NCT06807879

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: University of Lahore · Academic / Other
• Sex: All
• Age: 60 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stroke
• Balance
• Ischemic Stroke
• Function
• OEP

Interventions

Type	Name	Description
BEHAVIORAL	Modified Otago Exercise with Routine care Physical therapy	To improve the efficacy of the balance improvement intervention, we modified the OEP by incorporating the additional walking, recommended by the OEP guidelines, into a single exercise session and conducting it as a group exercise program in accordance with a previous meta-analysis (Chiu et al., 2021) . As shown in Figure 1, the modified-OEP group intervention consisted of 15 min of walking followed by a 30 min Otago Exercise Program consisting of balance and strength training, followed by another 15 min of walking. The 15 min walking was accomplished through continuous walking at an individual pace in the \~15m training room. Participants were asked to walk 15 m, make a U-turn towards the left side, walk 15 m, then make a U-turn towards the right side at the next turning point, in order to achieve an equivalent effect on the promoted benefit of symmetry when turning left and right. This was repeated until the session was complete.
BEHAVIORAL	Routine Care Physical Therapy	The routine care physical therapy session typically involves a variety of exercises aimed at general strengthening, stretching, and basic gait training. 1 hour of standard physiotherapy exercises focusing on general strengthening, stretching, and basic gait training. The session included a combination of exercises aimed at general strengthening, such as core stability exercises, muscle-strengthening exercises with weights or resistance bands and functional movements like squats and lunges. Stretching exercises targeting key muscle groups like hamstrings will be incorporated to improve flexibility and range of motion. Gait training will focus on activities like side lunges, step-ups, and balance exercises to enhance walking ability and postural control. Additionally, the plan emphasized progressive challenges incorporating a mix of static and dynamic balance exercises using tools like foam pads or balance boards.

Timeline

• Start date: 2024-01-25
• Primary completion: 2024-11-13
• Completion: 2024-12-19
• First posted: 2025-02-04
• Last updated: 2025-02-04

Locations

1 site across 1 country: Pakistan