Effect of stimulation with electrical current associated with exercise in stroke: randomized controlled clinical trial

• Register: REBEC
• Last refreshed on: 29 May 2023
• Main ID: RBR-22vxvq
• Date of registration: 10/10/2016
• Prospective Registration: No
• Primary sponsor: Universidade Federal de Sergipe
• Public title: Effect of stimulation with electrical current associated with exercise in stroke: randomized controlled clinical trial
• Scientific title: Effect of interferential current associated with exercise in stroke: randomized controlled clinical trial
• Date of first enrolment: 31/10/2015
• Recruitment status: Recruiting
• URL: http://ensaiosclinicos.gov.br/rg/RBR-22vxvq
• Study type: Intervention
• Study design: Treatment clinical trial, randomized, crossover, double-blind, controlled, with two arms.
• Phase: N/A

Countries of recruitment

Brazil

Contacts

• Name: Daniela da Costa Maia
• Affiliation: Universidade Federal de Sergipe

• Name: Daniela da Costa Maia
• Affiliation: Universidade Federal de Sergipe

Key inclusion & exclusion criteria

Inclusion criteria: Patients with stroke in mild or moderate spastic phase, both genders, aged 30 to 70 years and without physical therapy concomitant during the training period.
Exclusion criteria: Patients who present score less than 24 on the Mini-mental exam, psychiatric condition, cognitive decline or dementia influencing the communication process, musculoskeletal, neuromuscular, or recent cardiopulmonary disorder, patients who can not walk and sit independently, present anesthesia in the trunk region or refuse to participate.

Age minimum: 30Y
Age maximum: 70Y
Gender: -

Health Condition(s) or Problem(s) studied

Stroke

C10.228.140.300.775

Intervention(s)

E02.331

E02.779.483

Initially, patients will be randomly assigned to one of two study groups: active IFC and placebo IFC.
In the active IFC group, eighteen patients will undergo interferential current application for five sessions with two pacing channels, four rectangular surface adhesive electrodes (9 x 5 cm) applied crosswise, in the paravertebral region. Two electrodes will be positioned five feet away from the spinous process of the first thoracic vertebra. Two other electrodes will be positioned to five centimeters from the third lumbar vertebra. The duration of application will be 30 minutes, with a beat frequency of 100 Hz, pulse duration of 100 us and intensity up to the maximum local muscle contraction, comfortable for the patient. After application of the current, the subjects will be treated by a protocol with exercises for trunk control for 30 minutes.
In the placebo IFC group, eighteen individuals also will pass through five treatment sessions. They will be connected to an interferential current apparatus with modified electrostimulation circuit, which current will be release only the first 40 seconds of stimulation. Then, this current will cease. The duration of application will be 30 minutes and then the subjects will be treated by exercise protocol for trunk control, equal to the active IFC group, during 30 minutes.
After completion of the protocols in both groups, patients will have one interval of a week and then they will receive the opposite treatment. Thus, all patients will undergo 10 treatment sessions, five in each group.

Other

Primary Outcome(s)

Increase of trunk control of the subjects stimulated by active IFC. For assessment of trunk control, the Trunk Impairment Scale, Postural Assessment Scale for
Stroke Patients and Functional Reach Test will be used. And for verification the expected outcome, a variation of at least 5% in scales and test used pre and post intervention will be considered.

Secondary Outcome(s)

Reduction of pain intensity at rest and movement, fatigue, catastrophizing and hypertonia, increase of the pressure pain threshold, muscle flexibility and self-esteem. To assess these variables will be used: numerical scale of 11 points, Catastrophizing Pain Scale, modified Ashworth Scale, digital algometry, fleximetry and Rosenberg Self-Esteem Scale, respectively. To check the expected outcomes, a variation of at least 5% in each scale and test used before and after treatment will be considered.

Source(s) of Monetary Support

Universidade Federal de Sergipe

Secondary Sponsor(s)

Universidade Federal de Sergipe