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Effects of Combined Robot-assisted Therapy With Mirror Priming in Stroke Patients

Primary Purpose

Chronic Stroke

Status

Completed

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

Robotic training with mirror therapy

Robotic-assisted training

About this trial

This is an interventional treatment trial for Chronic Stroke focused on measuring Stroke, Mirror therapy, Robotic Training, Neurorehabilitation

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Brain injury more than 3 months.
Modified Ashworth Scale proximal part ≤ 3, Modified Ashworth Scale distal part ≤ 2, and no serious muscle spasms.
The myoelectric signal can be detected to activate the instrument
unilateral paresis (FMA score<60)
no serious cognitive impairment (i.e., Mini Mental State Exam score > 24)
can provide informed consent

Exclusion Criteria:

Other neurological disease
Complete sense of body defect
Inability to understand instructions
current participation in any other research
Botulinum Toxin injection within 3 months

Sites / Locations

Chang Gung Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Robotic training with mirror therapy

Robotic-assisted training

Arm Description

20 minutes mirror therapy followed by 40 minutes robotic-assisted training

20 minutes sham mirror therapy followed by 40 minutes robotic-assisted training

Outcomes

Primary Outcome Measures

Change scores of Fugl-Myer Assessment (FMA)

The UE-FMA subscale will be used to assess the sensorimotor impairment level of UE in patients after stroke. The UE-FMA contains 33 movements with a score range from 0 to 66. A higher UE-FMA score indicates less impairment of the paretic limb. The validity and reliability of FMA is good to excellent.

Change scores of Active Range of Motion (AROM)

Patient performs the exercise to move the joint without any assistance to the muscles surrounding the joint.

Change scores of grip and pinch power(Jamar hand dynamometer)

The Jamar hand dynamometer is the most widely cited in the literature and accepted as the gold standard by which other dynamometers are evaluated. Excellent concurrent validity of the Jamar hand dynamometer is reported. The Jamar hand dynamometer measure the grip-strength. The norm of healthy male aged 18 to 75 years is from 64.8 lb to 121.8 lb, while the norm of healthy female aged 18 to 75 years is from 41.5 lb to 78.7 lb. Higher value represent a greater grip-strength.

Change scores of MyotonPro

Investigators will use the MyotonPRO device to evaluate the viscoelastic properties of UE muscles.

Change scores of Modified Ashworth Scale (MAS)

The MAS is a 6-point ordinal scale that measures muscle spasticity in patients with brain lesions. Higher score indicates higher muscle tone. Investigators will assess the MAS scores of UE muscles, including biceps, triceps, wrist flexors and extensors, and finger flexors and extensors. The validity and reliability of MAS for patients with stroke were established to be adequate to good.

Change scores of Medical Research Council scale (MRC)

The MRC is an ordinal scale that assesses muscle strength. The scoring for each muscle ranges from 0 to 5, with a higher score indicates stronger muscle. The reliability of MRC for all muscle groups was good to excellent in patients with stroke.

Change scores of pressure pain threshold

The Commander Algometer (JTECH Medical, USA) is designed for easy handling and fine resolution to identify clinically significant pain sensitivity changes. The Commander Algometer provides a convenient, efficient, objective pain evaluation tool for treatment planning, progress evaluation and case management. The measured pressure thresholds/tolerances and trigger point tenderness will be reported by patients.

Change scores of Revised Nottingham Sensory Assessment (RNSA)

Changes in sensation before and after intervention will be measured with rNSA. Tactile sensation,proprioception, and stereognosis will be assessed with various sensory modalities. The rNSA is scored based on a 3-point ordinal scale (0-2) with a higher score indicates better sensation. The psychometric properties of rNSA have been established in patients with stroke.

Change scores of Wolf Motor Function Test (WMFT)

The Wolf Motor Function Test evaluates upper extremity motor function via 15 function-based tasks and 2 strength-based tasks. The Wolf Motor Function Test -time evaluates the time required to complete the function-based tasks, and the Wolf Motor Function Test -quality assesses functional ability on a 6-point ordinal scale. A lower Wolf Motor Function Test -time performance indicates faster movement, whereas a higher Wolf Motor Function Test -quality score suggests better quality of movement. The psychometric properties of Wolf Motor Function Test have been established in stroke patients.

Change scores of Jamar hand dynamometer

Change scores of Mini-Mental State Exam (MMSE)

The Mini-Mental State Examination (MMSE) is the most commonly administered psychometric screening assessment of cognitive functioning. The MMSE is used to screen patients for cognitive impairment, track changes in cognitive functioning over time, and often to assess the effects of therapeutic agents on cognitive function. The total score of MMSE ranged from 0 to 30. Higher values represent a better cognitive functioning.

