A Randomized Controlled Trial to Study the Effectiveness of Interactive, Virtual Tele- Physiotherapy for Improving Motor Function and Quality of Life in Stroke Patients: A Study Protocol

Introduction: Telephysiotherapy (TPT) is provision of physiotherapy services using telecommunication technology such as audio call or video call to facilitate the physiotherapy management of patients within their own homes. In the absence of which the patients may have to discontinue physiotherapy treatment that may result into poor motor outcomes leading to deterioration of the quality of life (QoL). Methodology: This is a study protocol designed to study the effectiveness of TPT intervention in Stroke patients. The objective is to study whether TPT is effective for Stroke Rehabilitation in improving motor function and quality of life. An exercise protocol will be administered to patients suffering from mild to moderate stroke those grading less than or equal to 4 on a Modified Rankin Study Protocol Gudhe et al.; JPRI, 33(51B): 187-193, 2021; Article no.JPRI.76952 188 Scale (mRS=<4). A total 40 patients will be recruited in the study, divided into 2 groups –Group A and Group B, where Group A will receive the exercise therapy through Tele Physiotherapy & Group B will receive Out-Patient-Based (OPD-based) Physiotherapy. Participants of both the groups will be called to the OPD at the baseline and at the end of 6 weeks intervention. The patients shall be assessed at the baseline and at the end of intervention using Fugl-Meyer Assessment (FMA), Dynamic Gait Index (DGI), Functional Independence Measure (FIM) and Stroke Specific Quality Of Life scale (SS-QOL) to evaluate their motor function, gait, functional status and quality of life respectively. Ethical Considerations: Approval from the Institutional Ethics committee of the institute is obtained. Participation in study will be voluntary and only the patients willing to give the written informed consent will be recruited for the study. Results: The results of the study will be published and disseminated in peer-reviewed journals.


INTRODUCTION
Stroke is one of India's most common causes of death and disability. Early initiation of rehabilitation at the earliest helps to improve patient outcomes. The rehabilitation for stroke is an ongoing process and maybe given on inpatient or out-patient basis mainly to improve the physical function and quality of life [1].

Need of Study
In low-income and middle-income countries like India where the resources for providing rehabilitative services are often limited, physical therapy approaches that can be implemented in low-resource settings need to be devised, tested and promoted in the community [1].
Accessibility of healthcare service became a major healthcare service gap affecting overall healthcare due to the Covid-19 outbreak [1]. Due of the pandemic and lockdown, the number of overall patients attending clinics reduced considerably [2] Also, number of stroke patients coming for OPD follow-up and rehabilitation has considerably reduced . This could be due to decreased availability of public transport and fear of acquiring SARS-CoV-2 infection. The abrupt interruption in rehabilitation may cause worsening of the functional outcomes of poststroke patients. In order to maintain the continuum of care for stroke care and reduce morbidity and mortality, tele-health and telerehabilitation have been proposed and implemented as a remedial measure for the poststroke rehabilitation [3]. The TPT has already shown effectiveness in improving clinical outcomes in developed countries but such studies are lacking in the context of developing countries where there are limited resources and the literacy rate is low. Thus, this study is designed to be undertaken in the context of a developing country like India [4].

