Unilateral vs. Bilateral Approaches to Hybrid Stroke Rehabilitation

Not Applicable

• Conditions: Stroke
• Interventions: Procedure: Robot-Assisted Training; Procedure: Bilateral Hybrid Intervention; Procedure: Unilateral Hybrid Intervention

• Registration Number: NCT02451280
• Lead Sponsor: Chang Gung Memorial Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-05-19
• Study First Submitted QC: 2015-05-20
• Study First Posted: 2015-05-21
• Study Start: 2015-06
• Status Verified: 2016-06
• Last Update Submitted: 2016-07-06
• Last Update Posted: 2016-07-07
• Primary Completion: 2019-05
• Study Completion: 2019-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 72

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Robot-Assisted Training Group	Robot-Assisted Training	Participants will receive 6 weeks of RT training using the BMT in each session.
Bilateral Hybrid Intervention Group	Bilateral Hybrid Intervention	Participants will receive 6 weeks of bilateral RT training using the BMT and BAT training in each session.
Unilateral Hybrid Intervention Group	Unilateral Hybrid Intervention	Participants will receive 6 weeks of bilateral RT training using the BMT and UAT training in each session.

Primary Outcome Measures

Name	Time	Method
Change scores of Fugl-Meyer assessment(FMA)	baseline, 3 weeks, 6 weeks, 18 weeks

Secondary Outcome Measures

Name	Time	Method
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
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 Medical Research Council scale (MRC)	baseline, 3 weeks, 6 weeks
Change scores of Action research arm test (ARAT)	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 Motor activity log (MAL)	baseline, 6 weeks, 18 weeks
Change scores of kinematic analysis	baseline, 6 weeks
Change scores of Adverse effects	baseline, 3 weeks, 6 weeks
Change scores of Hand strength	baseline, 3 weeks, 6 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 Algometer	baseline, 6 weeks
Change scores of Revised Nottingham Sensory Assessment (rNSA)	baseline, 6 weeks

Trial Locations

Locations (3)

Taipei Hospital, Ministry of Health and Welfare; 🇨🇳 New Taipei City, Taiwan

Chang Gung Memorial Hospital; 🇨🇳 Kwei-Shan, Tao-Yuan, Taiwan

Lo-Sheng Sanatorium and Hospital; 🇨🇳 Kwei-shan, Toayuan county, Taiwan