 weeks
baseline, 3 weeks, 6 weeks, 18 weeks
Change scores of EuroQol Quality of Life Scale (EQ-5D)
Time Frame: baseline, 6 weeks
baseline, 6 weeks
Change scores of Hand strength
Time Frame: baseline, 3 weeks, 6 weeks
baseline, 3 weeks, 6 weeks
Change scores of Motor activity log (MAL)
Time Frame: baseline, 6 weeks, 18 weeks
baseline, 6 weeks, 18 weeks
Change scores of ABILHAND Questionnaire
Time Frame: baseline, 6 weeks, 18 weeks
baseline, 6 weeks, 18 weeks
Change scores of 10-meter walking test
Time Frame: baseline, 6 weeks
baseline, 6 weeks
Change scores of Nottingham Extended ADL Questionnaire (NEADL)
Time Frame: baseline, 6 weeks, 18 weeks
baseline, 6 weeks, 18 weeks
Change scores of Adelaide Activities Profile (AAP)
Time Frame: baseline, 6 weeks
baseline, 6 weeks
Change scores of Accelerometer
Time Frame: baseline, 6 weeks
baseline, 6 weeks
Change scores of kinematic analysis
Time Frame: baseline, 6 weeks
baseline, 6 weeks
Change scores of Adverse effects
Time Frame: baseline, 3 weeks, 6 weeks
baseline, 3 weeks, 6 weeks
Change scores of Algometer
Time Frame: baseline, 6 weeks
baseline, 6 weeks
Change scores of Revised Nottingham Sensory Assessment (rNSA)
Time Frame: baseline, 6 weeks
baseline, 6 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.
Chang Gung Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

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.
June 1, 2015

Primary Completion (Anticipated)

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.
May 1, 2019

Study Completion (Anticipated)

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.
May 1, 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).
May 19, 2015

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.
May 20, 2015

First Posted (Estimate)

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.
May 21, 2015

Study Record Updates

Last Update Posted (Estimate)

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.
July 7, 2016

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.
July 6, 2016

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.
June 1, 2016

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.
  • 103-1621A3

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