Clinical trial NCT05226988: Effect of Hybrid Robot-assisted Training Using End-effector and Exoskeleton Devices in Distal Upper Extremity After Stroke：Motor Control, Motor and Daily Function, Quality of Life
Official title: The Study Firstly Proposes a Hybrid Robot-assisted Training Program, Which Combines Two Types of Robotic Systems, to Enhance the Effectiveness of Robot-assisted Training and Provide a New Approach for Motor Training of Upper Limb in Stroke Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: neurorehabilitation
robot-assisted training
upper extremity
motor control
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2022-02-07
Enrollment: 70
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to examine the immediate and long-term effects of hybrid robot-assisted training (Hybrid-RT), exoskeleton robot-assisted training (Exo-RT), end-effector robot-assisted training (EE-RT), and conventional training on stroke patients' motor performance, daily life functions, quality of life, and self-efficacy.

Detailed description: Stroke is a leading cause of long-term disability, and most stroke survivors have chronic upper limb dysfunction, which affects participation in activities of daily living. In addition to conventional rehabilitation training, robot-assisted training has been advocated as a contemporary approach of hand function training. Robotic devices can be categorized into exoskeleton and end-effector types based on their mechanical design. However, previous studies did not reach an agreement on the effectiveness of two types of robot-assisted training. The study firstly proposes a hybrid robot-assisted training program, which combines two types of robotic systems, to enhance the effectiveness of robot-assisted training and provide a new approach for motor training of upper limb in stroke patients. Secondly, the relative effects of the two types of robot-assisted training will be compared. The purpose of this study is to examine the immediate and long-term effects of hybrid robot-assisted training , exoskeleton robot-assisted training , end-effector robot-assisted training , and conventional training on stroke patients' motor performance, daily life functions, quality of life, and self-efficacy. The study will recruit stroke patients and randomly assign them to the hybrid robot-assisted training, exoskeleton robot-assisted training, end-effector robot-assisted training, and conventional training groups. Each participant will receive training 3 sessions a week for 6 consecutive weeks. Participants will be assessed at baseline, after the intervention, and at 3-month follow-up. Repeated measures of analysis of variance will be used to evaluate the changes within each intervention group at three evaluation times and to compare the differences between the four intervention groups. In order to understand the motor learning effects after receiving different interventions, the investigator use kinematic analysis to investigate the movement control mechanism of upper limb movements. The findings of this study will build the evidence-based foundation for bridging the gap between basic science and clinical application.

Eligibility criteria: Inclusion Criteria:

* Stroke more than 3 months.
* Modified Ashworth Scale proximal part ≤ 3, Modified Ashworth Scale distal part ≤ 2, and no serious muscle spasms.
* The myoelectric signal can be detected to activate the instrument
* Unilateral paresis (FMA score\<60)
* No serious cognitive impairment (i.e., Mini Mental State Exam score \> 24)
* Can provide informed consent

Exclusion Criteria:

* Other neurological disease
* Complete sense of body defect
* Inability to understand instructions
* current participation in any other research
* Botulinum Toxin injection within 3 months

Primary outcomes:
measure: Change scores of Fugl-Myer Assessment (FMA)
timeFrame: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
measure: Change scores of Active Range of Motion (AROM)
timeFrame: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
measure: Change scores of grip and pinch power
timeFrame: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
measure: Change scores of Modified Ashworth (MAS)
timeFrame: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
measure: Change scores of Medical Research Council (MRC)
timeFrame: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
measure: Change scores of Revised Nottingham Sensory Assessment (rNSA)
timeFrame: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
measure: Change scores of Wolf Motor Function Test (WMFT)
timeFrame: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
measure: Change scores of Mini-Mental State Exam (MMSE)
timeFrame: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
measure: Change scores of Montreal Cognitive Assessment (MoCA)
timeFrame: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
measure: Change scores of Motor Activity Log (MAL)
timeFrame: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
measure: Change scores of Nottingham Extended Activities of Daily Living Scale (NEADL)
timeFrame: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
measure: Change scores of Stroke Impact Scale (SIS)
timeFrame: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
measure: Change scores of stroke self-efficacy questionnaire (SSEQ)
timeFrame: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
measure: Change scores of Daily Living Self-Efficacy Scale (DLSES)
timeFrame: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
measure: Change scores of Functional Abilities Confidence Scale (FACS)
timeFrame: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
measure: Kinematic analysis
timeFrame: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
measure: Change scores of pain threshold measurements
timeFrame: Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memotial Hospital
Study officials:
References: