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Tele-physiotherapy on Post-stroke Hemiplegia Patients

Primary Purpose

Hemiplegia, Muscle Spasticity

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Conventional Physiotherapy + telephysiotherapty
Sponsored by
Universidad Católica San Antonio de Murcia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemiplegia focused on measuring hemiplegia, stroke, telephyisiotherapy, older adults

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Catholic University of Murcia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Control

Arm Description

Conventional phyisiotherapy + telecare

Conventional physiotherapy

Outcomes

Primary Outcome Measures

Changes in muscle activity
Main outcome will be changes in electromyogrpahic activity. A change of plus 10 microvolts will be considered as an effective intervention.

Secondary Outcome Measures

Fugl-Meyer test score
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).

Full Information

First Posted
August 7, 2022
Last Updated
September 19, 2023
Sponsor
Universidad Católica San Antonio de Murcia
Collaborators
Hermanas Hospitalarias del Sagrado Corazón de Jesús, Hospital Universitario Virgen de la Arrixaca
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1. Study Identification

Unique Protocol Identification Number
NCT06048432
Brief Title
Tele-physiotherapy on Post-stroke Hemiplegia Patients
Official Title
Effect of Tele-physiotherapy on Patients With Post-stroke Hemiplegia During covid19 Lockdown
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
January 31, 2021 (Actual)
Study Completion Date
January 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Católica San Antonio de Murcia
Collaborators
Hermanas Hospitalarias del Sagrado Corazón de Jesús, Hospital Universitario Virgen de la Arrixaca

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemiplegia, Muscle Spasticity
Keywords
hemiplegia, stroke, telephyisiotherapy, older adults

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare Provider
Masking Description
Two groups of patients with post-stroke hemiplegia will be treated only with conventional physiotherapy or with physiotherapy plus telecare.
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Conventional phyisiotherapy + telecare
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Conventional physiotherapy
Intervention Type
Other
Intervention Name(s)
Conventional Physiotherapy + telephysiotherapty
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in muscle activity
Description
Main outcome will be changes in electromyogrpahic activity. A change of plus 10 microvolts will be considered as an effective intervention.
Time Frame
Determinations will be done through study completion, an average of 1 year.
Secondary Outcome Measure Information:
Title
Fugl-Meyer test score
Description
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).
Time Frame
Determinations will be done through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan José Hernández Morante, PhD
Organizational Affiliation
Universidad Católica San Antonio de Murcia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Catholic University of Murcia
City
Murcia
ZIP/Postal Code
30107
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD will be posted online in a public repository
Citations:
PubMed Identifier
31511629
Citation
Gamez AB, Hernandez Morante JJ, Martinez Gil JL, Esparza F, Martinez CM. The effect of surface electromyography biofeedback on the activity of extensor and dorsiflexor muscles in elderly adults: a randomized trial. Sci Rep. 2019 Sep 11;9(1):13153. doi: 10.1038/s41598-019-49720-x.
Results Reference
background
PubMed Identifier
35378544
Citation
Gamez Santiago AB, Martinez Caceres CM, Hernandez-Morante JJ. Effectiveness of Intensively Applied Mirror Therapy in Older Patients with Post-Stroke Hemiplegia: A Preliminary Trial. Eur Neurol. 2022;85(4):291-299. doi: 10.1159/000522413. Epub 2022 Apr 4.
Results Reference
background

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Tele-physiotherapy on Post-stroke Hemiplegia Patients

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