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

NCT ID: NCT02254616

Last Updated: 2019-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-01
• Study Completion Date: 2017-10-11

Brief 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.

Detailed 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.

Conditions

Cerebrovascular Accident

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Mirror therapy with tDCS

Functional training will consist of unilateral and bilateral functional tasks in daily living, and last for 30 minutes. Some examples are mopping the table by using the affected hand or scooping beans from a bowl with one hand while the other hand stabilizes the bowl. The principles of part-task practice and whole-task practice will be applied based on the participant's performance level.Functional training will consist of unilateral and bilateral functional tasks in daily living, and last for 30 minutes. Some examples are mopping the table by using the affected hand or scooping beans from a bowl with one hand while the other hand stabilizes the bowl. The principles of part-task practice and whole-task practice will be applied based on the participant's performance level.

Group Type: EXPERIMENTAL

Mirror Therapy with tDCS

Intervention Type: BEHAVIORAL

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

The MT only group will receive a 60-minute MT per session followed by a 30-minute functional training. Participant will go through the same protocol as that for the MT+tDCS and MT+sham tDCS groups with no tDCS presented in setting. This group is for evaluating placebo effect of the present of tDCS application.

Group Type: ACTIVE_COMPARATOR

Mirror Therapy

Intervention Type: BEHAVIORAL

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. During the 60-mimute conventional training, interventions will include passive range of movement and muscle tone normalization techniques of the affected arm, and gross motor training (e.g., shoulder ladder activity), fine motor training (e.g., grasping cones), and muscle strength training in a unilateral and bilateral manners. During the 30-minute functional training, the same principles to those in the MT groups will be applied.

Group Type: ACTIVE_COMPARATOR

Control Intervention

Intervention Type: BEHAVIORAL

The CI group will receive a 60-minute conventional stroke rehabilitation training followed by a 30-minute functional training.

Mirror Therapy with sham-tDCS

Functional training will consist of unilateral and bilateral functional tasks in daily living, and last for 30 minutes. Some examples are mopping the table by using the affected hand or scooping beans from a bowl with one hand while the other hand stabilizes the bowl. The principles of part-task practice and whole-task practice will be applied based on the participant's performance level.

Group Type: ACTIVE_COMPARATOR

Mirror Therapy with sham-tDCS

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

Mirror Therapy

The MT group will receive a 60-minute MT per session followed by a 30-minute functional training.

Intervention Type: BEHAVIORAL

Control Intervention

The CI group will receive a 60-minute conventional stroke rehabilitation training followed by a 30-minute functional training.

Intervention Type: BEHAVIORAL

Other Intervention Names

MTtDCS; MTtDCS(m); MT; CI

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ching-Yi Wu, ScD

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital

Locations

Yong Cheng Rehabilitation Clinic

Taipei, , Taiwan

Xing Cheng Rehabilitation Clinic

Taipei, , Taiwan

Chang Gung Memorial Hospital

Taoyuan District, , Taiwan

Lo-Sheng Sanatorium and Hospital

Taoyuan District, , Taiwan

Countries

Taiwan

References

Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.

Reference Type: DERIVED

PMID: 33175411 (View on PubMed)

Other Identifiers

102-5696A3

Identifier Type: -

Identifier Source: org_study_id