Hybrid Approach to Mirror Therapy and Transcranial Direct Current Stimulation for Stroke Recovery

Cerebrovascular Accident Clinical Trial

Official title:

Hybrid Approach to Mirror Therapy and Transcranial Direct Current Stimulation for Stroke Recovery: A Follow up Study on Brain Reorganization, Motor Performance of Upper Extremity, Daily Function, and Activity Participation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02254616
• Other study ID #: 102-5696A3
• Status: Completed
• Phase: N/A
• Start date: August 1, 2014
• Est. completion date: October 11, 2017

Study information

• Verified date: January 2019
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

We hypothesize that (1) the hybrid therapy will induce greater improvements on some health-related outcomes compared to other therapies; (2) such benefits will retain at 6-month follow-up; (3) better motor control and brain reorganization will be found in the hybrid therapy than the other therapies; (4) correlations will be found between brain activity and movement kinematics/health-related outcomes.

Description:

Chronic stroke participants will be recruited from the Chang Gung Memorial Hospital and then were randomly assigned to 1 of the 4 groups: MT+tDCS, MT+sham tDCS, MT, and CI groups. The participants in each group receive equivalent amounts of treatment.

Analysis of covariance (ANCOVA), controlling for the pretest differences, will be separately performed for each outcome measure to test the effects of different intervention groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 11, 2017
• Est. primary completion date: July 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• First episode of stroke in cortical regions

• Time since stroke more than 6 months

• Initial motor part of UE of FMA score ranging from 24 to 52, indicating moderate to mild movement impairment

• No severe spasticity in any joints of the affected arm (Modified Ashworth Scale = 2)

• No serious cognitive impairment (i.e., Mini Mental State Exam score? 24)

• Willing to sign the informed consent form.

Exclusion Criteria:

• Aphasia that might interfere with understanding instructions

• Visual/attention impairments that might interfere with the seeing of mirror illusion, including hemineglect/hemianopsia

• Major health problems or poor physical conditions that might limit participation

• Currently participation in any other research

• Previous brain neurosurgery

• Metallic implants within the brain.

Related Conditions & MeSH terms

• Cerebrovascular Accident
• Stroke

Intervention

Behavioral:
• Mirror Therapy with tDCS
The MTtDCS group will receive a 20-minute tDCS at 1.5 mA current intensity per session followed by a 40-minute mirror therapy and 30-minute functional training during the first two weeks. Sixty-minute pure mirror therapy during the last 2 weeks, and followed by a 30-minute functional training.
• Mirror Therapy with sham-tDCS
The MTtDCS(m) group will receive a 20-minute sham-tDCS per session followed by a 40-minute mirror therapy and 30-minute functional training during the first two weeks. Sixty-minute pure mirror therapy during the last 2 weeks, and followed by a 30-minute functional training.
• Mirror Therapy
The MT group will receive a 60-minute MT per session followed by a 30-minute functional training.
• Control Intervention
The CI group will receive a 60-minute conventional stroke rehabilitation training followed by a 30-minute functional training.

Locations

Country	Name	City	State
Taiwan	Xing Cheng Rehabilitation Clinic	Taipei
Taiwan	Yong Cheng Rehabilitation Clinic	Taipei
Taiwan	Chang Gung Memorial Hospital	Taoyuan
Taiwan	Lo-Sheng Sanatorium and Hospital	Taoyuan

