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rTMS and Conventional Physical Therapy After Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
rTMS
conventional physical therapy
Sponsored by
Universidade Federal de Pernambuco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring transcranial magnetic stimulation, spasticity, physiotherapy, Rehabilitation

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • stroke onset ≥ 6 months;
  • muscle tone at the wrist with a modified Ashworth scale (MAS) score between 1+ and 3;
  • minimum age of 30 years old and maximum age of 75 years;
  • absence of cognitive impairment, as determined by the cut-off scores on the Mini-mental state exam

Exclusion Criteria:

  • history of seizure or cerebral aneurism;
  • antispasticity drugs within 6 months before enrollment;
  • previous surgery involving metallic implants;
  • unstable vital signs;
  • other neurological diseases
  • aphasia

Sites / Locations

  • Applied Neuroscience Laboratory-LANA

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

rTMS

control

Arm Description

The experimental group received rTMS to the primary motor cortex of the unaffected side in 10 sessions, 3 days per week, and conventional physical therapy

The control group received sham stimulation (same area as the experimental group) in 10 sessions, 3 days per week, and conventional physical therapy

Outcomes

Primary Outcome Measures

Change from Modified Ashworth scale
Modified Ashworth scale (MAS) uses a 6-point scale to score the average resistance to passive movement for each joint. In this study, the tonus of the wrist flexor muscles was tested
change from spinal excitability via Hoffmann reflex of the median nerve
assess the effects of the intervention (rTMS and physical therapy) on spinal excitability as measured by the change The Hmax/Mmax ratio (calculated by dividing the maximal amplitude of the H wave by that of the M wave in median nerve) before (baseline), after treatment and after follow-up

Secondary Outcome Measures

change from Fugl-Meyer assessment
The Fugl-Meyer assessment (FMA) is considered the gold standard for evaluating the motor function recovery. It is designed to assess motor functioning, balance, sensation, and joint functioning. It is applied within clinical and in research contexts to determine the disease severity, describe motor recovery, and plan and assess interventions. In the present study, the 33-item of the UL section was employed. The items are rated on 3-point ordinal scale, as follows: 0= unable to perform; 1= partial ability to perform; and 2= near normal ability to perform. The UL subscale evaluates motor function recovery in six domains: flexor and extensor synergies, non-synergic movements, wrist and hand movements, and coordination and speed
change from cortical excitability via single transcranial magnetic stimulation
assess the effects of the intervention (rTMS and physical therapy) on motor cortex excitability as measured by the change in motor evoked potential (using transcranial magnetic stimulation) before and after each session

Full Information

First Posted
June 6, 2013
Last Updated
June 11, 2013
Sponsor
Universidade Federal de Pernambuco
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1. Study Identification

Unique Protocol Identification Number
NCT01875536
Brief Title
rTMS and Conventional Physical Therapy After Stroke
Official Title
Efficacy of Coupling Repetitive Transcranial Magnetic Stimulation and Conventional Physical Therapy to Reduce Upper Limb Spasticity in Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Pernambuco

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Given previous evidence that non invasive brain stimulation enhances the effects of conventional therapies, this randomized sham-controlled trial with 4-weeks follow-up aimed to determine if the repetitive transcranial magnetic stimulation (rTMS)combined with conventional physical therapy (VRT) would be superior to physical therapy in improving upper limb function and quality of life with chronic stroke individuals.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
transcranial magnetic stimulation, spasticity, physiotherapy, Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
rTMS
Arm Type
Experimental
Arm Description
The experimental group received rTMS to the primary motor cortex of the unaffected side in 10 sessions, 3 days per week, and conventional physical therapy
Arm Title
control
Arm Type
Sham Comparator
Arm Description
The control group received sham stimulation (same area as the experimental group) in 10 sessions, 3 days per week, and conventional physical therapy
Intervention Type
Device
Intervention Name(s)
rTMS
Intervention Description
The subjects were seated in a comfortable chair with head and arm rests. Focal TMS of the motor cortex was performed with a 70-mm figure-8 coil attached to magnetic stimulator stimulation parameters : frequency of 1Hz on the uninjured hemisphere by stroke; 1500 pulses with an intensity of 90% of MT 10 sessions of rTMS, one per day, always before conventional physical therapy
Intervention Type
Behavioral
Intervention Name(s)
conventional physical therapy
Intervention Description
The physical therapy program was composed of the activities of flexibility, transfer and posture, strength, coordination, balance, and sensory stimulation. The physical therapy was applied for about 30 minutes, three days per week.
Primary Outcome Measure Information:
Title
Change from Modified Ashworth scale
Description
Modified Ashworth scale (MAS) uses a 6-point scale to score the average resistance to passive movement for each joint. In this study, the tonus of the wrist flexor muscles was tested
Time Frame
at baseline, 1 month and 2 months
Title
change from spinal excitability via Hoffmann reflex of the median nerve
Description
assess the effects of the intervention (rTMS and physical therapy) on spinal excitability as measured by the change The Hmax/Mmax ratio (calculated by dividing the maximal amplitude of the H wave by that of the M wave in median nerve) before (baseline), after treatment and after follow-up
Time Frame
at baseline, 1 month and 2 months
Secondary Outcome Measure Information:
Title
change from Fugl-Meyer assessment
Description
The Fugl-Meyer assessment (FMA) is considered the gold standard for evaluating the motor function recovery. It is designed to assess motor functioning, balance, sensation, and joint functioning. It is applied within clinical and in research contexts to determine the disease severity, describe motor recovery, and plan and assess interventions. In the present study, the 33-item of the UL section was employed. The items are rated on 3-point ordinal scale, as follows: 0= unable to perform; 1= partial ability to perform; and 2= near normal ability to perform. The UL subscale evaluates motor function recovery in six domains: flexor and extensor synergies, non-synergic movements, wrist and hand movements, and coordination and speed
Time Frame
at baseline, 1 month and 2 months
Title
change from cortical excitability via single transcranial magnetic stimulation
Description
assess the effects of the intervention (rTMS and physical therapy) on motor cortex excitability as measured by the change in motor evoked potential (using transcranial magnetic stimulation) before and after each session
Time Frame
per-session: at baseline and one hour (after physical therapy)
Other Pre-specified Outcome Measures:
Title
change from stroke specific quality of life scale
Description
the stroke specific quality of life scale (SSQOL) is used to provide an assessment of health-related quality of life specific to patients with stroke. The scale is a self-report (reference to the past two weeks) containing 49 items distributed into 12 domains (mobility, energy, upper extremity function, work/productivity, mood, self-care, social roles, family roles, vision, language, thinking and personality), rated on a 5-point scale. The total score (maximum 245) and the upper extremity function scores (maximum of 25) can be considered for analyses. The Brazilian version of the SSQOL was used in this study
Time Frame
at baseline, 1 month and 2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: stroke onset ≥ 6 months; muscle tone at the wrist with a modified Ashworth scale (MAS) score between 1+ and 3; minimum age of 30 years old and maximum age of 75 years; absence of cognitive impairment, as determined by the cut-off scores on the Mini-mental state exam Exclusion Criteria: history of seizure or cerebral aneurism; antispasticity drugs within 6 months before enrollment; previous surgery involving metallic implants; unstable vital signs; other neurological diseases aphasia
Facility Information:
Facility Name
Applied Neuroscience Laboratory-LANA
City
Recife
State/Province
Pernambuco
ZIP/Postal Code
50740-560
Country
Brazil

12. IPD Sharing Statement

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rTMS and Conventional Physical Therapy After Stroke

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