Tele-physiotherapy on Post-stroke Hemiplegia Patients

Not Applicable

Completed

• Conditions: Muscle Spasticity; Hemiplegia
• Interventions: Other: Conventional Physiotherapy + telephysiotherapty

• Registration Number: NCT06048432
• Lead Sponsor: Universidad Católica San Antonio de Murcia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Primary Completion: 2021-01-31
• Study Completion: 2022-01-31
• Study First Submitted: 2022-08-07
• Status Verified: 2023-09
• Study First Submitted QC: 2023-09-19
• Last Update Submitted: 2023-09-19
• Study First Posted: 2023-09-21
• Last Update Posted: 2023-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Conventional Physiotherapy + telephysiotherapty	Conventional phyisiotherapy + telecare
Control	Conventional Physiotherapy + telephysiotherapty	Conventional physiotherapy

Primary Outcome Measures

Name	Time	Method
Changes in muscle activity	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 Outcome Measures

Name	Time	Method
Fugl-Meyer test score	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).

Trial Locations

Locations (1)

Catholic University of Murcia; 🇪🇸 Murcia, Spain