Tele-physiotherapy on Post-stroke Hemiplegia Patients

NCT06048432 | Completed

• 1 other identifier: TELEFISIO-ON-COVID
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemiplegia; Muscle Spasticity

Keywords

hemiplegia; stroke; telephyisiotherapy; older adults

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Fugl-Meyer test score

  Determinations will be done through study completion, an average of 1 year

Study Arms (2)

Intervention

EXPERIMENTAL

Conventional phyisiotherapy + telecare

Other: Conventional Physiotherapy + telephysiotherapty

Control

ACTIVE COMPARATOR

Conventional physiotherapy

Other: Conventional Physiotherapy + telephysiotherapty

Interventions

Conventional Physiotherapy + telephysiotherapty 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; Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients with hemiplegia as a consequence of an ischaemic stroke
• To be older than 65 years
• Voluntarily participate in the study

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Católica San Antonio de Murcia: lead
• Hermanas Hospitalarias del Sagrado Corazón de Jesús: collaborator
• Hospital Universitario Virgen de la Arrixaca: collaborator

Study Sites (1)

Catholic University of Murcia

Murcia, 30107, Spain

Location

Related 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.

  PMID: 31511629 BACKGROUND

• 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.

  PMID: 35378544 BACKGROUND

MeSH Terms

Conditions

Hemiplegia; Muscle Spasticity; Stroke

Condition Hierarchy (Ancestors)

Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Juan José Hernández Morante, PhD

  Universidad Católica San Antonio de Murcia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Two groups of patients with post-stroke hemiplegia will be treated only with conventional physiotherapy or with physiotherapy plus telecare.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

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

Study Record Dates

• First Submitted: August 7, 2022
• First Posted: September 21, 2023
• Study Start: January 1, 2020
• Primary Completion: January 31, 2021
• Study Completion: January 31, 2022
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

ES (1)