Study Design

       Two group pretest posttest Randomized Controlled trial

 Study Location

       Prem Physiotherapy and Rehabilitation College ,Panipat

Study Setting

       Prem Physiotherapy and Rehabilitation College, Panipat

 Study Participants

       Patients with stroke

 Sampling Method

      Purposive sampling

3.5. Procedure

3.5.1. Ethical Statement

Ethical clearance will be obtained from Institutional Ethical Committee, Maharishi Markandeshwar (Deemed to be University). Guidelines of Declaration of Helsinki (2013) and National Ethical guidelines for the Biomedical and Health Research involving Human participants given by Indian Council of Medical Research (2017) will be followed for the study.⁴⁹

Recruitment

Individuals with 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 both English (Annexure 1) and Hindi (Annexure 2) written informed consent will be obtained from all participants. Outcome measurements will be taken at baseline, at 4 week and after completion of intervention at 8 weeks

 Procedure

Ethical Statement

Ethical clearance will be obtained from Institutional Ethical Committee, Maharishi Markandeshwar (Deemed to be University). Guidelines of Declaration of Helsinki (2013) and National Ethical guidelines for the Biomedical and Health Research involving Human participants given by Indian Council of Medical Research (2017) will be followed for the study.⁴⁹

 Recruitment

Individuals with 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 both English (Annexure 1) and Hindi (Annexure 2) written informed consent will be obtained from all participants. Outcome measurements will be taken at baseline, at 4 week and after completion of intervention at 8 weeks.

  Sample Size

Sample size estimation is done by G*Power 3.1.9.4 software (Heinrich-heine- Universität Düsseldorf, Germany)   using effect size of included outcome measures used in previous studies, 5% Level of Significance, 95% power and considering a dropout rate of 20%. Sample size calculation using Fugl Meyer Scale is more appropriate so the included total sample size for this study will be 62.

Selection Criteria

 Inclusion criteria

·         Both male and female patients.

·         First-ever ischemic or hemorrhagic (not evacuated) stroke confirmed by neuroimaging (computed tomography, CT or magnetic resonance, MR)

·         Age between 45 to 70 years

·         Patient having stroke from 2 months up to 6 months.

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

·         Mild to moderate spasticity (modified ashworth scale <2).

·         Sufficient cognitive ability to follow the instructions (mini-mental state examination score >24)

·         Patient with Brunnstrom Score-Stage II and III

·         Willing to participate  

 Exclusion Criteria

·       Progressing stroke

·       Visual problems that might prohibit them performing the task

·       Excessive joint contracture of UE

·       Other neurological (Parkinsonism, multiple sclerosis) or psychological            disorders(depression, dementia ),orthopaedic disease (previous fractures,or deformities caused by inflammatory arthopathies such as rheumatoid arthritis)

·       Received botulinum toxin injections within 3 months

   Outcome Measures

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

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

Variables

 Dependent Variables

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

 Motor Evaluation Scale for Upper Extermity in Stroke Patients

 Independent Variables

 Tele Based Supervision for Task Oriented Exercises

Institutional Based  Supervision for Task Oriented Exercises

Materials to be used

Pen and Paper, couch

 Interventions

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

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