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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04446273
• Other study ID #: 202004105RINB
• Status: Recruiting
• Phase: N/A
• Start date: July 3, 2020
• Est. completion date: December 31, 2025

Study information

• Verified date: August 2023
• Source: National Taiwan University Hospital
• Contact: Kehchung Lin, ScD
• Phone: +886233668180
• Email: kehchunglin[@]ntu.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stroke

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Fongyuan Hospital	Taichung
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (3)

Lead Sponsor	Collaborator
National Taiwan University Hospital	Ministry of Science and Technology, Taiwan, National Health Research Institutes, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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..
Secondary	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..
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.