Proximal Priority Versus Distal Priority Robotic Priming Effects in Patients With Chronic Stroke

Effects of Proximal Priority Versus Distal Priority Robotic Priming Technique With Rehabilitation Therapy of Upper-Limb Functions in Patients With Chronic Stroke

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke
• Intervention / Treatment: Device: Bi-Manu-Track

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.

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kehchung Lin, ScD; Phone Number: +886233668180; Email: kehchunglin@ntu.edu.tw

Study Locations

• Taiwan
  • New Taipei City, Taiwan
    • Recruiting
    • Taipei Tzu Chi Hospital
    • Contact: Wan-Ling Hsu, MS; Email: mysalvia@gmail.com
  • Taichung, Taiwan
    • Recruiting
    • Fongyuan Hospital
    • Contact: Chih-Chieh Kuo, MS; Email: snowwinglightsea@hotmail.com
  • Taipei, Taiwan, 116
    • Recruiting
    • Taipei Municipal Wan Fang Hospital
    • Contact: Han-Ting Tsai, MS; Email: 97463@w.tmu.edu.tw
  • Taipei
    • Taipei, Taipei, Taiwan, 100
      • Recruiting
      • National Taiwan University Hospital
      • Contact: Keh-chung Lin, ScD; Phone Number: 886 233668180; Email: kehchunglin@ntu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PRI group; The PRI and DRI groups will receive an equal amount of treatment time, comprising 1.5 hours per day, 3 days per week, for 6 weeks. The PRI protocol provides robotic training for 45 minutes and impairment-oriented training for 45 minutes. The PRI group will start from the Bi-Manu-Track proximal mode (i.e., forearm) and then the Bi-Manu-Track distal mode (i.e., wrist).	Device: Bi-Manu-Track; The PRI and DRI protocol provide robotic training for 45 minutes and impairment-oriented training for 45 minutes. The PRI group will start from the Bi-Manu-Track proximal mode (i.e., forearm) and then the Bi-Manu-Track distal mode (i.e., wrist). The DRI group will start from the Bi-Manu-Track distal mode (i.e., wrist) and then the Bi-Manu-Track proximal mode (i.e., forearm).In every session of robotic training, the patient will practice bilateral passive range of motion exercise, in which affected upper extremity is assisted by the unaffected side, and bilateral active range of motion exercise. Robotic training will be followed by impairment-oriented training.; Other Names: impairment-oriented training
Active Comparator: DRI group; The PRI and DRI groups will receive an equal amount of treatment time, comprising 1.5 hours per day, 3 days per week, for 6 weeks. The DRI protocol provides robotic training for 45 minutes and impairment-oriented training for 45 minutes. The DRI group will start from the Bi-Manu-Track distal mode (i.e., wrist) and then the Bi-Manu-Track proximal mode (i.e., forearm).	Device: Bi-Manu-Track; The PRI and DRI protocol provide robotic training for 45 minutes and impairment-oriented training for 45 minutes. The PRI group will start from the Bi-Manu-Track proximal mode (i.e., forearm) and then the Bi-Manu-Track distal mode (i.e., wrist). The DRI group will start from the Bi-Manu-Track distal mode (i.e., wrist) and then the Bi-Manu-Track proximal mode (i.e., forearm).In every session of robotic training, the patient will practice bilateral passive range of motion exercise, in which affected upper extremity is assisted by the unaffected side, and bilateral active range of motion exercise. Robotic training will be followed by impairment-oriented training.; Other Names: impairment-oriented training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fugl-Meyer Assessment	Fugl-Meyer Assessment is used to assess motor impairment of body function, including ranges of motion of the upper extremity (UE) joints, and grasping, coordination, and speed of UE. movement.	Fugl-Meyer Assessment will be administered to participants at baseline.
Fugl-Meyer Assessment	Fugl-Meyer Assessment is used to assess motor impairment of body function, including ranges of motion of the UE joints, and grasping, coordination, and speed of UE movement.	Fugl-Meyer Assessment will be administered to participants at immediately after intervention.
Fugl-Meyer Assessment	Fugl-Meyer Assessment is used to assess motor impairment of body function, including ranges of motion of the UE joints, and grasping, coordination, and speed of UE. movement.	Fugl-Meyer Assessment will be administered to participants at three months after intervention.
Medical Research Council Scale	Medical Research Council Scale is used to assess muscle power of the affected upper extremity joints.	Medical Research Council Scale will be administered to participants at baseline.
Medical Research Council Scale	Medical Research Council Scale is used to assess muscle power of the affected upper extremity joints.	Medical Research Council Scale will be administered to participants immediately after intervention.
Medical Research Council Scale	Medical Research Council Scale is used to assess muscle power of the affected upper extremity joints.	Medical Research Council Scale will be administered to participants three months after intervention.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Wolf Motor Function Test	The Wolf Motor Function Test is used to assess functional motor ability of the upper extremity with 15 functional tasks.	The Wolf Motor Function Test will be administered to participants at baseline.
The Wolf Motor Function Test	The Wolf Motor Function Test is used to assess functional motor ability of the upper extremity with 15 functional tasks.	The Wolf Motor Function Test will be administered to participants immediately after intervention.
The Wolf Motor Function Test	The Wolf Motor Function Test is used to assess functional motor ability of the upper extremity with 15 functional tasks.	The Wolf Motor Function Test will be administered to participants three months after intervention.
The ABILHAND Questionnaire	The ABILHAND Questionnaire is an inventory of 23 manual activities on which the patient provides his or her self-perceived performing difficulty on a 3-level scale (impossible, difficult, easy).	The ABILHAND Questionnaire will be administered to participants at baseline.
The ABILHAND Questionnaire	The ABILHAND Questionnaire is an inventory of 23 manual activities on which the patient provides his or her self-perceived performing difficulty on a 3-level scale (impossible, difficult, easy).	The ABILHAND Questionnaire will be administered to participants immediately after intervention..
