Transcranial Direct Current Stimulation Combined Neuromuscular Electrical Stimulation on Motor Recovery in Stroke
1 other identifier
interventional
30
0 countries
N/A
Brief Summary
The purpose of this study was to investigate the effects of the combination treatment strategy. A randomized, double-blinded and sham-stimulation study was conducted. Twenty-six participants with chronic stroke (onset \> 6 months) were assigned into one of three groups (tDCS combined with NMES, tDCS combined with sham NMES, or sham tDCS combined with sham NMES) by block randomization. In addition to conventional rehabilitation, all subjects received an additional protocol with a total of 15 sessions for 3 weeks (5 times per week, 30 minutes daily). The UE subscale of Fugl-Meyer assessment (UE-FMA) and Action Research Arm Test (ARAT) as primary outcome measures were assessed at beginning of the intervention, after 3-week of treatment, and one-month follow-up. No significant differences in the primary outcome measures at post-treatment and one-month follow-up were found among the tDCS combined with NMES group (n=9), tDCS combined with sham NMES group (n=9), and the sham tDCS combined with sham NMES group (n=8). However, significant changes in UE-FMA (from baseline to post-treatment, p= .02) and ARAT (from baseline to post-treatment, p= .04) score were found for the tDCS combined with NMES group. This preliminary study reveals that the tDCS combined with NMES appears to be beneficial to UE motor recovery after stroke but is not superior to the tDCS alone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2017
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 13, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2019
CompletedFirst Submitted
Initial submission to the registry
August 14, 2019
CompletedFirst Posted
Study publicly available on registry
August 16, 2019
CompletedAugust 16, 2019
August 1, 2019
2.5 years
August 14, 2019
August 15, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
upper extremity subscale of Fugl-Meyer assessment
The Fugl-Meyer assessment consists of the 33-item upper-extremity (UE-FM) and 17-item lower-extremity subscales.(Fugl-Meyer et al., 1975) The items of the FM are mainly scored on a 3-point scale, from 0 to 2. The total score of the UE-FM ranges from 0 to 66.
at beginning of the intervention, after 3-week of treatment, and one-month follow-up
Action Research Arm Test
The ARAT(Lyle, 1981) has 19 items in four categories: grasp, grip, pinch, and gross movement. Each item is graded on a 4-point scale, from 0 to 3. The total score has a range of 0 to 57.
at beginning of the intervention, after 3-week of treatment, and one-month follow-up
Study Arms (3)
tDCS combined with NMES
EXPERIMENTALIn addition to conventional rehabilitation, all subjects received an additional tDCS combined with NMES protocol with a total of 15 sessions for 3 weeks (5 times per week, 30 minutes daily).
tDCS combined with sham NMES
ACTIVE COMPARATORIn addition to conventional rehabilitation, all subjects received an additional tDCS combined with sham NMES protocol with a total of 15 sessions for 3 weeks (5 times per week, 30 minutes daily).
sham tDCS combined with sham NMES
SHAM COMPARATORIn addition to conventional rehabilitation, all subjects received an additional sham tDCS combined with sham NMES protocol with a total of 15 sessions for 3 weeks (5 times per week, 30 minutes daily).
Interventions
Eligibility Criteria
You may qualify if:
- First onset
- Ischemic stroke
- Stroke onset \> 6 months
- Brunnstrom recovery stage: ≧3
- Modified Ashworth Scale Elbow flexor : ≦3
You may not qualify if:
- Severe language or cognitive impairment
- Orthopaedic or neurological problems
- Pregnancy
- Contraindications for tDCS or NMES
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 14, 2019
First Posted
August 16, 2019
Study Start
January 13, 2017
Primary Completion
July 30, 2019
Study Completion
July 31, 2019
Last Updated
August 16, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share