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rTMS Study to Improve Functional Performance for Patients With Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Phase 3
Locations
Taiwan
Study Type
Interventional
Intervention
rTMS
Sponsored by
Taipei Medical University WanFang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring repetitive transcranial magnetic stimulation, postural, balance, mobility, leg, stroke

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • unilateral hemiplegia caused by the stroke,
  • first ever stroke,
  • time since stroke: 10-90 days,
  • age: 18-80 y/o,
  • Functional ambulation classification (FAC): 0-2,

Exclusion Criteria:

  • contraindication to TMS (eg, pacemaker, seizure history, pregnancy),
  • cranial metal implants
  • intracranial hemorrhage associated with tumor or arteriovenous malformation, craniotomy
  • able to complete Timed Up and Go (TUG) test within 2 minutes
  • unable to walk normally before the stroke
  • those whose motor evoked potentials (MEP) of M1-UH were absent in the pretest

Sites / Locations

  • Shuang Ho Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

real rTMS

sham rTMS

Arm Description

Experimental included the a daily real rTMS session for 15 mins followed by a physical therapy for 45 mins.

the control interventions included a daily sham rTMS session for 15 minutes followed by a physical therapy for 45 minutes.

Outcomes

Primary Outcome Measures

Timed Up and Go (TUG)

Secondary Outcome Measures

the lower extremity subscale of Fugl-Meyer Assessment (FMA-LE)
The balance and gait subscales of Tinetti Performance Oriented Mobility Assessment (POMA-b and POMA-g)
Barthel Index (BI)
Postural control was assessed by Postural Assessment Scale for Stroke (PASS)
PASS which examines the patient's ability to maintain or change a given posture and is applicable to patients with very poor postural performance. This instrument has been reported to have a good validity and reliability at different recovery stages after stroke, minimal floor and ceiling effect, and be sensitive to changes in severe stroke patients at early stage after stroke.
modified Rankin Scale (MRS)

Full Information

First Posted
December 4, 2013
Last Updated
December 10, 2015
Sponsor
Taipei Medical University WanFang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02006875
Brief Title
rTMS Study to Improve Functional Performance for Patients With Stroke
Official Title
The Potential Benefit of 1-Hz rTMS to Improve Gross Motor Function After Stroke: A Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Medical University WanFang Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To use repetitive transcranial magnetic stimulation (rTMS) to treat stroke patients is getting a popular idea. Previous studies seemed to support its effects on facilitating motor recovery after stroke. This study focuses on the motor recovery of lower extremities. Investigators conducted the study to evaluate the treatment effect of rTMS on the functional performance of lower extremities in terms of postural control, balance, and mobility in stroke patients. Investigators hypothesized that these performances could be improved through the better motor control of lower extremities caused by rTMS.
Detailed Description
Protocol: Setting: inpatient rehabilitation department of Shuang-Ho Hospital. Study population: Patients received inpatient treatment or rehabilitation for stroke in Shuang-Ho Hospital (SHH). Eligibility. Screening for eligibility was done by the 2 physiatrists from rehabilitation department of SHH. Study design: controlled trial with stratified randomization Blinding The patients were blinded by the real or sham coil of rTMS The assessors who performed the outcome measurements were blinded to the assignment of treatment. Measurements. Baseline demographic records. The stroke severity was measured by National Institutes of Health Stroke Scale (NIHSS), Modified Rankin Scale (MRS), Brunnstrum stage, and Manual muscle test (MMT) before intervention. Clinical assessments. Postural control was assessed by Postural Assessment Scale for Stroke Patients (PASS) The motor recovery of lower extremities was assessed by the lower extremity subscale of Fugl-Meyer Assessment (FMA-LE) The balance and gait subscales of Tinetti Performance Oriented Mobility Assessment (POMA-b and POMA-g) Timed Up and Go (TUG) test was used to assess the gross mobility. Barthel Index (BI) for the ADL independence modified Rankin Scale (MRS) for disability classification were also collected. These measurements (including the clinical and corticomotor excitability assessments) are performed by one researcher who are responsible for the measurements. Compliance and side effect. The compliance of interventions were investigated. The attendance of treatments (including rTMS sessions and physical therapy sessions) and possible side effect/discomfort were recorded during the interventions by a researcher. He also tries to understand the reason of drop-out from the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
repetitive transcranial magnetic stimulation, postural, balance, mobility, leg, stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
real rTMS
Arm Type
Experimental
Arm Description
Experimental included the a daily real rTMS session for 15 mins followed by a physical therapy for 45 mins.
Arm Title
sham rTMS
Arm Type
Sham Comparator
Arm Description
the control interventions included a daily sham rTMS session for 15 minutes followed by a physical therapy for 45 minutes.
Intervention Type
Device
Intervention Name(s)
rTMS
Other Intervention Name(s)
Magstim Rapid2
Intervention Description
Interventions started on the next weekday after pretest and were performed once a day for 15 consecutive weekdays. Participants in the E and C groups received rTMS (either real or sham, 1 Hz, 15 minutes), followed by a session of physical therapy for 45 minutes.
Primary Outcome Measure Information:
Title
Timed Up and Go (TUG)
Time Frame
Up to 3 months after interventions completed
Secondary Outcome Measure Information:
Title
the lower extremity subscale of Fugl-Meyer Assessment (FMA-LE)
Time Frame
up to 3 months after the intervention completed
Title
The balance and gait subscales of Tinetti Performance Oriented Mobility Assessment (POMA-b and POMA-g)
Time Frame
up to 3 months after the interventions completed
Title
Barthel Index (BI)
Time Frame
Up to 3 months after interventions completed
Title
Postural control was assessed by Postural Assessment Scale for Stroke (PASS)
Description
PASS which examines the patient's ability to maintain or change a given posture and is applicable to patients with very poor postural performance. This instrument has been reported to have a good validity and reliability at different recovery stages after stroke, minimal floor and ceiling effect, and be sensitive to changes in severe stroke patients at early stage after stroke.
Time Frame
up to 3 months after the intervention completed
Title
modified Rankin Scale (MRS)
Time Frame
Up to 3 months after interventions completed

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: unilateral hemiplegia caused by the stroke, first ever stroke, time since stroke: 10-90 days, age: 18-80 y/o, Functional ambulation classification (FAC): 0-2, Exclusion Criteria: contraindication to TMS (eg, pacemaker, seizure history, pregnancy), cranial metal implants intracranial hemorrhage associated with tumor or arteriovenous malformation, craniotomy able to complete Timed Up and Go (TUG) test within 2 minutes unable to walk normally before the stroke those whose motor evoked potentials (MEP) of M1-UH were absent in the pretest
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yen-Nung Lin, MD, MS
Organizational Affiliation
Department of Physical Medicine and Rehabilitation, Wan Fang Hospital, Taipei Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shuang Ho Hospital
City
New Taipei City
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
25679340
Citation
Lin YN, Hu CJ, Chi JY, Lin LF, Yen TH, Lin YK, Liou TH. Effects of repetitive transcranial magnetic stimulation of the unaffected hemisphere leg motor area in patients with subacute stroke and substantial leg impairment: A pilot study. J Rehabil Med. 2015 Apr;47(4):305-10. doi: 10.2340/16501977-1943.
Results Reference
derived

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rTMS Study to Improve Functional Performance for Patients With Stroke

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