In this randomized control trial study the effects of biofeedback therapy in addition to current occupational therapy exercises were studied on 24 stroke patients (9 males and 15 females) in one setting; Rehabilitation Center of Tabasom (Tehran, Iran). Participants were selected based on inclusion criteria such as: 1- stroke diagnosis by neurologist, 2- scoring 22 and more in mini mental state examination (MMSE), 3- recognized as having score 2 and more in modified Ashworth test of spasticity, 4- absence of accompanying disorders such as seizure, psychological disorders, hearing or visual problem, or orthopedic disorders in upper extremities, 5- at least three months passed from incidence of stroke, 6- interested in participating in the study and 7- not suffering from hemianopia, Wernicke aphasia and global aphasia. This study and research was approved by “University of Social Welfare and Rehabilitation ethical committee”. Informed consents were obtained prior to experiment and contents were comprehended and signed by patients or their legal representative.
All participants were provided with the information sheet and ensured that their participation in the research is voluntary and they are able to withdraw from the study in every stage of the process. Following their consent data were collected in the participant’s convenient time and day. All people with stroke who provided consent to the study were included in the study. Subjects were blinded to the purpose of the study. There were five tools for collecting data. A questionnaire was used within which data on age, sex, right or left dominance, effected side, post-stroke duration, and the duration of receiving rehabilitation services were collected.
Folstein’s mini-mental state examination (MMSE) with 6 subscales for orientation, registration, attention, calculation, recall, and language and praxis tests was used to estimate the patients’ cognitive ability to participate in biofeedback therapy [
20]. The modified Ashworth scale was used to measure the severity of spasticity in effected hand [
21-
24]. This scale has been designed to rating spasticity in different muscles and its spectrum rates are from zero (no increase in tonicity) to 4 (rigidity in flexion and extension). Then, the active range of motion (ROM) in upper limbs’ joints including elbow, wrist and matacarpophalangeal were measured by goniometry. The extension ROM in elbow was measured in supine position. Because measuring of ROM in elbow starts from 150 degree full flexion and reaches zero degree, the full extension, therefore the angle of extension in elbow was subtracted from 150 to show a positive trend during increase in ROM. The ranges of motion in the wrist and finger were measured in a sagittal plane.
The ROM in the wrist was from zero to 70 degree full extension and in the finger was 90 degree in full extension.
Finally, the Barthel index (BI) was used to asses daily function status and independency in 10 categories of activities including bowel, bladder, grooming, toilet use, feeding, transfer, mobility, dressing, steps, and bathing. All assessments were repeated after the intervention period [
25].
Participants were randomly assigned in the experimental or control groups. Participants in both groups received current occupational therapy including muscle stretching, positioning, facilitating normal patterns of movement, facilitator and inhibitory techniques, reflex inhibitory patterns, facilitating higher level reflexes and muscle tone normalization. Participants in experimental group received an additional biofeedback therapy for 10 minutes; altogether for 45 minutes each session. Intervention duration included three sessions a week for three months (altogether 36 sessions).
In biofeedback therapy, after stabilizing hand on the table with a hand-rest, electrodes were set on the bulk of wrist extensor muscles and lateral epicondyle of humerus, patients sat in front of monitor and watched the diagram of muscular contraction. By adjusting the threshold, if the patient could produce an activity in the extensor muscles above the threshold, music broadcasted from the machine. Therefore, he/she could receive appropriate feedback about contraction in the targeted muscle either in visual or auditory signals. The biofeedback tool in this research was Procomp Infiniti 5 channel model, made in USA.
The collected data from the two groups were analyzed using SPSS-20. Descriptive statistics were used for quantitative and qualitative data, and the statistical test was Kolmogorov-Smirnov that used to evaluate normal distribution of data. Equality of variables between the two groups was compared before intervention using independent t-test for quantitative and χ2 tests for qualitative variables. Statistical variance analysis for repeated measures (repeated measure ANOVA) was used to study the changes in test scores in each group during consequent assessments and then the mean scores of each test during sequential testing were compared in each group separately using paired t-test (P < 0.01).