Effects of Otago and Gaze Stabilization Exercises on Balance, Gait and QOL in Elderly Stroke Patients

February 20, 2025 updated by: Riphah International University

Effects of Otago Exercises and Gaze Stabilization Exercises on Balance, Gait and Quality of Life in Elderly Stroke Patients

To compare effects of otago exercises and Gaze stabilization exercises on Balance, gait and quality of Life in elderly stroke patients

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Study design will be a randomized clinical trial . Total 46 stroke patients will be recruited from Riphah Rehabilitation center and General hospital, Lahore by using non-probability convenience sampling technique. Patients will be randomized and allocated into two intervention groups based on inclusion and exclusion criteria. Patients in group A will receive Gaze Stabilization Exercises with conventional baseline treatment and group B patients will receive Otago Exercises with conventional baseline treatment. Patients will receive treatment of 40 minutes per session for 5 days a week for 8 weeks. Berg Balance Scale, Dynamic Gait Index and Stroke specific quality of life will be used as assessment tools. Data will be analyzed by using SPSS 26 version.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
46

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Pakistan
    • Fedral
      • Islamabad, Fedral, Pakistan, 44000
        • Recruiting
        • Riphah International University
        • Contact:
        • Contact:
          • zeest Hashmi, MS NMPT
          • Phone Number: 03224655851
        • Principal Investigator:
          • Hifza Riaz, MS NMPT

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Had ischemic or haemorrhagic stroke ≤6 months
  • Berg Balance Scale (BBS) score between 35 and 45
  • Dynamic Gait Index score between 11 and 19
  • Mini-mental status exam scores > 24

Exclusion Criteria:

  • Participants with severe vision or hearing impairment
  • Neurological disorders including epilepsy, Alzheimer's disease, vertigo, Parkinson disease, and stroke, muscular disorders which limit functional activity (OA, RA, etc)
  • Medications that affect balance, severe cardiovascular conditions, recent lower limb injury or surgery
  • Peripheral vestibular disorder

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: gaze stabilization exercise
Patients in group A will receive Gaze Stabilization Exercises with conventional baseline treatment
Other: gaze stabilization exercise
Patients in group A will receive Gaze Stabilization Exercises with conventional baseline treatment
Active Comparator: otago exercise
Patients in group B will receive Otago Exercises with conventional baseline treatment.
Other: otago exercise
group B patients will receive Otago Exercises with conventional baseline treatment

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Berg Balance Scale
Time Frame: 10 months
Berg Balance Scale Most reliable balance measuring tools for people suffered from stroke known as Berg Balance Scale. There are 14 questions in it, which aims at testing balance while sitting, standing, or performing specific movements. The total score on the Berg Balance Scale ranges from 0 to 56. 41-56: Have good balance and are at a low risk of falling. 21-40: Individuals have an increased risk of falling and may benefit from interventions to improve balance. 0-20: Individuals in this range have a significant balance impairment and are at a high risk of falling, requiring more intensive intervention and possibly assistance with mobility. Most of researches supported the validity and reliability of the BBS especially with stroke patients with high interclass correlation coefficients (ICCs) 0. 90
10 months
Dynamic Gait Index
Time Frame: 10 months
Dynamic Gait Index A tool for assessing gait, balance and fall risk in stroke patients is known as Dynamic Gait Index. It involves eight generic movements that are representative of common gait problems like turning the head while walking, stepping over an object, or changing speed. Consist of total 0-24 score . Between 22-24: Normal and < 19: Abnormal. Scores below 19 are indicative of gait dysfunction . Dynamic Gait Index validity is 0. 90. The overall reliability was high (overall intra-class correlation coefficient = .96
10 months
Stroke-Specific Quality of Life (SS-QOL)
Time Frame: 10 months
Stroke-Specific Quality of Life (SS-QOL) is a specially developed tool for estimating the quality of life of stroke survivors. SS-QOL scale consists of 49 items, comprises 12 domains include Energy, Family Roles, Language, Mobility, Mood, Personality, Self-care, Social Roles, Thinking, Upper Extremity Function, Vision, and Work/Productivity. Each item is scored on a 5-point Likert scale. where 1 indicates the most severe impairment and 5 indicates no impairment. The total score can range from 49 to 245, with higher scores representing better quality of life. In the SS-QOL domains, the Cronbach's alpha coefficients are generally provided with values of between 0. 73 and 0. 96. Concurrent validity was high with r = 0.94-0.95
10 months

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dr.Zeest Hashmi, MSNMPT, Riphah International University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 15, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 20, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REC/RCR & AHS/24/0237

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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