StrokeNCT06927323
Otago Exercise Program Combined With Action Observation Training in Stroke Patients
A study testing Otago exercise program in people with Stroke, run by Riphah International University.
Trial summary
Stroke is one of the main causes of adult disability worldwide and global health problem. Due to ongoing neurological sequelae post stroke patients have a two-fold higher risk of falling than other people with same age or gender. As the stroke patients, balance is impaired and can lead to complications such as fall. Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Stroke
- What is being tested?
- Otago exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 10 Apr 2025to 30 Oct 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants fulfilling given criteria will be included in this study
- Both male and female participants will be included
- The age limit for the participants will be 40-65 years
- Sub-acute and chronic ischemic stroke up to 2 years.
- Participants with BBS score between 35-40.
- Participants having Montreal Cognitive Assessment (MoCA) score greater than 24 (out of 30).
- Participants can walk with or without assistance.
Who cannot join
- Participants having given criteria will be excluded from this study
- Participants with other neurological diseases.
- Participants who will not be able to understand the informed consent form.
- Participants already involved in an exercise program for fall prevention.
- Participants have no visual field defect, no abnormality in the vestibular organs, no orthopedic disease, and an unrestricted range of motion.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of Otago Exercise Program Combined With Action Observation Training on Balance, Gait and Functional Activities in Post Stroke Patients
Stroke is one of the main causes of adult disability worldwide and global health problem. Due to ongoing neurological sequelae post stroke patients have a two-fold higher risk of falling than other people with same age or gender. As the stroke patients, balance is impaired and can lead to complications such as fall. Promising interventions that could be beneficial to improve the aspects of gait and balance include Otago exercises and Action observation training. The objective of this study is to determine the effects of Otago exercise combined with Action observation (AO) training on the balance, gait and functional activities in post stroke patients.
A double-blinded randomized control trial will be conducted at Rehabilitation centers, outpatient clinics, and Hospitals for ten months. The sample size will consist of 60 participants. Participants which meet the inclusion criteria will be taken through non-probability convenience sampling technique. Participants will be randomly assigned into two groups: 30 to action observation (AO) training plus Otago exercise group (n= 30) and 30 to Otago exercise group (n= 30). The AO plus Otago and Otago groups will be performed 35 to 40 minutes of strength training and balance exercises from the Otago Exercise Program 3 times a week for 12 weeks. Data will be collected through various assessment tools including Berg Balance Scale (for balance), Dynamic gait index (for gait) and Functional Independence Measure (for functional activities). The effects of the interventions will be measured at pre-treatment and post-intervention. Paired t-test will be adopted to find the statistical difference within the groups and independent t-test will be applied to find the statistical difference between the groups. Data analysis will be performed by using SPSS 26 software.
- Conditions
- Stroke
- Being tested
- Otago exercise program
- Keywords
- Action observation training, Otago exercises, Stroke, Gait, Balance
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Otago exercise programOther
Also called Action Observation Training combined with Otago exercise program
The Otago Exercise Program is composed of strength training and balance training. Strength training consisted of flexion and extension exercises of the knee, ankle, and toe joints, as well as hip opening exercises to strengthen the sides of the pelvis. Balance training consisted of walking backwards, walking in a figure of eight, heel-toe walking, standing on one leg, walking on the heels, walking on the toes, heel-toe walking backwards, standing up from a sitting position, and walking up stairs. Otago exercise program will be performed with action observation train will be instructed to watch a video on a 22-inch screen positioned 1 meter away from them, while comfortably seated in a chair with armrests. They are not allowed to follow along or engage in any movement while watching the video.
| Study group | Role | What they receive |
|---|---|---|
| A. Otago Exercise Program | Experimental | The Otago Exercise Program (Group A) includes specific exercises for strength and balance improvement. These exercises were conducted three times a week. Each training session lasted for 35-40 minutes. Receives: Other: Otago exercise program |
| B. Action Observation Training combined with Otago exercise program | Experimental | Participants will be instructed to watch a video on a 22-inch screen positioned 1 meter away from them, while comfortably seated in a chair with armrests. They are not allowed to follow along or engage in any movement while watching the video. The duration of the video viewing will be 17 minutes (1 minute for each video), followed by a 35-minutes of exercise (2 minutes maximum per session). Receives: Other: Otago exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Berg Balance Scale (for balance)
The BBS is constructed to assess balance ability of older people and identify their risk for falling. The BBS is a 14-task scale that requires subjects to maintain their balance in positions and tasks of increasing difficulty. Specific components of the BBS parallel some gait requirements such as unsupported leg stance and standing with 1 foot in front of the other. Other components address tasks such as rising to stand or standing unsupported. It has an ordinal scale of 0 to 4 points (best performance, 56). The BBS is well documented and has strong psychometric properties for people with stroke. For subjects with stroke, the interrater and intrarater reliability were found to be .97 and .98, respectively. A score of 44 or less has been found to indicate a higher risk of falls.
