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

Overview

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.

Interventions

• Device Robots can aid in distal UE rehabilitation through exoskeleton (EXO)
  Exoskeleton robot-assisted therapy Each EXO robot-assisted therapy session consists of continuous passive motion (30 percent of duration), active-assisted training (30 percent of duration), and interactive training (40 percent of duration) using the Hand of Hope (HOH) robotic hand system . HOH is an exoskeleton type of robot that is worn on the dorsal side of the impaired hand with 2 surface EMG sensors attached to the extensor digitorum and flexor digitorum superficialis.
• Device End-effector robot-assisted therapy (EE)
  Each EE robot-assisted therapy session consists of continuous passive motion (30 percent of duration), active-assisted training (30 percent of duration), and interactive training (40 percent of duration) using the Amadeo robotic system. Amadeo is an end-effector robot with 5 finger slides, which are attached to the fingertips and the thumb via magnetic finger pads. The integrated sensor for each finger allows the robot system to provide patients with real-time visual feedback of finger strengths
• Behavioral Unilateral task-oriented therapy
  The therapy will focus on task-oriented therapy with the affected UE and the training tasks involve proximal or distal UE movement, such as ringing a bell, picking up coins, grasping and releasing various cups, and other functional movements involved in daily activities. The level of challenge will be adapted according to patient ability and improvement during training.
• Behavioral Bilateral task-oriented therapy
  The functional training tasks emphasize UE movements (gross or fine motor tasks) involved in daily activities but focus on both UEs moving synchronously, such as opening 2 closet doors, grasping and releasing 2 towels, wiping the table with 2 hands, and so on. The activities can also be graded in terms of difficulty and task requirements, according to the impairment level and the progression of the UE of each participant.

Primary outcome measures

• Mini-Mental State Examination (MMSE) [Time frame: baseline , after the completion of the 18-session intervention , and 3 month after intervention]
• Fugl-Meyer Assessment for Upper Extremity (FMA-UE) [Time frame: baseline , after the completion of the 18-session intervention , and 3 month after intervention]
• Modified Ashworth scale of muscle spasticity (MAS) [Time frame: baseline , after the completion of the 18-session intervention , and 3 month after intervention]
• Grip and pinch strength [Time frame: baseline , after the completion of the 18-session intervention , and 3 month after intervention]
• Medical Research Council scale (MRC) [Time frame: baseline , after the completion of the 18-session intervention , and 3 month after intervention]
• Revised Nottingham Sensory Assessment (rNSA) [Time frame: baseline , after the completion of the 18-session intervention , and 3 month after intervention]
• Wolf Motor Function Test (WMFT) [Time frame: baseline , after the completion of the 18-session intervention , and 3 month after intervention]
• Motor Activity Log (MAL) [Time frame: baseline , after the completion of the 18-session intervention , and 3 month after intervention]
• Nottingham Extended Activities of Daily Living Scale (NEADL): [Time frame: baseline , after the completion of the 18-session intervention , and 3 month after intervention]
• Stroke Impact Scale Version 3.0 (SIS 3.0) [Time frame: baseline , after the completion of the 18-session intervention , and 3 month after intervention]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Taiwan · 1 center

• Chang Gung Memotial Hospital — Taoyuan

Identifiers

NCT: NCT06258538 · 202301367B0

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