Tele-physiotherapy on Post-stroke Hemiplegia Patients

NCT06048432 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-09-21

No results posted yet for this study

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.

Conditions

  • Hemiplegia
  • Muscle Spasticity

Interventions

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.

Sponsors & Collaborators

  • Hermanas Hospitalarias del Sagrado Corazón de Jesús

    collaborator UNKNOWN
  • Hospital Universitario Virgen de la Arrixaca

    collaborator OTHER
  • Universidad Católica San Antonio de Murcia

    lead OTHER

Principal Investigators

  • Juan José Hernández Morante, PhD · Universidad Católica San Antonio de Murcia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-01
Primary Completion
2021-01-31
Completion
2022-01-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06048432 on ClinicalTrials.gov