Balance; DistortedNCT06845709
Effects of Otago and Gaze Stabilization Exercises on Balance, Gait and QOL in Elderly Stroke Patients
A study testing gaze stabilization exercise and otago exercise in people with Balance; Distorted and Gait, Hemiplegic, run by Riphah International University at 1 site in Pakistan.
Trial summary
To compare effects of otago exercises and Gaze stabilization exercises on Balance, gait and quality of Life in elderly stroke patients Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Balance; Distorted, Gait, Hemiplegic, Quality of Life
- What is being tested?
- gaze stabilization exercise and otago exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Sep 2024to 15 Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Riphah International University
Islamabad, Fedral, 44000
zeest Hashmi, MS NMPT, 03224655851
Imran Amjad, PhD, 03324390125, Imran.amjad@riphah.edu.pk
About this study
Official title: 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
Read the 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.
- Conditions
- Balance; Distorted, Gait, Hemiplegic, Quality of Life
- Being tested
- gaze stabilization exercise, otago exercise
- Keywords
- Balance; Distorted, Gait, Hemiplegic, Quality of Life
- Medical subject headings
- Gait Disorders, Neurologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gaze stabilization exerciseOther
Patients in group A will receive Gaze Stabilization Exercises with conventional baseline treatment
otago exerciseOther
group B patients will receive Otago Exercises with conventional baseline treatment
| Study group | Role | What they receive |
|---|---|---|
| gaze stabilization exercise | Experimental | Patients in group A will receive Gaze Stabilization Exercises with conventional baseline treatment Receives: Other: gaze stabilization exercise |
| otago exercise | Active comparator | Patients in group B will receive Otago Exercises with conventional baseline treatment. Receives: Other: otago exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start1 Sep 2024
- Primary completion1 Mar 2025 (estimated)
- Study completion15 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Balance; DistortedStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr.Zeest Hashmi, MSNMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06845709
- Sponsor's protocol ID
- REC/RCR & AHS/24/0237
- Status last verified
- Feb 2025
- First submitted
- 20 Feb 2025
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36771390Mead 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.
PubMed 36725717Sim 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.
PubMed 37979469
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Otago Exercises and Gaze Stabilization Exercises on Balance, Gait and Quality of Life in Elderly Stroke Patients
- ClinicalTrials.gov ID
- NCT06845709
- Acronym / sponsor ID
- REC/RCR & AHS/24/0237
- Conditions
- Balance; Distorted, Gait, Hemiplegic, Quality of Life
- Keywords
- Balance; Distorted, Gait, Hemiplegic, Quality of Life
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 15 Apr 2025 (estimated)
- First posted
- 25 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare effects of otago exercises and Gaze stabilization exercises on Balance, gait and quality of Life in elderly stroke patients
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| gaze stabilization exercise | Experimental | Other: gaze stabilization exercisePatients in group A will receive Gaze Stabilization Exercises with conventional baseline treatment |
| otago exercise | Active comparator | Other: otago exercisePatients in group B will receive Otago Exercises with conventional baseline treatment. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gaze stabilization exercisePatients in group A will receive Gaze Stabilization Exercises with conventional baseline treatment | Other | gaze stabilization exercise |
| otago exercisegroup B patients will receive Otago Exercises with conventional baseline treatment | Other | otago exercise |
Primary outcome
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Background: PubMed 36771390Di 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.
- Background: PubMed 36725717Mead 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.
- Background: PubMed 37979469Sim 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr.Zeest Hashmi, MSNMPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gaze stabilization exercise and otago exercise in people with Balance; Distorted and Gait, Hemiplegic, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zeest Hashmi, MS NMPT (03224655851, zeesthashmi1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Berg Balance Scale (time frame: 10 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06845709, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2025.