NCT06845709

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 25, 2025

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2025

Completed
Last Updated

February 25, 2025

Status Verified

February 1, 2025

Enrollment Period

6 months

First QC Date

February 20, 2025

Last Update Submit

February 20, 2025

Conditions

Keywords

Balance; DistortedGait, HemiplegicQuality of Life

Outcome Measures

Primary Outcomes (3)

  • Berg Balance Scale

    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

    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)

    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

Study Arms (2)

gaze stabilization exercise

EXPERIMENTAL

Patients in group A will receive Gaze Stabilization Exercises with conventional baseline treatment

Other: gaze stabilization exercise

otago exercise

ACTIVE COMPARATOR

Patients in group B will receive Otago Exercises with conventional baseline treatment.

Other: otago exercise

Interventions

Patients in group A will receive Gaze Stabilization Exercises with conventional baseline treatment

gaze stabilization exercise

group B patients will receive Otago Exercises with conventional baseline treatment

otago exercise

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Riphah International University

Islamabad, Fedral, 44000, Pakistan

RECRUITING

Related Publications (3)

  • Di Vincenzo O, Luisi MLE, Alicante P, Ballarin G, Biffi B, Gheri CF, Scalfi L. The Assessment of the Risk of Malnutrition (Undernutrition) in Stroke Patients. Nutrients. 2023 Jan 29;15(3):683. doi: 10.3390/nu15030683.

    PMID: 36771390BACKGROUND
  • Mead GE, Sposato LA, Sampaio Silva G, Yperzeele L, Wu S, Kutlubaev M, Cheyne J, Wahab K, Urrutia VC, Sharma VK, Sylaja PN, Hill K, Steiner T, Liebeskind DS, Rabinstein AA. A systematic review and synthesis of global stroke guidelines on behalf of the World Stroke Organization. Int J Stroke. 2023 Jun;18(5):499-531. doi: 10.1177/17474930231156753. Epub 2023 Mar 1.

    PMID: 36725717BACKGROUND
  • Sim J, Shin C. Two stroke education programs designed for older adults. Geriatr Nurs. 2024 Jan-Feb;55:105-111. doi: 10.1016/j.gerinurse.2023.10.014. Epub 2023 Nov 17.

    PMID: 37979469BACKGROUND

MeSH Terms

Conditions

Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Dr.Zeest Hashmi, MSNMPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zeest Hashmi, MS NMPT

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients will be divided 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2025

First Posted

February 25, 2025

Study Start

September 1, 2024

Primary Completion

March 1, 2025

Study Completion

April 15, 2025

Last Updated

February 25, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations