Clinical trial NCT04446273: Proximal Priority Versus Distal Priority Robotic Priming Effects in Patients With Chronic Stroke
Official title: Effects of Proximal Priority Versus Distal Priority Robotic Priming Technique With Rehabilitation Therapy of Upper-Limb Functions in Patients With Chronic Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Upper extremity rehabilitation
Proximal priority
Distal priority
Robotic therapy
Bilateral motor priming
Impairment-oriented training
Task-oriented training
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: National Health Research Institutes, Taiwan
name: Ministry of Science and Technology, Taiwan
First posted: 2020-06-24
Enrollment: 72
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized into the proximal priority robotic priming and impairment-oriented training or the distal priority robotic priming and impairment-oriented training groups and receive 18 intervention sessions
Primary purpose: TREATMENT

Brief summary: This is a single-blind randomized comparative efficacy study involving 54-72 participants with chronic stroke. Participants will be randomized into proximal priority robotic group or distal priority robotic group and receive 18 intervention sessions (90 min/d, 3 d/wk for 6 weeks). The Fugl-Meyer Assessment Upper Extremity subscale, Medical Research Council Scale, Revised Nottingham Sensory Assessment, and Wolf Motor Function Test will be administered at baseline, after treatment, and at the 3-month follow-up. Two-way repeated-measures analysis of variance and the Chi-Square Automatic Interaction Detector Method will be used to examine the comparative efficacy and predictors of outcome, respectively, after intervention.

Detailed description: Background. The sequence of establishing proximal stability or function before facilitation of the distal body part has long been recognized in stroke rehabilitation practice but lacks scientific evidence. This study plans to examine the effects of proximal priority robotic priming and impairment-oriented training (PRI) and distal priority robotic priming and impairment-oriented training (DRI).

Methods. This is a single-blind randomized comparative efficacy study involving 54-72 participants with chronic stroke. Participants will be randomized into PRI or DRI groups and receive 18 intervention sessions (90 min/d, 3 d/wk for 6 weeks). The Fugl-Meyer Assessment Upper Extremity subscale, Medical Research Council Scale, Revised Nottingham Sensory Assessment, and Wolf Motor Function Test will be administered at baseline, after treatment, and at the 3-month follow-up. Two-way repeated-measures analysis of variance and the Chi-Square Automatic Interaction Detector Method will be used to examine the comparative efficacy and predictors of outcome, respectively, after PRI and DRI.

Eligibility criteria: Inclusion Criteria:

* The inclusion criteria are age between 20 and 75 years old, more than 3 months after the onset of a first unilateral ischemic or hemorrhagic stroke, moderate to severe UE motor impairment (i.e., total UE score of the Fugl-Meyer Assessment \[FMA\] score between 18 and 56), no severe spasticity in any joints of the affected arm (modified Ashworth Scale score \<3 in any of the affected shoulder, elbow, wrist, and fingers), able to follow instructions (Mini-Mental State Examination total score \>24), no UE fractures in the past 3 months, and not simultaneously participating in other medication or rehabilitation studies.

Exclusion Criteria:

* The exclusion criteria are other neurologic, neuromuscular, or orthopedic disease, such as epilepsy, or severe health or physical conditions that might impede participation in this study.

Primary outcomes:
measure: Fugl-Meyer Assessment
timeFrame: Fugl-Meyer Assessment will be administered to participants at baseline.
measure: Fugl-Meyer Assessment
timeFrame: Fugl-Meyer Assessment will be administered to participants at immediately after intervention.
measure: Fugl-Meyer Assessment
timeFrame: Fugl-Meyer Assessment will be administered to participants at three months after intervention.
measure: Medical Research Council Scale
timeFrame: Medical Research Council Scale will be administered to participants at baseline.
measure: Medical Research Council Scale
timeFrame: Medical Research Council Scale will be administered to participants immediately after intervention.
measure: Medical Research Council Scale
timeFrame: Medical Research Council Scale will be administered to participants three months after intervention.
Secondary outcomes:
measure: The ABILHAND Questionnaire
timeFrame: The ABILHAND Questionnaire will be administered to participants at baseline.
measure: The ABILHAND Questionnaire
timeFrame: The ABILHAND Questionnaire will be administered to participants immediately after intervention..
measure: The ABILHAND Questionnaire
timeFrame: The ABILHAND Questionnaire will be administered to participants three months after intervention..
measure: The Stoke Impact Scale 3.0
timeFrame: The Stoke Impact Scale 3.0 will be administered to participants at baseline.
measure: The Stoke Impact Scale 3.0
timeFrame: The Stoke Impact Scale 3.0 will be administered to participants immediately after intervention.
measure: The Stoke Impact Scale 3.0
timeFrame: The Stoke Impact Scale 3.0 will be administered to participants three months after intervention.
measure: The Stroke Self-Efficacy Questionnaire
timeFrame: The Stroke Self-Efficacy Questionnaire will be administered to participants at baseline.
measure: The Stroke Self-Efficacy Questionnaire
timeFrame: The Stroke Self-Efficacy Questionnaire will be administered to participants immediately after intervention.
measure: The Stroke Self-Efficacy Questionnaire
timeFrame: The Stroke Self-Efficacy Questionnaire will be administered to participants three months after intervention.
measure: The Wolf Motor Function Test
timeFrame: The Wolf Motor Function Test will be administered to participants at baseline.
measure: The Wolf Motor Function Test
timeFrame: The Wolf Motor Function Test will be administered to participants immediately after intervention.
measure: The Wolf Motor Function Test
timeFrame: The Wolf Motor Function Test will be administered to participants three months after intervention.
measure: The Montreal Cognitive Assessment
timeFrame: The Montreal Cognitive Assessment will be administered to participants at baseline.
measure: The Montreal Cognitive Assessment
timeFrame: The Montreal Cognitive Assessment will be administered to participants immediately after intervention.
measure: The Chedoke Arm and Hand Activity Inventory
timeFrame: The Chedoke Arm and Hand Activity Inventory will be administered to participants at baseline.
measure: The Chedoke Arm and Hand Activity Inventory
timeFrame: The Chedoke Arm and Hand Activity Inventory will be administered to participants immediately after intervention.
measure: The Chedoke Arm and Hand Activity Inventory
timeFrame: The Chedoke Arm and Hand Activity Inventory will be administered to participants three months after intervention.
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Fongyuan Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University
name: Keh-chung Lin, ScD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee YC, Li YC, Lin KC, Chen CL, Wu YH, Kuo C, Yeh YP, Liu TX. Effects of proximal priority and distal priority robotic priming techniques with impairment-oriented training of upper limb functions in patients with chronic stroke: study protocol for a single-blind, randomized controlled trial. Trials. 2021 Sep 8;22(1):604. doi: 10.1186/s13063-021-05561-6.