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

Chronic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03917511
• Other study ID #: 201801025B0
• Status: Completed
• Phase: N/A
• Start date: December 17, 2018
• Est. completion date: April 20, 2021

Study information

• Verified date: June 2021
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: April 20, 2021
• Est. primary completion date: April 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Brain injury more than 3 months.

2. Modified Ashworth Scale proximal part = 3, Modified Ashworth Scale distal part = 2, and no serious muscle spasms.

3. The myoelectric signal can be detected to activate the instrument

4. unilateral paresis (FMA score<60)

5. no serious cognitive impairment (i.e., Mini Mental State Exam score > 24)

6. can provide informed consent

Exclusion Criteria:

1. Other neurological disease

2. Complete sense of body defect

3. Inability to understand instructions

4. current participation in any other research

5. Botulinum Toxin injection within 3 months

Related Conditions & MeSH terms

• Chronic Stroke
• Stroke

Intervention

Behavioral:
• Robotic training with mirror therapy
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).
• Robotic-assisted training
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.

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Taoyuan City

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
Primary	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.	Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
Primary	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.	Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
Primary	Change scores of MyotonPro	Investigators will use the MyotonPRO device to evaluate the viscoelastic properties of UE muscles.	Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
Primary	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.	Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
Primary	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.	Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
Primary	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.	Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
Primary	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.	Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
Primary	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.	Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
Primary	Change scores of 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.	Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
Primary	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.	Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
Primary	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.	Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
Primary	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.	Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
Primary	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.	Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
Primary	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.	Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
Primary	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.	Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
Primary	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.	Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline), follow up test (3 months after completing intervention sessions)
Secondary	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.	Baseline, post test immediately after completing 18 intervention sessions (around 6 weeks after baseline)