EFFECTS of OTAGO EXERCISES in ADDITION to ROUTINE PHYSICAL THERAPY on BALANCE and FUNCTIONAL ACTIVITIES in PATIENTS with STROKE.

Not Applicable

Completed

• Conditions: Stroke; Balance; Ischemic Stroke; Function; OEP

• Registration Number: NCT06807879
• Lead Sponsor: University of Lahore

Brief Summary

Stroke is an extremely severe medical condition which is ranked as the second biggest cause of death worldwide as it claims an estimated 5.5 million lives per year. A stroke can result in enduring brain injury, prolonged disability, or fatality (Tsao et al., 2023) . There are two major types of stroke: Hemorrhagic stroke and Ischemic stroke. The most prevalent type is Ischemic, accounting for approximately 87% of strokes worldwide. It arises from a blockage in a blood vessel supplying the brain (Collaborators, 2022) . Also, the affected brain areas can result in functional limitations, cognitive changes, and emotional difficulties (Fihla, 2024) .

Moreover, given the potential cost-effectiveness of OEP compared to more intensive rehabilitation methods, its implementation could offer a pragmatic solution to improving the quality of life for individuals grappling with the enduring consequences of ischemic stroke.

Therefore, exploring the effectiveness of OEP in this specific population holds promise for advancing stroke rehabilitation strategies and potentially improving the lives of individuals living with the long-term effects of ischemic stroke.

Detailed Description

Study Design: Randomized Clinical Trial.

Screening:

Patients were screened to meet inclusion criteria. The consent form taken from patients then patients were randomly allocated into two groups ( 29 in each group).

Randomization:

Using the lottery approach, patients who met the inclusion criteria were split into experimental and control groups at random by the online tool for randomization.

Blinding:

To ensure precision and mitigating the bias the assessor of outcome was kept blind also. An independent assessor specialized in this technique and having more than 5 years experience screened patients, and they were subsequently randomly assigned to either the experimental group. The computer-generated allocation sequence was established prior to the study's commencement.

Assessment:

Data was collected at baseline, fourth week and then at the end of the eighth week. Baseline assessments will be conducted before the intervention. Post-intervention assessments will be conducted immediately after the intervention. Statistical analysis will include descriptive statistics, t-tests, and analysis of variance to compare the outcomes between the two groups.

Intervention:

The intervention group A received routine physical therapy in addition to the Otago Exercise Program, while the control group B received routine physical therapy alone.

GROUP A: ( Modified Otago Exercise with Routine care Physical therapy) GROUP B: ( ROUTINE CARE PHYSICAL THERAPY )

Outcome Measures:

Primary outcome:

Balance was assessed using the Berg Balance Scale (BBS)

Secondary outcomes:

Functional activities the physical performance was assessed using the 30-s Chair Stand Test (30 s-CST).

Ethical Considerations: This study has received ethical approval from the Institutional Review Board (IRB). Informed consent was obtained from all participants.

Data Analysis: Statistical software was used to analyze the data, with appropriate tests employed based on data normality to compare outcomes between groups.

Study Timeline

• Study Start: 2024-01-25
• Primary Completion: 2024-11-13
• Study Completion: 2024-12-19
• Status Verified: 2025-01
• Study First Submitted: 2025-01-29
• Study First Submitted QC: 2025-01-29
• Last Update Submitted: 2025-01-29
• Study First Posted: 2025-02-04
• Last Update Posted: 2025-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

Inclusion Criteria

• Participants aged between 60 to 70 years old (Verheyden et al., 2013).
• Both genders (Khumpaneid et al., 2022).
• Patients who have been diagnosed with ischemic stroke by a medical professional(Khumpaneid et al., 2022).
• Eligible for movement without using any walking aid equipment (Khumpaneid et al.,2022).
• Exercise less than 150 mins per week (Khumpaneid et al., 2022).
• Timed Up and Go score is more than 10 (Khumpaneid et al., 2022).
• Mini-Mental State Examination (MMSE) score ≥ 24 (Page et al., 2007).
• Urinary and bowel continence (Jin et al., 2023) .

Exclusion Criteria

• Patients who have severe cognitive impairment or communication difficulties (Jin et al., 2023).
• Participants who have neurological conditions (e.g., Parkinson's disease), vision problems or contagious diseases (Khumpaneid et al., 2022).
• Patients who have undergone surgery in the past 3 months (Jin et al., 2023

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Balance	Baseline, mid-intervention (4 weeks), and post-intervention (8 weeks).	Balance was assessed using the Berg Balance Scale (BBS). To determine the effects of Otago exercises in addition to routine physical therapy on balance and functional activities in patients with stroke.

Secondary Outcome Measures

Name	Time	Method
Functional activities	Baseline, mid-intervention (4 weeks), and post-intervention (8 weeks).	Functional activities was assessed using the 30-s Chair Stand Test (30 s-CST).

Trial Locations

Locations (1)

University Of Lahore Teaching Hospital; 🇵🇰 Lahore, Punjab, Pakistan