Unilateral vs. Bilateral Approaches to Hybrid Stroke Rehabilitation

Chang Gung Medical Foundation

Status: Unknown

Conditions: Stroke

Treatments: Procedure: Robot-Assisted Training; Procedure: Unilateral Hybrid Intervention; Procedure: Bilateral Hybrid Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT02451280

103-1621A3

Details and patient eligibility

About

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.

Enrollment: 72 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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72 participants in 3 patient groups

Unilateral Hybrid Intervention Group

Experimental group

Description:

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

Treatment:

Procedure: Unilateral Hybrid Intervention

Bilateral Hybrid Intervention Group

Experimental group

Description:

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

Treatment:

Procedure: Bilateral Hybrid Intervention

Robot-Assisted Training Group

Experimental group

Description:

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

Treatment:

Procedure: Robot-Assisted Training