Tele-physiotherapy on Post-stroke Hemiplegia Patients

Hemiplegia Clinical Trial

Official title:

Effect of Tele-physiotherapy on Patients With Post-stroke Hemiplegia During covid19 Lockdown

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06048432
• Other study ID #: TELEFISIO-ON-COVID
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: January 31, 2022

Study information

• Verified date: September 2023
• Source: Universidad Católica San Antonio de Murcia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 31, 2022
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hemiplegia
• Muscle Spasticity

Intervention

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.

Locations

Country	Name	City	State
Spain	Catholic University of Murcia	Murcia

Sponsors (3)

Lead Sponsor	Collaborator
Universidad Católica San Antonio de Murcia	Hermanas Hospitalarias del Sagrado Corazón de Jesús, Hospital Universitario Virgen de la Arrixaca

Country where clinical trial is conducted

Spain, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Determinations will be done through study completion, an average of 1 year.
Secondary	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).	Determinations will be done through study completion, an average of 1 year