NCT06846177

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 25, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2026

Completed
Last Updated

March 11, 2025

Status Verified

March 1, 2025

Enrollment Period

1.1 years

First QC Date

February 20, 2025

Last Update Submit

March 9, 2025

Conditions

Keywords

Task oriented trainingGraded activity trainingPost strokeFatigue

Outcome Measures

Primary Outcomes (1)

  • Fatigue Assessment scale (FAS)

    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

    6 weeks

Secondary Outcomes (2)

  • Timed Up and go test(Mobility)

    6 weeks

  • Dynamic gait index (Gait)

    6 weeks

Other Outcomes (2)

  • Checklist individual strength-Fatigue (CIS-F) (Screening tool)

    1st week

  • Borg's Rating of Perceived Exertion (Monitoring Tool

    6 weeks

Study Arms (2)

Graded Activity Training

EXPERIMENTAL

Graded Activity Training

Other: Graded Activity Training

Task Oriented Training

ACTIVE COMPARATOR

Task Oriented Training

Other: Task-Oriented Training

Interventions

4 types of progressive activities of 2 hour session two times/week with resting periods of 30 mins. Activities consist of treadmill walk ,walk on floor, core muscles exercises ,home tasks . To ensure the proper heart rate and loads during the exercises, measurements of individual heart rate and muscle strength are taken during the first session (baseline) with HR Tracking portable device and also during the session to continuously monitor HR of the Patient. To withdraw or adjust the training intensity for each patient Borg's Scale of Perceived Exertion is used throughout the session for monitoring Training intensity of endurance, muscle training, individual's effort and exertion level.

Graded Activity Training

4 task oriented physical fitness activities which include walk on floor, walk on inclined surface using treadmill ,sit to stand , stair climbing and descending for duration of 2 hour session with frequent breaks. Each treatment session began with 10 minutes of warm-up exercise, which consisted of passive stretching of the calf muscles, hamstring, and hip adductors. The level of difficulty and frequency for each task were gradually increased during the 6 weeks with the patients consent.10 minutes of cool down at the end of each treatment session.

Task Oriented Training

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helping Hand Institute of Rehabilitation Sciences

Mansehra, KPK, Pakistan

RECRUITING

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Dr.Aroosa Tariq, MS-NMPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr.Aroosa Tariq, MS-NMPT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2025

First Posted

February 25, 2025

Study Start

March 1, 2025

Primary Completion

March 20, 2026

Study Completion

April 25, 2026

Last Updated

March 11, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations