Tele-physiotherapy on Post-stroke Hemiplegia Patients

September 19, 2023 updated by: Juan Jose Hernández Morante, Universidad Católica San Antonio de Murcia

Effect of Tele-physiotherapy on Patients With Post-stroke Hemiplegia During covid19 Lockdown

The present preliminary randomized trial will be performed to compare the effectiveness of telephyisiotherapy plus physical exercises versus other conventional techniques (electromyographic biofeedback or conventional physiotherapy).

Participants will be chosen from Hospital Sagrado Corazón de Málaga, after the approval of the centre. One hundred and twenty patients with hemiplegia as a consequence of an ischaemic stroke will take part in the study. Selection criteria included to be older than 65 years, with two months of evolution after the stroke and with the left paretic side. In addition, they had to have a positive diagnosis of COVID-19. Positive cases will be confirmed by PCR. Due to the local sanitary regulations, all patients may require home confinement during 1 month without possibility to continue their rehabilitation program.

Physiological interventions started 20 days after the first negative PCR test.

Participants will be randomize in three different intervention groups, conventional therapy (n=40), carried out in the Hospital, biofeedback therapy (n=40), also conducted in the Hospital, and Telephyisiotherapy (TP) plus physical activity (n=40). The intervention period will last for three months, and participants will be re-evaluated 30 days later to confirm treatment effectiveness.

Measurements

Electromyographic activity and hand strength The mean electromyographic (EMG) activity will be determined with the Neurotrans Myoplus 2 Pro System (Verity Medical Ltd, UK), the same instrument used to carry out the intervention. The isometric strength (Nw) of the hand will be assessed with a hand-held digital dynamometer (Smedley digital hand dynamometer, RMS Ltd., UK).

Functional tests In the present work, the Fugl-Meyer will be used to determine the functional status of patients with stroke. The patients with better functionality had superior scores. In addition, the ability of the patients to perform basic daily living activities was determined through the Barthel index. Considering the advanced age of the participants, three extra-scales will be determined: the FRAIL scale, the short physical performance battery (SPPB) and the Strength, assistance in walking, rise from a chair, climb stairs and falls (SARC-F) scale will be evaluated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Murcia, Spain, 30107
        • Catholic University of Murcia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with hemiplegia as a consequence of an ischaemic stroke
  • To be older than 65 years
  • Voluntarily participate in the study

Exclusion Criteria:

  • To suffer from dementia or severe cognitive decline
  • To have any specific contraindication for sport practice (as suffering from joint pain, etc.)
  • Those with any diagnosis of severe pathology (cancer, cardiovascular event, etc.) during the study period.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Conventional phyisiotherapy + telecare
Other: Conventional Physiotherapy + telephysiotherapty
Patients assigned to the telephyisiotherapy (TP) group will carry out a half-hour session of conventional therapy, plus a 1-hour session of physical exercise, which will be carried out through the administration of tutorial videos, telephone instructions or by email.
Active Comparator: Control
Conventional physiotherapy
Other: Conventional Physiotherapy + telephysiotherapty
Patients assigned to the telephyisiotherapy (TP) group will carry out a half-hour session of conventional therapy, plus a 1-hour session of physical exercise, which will be carried out through the administration of tutorial videos, telephone instructions or by email.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in muscle activity
Time Frame: Determinations will be done through study completion, an average of 1 year.
Main outcome will be changes in electromyogrpahic activity. A change of plus 10 microvolts will be considered as an effective intervention.
Determinations will be done through study completion, an average of 1 year.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fugl-Meyer test score
Time Frame: Determinations will be done through study completion, an average of 1 year
Changes in the specific functional capacity of stroke patients will be determined by the Fugl-Meyer test. A change greater than 10% will be considered beneficial. The Fugl-Meyer test score ranges from 0-66. Higher scores represent better functionality (further information at: PMID: 1135616).
Determinations will be done through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Católica San Antonio de Murcia

Collaborators

Hospital Universitario Virgen de la Arrixaca
Hermanas Hospitalarias del Sagrado Corazón de Jesús

Investigators

  • Principal Investigator: Juan José Hernández Morante, PhD, Universidad Católica San Antonio de Murcia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

January 31, 2021

Study Completion (Actual)

January 31, 2022

Study Registration Dates

First Submitted

August 7, 2022

First Submitted That Met QC Criteria

September 19, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 19, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TELEFISIO-ON-COVID

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD will be posted online in a public repository

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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