Clinical trial NCT03773653: Synergistic Bilateral Upper-Limb Stroke Rehabilitation Based on Robotic Priming Technique
Official title: Synergistic Bilateral Upper-Limb Stroke Rehabilitation Based on Robotic Priming Technique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke Rehabilitation
Keywords: stroke, robot-assisted therapy, mirror therapy
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2018-12-12
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This comparative efficacy study will be based on a 3-armed controlled trial: bilateral robotic priming combined with bilateral arm training (bilateral RT+BAT), bilateral robotic priming combined with mirror therapy (bilateral RT+MT), and the control intervention (bilateral RT+IOT). The goal of this 4-year project is to provide scientific evidence of the comparative efficacy research of hybrid interventions based on unilateral vs. bilateral approach to upper limb rehabilitation in subacute and chronic stroke.

Detailed description: This proposed research fits in the NHRI research priority 4-1 by addressing innovative treatment strategies for stroke that is in desperate need of scientific scrutiny. Stroke is one of the major medical conditions that lead to long-term disability and causes heavy health care and financial burden. Advances in clinical and translational neurosciences have led to the new development of stroke rehabilitation. Current stroke rehabilitation programs such as robotic therapy, mirror therapy, and bilateral arm training are bilateral approaches to intensive practice based on the tenet of practice-dependent neuroplasticity. Bilateral robotic therapy can potentially be a movement-based priming technique to promote rebalancing of cortical excitability and create an enriched neuroplastic environment by priming the brain to facilitate motor and functional recovery. This proposed research project will: (1) examine the effects of bilateral robotic priming combined with bilateral arm training approach versus bilateral robotic priming combined with mirror therapy, relative to the control intervention approach (bilateral robotic priming combined with impairment-oriented training) on sensorimotor function, daily function, self-efficacy, quality of life, and motor control strategy in patients with stroke, (2) investigate the 3-month retention effects of robotic priming combined with contemporary rehabilitation approaches (i.e., bilateral arm training and mirror therapy) and the control intervention, and (3) identify the potential predictors of functionally relevant changes after therapy.

Eligibility criteria: Inclusion Criteria:

(1) ⩾3 months onset from a first-ever unilateral stroke; (2) age range from 18 to 80 years; (3) baseline upper extremity motor score on the Fugl-Meyer Assessment \>10 (Fugl-Meyer et al., 1975); (4) no severe spasticity in any joints of the affected arm (Modified Ashworth Scale ⩽ 3) (Charalambous, 2014); (5) able to follow study instructions (Mini Mental State Examination Score ⩾24) (Skidmore et al., 2010); (6) no serious vision deficits and no other neurologic or major orthopedic diseases; (7) able to participate in a rehabilitation intervention program for 6 weeks; and (8) no participation in other studies during the study period and willing to provide written informed consent.

Exclusion Criteria:

(1) acute inflammation and (2) major medical problems or poor physical conditions that might interfere with participation.

Primary outcomes:
measure: Change from Baseline Fugl-Meyer Assessment (FMA) at 6 weeks, and 18 weeks
timeFrame: Baseline, 6 weeks, and 18 weeks
measure: Change from Baseline ABILHAND Questionnaire at 6 weeks, and 18 weeks
timeFrame: Baseline, 6 weeks, and 18 weeks
measure: Change from Baseline Stroke Impact Scale Version 3.0 (SIS 3.0) at 6 weeks, and 18 weeks
timeFrame: Baseline, 6 weeks, and 18 weeks
Secondary outcomes:
measure: Change from Baseline Goal Attainment Scaling (GAS) at 6 weeks.
timeFrame: Baseline and 6 weeks
measure: Change from Baseline Functional Independence Measure (FIM) at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change from Baseline Stroke Self Efficacy Questionnaire (SSEQ) at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change from Baseline Activity level as evaluated by actigraphy at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change from Baseline Possible adverse response at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change from Baseline Wolf Motor Function Test (WMFT) score at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change from Baseline Revised Nottingham Sensory Assessment (rNSA) at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change from Baseline Medical Research Council scale (MRC) at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change from lateral pinch strength at 6 weeks
timeFrame: Baseline and 6 weeks
measure: Change from Baseline Chedoke Arm and Hand Activity Inventory (CAHAI) score at 6 weeks
timeFrame: Baseline and 6 weeks
Other outcomes:
Locations:
city: New Taipei
country: Taiwan
facility: Taipei Tzu Chi Hospital, Buddhist Tzu Chi Foundation
city: Taichung
country: Taiwan
facility: Feng Yuan Hospital, Ministry of Health and Welfare
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Hospital, Ministry of Health and Welfare
city: Taoyuan
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital, Chang Gung Medical Foundation
Study officials:
affiliation: School of Occupational Therapy, National Taiwan University, Taipei, Taiwan
name: Keh-chung Lin, ScD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee YC, Li YC, Lin KC, Yao G, Chang YJ, Lee YY, Liu CT, Hsu WL, Wu YH, Chu HT, Liu TX, Yeh YP, Chang C. Effects of robotic priming of bilateral arm training, mirror therapy, and impairment-oriented training on sensorimotor and daily functions in patients with chronic stroke: study protocol of a single-blind, randomized controlled trial. Trials. 2022 Jul 15;23(1):566. doi: 10.1186/s13063-022-06498-0.
citation: Li YC, Lin KC, Chen CL, Yao G, Chang YJ, Lee YY, Liu CT. A Comparative Efficacy Study of Robotic Priming of Bilateral Approach in Stroke Rehabilitation. Front Neurol. 2021 Jul 12;12:658567. doi: 10.3389/fneur.2021.658567. eCollection 2021.