COMPARISON BETWEEN INSTITUTIONAL BASED SUPERVISION AND TELE BASED SUPERVISION FOR TASK ORIENTED EXERCISES ON UPPER LIMB MOTOR PERFORMANCE AND FUNCTIONAL ABILITY AMONG PATIENTS WITH STROKE

Study Design

Two group pretest posttestRandomized Controlled trial

Study Location

Prem Physiotherapy and RehabilitationCollege ,Panipat

Study Setting

Prem Physiotherapy and Rehabilitation College,Panipat

Study Participants

Patientswith stroke

Sampling Method

Purposivesampling

3.5. Procedure

3.5.1. Ethical Statement

Ethical clearance will be obtained fromInstitutional Ethical Committee, Maharishi Markandeshwar (Deemed to beUniversity). Guidelines of Declaration of Helsinki (2013) and National Ethicalguidelines for the Biomedical and Health Research involving Human participantsgiven by Indian Council of Medical Research (2017) will be followed for thestudy.49

Recruitment

Individualswith stroke will be selected according to predefine selection criteria.Participants meeting the inclusion criteria will be included in the study.Procedure of the study will be explained prior to the intervention and bothEnglish (Annexure 1) and Hindi (Annexure 2) written informed consent will be obtained from all participants. Outcomemeasurements will be taken at baseline, at 4 week and after completion ofintervention at 8 weeks

Procedure

Ethical Statement

Ethical clearance will be obtained fromInstitutional Ethical Committee, Maharishi Markandeshwar (Deemed to beUniversity). Guidelines of Declaration of Helsinki (2013) and National Ethicalguidelines for the Biomedical and Health Research involving Human participantsgiven by Indian Council of Medical Research (2017) will be followed for thestudy.49

Recruitment

Individualswith stroke will be selected according to predefine selection criteria.Participants meeting the inclusion criteria will be included in the study.Procedure of the study will be explained prior to the intervention and bothEnglish (Annexure 1) and Hindi (Annexure 2) written informed consent will be obtained from all participants. Outcomemeasurements will be taken at baseline, at 4 week and after completion ofintervention at 8 weeks.

Sample Size

Samplesize estimation is done by G*Power 3.1.9.4 software (Heinrich-heine- UniversitätDüsseldorf, Germany)  using effect size of included outcome measuresused in previous studies, 5% Level of Significance, 95% power and considering adropout rate of 20%. Sample size calculation using Fugl Meyer Scale is moreappropriate so the included total sample size for this study will be 62.

Selection Criteria

Inclusion criteria

·        Both male andfemale patients.

·        First-ever ischemic or hemorrhagic (notevacuated) stroke confirmed by neuroimaging (computed tomography, CT ormagnetic resonance, MR)

·        Age between 45 to 70 years

·        Patient havingstroke from 2 months up to 6 months.

·        Moderate tomild motor impairment (Fugl Meyer Assessment 26-56)

·        Mild tomoderate spasticity (modified ashworth scale <2).

·        Sufficientcognitive ability to follow the instructions (mini-mental state examinationscore >24)

·        Patient withBrunnstrom Score-Stage II and III

·        Willing to participate

Exclusion Criteria

·       Progressingstroke

·       Visualproblems that might prohibit them performing the task

·       Excessivejoint contracture of UE

·       Otherneurological (Parkinsonism, multiple sclerosis) or psychological            disorders(depression, dementia ),orthopaedicdisease (previous fractures,or deformities caused by inflammatory arthopathiessuch as rheumatoid arthritis)

·      Received botulinum toxin injectionswithin 3 months

Outcome Measures

Fugl-Meyer Assessment Scale for Upper Extremity: FMAis arranged hierarchically and evaluate aspects of movement, reflexes,coordination, and speed. The upper extremity measure is scored out of 66, withsub scores for the upper arm 36, for the wrist 10, for the hand 14, and 6 forcoordination and speed of movement.19

Motor Evaluation Scale for Extremity in StrokePatients: The MESUPES assessment tool is anordinal scale that rewards only qualitatively normal movements in the pareticarm. The scale items reflect the domains of body functions/structures andactivity according to the International Classification of Functioning,Disability and Health. The MESUPES includes eight arm items with six responsecategories (scores 0-5), and nine hand items with three response categories(scores 0-2). The items are briefly described in annexure 7. The maximum scorefor the MESUPES is 58. For the arm function (MESUPES-arm test), the tasks areperformed in three consecutive phases.25

Variables

Dependent Variables

Fugl Meyer Assessment Scale for Upper Extermity(FMA-UE)

MotorEvaluation Scale for Upper Extermity in Stroke Patients

Independent Variables

TeleBased Supervision for Task Oriented Exercises

InstitutionalBased  Supervision for Task OrientedExercises

Materials to be used

Pen and Paper, couch

Interventions

A written consent will be obtained from all patients who met theinclusion criteria of the study will be taken and required assessment of everypatient will be done. Total 62 patients will be taken which will divide into 2groups. Participants will beurged not to switch their therapy regimens while they are enrolled in the studyand to refrain from taking part in any other arm-hand performance-relatedstudies. Group A will receive Tele Based Supervision for task orientedexercises and group B receive Institution Based Supervision for task orientedexercises.

Task oriented exercises will be given for 3 days per week for 8 weeks(i.e. 24 treatment sessions)  for 30minutes to both the groups. 30 sec rest will be given before changing task. Datawill be collect by means of Fugl-Meyer Assessment for Upper Extremity, motorevaluation scale for upper extremity in stroke patients. Three readings will betaken one before the treatment ,2nd after 4th  week i.e. 12th treatment sessionand 3rd after 8th weeks i.e. after 24thtreatment sessions. Follow up will be taken after one month.

Text Box: Enrollment