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

Overview

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.

Interventions

• 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 affect

Primary outcome measures

• Fugl-Meyer Assessment [Time frame: Fugl-Meyer Assessment will be administered to participants at baseline.]
• Fugl-Meyer Assessment [Time frame: Fugl-Meyer Assessment will be administered to participants at immediately after intervention.]
• Fugl-Meyer Assessment [Time frame: Fugl-Meyer Assessment will be administered to participants at three months after intervention.]
• Medical Research Council Scale [Time frame: Medical Research Council Scale will be administered to participants at baseline.]
• Medical Research Council Scale [Time frame: Medical Research Council Scale will be administered to participants immediately after intervention.]
• Medical Research Council Scale [Time frame: Medical Research Council Scale will be administered to participants three months after intervention.]

Secondary outcome measures (12)

• The ABILHAND Questionnaire [Time frame: The ABILHAND Questionnaire will be administered to participants at baseline.]
• The ABILHAND Questionnaire [Time frame: The ABILHAND Questionnaire will be administered to participants immediately after intervention..]
• The ABILHAND Questionnaire [Time frame: The ABILHAND Questionnaire will be administered to participants three months after intervention..]
• The Stoke Impact Scale 3.0 [Time frame: The Stoke Impact Scale 3.0 will be administered to participants at baseline.]
• The Stoke Impact Scale 3.0 [Time frame: The Stoke Impact Scale 3.0 will be administered to participants immediately after intervention.]
• The Stoke Impact Scale 3.0 [Time frame: The Stoke Impact Scale 3.0 will be administered to participants three months after intervention.]
• The Stroke Self-Efficacy Questionnaire [Time frame: The Stroke Self-Efficacy Questionnaire will be administered to participants at baseline.]
• The Stroke Self-Efficacy Questionnaire [Time frame: The Stroke Self-Efficacy Questionnaire will be administered to participants immediately after intervention.]
• The Stroke Self-Efficacy Questionnaire [Time frame: The Stroke Self-Efficacy Questionnaire will be administered to participants three months after intervention.]
• The Wolf Motor Function Test [Time frame: The Wolf Motor Function Test will be administered to participants at baseline.]
• The Wolf Motor Function Test [Time frame: The Wolf Motor Function Test will be administered to participants immediately after intervention.]
• The Wolf Motor Function Test [Time frame: The Wolf Motor Function Test will be administered to participants three months after intervention.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Taiwan · 4 centers

• National Taiwan University Hospital — Taipei
• Taipei Tzu Chi Hospital — New Taipei City
• Fongyuan Hospital — Taichung
• Taipei Municipal Wan Fang Hospital — Taipei

Publications

• Wu SY, Li YC, Chen YW, Chen CL, Pan HC, Lin KC, Lau HY. Construct validity, responsiveness, minimal detectable change, and minimal clinically important difference of the stroke self-efficacy questionnaire in individuals receiving stroke rehabilitation. Disabil Rehabil. 2024 Dec;46(25):6195-6203. doi: 10.1080/09638288.2024.2324122. Epub 2024 Mar 3. PMID 38433459
• 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

Identifiers

NCT: NCT04446273 · 202004105RINB

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