Tele-physiotherapy on Post-stroke Hemiplegia Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2022-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hemiplegia Muscle Spasticity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two groups of patients with post-stroke hemiplegia will be treated only with conventional physiotherapy (CONTROL) or with physiotherapy plus telecare (INTERVENTION).

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Two groups of patients with post-stroke hemiplegia will be treated only with conventional physiotherapy or with physiotherapy plus telecare.

Study Groups

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Intervention

Conventional phyisiotherapy + telecare

Group Type EXPERIMENTAL

Conventional Physiotherapy + telephysiotherapty

Intervention Type OTHER

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.

Control

Conventional physiotherapy

Group Type ACTIVE_COMPARATOR

Conventional Physiotherapy + telephysiotherapty

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No