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-Meyer Assessment (FMA)	The upper-extremity subscale of the FMA will be used to assess motor impairment. The 33 upper limb items measure the movement and reflexes of the shoulder/elbow/forearm, wrist, hand, and coordination/speed. They are scored on a 3-point ordinal scale (0-cannot perform, 1-performs partially, 2-performs fully). The maximum score is 66, indicating optimal recovery. The sub-score of a proximal shoulder/elbow (FMA s/e: 0-42) and a distal hand/wrist (FMA h/w: 0-24) will be also calculated to investigate the treatment effects on separate upper extremity elements. The reliability, validity, and responsiveness of the FMA in stroke patients have been shown to be good.	Baseline, 2 weeks, 4 weeks, 16 weeks, and 28 weeks
Primary	Change scores of Wolf Motor Function Test (WMFT)	The assessment requires the participant to perform 15 function-based and 2 strength-based tasks. The tasks are averaged to produce a score in seconds that ranges from 0 to 120 seconds. For functional ability scoring, we used a 6-point ordinal scale where 0 indicates "does not attempt with the involved arm" and 5 indicates "arm does participate; movement appears to be normal." The clinimetrics of the WMFT has been ascertained in stroke patients (Wolf et al., 2005).	Baseline, 2 weeks, and 4 weeks
Primary	Change scores of Motor Activity Log (MAL)	The MAL consists of 30 structured questions to interview how the patients rate the frequency (amount of use subscale) and quality (quality of movement subscale) of movements while using their affected arm to accomplish each of the 30 daily activities. The score of each item ranges from 0 to 5, and the higher scores indicate more frequently used or higher quality of movements. The clinimetric properties of the MAL in stroke patients have been validated (Uswatte, Taub, Morris, Light, & Thompson, 2006).	Baseline, 2 weeks, and 4 weeks, 16 weeks, and 28 weeks
Primary	Change scores of Stroke Impact Scale Version 3.0 (SIS 3.0)	The SIS 3.0 is a stroke-specific instrument of health-related quality of life. It contains 59 items measuring 8 domains (i.e., strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion. memory and thinking and participation) with a single item assessing perceived overall recovery from stroke. Items are rated on a 5-point Likert scale with lower scores indicating greater difficulty in task completion during the past week. The reliability, validity, and responsiveness have been shown to be satisfactory in stroke patients.	Baseline, 2 weeks, and 4 weeks, 16 weeks, and 28 weeks
Primary	Change scores of Revised Nottingham Sensory Assessment (rNSA)	The rNSA includes tactile sensation, kinesthetic sensation, and stereognosis. The rNSA is reliable measure of sensory function in stroke patients. For tactile sensation, the patient will be asked to indicate whenever he or she feels the test sensation. For kinesthetic sensations, all 3 aspects of movement will be tested: appreciation of movement, its direction and accurate joint position sense. The limb on the affected side of the body will be supported and moved by the examiner in various directions but movement is only at one joint at a time. The patients will be asked to mirror the change of movement with the other limb. For stereognosis, the object will be placed in the patient's hand for a maximum of 30 seconds. Identification is by naming, description or by pair-matching with an identical set. The object may be moved around the affected hand by the examiner. The rNSA has good intrarater and interrater reliability (Lincoln, Jackson, & Adams, 1998).	Baseline, and 4 weeks
Secondary	Change scores of Adelaide Activities Profile (AAP)	AAP will be applied to indicate the level of participation in household and community activities. This profile includes 21 activities in the four areas: domestic chores, household maintenance, service to others, and social activities. It scores on a scale of 0-3, with higher point meaning more frequent participation. The AAP is found to have good validity and reliability (Bond & Clark, 1998). The Nottingham Extended Activities of Daily Living (NEADL) Scale (Nouri, & Lincoln, 1987) is frequently used in clinical practice and research in rehabilitation to assess patients' independence in activities of daily living. Twenty-two activities are considered, which full in to 4 subscales: mobility, kitchen, domestic, and leisure activity. Responses are using 1 of 4 options (0 = not at all, 1 = with help, 2 = on my own with difficulty, 3 = on my own).	Baseline, and 4 weeks, 16 weeks, and 28 weeks
Secondary	Change scores of 10-Meter Walk Test (10MWT)	The 10MWT assess mobility function by measuring the time and the numbers of strides required to walk 10 meters under two conditions: (1) with the self-pace of each participant (self-pace); (2) with the speed that the participants walked as soon as possible. The velocity and stride length of the participant are calculated. Research has validated the 10MWT in measuring mobility in stroke.	Baseline, 4 weeks
Secondary	Change scores of Actigraphy	The activity monitors will be used to provide a direct and objective measure of the amount of the impaired arm movement outside the laboratory. This measure, quantitatively recording the amount of activity in free-living conditions, will be used to reflect increase in the amount of affected arm use over time. The participants will be asked to wear an activity monitor, Actigraphy (Ambulatory Monitoring Inc., New York), on each wrist for 3 consecutive days to measure what amount they actually do in their daily life before and immediately after treatment. The Actigraphy can be attached to the subject's limb and measures the motion of that limb through an accelerometer. In this project, acceleration will be sampled at 10 Hz and summed over a user-specified epoch. The recording epoch will be 2 seconds; recording capacity will be approximately 72 hours. The ratio of affected to non-affected arm movement is a reliable and valid real-life measure of treatment outcome.	Baseline, and 4 weeks
Secondary	Change scores of Kinematic analysis	The kinematic analysis will involve unilateral and bilateral tasks, in which the participants will be asked to perform by using the affected upper limb or both upper limb simultaneously. A motion analysis system with 7 cameras (VICON MX 30d, Oxford Metrics Inc., Oxford, UK) will be used to capture the motion of arm (s) in kinematic testing. The markers will be attached on the styloid processes of the ulna. Depending on the unilateral or bilateral tasks, the makers will be placed on the affected arm or the both arms, respectively.	Baseline, and 4 weeks
Secondary	Change scores of hand strength	The Baseline digital hydraulic hand dynamometer and pinch gauge (Fabrication Enterprises Inc, NY.) were used for measurement of grip and pinch strength. For the grip strength measurement, participants were instructed to squeeze the dynamometer with their hand as hard as they could. For the lateral pinch strength measurement, the pinch gauge was positioned between the pad of the thumb and the radial side of the middle phalanx of the index finger. For palmar pinch strength measurement, the pinch gauge was grasped between the pad of the thumb and the pad of the index finger. Participants were told to pinch as hard as they could. This method shows high repeatability (Haidar, Kumar, Bassi, & Deshmukh, 2004).	Baseline, 2 weeks, and 4 weeks
Secondary	Change scores of Stroop test	The Number Stroop Test of the Psychology Experiment Building Language (Mueller, & Piper, 2014) was used to assess the inhibition ability. Participants will be asked to respond to the amount but not the name of stimuli.	Baseline, and 4 weeks
Secondary	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, and 4 weeks