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

Recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

46

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 Contact

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

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
Intervention / Treatment
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

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

Riphah International University

Investigators

  • 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)

September 1, 2024

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

April 15, 2025

Study Registration Dates

First Submitted

February 20, 2025

First Submitted That Met QC Criteria

February 20, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 20, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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