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Unilateral vs. Bilateral Approaches to Hybrid Stroke Rehabilitation

Primary Purpose

Stroke

Status

Unknown status

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

Unilateral Hybrid Intervention

Bilateral Hybrid Intervention

Robot-Assisted Training

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke rehabilitation, robot-assisted therapy, hybrid therapy

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Lo-Sheng Sanatorium and Hospital
Chang Gung Memorial Hospital
Taipei Hospital, Ministry of Health and WelfareRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Unilateral Hybrid Intervention Group

Bilateral Hybrid Intervention Group

Robot-Assisted Training Group

Arm Description

Participants will receive 6 weeks of bilateral RT training using the BMT and UAT training in each session.

Participants will receive 6 weeks of bilateral RT training using the BMT and BAT training in each session.

Participants will receive 6 weeks of RT training using the BMT in each session.

Outcomes

Primary Outcome Measures

Change scores of Fugl-Meyer assessment(FMA)

Secondary Outcome Measures

Wolf Motor Function Test (WMFT)

Change scores of Box and block test (BBT)

Change scores of Action research arm test (ARAT)

Change scores of Medical Research Council scale (MRC)

Change scores of Modified Ashworth scale (MAS)

Change scores of Myoton

Change scores of Chedoke Arm and Hand Activity Inventory (CAHAI)

Change scores of Functional independent measure (FIM)

Change scores of Stroke Impact Scale (SIS 3.0 version)

Change scores of EuroQol Quality of Life Scale (EQ-5D)

Change scores of Hand strength

Change scores of Motor activity log (MAL)

Change scores of ABILHAND Questionnaire

Change scores of 10-meter walking test

Change scores of Nottingham Extended ADL Questionnaire (NEADL)

Change scores of Adelaide Activities Profile (AAP)

Change scores of Accelerometer

Change scores of kinematic analysis

Change scores of Adverse effects

Change scores of Algometer

Change scores of Revised Nottingham Sensory Assessment (rNSA)

Full Information

NCT ID

NCT02451280

First Posted

May 19, 2015

Last Updated

July 6, 2016

Sponsor

Chang Gung Memorial Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02451280

Brief Title

Unilateral vs. Bilateral Approaches to Hybrid Stroke Rehabilitation

Official Title

Unilateral vs. Bilateral Approaches to Hybrid Stroke Rehabilitation

Study Type

Interventional

2. Study Status

Record Verification Date

June 2016

Overall Recruitment Status

Unknown status

Study Start Date

June 2015 (undefined)

Primary Completion Date

May 2019 (Anticipated)

Study Completion Date

May 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Chang Gung Memorial Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke

Keywords

stroke rehabilitation, robot-assisted therapy, hybrid therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

72 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Unilateral Hybrid Intervention Group

Arm Type

Experimental

Arm Description

Participants will receive 6 weeks of bilateral RT training using the BMT and UAT training in each session.

Arm Title

Bilateral Hybrid Intervention Group

Arm Type

Experimental

Arm Description

Participants will receive 6 weeks of bilateral RT training using the BMT and BAT training in each session.

Arm Title

Robot-Assisted Training Group

Arm Type

Experimental

Arm Description

Participants will receive 6 weeks of RT training using the BMT in each session.

Intervention Type

Procedure

Intervention Name(s)

Unilateral Hybrid Intervention

Intervention Description

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).

Intervention Type

Procedure

Intervention Name(s)

Bilateral Hybrid Intervention

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Robot-Assisted Training

Intervention Description

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

Primary Outcome Measure Information:

Title

Change scores of Fugl-Meyer assessment(FMA)

Time Frame

baseline, 3 weeks, 6 weeks, 18 weeks

Secondary Outcome Measure Information:

Title

Wolf Motor Function Test (WMFT)

Time Frame

baseline, 6 weeks

Title

Change scores of Box and block test (BBT)

Time Frame

baseline, 3 weeks, 6 weeks, 18 weeks

Title

Change scores of Action research arm test (ARAT)

Time Frame

baseline, 3 weeks, 6 weeks

Title

Change scores of Medical Research Council scale (MRC)

