Clinical trial NCT04326140: Robot-assisted Therapy Combined With Mirror Priming in Upper Limb Training in Stroke
Official title: Robot-assisted Therapy Combined With Mirror Priming in Upper Limb Training in Stroke: Randomized Clinical Trial and Neuromuscular Mechanism
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: Robot assisted therapy
mirror priming
upper limb
neuromuscular mechanism
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2020-03-30
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This project will employ the robot-assisted system to assist patients to perform the grasping and releasing movement of both hands simultaneously while mirror priming strategy is applied, and, then, perform intensive and game-based finger movement training with the robotic assistance. This randomized controlled trial is the first study to explore the benefits of combined robotic-assisted therapy and mirror priming strategy in stroke patients. This proposed combined approach might be a novel combination of enhancing movement performance, daily function and quality of life for patients with stroke.

Detailed description: Approximately 70% to 80 % of stroke patients suffered from upper limb (UE) hemiparesis which limited their daily function and quality of life, as well as required considerable demands of long-term medical care. Robot-assisted training and mirror priming has been advocated as part of contemporary approaches. The robotic-assisted therapy mainly emphasized on the proximal part of UE, such as shoulder and elbow movement. While mirror priming strategy has been increasingly employed in the UE training, one question has been raised: the affected UE of stroke patients cannot complete the same movement as the sounded limb synchronously. This project will employ the robot-assisted system to assist patients to perform the grasping and releasing movement of both hands simultaneously while mirror priming strategy is applied, and, then, perform intensive and game-based finger movement training with the robotic assistance. This randomized controlled trial is the first study to explore the benefits of combined robotic-assisted therapy and mirror priming strategy in stroke patients. This proposed combined approach might be a novel combination of enhancing movement performance, daily function and quality of life for patients with stroke. This project will further explore the possible neuro-muscular mechanism underlying this combined mirror priming with robotic training. This project attempts to compare the cortical activation and neuromuscular control of patients with stroke and age-matched healthy adults in terms of electroencephalography (EEG) and muscle tone measurement. The findings of this study may lay an evidence-based foundation for bridging 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 Scale (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 scale (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 10-Meter Walk Test (10MWT)
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: Electromyography (EMG)
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: Task-based Electroencephalogram (EEG)
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 City
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Ching-yi Wu, ScD
role: PRINCIPAL_INVESTIGATOR
References: