Unilateral vs. Bilateral Approaches to Hybrid Stroke Rehabilitation

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: Unknown
• Conditions: Stroke
• Intervention / Treatment: Procedure: Unilateral Hybrid Intervention; Procedure: Bilateral Hybrid Intervention; Procedure: Robot-Assisted Training

• Study Type: Interventional
• Enrollment (Anticipated): 72
• Phase: Not Applicable

Contacts and Locations

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: Wu; Phone Number: 886-3-211-8800 Ext. 5761; Email: cywu@mail.cgu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 78 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Time Frame
Change scores of Fugl-Meyer assessment(FMA)	baseline, 3 weeks, 6 weeks, 18 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Anticipated): May 1, 2019
• Study Completion (Anticipated): May 1, 2019

Study Registration Dates

• First Submitted: May 19, 2015
• First Submitted That Met QC Criteria: May 20, 2015
• First Posted (Estimate): May 21, 2015

Study Record Updates

• Last Update Posted (Estimate): July 7, 2016
• Last Update Submitted That Met QC Criteria: July 6, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: robot-assisted therapy; stroke rehabilitation; hybrid therapy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: 103-1621A3