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

NCT03773653 | Completed

• 1 other identifier: 201804087RINB
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 5

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.

Conditions

Stroke Rehabilitation

Keywords

stroke, robot-assisted therapy, mirror therapy

Outcome Measures

Primary Outcomes (3)

• Change from Baseline Fugl-Meyer Assessment (FMA) at 6 weeks, and 18 weeks

  The upper-extremity subscale of the FMA will be used to assess motor impairment. FMA contains 33 items (scale 0-66). The higher summed score means the greater recovery of motor impairment.

  Baseline, 6 weeks, and 18 weeks

• Change from Baseline ABILHAND Questionnaire at 6 weeks, and 18 weeks

  The ABILHAND Questionnaire will be used to evaluate the ability of the upper limb in functional activities. ABILHAND contains 23 items (scale 0-69). The higher average score means the greater recovery of the ability of the upper limb in functional activities.

  Baseline, 6 weeks, and 18 weeks

• Change from Baseline Stroke Impact Scale Version 3.0 (SIS 3.0) at 6 weeks, and 18 weeks

  The SIS 3.0 is a stroke-specific health-related quality of life instrument. It consists of 59 items assessing 8 domains (i.e., strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion. memory and thinking and participation). Items are rated on a 5-point Likert scale, with lower scores indicating greater difficulty in task completion during the past week.

  Baseline, 6 weeks, and 18 weeks

Secondary Outcomes (10)

• Change from Baseline Goal Attainment Scaling (GAS) at 6 weeks.

  Baseline and 6 weeks

• Change from Baseline Functional Independence Measure (FIM) at 6 weeks

  Baseline and 6 weeks

• Change from Baseline Stroke Self Efficacy Questionnaire (SSEQ) at 6 weeks

  Baseline and 6 weeks

• Change from Baseline Activity level as evaluated by actigraphy at 6 weeks

  Baseline and 6 weeks

• Change from Baseline Possible adverse response at 6 weeks

  Baseline and 6 weeks

Study Arms (3)

BMT to be combined with BAT

EXPERIMENTAL

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

Behavioral: BMT to be combined with BAT

BMT to be combined with MT

EXPERIMENTAL

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

Behavioral: BMT to be combined with MT

BMT to be combined with IOT

ACTIVE COMPARATOR

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

Behavioral: BMT to be combined with IOT

Interventions

BMT to be combined with BAT 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 BAT

BMT to be combined with MT 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 MT

BMT to be combined with IOT 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.

BMT to be combined with IOT

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (5)

Taipei Tzu Chi Hospital, Buddhist Tzu Chi Foundation

New Taipei City, Taiwan

Location

Feng Yuan Hospital, Ministry of Health and Welfare

Taichung, Taiwan

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

Taipei Hospital, Ministry of Health and Welfare

Taipei, Taiwan

Location

Linkou Chang Gung Memorial Hospital, Chang Gung Medical Foundation

Taoyuan District, Taiwan

Location

Related Publications (2)

• 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.

  PMID: 35841056 DERIVED

• 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.

  PMID: 34322077 DERIVED

MeSH Terms

Conditions

Stroke

Interventions

glycine N-choloyltransferase

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Keh-chung Lin, ScD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2018
• First Posted: December 12, 2018
• Study Start: November 12, 2018
• Primary Completion: April 25, 2023
• Study Completion: April 25, 2023
• Last Updated: June 24, 2024

Record last verified: 2022-05

Locations

TW (5)