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Tele-physiotherapy on Post-stroke Hemiplegia Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06048432
Recruitment Status : Completed
First Posted : September 21, 2023
Last Update Posted : September 21, 2023
Sponsor:
Collaborators:
Hermanas Hospitalarias del Sagrado Corazón de Jesús
Hospital Universitario Virgen de la Arrixaca
Information provided by (Responsible Party):
Juan Jose Hernández Morante, Universidad Católica San Antonio de Murcia

Study Description
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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.


Condition or disease Intervention/treatment Phase
Hemiplegia Muscle Spasticity Other: Conventional Physiotherapy + telephysiotherapty Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two groups of patients with post-stroke hemiplegia will be treated only with conventional physiotherapy (CONTROL) or with physiotherapy plus telecare (INTERVENTION).
Masking: Double (Participant, Care Provider)
Masking Description: Two groups of patients with post-stroke hemiplegia will be treated only with conventional physiotherapy or with physiotherapy plus telecare.
Primary Purpose: Treatment
Official Title: Effect of Tele-physiotherapy on Patients With Post-stroke Hemiplegia During covid19 Lockdown
Actual Study Start Date : January 1, 2020
Actual Primary Completion Date : January 31, 2021
Actual Study Completion Date : January 31, 2022
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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).


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06048432


Locations
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Spain
Catholic University of Murcia
Murcia, Spain, 30107
Sponsors and Collaborators
Universidad Católica San Antonio de Murcia
Hermanas Hospitalarias del Sagrado Corazón de Jesús
Hospital Universitario Virgen de la Arrixaca
Investigators
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Principal Investigator: Juan José Hernández Morante, PhD Universidad Católica San Antonio de Murcia
More Information
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Publications:

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Responsible Party: Juan Jose Hernández Morante, Principal Investigator, Universidad Católica San Antonio de Murcia
ClinicalTrials.gov Identifier: NCT06048432    
Other Study ID Numbers: TELEFISIO-ON-COVID
First Posted: September 21, 2023    Key Record Dates
Last Update Posted: September 21, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD will be posted online in a public repository
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Juan Jose Hernández Morante, Universidad Católica San Antonio de Murcia:
hemiplegia
stroke
telephyisiotherapy
older adults
Additional relevant MeSH terms:
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Muscle Spasticity
Hemiplegia
Nervous System Diseases
Muscular Diseases
Musculoskeletal Diseases
 Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Paralysis