Unilateral vs. Bilateral Approaches to Hybrid Stroke Rehabilitation

NCT ID: NCT02451280

Last Updated: 2016-07-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2019-05-31

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.

Conditions

Stroke

Study Design

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

Study Groups

Unilateral Hybrid Intervention Group

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

Group Type: EXPERIMENTAL

Unilateral Hybrid Intervention

Intervention Type: PROCEDURE

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).

Bilateral Hybrid Intervention Group

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

Group Type: EXPERIMENTAL

Bilateral Hybrid Intervention

Intervention Type: PROCEDURE

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.

Robot-Assisted Training Group

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

Group Type: EXPERIMENTAL

Robot-Assisted Training

Intervention Type: PROCEDURE

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

Interventions

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).

Intervention Type: 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.

Intervention Type: 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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ching-Yi Wu, ScD

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital

Locations

Lo-Sheng Sanatorium and Hospital

Kwei-shan, Toayuan County, Taiwan

Site Status: NOT_YET_RECRUITING

Chang Gung Memorial Hospital

Kwei-Shan, Tao-Yuan, , Taiwan

Site Status: NOT_YET_RECRUITING

Taipei Hospital, Ministry of Health and Welfare

New Taipei City, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Ching-Yi Wu, ScD

Role: CONTACT

cywu@mail.cgu.edu.tw

886-3-2118800 ext. 5761

Facility Contacts

Wu

Role: primary

cywu@mail.cgu.edu.tw

886-3-211-8800 Ext. 5761

Ching-Yi Wu, ScD

Role: primary

cywu@mail.cgu.edu.tw

886-3-2118800 ext. 5761

References

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.

Reference Type: DERIVED

PMID: 31421096 (View on PubMed)

Other Identifiers

103-1621A3

Identifier Type: -

Identifier Source: org_study_id