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

January 29, 2025 updated by: Affaf Abid, University of Lahore

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54590
        • University of Lahore Teaching Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Modified Otago Exercise with Routine care Physical therapy
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 ~15 m 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: 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.
Experimental: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Balance
Time Frame: 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.
Baseline, mid-intervention (4 weeks), and post-intervention (8 weeks).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional activities
Time Frame: Baseline, mid-intervention (4 weeks), and post-intervention (8 weeks).
Functional activities was assessed using the 30-s Chair Stand Test (30 s-CST).
Baseline, mid-intervention (4 weeks), and post-intervention (8 weeks).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Lahore

Investigators

  • Principal Investigator: Mehwish Saghir, MS Neuro, University of Lahore
  • Study Director: Sana Ikram, MS MSK, University of Lahore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 25, 2024

Primary Completion (Actual)

November 13, 2024

Study Completion (Actual)

December 19, 2024

Study Registration Dates

First Submitted

January 29, 2025

First Submitted That Met QC Criteria

January 29, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 29, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC-UOL-/380/08/24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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