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Completed

NCT Number: NCT01875536

rTMS and Conventional Physical Therapy After Stroke

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Muscle Hypertonia Muscle Spasticity Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Applied Neuroscience Laboratory-LANA

Recife, Pernambuco, 50740-560, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rTMS

Device

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

Conventional Physical Therapy

Behavioral

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 outcomes

  1. Change from Modified Ashworth scale

    Time frame: at baseline, 1 month and 2 months

    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

  2. change from spinal excitability via Hoffmann reflex of the median nerve

    Time frame: at baseline, 1 month and 2 months

    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 outcomes

  1. change from Fugl-Meyer assessment

    Time frame: at baseline, 1 month and 2 months

    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

  2. change from cortical excitability via single transcranial magnetic stimulation

    Time frame: per-session: at baseline and one hour (after physical therapy)

    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

Other outcomes

  1. change from stroke specific quality of life scale

    Time frame: at baseline, 1 month and 2 months

    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

Sponsors and collaborators

Lead sponsor

Universidade Federal de Pernambuco

Other

Registry information

Official study title

Efficacy of Coupling Repetitive Transcranial Magnetic Stimulation and Conventional Physical Therapy to Reduce Upper Limb Spasticity in Stroke Patients

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jun 12, 2013
Registry last updated
Jun 12, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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