Background
Stroke or Cerebrovascular accident (CVA) is the sudden loss of neurological function caused by interruption to the blood flow to the brain. The World Health Organization (WHO) defines Stroke as "rapidly developing clinical signs of focal (or global) disturbance of cerebral function, with symptoms lasting 24 hours or longer or leading to death, with no apparent cause other than vascular origin" [5].
Among 240 causes of death, globally stroke is the second leading cause of death worldwide [6] Globally, incidence of stroke is about 25.7 million with 6.5 million deaths from stroke and 113 million DALYs are lost due to stroke [7] Stroke is one of India's most common causes of death and disability. The average annual incidence rate of stroke in India currently is 145 per 100,000 population, which is higher than the western nations [8].
The growing burden of stroke-related disability and the unmet need for rehabilitation following stroke in India poses a major public health challenge. Rehabilitation training is the most effective way to reduce motor impairments in stroke patients and is an important aspect of the continuum of care in stroke. Physiotherapy forms an important component of stoke rehabilitation and can be started as soon as the patient vitals are stable, once the acute hospital care of the stroke patient is completed. Stroke rehabilitation is a goal oriented, progressive process which enables a person with impairment to achieve their optimal physical, social and restoration of normal functional level. Post stroke rehabilitation helps to improve the functional status and independence in activities of daily living of the individual suffering from stroke [9,10].
The term 'Telehealth' or "Telemedicine' refers to the application of electronic or digital information and communication technology to assist patients for professional health, as well as for health education, public health, and health administration [11]. It can be classified as televisits, tele-supervision, tele-monitoring, teleinterpretation and tele-consultation. The delivery of rehabilitation and habilitation services via information and communication technology (ICT) is referred to as Tele-rehabilitation [2]. Telephysiotherapy (TPT) is a provision of physiotherapy services at a distance, using telecommunication technology such as video conferencing or telephone meeting, when an inperson visit to the patient is not a feasible option. TPT can be implemented and used to provide therapeutic exercise information to patients at home, allowing patients to skip long distance transport and undertake basic physiotherapy exercises in the comfort of their own house [12] TPT covers a wide variety of rehabilitation and habilitation services, including assessment, monitoring, prevention, intervention, supervision, education, consultation, and counseling on a clinical level [13].
Application of TPT can also ensure patient adherence to self-assessment and selfmanagement, result in improved clinical outcomes. With the removal of barriers (distance to clinic, transportation expense, travel time, and waiting time at clinics), flexible scheduling, and enhanced patient choice, the TPT aids in the timely delivery of interventions, resulting in a more patient-centered approach to care [14].

MATERIALS AND METHODS
This is a study protocol for studying effectiveness of TPT intervention in Stroke patients.
Study Design: Two-arm parallel randomized controlled trial.

Study Population:
Patients with mild to moderate stroke disability were considered for the study (mRS=<4) A total 40 patients were recruited in the study, divided into 2 groups -Group A and Group B, where Group A received Tele Physiotherapy & Group B received OPDbased Physiotherapy. The study will be conducted in OPD premises of Acharya Vinoba Bhave Rural Hospital (AVBRH), Sawangi for the OPD based Physiotherapy Group and for Tele-Physiotherapy Group the study setting will be respective patient's home. The patients will be selected using simple random sampling (using blinded chits). A sample size of 16 for each group was determined using the following formula. is the true mean response of the experimental treatment; is the true mean response of the control treatment is the clinically meaningful difference Considering 10 percent dropout rate with 80% power and a one-sided type I error level set to 5% a total of 40 patients, 20 in each group, the expected effect size is 0.33 units and the variance 2=0.4 [14].

Study Procedure
After receiving approval from the Institutional Ethics committee, the participants will be recruited from AVBRH physiotherapy OPD and screened for the inclusion and exclusion criteria. The patients with an access to a multimedia android phone, with good internet connectivity were considered and screened for the study.
Once they meet the inclusion criteria, an informed ethical consent will be taken from the patients to participate in the study. Total 40 patients will be recruited in the study. The study participants were randomly allocated into Group A that will receive Tele Physiotherapy and Group B that will receive OPD-based Physiotherapy. Participants of both the groups were called to the OPD prior to beginning the study and after 6 weeks. The patient was assessed in-person at the baseline and at the end line.
A Physician's opinion will be taken for both the group patients undergoing the 6-weeks study to ensure their physical fitness to participate in the 6 weeks rehabilitation program. Also, the patient in Group A will be closely monitored over the interactive video calls thrice a week for 6 weeks while administering Telephysiotherapy; while those in Group B shall be given OPD-based physiotherapy within the OPD premises.
The patients in both the groups shall be performing the exercises every alternate day. The TPT group shall be perform the same at home (guided by the physiotherapist), while the OPD-based group shall provide at the hospital OPD (treated by the same physiotherapist). Hence, the participants in both the group shall perform 18 sessions in the total of 6 weeks time span. The duration for each session will be 60 minutes for both the groups. It will be ensured by the therapist that the exercises provided to both the groups shall be dose-matched.
The aim of this study was to assess the effectiveness of the Telephysiotherapy; which shall be a modified version of home-care model with a better patient and care-giver education; thus patients in the Group A were given TPT interventions in their home environment.

