Effects of Circuit Training Combining Different Types of Distal Robot-assisted and Task-oriented Therapy on Motor Control, Motor and Daily Functions, and Quality of Life After Stroke

Chang Gung Medical Foundation

Status: Enrolling

Conditions: Stroke Patients

Treatments: Behavioral: Bilateral task-oriented therapy; Device: Robots can aid in distal UE rehabilitation through exoskeleton (EXO); Device: End-effector robot-assisted therapy (EE); Behavioral: Unilateral task-oriented therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06258538

202301367B0

Details and patient eligibility

About

This study proposes a novel stroke rehabilitation approach for upper extremity training by firstly combining different types of distal robot-assisted and task-oriented therapy in a circuit training program. The program could enhance UE functions, improving daily function, decrease caregiver burden and lower medical expenses associated with long-term care. Professionals can use these findings to promote the application of clinically empirical research and better understand the effects and mechanisms of circuit training.

Enrollment: 87 estimated patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. unilateral stroke ≥ 3 months onset
2. Fugl-Meyer Assessment for Upper Extremity (FMA-UE) score between 18 to 56, indicating different levels of motor impairments ;
3. without excessive spasticity in any of the UE joint (modified Ashworth scale ≤3 in proximal joints and modified Ashworth scale ≤2 in distal joints);
4. Mini Mental State Exam (MMSE) score > 24, indicating no serious cognitive impairment;
5. between the ages of 20 and 75 years -

Exclusion criteria

1. histories of other neurological diseases such as dementia, Parkinson's disease, and peripheral polyneuropathy;
2. difficulties in following and understanding instructions such as global aphasia;
3. enroll in other rehabilitation or drug studies simultaneously;
4. receiving Botulinum toxin injections within 3 months. -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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87 participants in 3 patient groups

distal robot-assisted and task-oriented therapy

Experimental group

Description:

Participants in the Circuit group received interventions for 20-min exoskeleton(EXO) and 20-min end-effector(EE) robot-assisted therapy, followed by 20-min uni- and 20-min bi- task-oriented therapy/session, 3 sessions/week for 6 consecutive weeks.

Treatment:

Behavioral: Unilateral task-oriented therapy

Device: End-effector robot-assisted therapy (EE)

Device: Robots can aid in distal UE rehabilitation through exoskeleton (EXO)

Behavioral: Bilateral task-oriented therapy

distal robot-assisted therapy alone

Experimental group

Description:

Participants in the Robot group received interventions for 40-min exoskeleton(EXO) and 40-min end-effector(EE) robot-assisted therapy/session, 3 sessions/week for 6 consecutive weeks.

Treatment:

Device: End-effector robot-assisted therapy (EE)

Device: Robots can aid in distal UE rehabilitation through exoskeleton (EXO)

task-oriented therapy alone

Active Comparator group

Description:

Participants in the task-oriented therapy(TOT) group received interventions for 40-min uni- and 40-min bi- task-oriented therapy/session, 3 sessions/week for 6 consecutive weeks.

Treatment:

Behavioral: Unilateral task-oriented therapy

Behavioral: Bilateral task-oriented therapy