Time Frame

baseline, 3 weeks, 6 weeks

Title

Change scores of Modified Ashworth scale (MAS)

Time Frame

baseline, 3 weeks, 6 weeks

Title

Change scores of Myoton

Time Frame

baseline, 6 weeks

Title

Change scores of Chedoke Arm and Hand Activity Inventory (CAHAI)

Time Frame

baseline, 6 weeks

Title

Change scores of Functional independent measure (FIM)

Time Frame

baseline, 3 weeks, 6 weeks

Title

Change scores of Stroke Impact Scale (SIS 3.0 version)

Time Frame

baseline, 3 weeks, 6 weeks, 18 weeks

Title

Change scores of EuroQol Quality of Life Scale (EQ-5D)

Time Frame

baseline, 6 weeks

Title

Change scores of Hand strength

Time Frame

baseline, 3 weeks, 6 weeks

Title

Change scores of Motor activity log (MAL)

Time Frame

baseline, 6 weeks, 18 weeks

Title

Change scores of ABILHAND Questionnaire

Time Frame

baseline, 6 weeks, 18 weeks

Title

Change scores of 10-meter walking test

Time Frame

baseline, 6 weeks

Title

Change scores of Nottingham Extended ADL Questionnaire (NEADL)

Time Frame

baseline, 6 weeks, 18 weeks

Title

Change scores of Adelaide Activities Profile (AAP)

Time Frame

baseline, 6 weeks

Title

Change scores of Accelerometer

Time Frame

baseline, 6 weeks

Title

Change scores of kinematic analysis

Time Frame

baseline, 6 weeks

Title

Change scores of Adverse effects

Time Frame

baseline, 3 weeks, 6 weeks

Title

Change scores of Algometer

Time Frame

baseline, 6 weeks

Title

Change scores of Revised Nottingham Sensory Assessment (rNSA)

Time Frame

baseline, 6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: ≥3 months onset from a first-ever unilateral stroke; minimal motor criteria to receive CIT (i.e., ≥10º wrist extension and ≥ 10º extension at the thumb and any two other digits); an initial FMA-UE score of 10 to 56, indicating mild to moderate and moderate to severe upper extremity motor impairment; no excessive spasticity in any of the joints of the affected arm (shoulder, elbow, wrist, and fingers); able to follow instructions and perform the study tasks (Mini Mental State Examination ≥ 22); without upper extremity fracture within 3 months; no participation in any rehabilitation experiments or drug studies during the study period; and (8) willing to provide written informed consent. Exclusion Criteria: acute inflammatory disease; major health problems or poor physical condition that might limit participation; and (3) attend any other study in recent 3 months.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ching-Yi Wu, ScD

Phone

886-3-2118800

Ext

5761

cywu@mail.cgu.edu.tw

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ching-Yi Wu, ScD

Organizational Affiliation

Chang Gung Memorial Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Lo-Sheng Sanatorium and Hospital

City

Kwei-shan

State/Province

Toayuan county

ZIP/Postal Code

333

Country

Taiwan

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Phone

886-3-211-8800 Ext. 5761

cywu@mail.cgu.edu.tw

Facility Name

Chang Gung Memorial Hospital

City

Kwei-Shan, Tao-Yuan

ZIP/Postal Code

333

Country

Taiwan

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ching-Yi Wu, ScD

Phone

886-3-2118800

Ext

5761

cywu@mail.cgu.edu.tw

Facility Name

Taipei Hospital, Ministry of Health and Welfare

City

New Taipei City

Country

Taiwan

Individual Site Status

Recruiting

12. IPD Sharing Statement

Citations:

PubMed Identifier

31421096

Citation

Hung CS, Lin KC, Chang WY, Huang WC, Chang YJ, Chen CL, Grace Yao K, Lee YY. Unilateral vs Bilateral Hybrid Approaches for Upper Limb Rehabilitation in Chronic Stroke: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2019 Dec;100(12):2225-2232. doi: 10.1016/j.apmr.2019.06.021. Epub 2019 Aug 14.

Results Reference

derived

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Unilateral vs. Bilateral Approaches to Hybrid Stroke Rehabilitation

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