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Clinical Trials/NCT06048432
NCT06048432
Completed
Not Applicable

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

Universidad Católica San Antonio de Murcia1 site in 1 country40 target enrollmentJanuary 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hemiplegia
Sponsor
Universidad Católica San Antonio de Murcia
Enrollment
40
Locations
1
Primary Endpoint
Changes in muscle activity
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2020
End Date
January 31, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Universidad Católica San Antonio de Murcia
Responsible Party
Principal Investigator
Principal Investigator

Juan Jose Hernández Morante

Principal Investigator

Universidad Católica San Antonio de Murcia

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Fugl-Meyer test score(Determinations will be done through study completion, an average of 1 year)

Study Sites (1)

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