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

NCT06780891 | Completed

• 1 other identifier: 0616-N-22
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Ischemic Attack, Transient; Brain Ischemia; Telephysical Therapy; Exercise Therapy; Neurological Disorders; Wearable Electronic Devices; Quality of life

Outcome Measures

Primary Outcomes (7)

• Quality of life (SF-36)

  Assessed using the SF-36 questionnaire, which evaluates physical and mental health domains. The scale consists of 36 questions, assesing physical function (10 items), physical role (4 items), bodily pain (2 items), general health status (5 items), vitality (4 items), social function (2 items), emotional role (3 items), mental health (5 items), and health transition (1 item). A higher score indicates better health status.

  Initial baseline assessment (week 1), assessment post-intervention (week 12) and assessment post-intervention 2 (week 24).

• Gait characteristics (GAITRite system and 6MWT)

  Assessed using the GAITRite system and the 6-minute walk test (6MWT). The GAITRite system will measure weight distribution, support surface, time in double support and single support, step time, step symmetry and length, and gait normality. Measurements will be taken while wearing shoes, both before and after performing the 6MWT. The 6-minute walk test (6MWT) is a validated test and is considered highly reliable for measuring gait in stroke patients. Additionally, its execution has been validated in environments with limited space (15 and 30 meters), making it easier to use. It will also allow us to assess the response to exertion, as well as the gait adjustments associated with fatigue.

  Initial baseline assessment (week 1), assessment post-intervention (week 12) and assessment post-intervention 2 (week 24).

• Fall risk and functional mobility (TUG)

  Asesssed using the Timed Up and Go (TUG) Test. It is a valid, reliable, and easy-to-administer fall risk test used to measure advanced functional mobility after a stroke. To perform this test, the patient must rise from a chair, walk three meters, and return to sit as quickly as possible.

  Initial baseline assessment (week 1), assessment post-intervention (week 12) and assessment post-intervention 2 (week 24).

• Balance (BBS)

  Assessed using the Berg Balance Scale (BBS), which is designed to evaluate balance and predict gait and fall risk. This scale complements the Timed Up and Go (TUG) test. It includes 14 tasks, with the patient's movement quality rated on a scale from 0 to 4. The maximum achievable score is 56/56.

  Initial baseline assessment (week 1), assessment post-intervention (week 12) and assessment post-intervention 2 (week 24).

• Walking and assistance (FAC)

  Assesed using the level of walking and assistance using the Functional Ambulation Classification (FAC) Scale . This scale evaluates the patient's walking capacity and the degree of support required, categorizing walking ability into six distinct levels.

  Initial baseline assessment (week 1), assessment post-intervention (week 12) and assessment post-intervention 2 (week 24).

• Fatigue associated with stroke (FSS)

  Assessed the level of fatigue related to the stroke using the Fatigue Severity Scale. It is a 9-item scale that captures the patient's subjective assessment of their fatigue and its impact on their life, with scores ranging from 1 to 7. The possible values range from 9 to 63, with a lower score indicating a better outcome.

  Initial baseline assessment (week 1), assessment post-intervention (week 12) and assessment post-intervention 2 (week 24).

• Handgrip strength (Digital Dynamometer)

  Measured to assess muscular strength and serves as a predictor of cardiovascular events, chronic diseases, and overall health. Studies highlight its predictive value. A digital dynamometer from the brand Vicfund will be used for its measurement.

  Initial baseline assessment (week 1), assessment post-intervention (week 12) and assessment post-intervention 2 (week 24).

Secondary Outcomes (8)

• Body mass index (BMI)

  Initial baseline assessment (week 1), assessment post-intervention (week 12) and assessment post-intervention 2 (week 24).

• Sagittal abdominal diameter (SAD)

  Initial baseline assessment (week 1), assessment post-intervention (week 12) and assessment post-intervention 2 (week 24).

• VO2 peak

  Initial baseline assessment (week 1), assessment post-intervention (week 12) and assessment post-intervention 2 (week 24).

• Blood pressure

  Initial baseline assessment (week 1), assessment post-intervention (week 12) and assessment post-intervention 2 (week 24).

• Biochemical levels

  Initial baseline assessment (week 1), assessment post-intervention (week 12) and assessment post-intervention 2 (week 24).

Study Arms (2)

Telephysical therapy group with educational session

EXPERIMENTAL

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.

Behavioral: Telephysical therapy; Behavioral: Educational session

Educational session with encouraged lifestyle modifications

ACTIVE COMPARATOR

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.

Behavioral: Educational session

Interventions

Telephysical therapy 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.

Telephysical therapy group with educational session

Educational session 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; Telephysical therapy group with educational session

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Cadiz: lead
• Hospital Universitario Virgen Macarena: collaborator

Study Sites (1)

Hospital Universitario Virgen Macarena

Seville, Sevilla, 41009, Spain

Location

MeSH Terms

Conditions

Stroke; Ischemic Attack, Transient; Brain Ischemia; Nervous System Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• David Manuel Lucena Antón, Doctor of PT

  University of Cadiz

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: January 17, 2025
• Study Start: January 14, 2025
• Primary Completion: March 31, 2025
• Study Completion: May 1, 2025
• Last Updated: May 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)