Effectiveness of Telephysical Therapy as a Secondary Stroke Prevention Tool in Patients With Minor Stroke.

NCT ID: NCT06780891

Last Updated: 2025-05-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-14
• Study Completion Date: 2025-05-01

Brief Summary

This study investigates the effectiveness of telephysiotherapy as a rehabilitation and secondary prevention tool in patients with minor stroke, TIA, or LACI, comparing an experimental group receiving tele-assisted aerobic and anaerobic exercises to a control group.

Detailed Description

Stroke is an acute disorder of cerebral blood flow that can cause transient or permanent alterations in the functionality of the brain, often resulting from ischemia or hemorrhage. Depending on the affected region and its severity, strokes range in impact, with minor strokes characterized by mild symptoms. Despite the potential for rapid symptom improvement in transient ischemic attacks (TIAs), both minor strokes and TIAs significantly impact long-term quality of life.

The implementation of physical rehabilitation, particularly through structured exercise, is critical for mitigating motor deficits, reducing fatigue, and improving functional capabilities post-stroke. Tele-physical therapy (TPT)/Therapeutic Tele-Assisted Exercise (T-TEx/T-FIS) has emerged as a promising approach for delivering rehabilitation remotely, offering convenience and ensuring continuity of care while addressing limitations posed by traditional in-person therapy. Recent systematic reviews suggest that TPT/T-TEx/T-FIS demonstrates comparable outcomes to conventional physiotherapy, highlighting its potential for wider adoption.

The hypothesis is that a 12-week tele-physiotherapy program can significantly improve cardiovascular health, reduce obesity, and enhance quality of life in patients with minor stroke, TIAs, or lacunar infarcts, compared to standard lifestyle recommendations alone. The primary objective is to evaluate the efficacy of tele-physiotherapy in addressing modifiable risk factors for secondary stroke prevention. Secondary goals include analyzing improvements in cardiorespiratory fitness, muscle strength, sleep quality, and fatigue, while promoting healthy lifestyle habits and tracking adherence to therapeutic exercise.

A single-blind, randomized controlled trial is proposed, wherein patients are divided equally into a control group and an experimental group receiving TPT. Participants will undergo assessments at baseline, 4 weeks, and 12 weeks, with a follow-up at 24 weeks to evaluate sustained benefits.

Conditions

Stroke; Physical Therapy Modality; Secondary Prevention; Physical Therapy Evaluation; Therapeutic Exercise; Randomized Controlled Trial; Cerebrovascular Accident (Stroke)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Telephysical therapy group with educational session

The intervention includes 12 weeks of therapeutic exercise delivered via tele-assistance. Participants will engage in aerobic and anaerobic activities focusing on cardiovascular fitness, muscle strength, and balance. A recorded educational session will provide uniform information on the protocol, including schedules and intervention details. Patients will complete prescribed exercises under virtual supervision and submit progress reports for monitoring adherence.

Group Type: EXPERIMENTAL

Telephysical therapy

Intervention Type: BEHAVIORAL

The experimental group is undergoing a tele-assisted therapeutic exercise program (T-TPT/T-FIS), which involves physical exercises aimed at improving cardiovascular fitness, muscle strength, and balance, among others. Participants will complete exercises under virtual supervision and submit progress reports.

Educational session

Intervention Type: BEHAVIORAL

The educational session will focus on raising awareness about stroke risk factors, such as hypertension, diabetes, and smoking, while promoting healthy lifestyle changes. The goal is to empower them with the knowledge to reduce stroke risk and improve overall well-being.

Educational session with encouraged lifestyle modifications

The control group will be encouraged to return to their regular daily activities and engage in exercise. Evaluations will be scheduled and communicated to participants. The control group will not receive direct intervention.

Group Type: ACTIVE_COMPARATOR

Educational session

Intervention Type: BEHAVIORAL

The educational session will focus on raising awareness about stroke risk factors, such as hypertension, diabetes, and smoking, while promoting healthy lifestyle changes. The goal is to empower them with the knowledge to reduce stroke risk and improve overall well-being.

Interventions

Telephysical therapy

The experimental group is undergoing a tele-assisted therapeutic exercise program (T-TPT/T-FIS), which involves physical exercises aimed at improving cardiovascular fitness, muscle strength, and balance, among others. Participants will complete exercises under virtual supervision and submit progress reports.

Intervention Type: BEHAVIORAL

Educational session

The educational session will focus on raising awareness about stroke risk factors, such as hypertension, diabetes, and smoking, while promoting healthy lifestyle changes. The goal is to empower them with the knowledge to reduce stroke risk and improve overall well-being.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Diagnosis: Subjects with a diagnosis of minor stroke, TIA, or LACI immediately after hospital discharge.
• Age: Between 35 and 85 years.
• Technology access: Ownership of a smartphone with Android operating system and internet access.
• Language skills: Ability to read, write, and understand instructions in Spanish, or the presence of a caregiver who can perform these tasks on behalf of the patient.
• Motor impairment: Minimal motor sequelae, defined by:
• "Timed Up and Go" (TUG) test: In less than 13.5 seconds.
• Score of 3-5 points on the Functional Ambulatory Category (FAC).
• Walking capacity: Ability to walk independently for 500 meters without technical or physical assistance.
• Spasticity: Minimal or absent spasticity (score of 0-1 on Ashworth Scale

Exclusion Criteria

• Oxygen dependency: Dependency on auxiliary oxygen.
• Uncontrolled or unstable conditions: Including angina pectoris, hypertension (defined as resting systolic blood pressure >180 mm Hg and diastolic >110 mm Hg), arrhythmias (atrial/ventricular), sinus tachycardia (heart rate >120/min), and diabetes mellitus.
• Orthostatic hypotension: Drop in blood pressure >20 mm Hg with associated symptoms.
• Significant aortic stenosis: Defined as a diameter <1 cm², or aortic dissection.
• Uncompensated cardiac failure: Including third-degree atrioventricular block without a pacemaker, active myocarditis/pericarditis, and atrial fibrillation.
• Recent embolism: Pulmonary or systemic embolism, or acute thrombophlebitis.
• Systemic illness or fever: Presence of acute systemic disease or fever.
• Musculoskeletal conditions: That prevent participation in the therapeutic exercise program.
• Other metabolic conditions: Such as acute thyroiditis, hypo/hyperkalemia, and hypovolemia (until treated).
• Severe psychological disorders: Diagnosed severe psychological conditions.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitario Virgen Macarena

OTHER

Sponsor Role: collaborator

University of Cadiz

OTHER

Sponsor Role: lead

Responsible Party

Ignacio Pastor Ruiz

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Manuel Lucena Antón, Doctor of PT

Role: STUDY_DIRECTOR

University of Cadiz

Locations

Hospital Universitario Virgen Macarena

Seville, Sevilla, Spain

Countries

Spain

Other Identifiers

0616-N-22

Identifier Type: -

Identifier Source: org_study_id