Synergistic Bilateral Upper-Limb Stroke Rehabilitation Based on Robotic Priming Technique

NCT ID: NCT03773653

Last Updated: 2024-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-12
• Study Completion Date: 2023-04-25

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.

Conditions

Stroke Rehabilitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

BMT to be combined with BAT

Participants in this group will receive bilateral robotic priming and bilateral arm training or mirror therapy within the 90-minute training sessions.

Group Type: EXPERIMENTAL

BMT to be combined with BAT

Intervention Type: BEHAVIORAL

Specifically, the participants will first receive 40 to 45 minutes of bilateral robotic priming using the BMT. After the robotic priming, participants will receive another 40 to 45 minutes training in tasks focusing on bilateral symmetric movements of both ULs.

BMT to be combined with MT

Participants in this group will receive bilateral robotic priming and mirror therapy within the 90-minute training sessions.

Group Type: EXPERIMENTAL

BMT to be combined with MT

Intervention Type: BEHAVIORAL

Similar to the RT+BAT group, the participants will first receive 40 to 45 minutes of bilateral robotic priming delivered by the BMT with the same priming protocol. After bilateral robotic priming, participants will receive 40 to 45 minutes of mirror therapy.

BMT to be combined with IOT

Participants in this group will receive bilateral robotic priming and impairment-oriented training within one 90-minute training session.

Group Type: ACTIVE_COMPARATOR

BMT to be combined with IOT

Intervention Type: BEHAVIORAL

Similar to the RT+BAT group, the participants will first receive 40 to 45 minutes of bilateral robotic priming delivered by the BMT with the same priming protocol. After bilateral robotic priming, participants will receive 40 to 45 minutes of impairment-oriented training.

Interventions

BMT to be combined with BAT

Specifically, the participants will first receive 40 to 45 minutes of bilateral robotic priming using the BMT. After the robotic priming, participants will receive another 40 to 45 minutes training in tasks focusing on bilateral symmetric movements of both ULs.

Intervention Type: BEHAVIORAL

BMT to be combined with MT

Similar to the RT+BAT group, the participants will first receive 40 to 45 minutes of bilateral robotic priming delivered by the BMT with the same priming protocol. After bilateral robotic priming, participants will receive 40 to 45 minutes of mirror therapy.

Intervention Type: BEHAVIORAL

BMT to be combined with IOT

Similar to the RT+BAT group, the participants will first receive 40 to 45 minutes of bilateral robotic priming delivered by the BMT with the same priming protocol. After bilateral robotic priming, participants will receive 40 to 45 minutes of impairment-oriented training.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Keh-chung Lin, ScD

Role: PRINCIPAL_INVESTIGATOR

School of Occupational Therapy, National Taiwan University, Taipei, Taiwan

Locations

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Foundation

New Taipei City, , Taiwan

Feng Yuan Hospital, Ministry of Health and Welfare

Taichung, , Taiwan

National Taiwan University Hospital

Taipei, , Taiwan

Taipei Hospital, Ministry of Health and Welfare

Taipei, , Taiwan

Linkou Chang Gung Memorial Hospital, Chang Gung Medical Foundation

Taoyuan District, , Taiwan

Countries

Taiwan

References

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.

Reference Type: DERIVED

PMID: 35841056 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34322077 (View on PubMed)

Other Identifiers

201804087RINB

Identifier Type: -

Identifier Source: org_study_id