Data Collection Tools
Patients will be assessed on the following outcome measures at the baseline and endline. Group A: Telephysiotherapy group -An individualized exercise program will be prescribed and explained to the patient and their care-giver. The care-giver will also be informed to get in touch with primary physician of patient in case any signs of patient discomfort if experienced anytime during the period of 6 weeks duration.
The patient and the care-giver will be trained regarding various abnormal pattern/synergies that the muscles of the upper and lower limb could go into during the post-stroke recovery phase. The care-giver will also be made aware regarding patient positioning and the postures to be avoided. He will be taught to assist the exercises to be performed by the patient and monitor when the patient is performing the exercises in their home settings, and also to be present for the TPT sessions throughout. The TPT session will be scheduled every alternate day. Both the patient and care-giver will be present while the tele-therapy. Demonstration of exercise will be done by the therapist on the whatsapp video call; followed by performance of the exercises by the patient / maybe assisted by the care-giver where required and this will also be monitored by the physiotherapist on the video call. Information regarding correction of exercise will be done simultaneously by the therapist. The TPT session will last for about 60 minutes. And each patient will be given a total of 18 such video-conferencing sessions conducted in the time span of 6 weeks.
The patients will be asked to perform exercises by themselves on Sunday and record a video and send to the therapist on whatsapp with the help of their care-giver; so that information regarding correction of exercise can be done by the therapist after assessing the video. The caregiver can be the spouse, sibling or children of the patient. Telephone calls will be made to these TPT patients from time-to-time so that they do not miss their TPT session to ensure adequate patient compliance. The exercise protocol shall be progressed on a weekly basis.
Group B: OPD-based group -The Group B participants will be given exercises directly by the physiotherapist at the OPD department of AVBRH. Patient and Care-giver education was provided in the similar manner as for Group A. And same exercise protocol was followed as in group A but on one-on-one basis in OPD set-up. The exercises protocol will be dose matched as in group A and will also be progressed on a weekly basis. -Patients willing to give informed consent and obeying instructions. -Patient with a dedicated care-giver (could be any of the family member)

Exclusion criteria
-Patients with stroke more than a year.
-Patients with uncontrolled diabetes mellitus, hypertension. -Patients with Deep vein thrombosis.
-Patient with any other sensory or cognitive disability such as aphasia etc -Patients who are unable to follow instructions -mRS score greater than Grade 4

Statistical Analysis
The Shapiro-Wilk test for normality is will be used to check the normality of the data; given the small sample size of the study. Independent Student's t-test will be used to compare the progress of the two treatment groups (Group A and Group B) at baseline and at the end of 6 th week of clinical intervention. Analysis of variance (ANOVA) will be used to compare scores at baseline and at the end of 6 th week of clinical intervention for both the groups.
The statistician will be blinded as to which group as given what kind of intervention to prevent any bias in analysis of results.

CONLUSION
On the basis of our study findings, a New Model of Health Care that is both inexpensive and efficient can be devised and delivered to the communities affected by disability in the urban and rural setups.
This technique of Tele-physiotherapy can be effectively used in bed-ridden and immune-compromised patients. Also, Tele-physiotherapy can be effectively combined in-complement with the conventional physiotherapy.
In times of existing pandemic, technique of Telephysiotherapy can be utilized as a boon, thus ensuring social distancing; without hampering patient recovery.

ETHICAL CONSIDERATIONS AND INFORMED CONSENT
The approval from the Institutional Ethics committee of the institute has been obtained before proceeding for the study. The participation will be purely voluntary and all respondents will be given the choice whether or not to participate in the study; or withdraw from the study before its completion.
Only those patients, who are willing to participate in the study and willing to give the written consent after being fully informed about the aim and scope of the study will be recruited for the study. The participation will be purely voluntary and all respondents will be given the choice whether or not to participate in the study; or withdraw from the study before its completion.
The name and address of the participants would be kept confidential, so that the identity of the patients is not revealed anywhere in the study findings.