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

NCT04446273 | Recruiting DMC

• 1 other identifier: 202004105RINB
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 4

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.

Conditions

Stroke

Keywords

Upper extremity rehabilitation; Proximal priority; Distal priority; Robotic therapy; Bilateral motor priming; Impairment-oriented training; Task-oriented training

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (17)

• The ABILHAND Questionnaire

  The ABILHAND Questionnaire will be administered to participants at baseline.

• The ABILHAND Questionnaire

  The ABILHAND Questionnaire will be administered to participants immediately after intervention..

• The ABILHAND Questionnaire

  The ABILHAND Questionnaire will be administered to participants three months after intervention..

• The Stoke Impact Scale 3.0

  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 will be administered to participants immediately after intervention.

Study Arms (2)

PRI group

EXPERIMENTAL

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

DRI group

ACTIVE COMPARATOR

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

Interventions

Bi-Manu-Track DEVICE

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.

Also known as: impairment-oriented training

DRI group; PRI group

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• National Health Research Institutes, Taiwan: collaborator
• Ministry of Science and Technology, Taiwan: collaborator

Study Sites (4)

National Taiwan University Hospital

Taipei, Taipei, 100, Taiwan

RECRUITING

Taipei Tzu Chi Hospital

New Taipei City, Taiwan

RECRUITING

Fongyuan Hospital

Taichung, Taiwan

RECRUITING

Taipei Municipal Wan Fang Hospital

Taipei, 116, Taiwan

RECRUITING

Related Publications (1)

• 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.

  PMID: 34496938 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Keh-chung Lin, ScD

  National Taiwan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kehchung Lin, ScD

CONTACT

+886233668180; kehchunglin@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Initial and outcome assessments will be administered by a well-trained and certified occupational therapist who is blinded to the group assignment, study hypotheses, and intervention of the patients.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: June 18, 2020
• First Posted: June 24, 2020
• Study Start: July 3, 2020
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (4)