Efficacy of High Frequency Repetitive Transcranial Magnetic Stimulation Associated With Physical Therapy to Reduce Upper Limb Spasticity in Post Stroke Patients: Double Blinded, Randomized and Controlled Clinical
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Stroke
- Sponsor
- Universidade Federal de Pernambuco
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Spasticity
- Last Updated
- 8 years ago
Overview
Brief Summary
In this study, it is being investigated if the association between high frequency repetitive transcranial magnetic stimulation associated with motor physical therapy reduces spasticity, increases upper limb motor function, and quality of life of post-chronic stroke patients than motor physical therapy alone. For this purpose, patients included will be submitted to ten sessions with active or sham hf-rTMS followed by a protocol of physical therapy.
Investigators
Kátia Monte-Silva
principal investigator
Universidade Federal de Pernambuco
Eligibility Criteria
Inclusion Criteria
- •Age 30 to 75 years;
- •Both sexes;
- •With diagnosis of ischemic or hemorrhagic stroke proven by means of computed tomography or magnetic resonance imaging;
- •Spasticity grade will be assessed using the Ashworth modified scale (BOHANNON \& SMITH, 1987), with score +1, 2 or 3 for the wrist flexors of the affected upper limb;
- •With absence of cognitive deficit verified by the Folstein Mini Mental State Examination (score ≥ 20) modified for the Brazilian population (BRUCKI et al., 2003)
Exclusion Criteria
- •Contraindications to and EMT (ROSSINI et al., 2015)
- •Clinical evidence of multiple brain lesions
- •Trauma-orthopedic injury that limits the range of motion of the upper limb
- •Presence of visual and / or communication deficit
- •Involvement of other interventions focused on reducing spasticity
- •Modification of medications in the last 30 days.
Outcomes
Primary Outcomes
Spasticity
Time Frame: before 10 sessions, before and after each session (every day), after 10 daily sessions and after 30 days
Change from degree of Spasticity: ordinal variable measured through the Ashworth Modified Scale, expressed as scores graded from +1 to 3. The EMA is a qualitative instrument with ordinal measures that scores the degree of spasticity presented by the resting muscle from zero to four, in increasing order of intensity.
Secondary Outcomes
- Cortical excitability(before and after 10 daily sessions and after 30 days)
- Quality of life(before and after 10 daily sessions and after 30 days)
- Qualitative and quantitative of moviment(before and after 10 daily sessions and after 30 days)
- Changes on Patient Global Impression of Change Scale(before and after 10 daily sessions and after 30 days)
- Variation of the median nerve Hmax / Mmax ratio(before and after 10 sessions and after 30 days)
- Sensory-motor function of the upper limb(before and after 10 daily sessions and after 30 days)
- Dynamometry(before and after 10 daily sessions and after 30 days)