The ABILHAND Questionnaire	The ABILHAND Questionnaire is an inventory of 23 manual activities on which the patient provides his or her self-perceived performing difficulty on a 3-level scale (impossible, difficult, easy).	The ABILHAND Questionnaire will be administered to participants three months after intervention..
The Stoke Impact Scale 3.0	The Stoke Impact Scale 3.0 is a 59-item questionnaire that measures perceived disability and health-related quality of life after stroke in eight domains: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory/thinking, and participation/role function.	The Stoke Impact Scale 3.0 will be administered to participants at baseline.
The Stoke Impact Scale 3.0	The Stoke Impact Scale 3.0 is a 59-item questionnaire that measures perceived disability and health-related quality of life after stroke in eight domains: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory/thinking, and participation/role function.	The Stoke Impact Scale 3.0 will be administered to participants immediately after intervention.
The Stoke Impact Scale 3.0	The Stoke Impact Scale 3.0 is a 59-item questionnaire that measures perceived disability and health-related quality of life after stroke in eight domains: strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion, memory/thinking, and participation/role function.	The Stoke Impact Scale 3.0 will be administered to participants three months after intervention.
The Stroke Self-Efficacy Questionnaire	The Stroke Self-Efficacy Questionnaire is a 13-item questionnaire to evaluate self-efficacy in functioning after stroke.	The Stroke Self-Efficacy Questionnaire will be administered to participants at baseline.
The Stroke Self-Efficacy Questionnaire	The Stroke Self-Efficacy Questionnaire is a 13-item questionnaire to evaluate self-efficacy in functioning after stroke.	The Stroke Self-Efficacy Questionnaire will be administered to participants immediately after intervention.
The Stroke Self-Efficacy Questionnaire	The Stroke Self-Efficacy Questionnaire is a 13-item questionnaire to evaluate self-efficacy in functioning after stroke.	The Stroke Self-Efficacy Questionnaire will be administered to participants three months after intervention.
The Montreal Cognitive Assessment	The Montreal Cognitive Assessment is a cognitive screening assessment that is used to measure several cognitive domains, which include working memory, delayed recall, visuospatial abilities, executive functions, attention, concentration, language, and orientation to time and place. The total score ranges from 0 to 30. One extra point is added to adjust the total score for participants who received less than 12 years of education.	The Montreal Cognitive Assessment will be administered to participants at baseline.
The Montreal Cognitive Assessment	The Montreal Cognitive Assessment is a cognitive screening assessment that is used to measure several cognitive domains, which include working memory, delayed recall, visuospatial abilities, executive functions, attention, concentration, language, and orientation to time and place. The total score ranges from 0 to 30. One extra point is added to adjust the total score for participants who received less than 12 years of education.	The Montreal Cognitive Assessment will be administered to participants immediately after intervention.
The Chedoke Arm and Hand Activity Inventory	The CAHAI evaluates the functional ability of the affected arm and hand to perform tasks after stroke. The 13 items contained in the CAHAI represent bimanual meaningful everyday activities and are made up a variety of the upper-extremity characteristics, including strength, dexterity, coordination, and grasp. The 7-point activity scale is used in the CAHAI, where 1 indicates "performing less than 25% of the effort to complete the task" and 7 indicates "the participants' affected upper extremity is able to complete the task competently independently." The reliability and validity of the CAHAI have been ascertained in stroke.	The Chedoke Arm and Hand Activity Inventory will be administered to participants at baseline.
The Chedoke Arm and Hand Activity Inventory	The CAHAI evaluates the functional ability of the affected arm and hand to perform tasks after stroke. The 13 items contained in the CAHAI represent bimanual meaningful everyday activities and are made up a variety of the upper-extremity characteristics, including strength, dexterity, coordination, and grasp. The 7-point activity scale is used in the CAHAI, where 1 indicates "performing less than 25% of the effort to complete the task" and 7 indicates "the participants' affected upper extremity is able to complete the task competently independently." The reliability and validity of the CAHAI have been ascertained in stroke.	The Chedoke Arm and Hand Activity Inventory will be administered to participants immediately after intervention.
The Chedoke Arm and Hand Activity Inventory	The CAHAI evaluates the functional ability of the affected arm and hand to perform tasks after stroke. The 13 items contained in the CAHAI represent bimanual meaningful everyday activities and are made up a variety of the upper-extremity characteristics, including strength, dexterity, coordination, and grasp. The 7-point activity scale is used in the CAHAI, where 1 indicates "performing less than 25% of the effort to complete the task" and 7 indicates "the participants' affected upper extremity is able to complete the task competently independently." The reliability and validity of the CAHAI have been ascertained in stroke.	The Chedoke Arm and Hand Activity Inventory will be administered to participants three months after intervention.

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Collaborators: Ministry of Science and Technology, Taiwan; National Health Research Institutes, Taiwan
• Investigators: Principal Investigator: Keh-chung Lin, ScD, National Taiwan University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 3, 2020
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: June 18, 2020
• First Submitted That Met QC Criteria: June 22, 2020
• First Posted (Actual): June 24, 2020

Study Record Updates

• Last Update Posted (Actual): February 25, 2026
• Last Update Submitted That Met QC Criteria: February 24, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Robotic therapy; Upper extremity rehabilitation; Proximal priority; Distal priority; Bilateral motor priming; Impairment-oriented training; Task-oriented training
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: 202004105RINB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No