Graded Activity Training and Task- Oriented Training on Post-Stroke Fatigue

Not Applicable

Recruiting

• Conditions: Post-Stroke Fatigue

• Registration Number: NCT06846177
• Lead Sponsor: Riphah International University

Brief Summary

The aim of this randomized controlled trial is to determine the effects of Graded Activity Training and Task Oriented Training on Fatigue in Post-Stroke Patients. Until now there is very limited work found on fatigue so this will increase quality of life in stroke patients and potentially reduce burden on healthcare system.

Detailed Description

Post stroke fatigue (PSF) is one of the most common outcomes of stroke. PSF is defined as "overwhelming feeling of exhaustion or tiredness" as a result of stroke PSF is an undesirable outcome by which patient's ability in study participation, adherence to medication and effectiveness of rehabilitation decrease which is unrelated to exertion, and does not typically improve with rest. Prevalence rate of PSF ranges between 25% and 85% One out of two stroke survivors experience post-stroke fatigue. The relationship between physical deconditioning and fatigue is bidirectional there was a negative relationship between fatigue and aerobic fitness in chronic stroke. PSF may arise from physical deconditioning (physical fatigue). Therefore, improving physical endurance through physical activity training could potentially reduce fatigue complaints.

The rationale of this study is to determine how task-oriented training and graded activity training effect stroke patient's levels of fatigue and to develop an improved fatigue management intervention protocol. This study will also determine effects of how both interventions affect Mobility and Gait. By doing so, we can identify a more effective PSF intervention plan, which will help reduce the burden on the healthcare system and will lessen strain on caregivers and in turn enhance patient quality of life.

Study Timeline

• Study First Submitted: 2025-02-20
• Study First Submitted QC: 2025-02-24
• Study First Posted: 2025-02-25
• Status Verified: 2025-03
• Study Start: 2025-03-01
• Last Update Submitted: 2025-03-09
• Last Update Posted: 2025-03-11
• Primary Completion: 2026-03-20
• Study Completion: 2026-04-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Both male and female of age 40 to 60 years.
• Patient with both ischemic or hemorrhagic stroke.
• Patient with both right and left hemiplegia.
• Checklist Individual (CIS-F) fatigue score of 40 or more.
• Patients who had sustained a stroke more than 4 months before recruitment.
• Patients who can independently walk for 10 meters (about 33 feets)

Exclusion Criteria

• Patients with severe comorbid health conditions (such as cardiac diseases, pulmonary diseases like COPD, Orthopedic Conditions Arthritis, joint replacements).
• Patients with uncontrolled diabetes, hypertension, Depression and Anxiety.
• Patients who are not willing to participate.
• Patient with any medications that can affect their ability to engage in physical training program like Antidepressants, Beta-Blockers, corticosteroids etc.
• Pregnant women.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Fatigue Assessment scale (FAS)	6 weeks	The FAS is a 10-item scale is used to evaluate symptoms of chronic fatigue. In contrast to other similar measures description of the fatigue experienced is presented for the total score of l\<22 indicates normal, levels of fatigue between 22 to 34 indicates mild to moderate fatigue and score 35 or more indicates severe fatigue

Secondary Outcome Measures

Name	Time	Method
Dynamic gait index (Gait)	6 weeks	The DGI is 8 item scale to assess gait. The scoring of the DGI is based on a 4 point scale ranging from 0 to 3, with 0 indicating severe impairment and 3 indicating normal ability. The best performance total score is 24. A low composite DGI score thus indicates greater impairment
Timed Up and go test(Mobility)	6 weeks	The Timed Up and Go (TUG) is a commonly used outcome measure that is used to assess mobility and fall risk among older adults. It is a simple test that measures how quickly you can stand up, walk 10 feet, turn around, walk back, and sit down. cut off score of ≥12 seconds indicates high risk of fall.

Trial Locations

Locations (1)

Helping Hand Institute of Rehabilitation Sciences; 🇵🇰 Mansehra, KPK, Pakistan