Change scores of Motor Activity Log (MAL)

The Motor Activity Log evaluates the amount of use (AOU) and quality of movement (QOM) of the affected hand in completing 30 common daily tasks. Scoring of each task ranges from 0 to 5, with higher scores indicating more use or better movement quality. The responsiveness, validity, and reliability have been established in stroke patients.

Change scores of Nottingham Extended Activities of Daily Living Scale (NEADL)

The NEADL is a self-report scale that measures instrumental activities of daily living. It evaluates 4 areas of daily living, including mobility, kitchen, domestic, and leisure activities. The total score is 0-66, and a higher score indicates better daily functional ability. The psychometric properties of NEADL have been well established.

Change scores of Stroke Impact Scale (SIS)

The SIS 3.0 will be used to evaluate health-related quality of life for patients with stroke. The SIS assesses eight domains (strength, hand function, ADL/IADL, mobility, communication, emotion, memory and thinking, and participation/role function) with 59 test items.

Change scores of stroke self-efficacy questionnaire (SSEQ)

the Stroke Self-Efficacy Questionnaire (SSEQ) , a questionnaire developed to measure the most relevant self-efficacy and self-management domains specific to the stroke population. It contains 13 items that are rated on a 0 - 10 scale, with higher scores indicating greater levels of self-efficacy. Questionnaire includes a range of relevant functional tasks such as walking, getting comfortable in bed, as well as some self-management tasks.

Change scores of Daily Living Self-Efficacy Scale (DLSES)

The DLSES is designed to measure self-efficacy in psychosocial functioning and self-efficacy in activities of daily living, regardless of level of physical impairment.

Change scores of Functional Abilities Confidence Scale (FACS)

The Functional Abilities Confidence Scale (FACS) was designed to measure the degree of self-efficacy or confidence a patient exhibits with various movements or postures.

Secondary Outcome Measures

Kinematic Analysis

The movements of the arm and trunk will be captured by a 7-camera motion analysis system during unilateral and bilateral reaching tasks. Kinematic variables, such as reaction time, movement time, peak velocity, path length during the tasks can assess a patient's motor function in daily activities after intervention.

Full Information

NCT ID

NCT03917511

First Posted

January 8, 2019

Last Updated

February 11, 2022

Sponsor

Chang Gung Memorial Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03917511

Brief Title

Effects of Combined Robot-assisted Therapy With Mirror Priming in Stroke Patients

Official Title

Effects of Combined Robot-assisted Therapy With Mirror Priming on Hand Function and Health-related Conditions in Patients With Stroke.

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Completed

Study Start Date

December 17, 2018 (Actual)

Primary Completion Date

April 20, 2021 (Actual)

Study Completion Date

April 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to examine the effects of combining robotic-assisted training and mirror therapy on upper extremity motor and physiological function, daily functions, quality of life and self-efficacy in stroke patients.

Detailed Description

Based on trigger theory, this study designed a combining robotic-assisted training and mirror therapy. Before robotic-assisted training, a mirror therapy is performed to double the healing effect of robotic-assisted training. This study hypothesized that combining robotic-assisted training and mirror therapy can improve the performance of hand function in stroke patients and promote daily life function, quality of life, and self-efficacy compared to single machine-assisted therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Stroke

Keywords

Stroke, Mirror therapy, Robotic Training, Neurorehabilitation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

43 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Robotic training with mirror therapy

Arm Type

Experimental

Arm Description

20 minutes mirror therapy followed by 40 minutes robotic-assisted training

Arm Title

Robotic-assisted training

Arm Type

Sham Comparator

Arm Description

20 minutes sham mirror therapy followed by 40 minutes robotic-assisted training

Intervention Type

Behavioral

Intervention Name(s)

Robotic training with mirror therapy

Intervention Description

Participants will receive 18 intervention sessions for about 6 consecutive weeks in a clinical setting (1 hour per session, 3 sessions per week). For each intervention session, participants will first receive 20 minutes mirror therapy followed by 40 minutes robotic-assisted training (robotic-assisted training includes 10 minutes active/passive training mode and 30 minutes robot-participant interactive training mode).

Intervention Type

Behavioral

Intervention Name(s)

Robotic-assisted training

Intervention Description

The training procedure will be the same as the robotic-assisted training with mirror therapy group except that sham mirror therapy will be provided in the first 20 minutes in the intervention session.

Primary Outcome Measure Information:

Title

Change scores of Fugl-Myer Assessment (FMA)

Description

Time Frame