Unilateral vs. Bilateral Approaches to Hybrid Stroke Rehabilitation

Stroke Clinical Trial

Official title:

Unilateral vs. Bilateral Approaches to Hybrid Stroke Rehabilitation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02451280
• Other study ID #: 103-1621A3
• Status: Recruiting
• Phase: N/A
• First received: May 19, 2015
• Last updated: July 6, 2016
• Start date: June 2015
• Est. completion date: May 2019

Study information

• Verified date: June 2016
• Source: Chang Gung Memorial Hospital
• Contact: Ching-Yi Wu, ScD
• Phone: 886-3-2118800
• Email: cywu[@]mail.cgu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: May 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

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).
• 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.
• 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

Locations

Country	Name	City	State
Taiwan	Lo-Sheng Sanatorium and Hospital	Kwei-shan	Toayuan county
Taiwan	Chang Gung Memorial Hospital	Kwei-Shan, Tao-Yuan
Taiwan	Taipei Hospital, Ministry of Health and Welfare	New Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change scores of Fugl-Meyer assessment(FMA)		baseline, 3 weeks, 6 weeks, 18 weeks	No
Secondary	Wolf Motor Function Test (WMFT)		baseline, 6 weeks	No
Secondary	Change scores of Box and block test (BBT)		baseline, 3 weeks, 6 weeks, 18 weeks	No
Secondary	Change scores of Action research arm test (ARAT)		baseline, 3 weeks, 6 weeks	No
Secondary	Change scores of Medical Research Council scale (MRC)		baseline, 3 weeks, 6 weeks	No
Secondary	Change scores of Modified Ashworth scale (MAS)		baseline, 3 weeks, 6 weeks	No
Secondary	Change scores of Myoton		baseline, 6 weeks	No
Secondary	Change scores of Chedoke Arm and Hand Activity Inventory (CAHAI)		baseline, 6 weeks	No
Secondary	Change scores of Functional independent measure (FIM)		baseline, 3 weeks, 6 weeks	No
Secondary	Change scores of Stroke Impact Scale (SIS 3.0 version)		baseline, 3 weeks, 6 weeks, 18 weeks	No
Secondary	Change scores of EuroQol Quality of Life Scale (EQ-5D)		baseline, 6 weeks	No
Secondary	Change scores of Hand strength		baseline, 3 weeks, 6 weeks	No
Secondary	Change scores of Motor activity log (MAL)		baseline, 6 weeks, 18 weeks	No
Secondary	Change scores of ABILHAND Questionnaire		baseline, 6 weeks, 18 weeks	No
Secondary	Change scores of 10-meter walking test		baseline, 6 weeks	No
Secondary	Change scores of Nottingham Extended ADL Questionnaire (NEADL)		baseline, 6 weeks, 18 weeks	No
Secondary	Change scores of Adelaide Activities Profile (AAP)		baseline, 6 weeks	No
Secondary	Change scores of Accelerometer		baseline, 6 weeks	No
Secondary	Change scores of kinematic analysis		baseline, 6 weeks	No
Secondary	Change scores of Adverse effects		baseline, 3 weeks, 6 weeks	No
Secondary	Change scores of Algometer		baseline, 6 weeks	No
Secondary	Change scores of Revised Nottingham Sensory Assessment (rNSA)		baseline, 6 weeks	No