Measured: 8 weeks
Dynamic Gait Index (for gait)
The DGI is 8 items test that includes walking, walking while changing speed, walking while turning the head horizontally and vertically, walking with pivot turn, walking over and around obstacles, and stair climbing. The scoring of the DGI is based on a 4-point scale ranging from 0 to 3, with 0 indicating severe impairment and 3 indicating normal ability. The best performance total score is 24. A low composite DGI score thus indicates greater impairment in functional mobility. The DGI has been found to be reliable and valid for older people (.96) (ICC.98). Scores of or below 19 points on the DGI indicate a risk of falling in older people and a score of less than 12 points discriminated between fallers and non-fallers.
Measured: 8 weeks
Functional Independence Measure (for functional activities)
The FIM instrument is a minimum data set that measures 18 functional activities, 13 of which involve motor activities and 5 of which involve cognitive activities. The tool has a 7-level scale for scoring each of the items. For example, a score of 1 means that a patient is dependent and is able to provide less than 25% of the effort for a given activity, and a score of 7 means that a patient is completely independent and can perform an activity without assistive devices in a safe and timely manner.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start10 Apr 2025 (estimated)
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aruba Saeed, Phd, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06927323
- Sponsor's protocol ID
- REC/0243 Rimsha Ashfaq
- Status last verified
- Apr 2025
- First submitted
- 7 Apr 2025
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Otago Exercise Program Combined With Action Observation Training on Balance, Gait and Functional Activities in Post Stroke Patients
- ClinicalTrials.gov ID
- NCT06927323
- Acronym / sponsor ID
- REC/0243 Rimsha Ashfaq
- Conditions
- Stroke
- Keywords
- Action observation training, Otago exercises, Stroke, Gait, Balance
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 10 Apr 2025 (estimated)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 15 Apr 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.
Stroke is one of the main causes of adult disability worldwide and global health problem. Due to ongoing neurological sequelae post stroke patients have a two-fold higher risk of falling than other people with same age or gender. As the stroke patients, balance is impaired and can lead to complications such as fall. Promising interventions that could be beneficial to improve the aspects of gait and balance include Otago exercises and Action observation training. The objective of this study is to determine the effects of Otago exercise combined with Action observation (AO) training on the balance, gait and functional activities in post stroke patients.
A double-blinded randomized control trial will be conducted at Rehabilitation centers, outpatient clinics, and Hospitals for ten months. The sample size will consist of 60 participants. Participants which meet the inclusion criteria will be taken through non-probability convenience sampling technique. Participants will be randomly assigned into two groups: 30 to action observation (AO) training plus Otago exercise group (n= 30) and 30 to Otago exercise group (n= 30). The AO plus Otago and Otago groups will be performed 35 to 40 minutes of strength training and balance exercises from the Otago Exercise Program 3 times a week for 12 weeks. Data will be collected through various assessment tools including Berg Balance Scale (for balance), Dynamic gait index (for gait) and Functional Independence Measure (for functional activities). The effects of the interventions will be measured at pre-treatment and post-intervention. Paired t-test will be adopted to find the statistical difference within the groups and independent t-test will be applied to find the statistical difference between the groups. Data analysis will be performed by using SPSS 26 software.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A. Otago Exercise Program | Experimental | Other: Otago exercise programThe Otago Exercise Program (Group A) includes specific exercises for strength and balance improvement. These exercises were conducted three times a week. Each training session lasted for 35-40 minutes. |
| B. Action Observation Training combined with Otago exercise program | Experimental | Other: Otago exercise programParticipants will be instructed to watch a video on a 22-inch screen positioned 1 meter away from them, while comfortably seated in a chair with armrests. They are not allowed to follow along or engage in any movement while watching the video. The duration of the video viewing will be 17 minutes (1 minute for each video), followed by a 35-minutes of exercise (2 minutes maximum per session). |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participants fulfilling given criteria will be included in this study
- Both male and female participants will be included
- The age limit for the participants will be 40-65 years
- Sub-acute and chronic ischemic stroke up to 2 years.
- Participants with BBS score between 35-40.
Key exclusion criteria (5 listed)
- Participants having given criteria will be excluded from this study
- Participants with other neurological diseases.
- Participants who will not be able to understand the informed consent form.
- Participants already involved in an exercise program for fall prevention.
- Participants have no visual field defect, no abnormality in the vestibular organs, no orthopedic disease, and an unrestricted range of motion.
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 |
|---|---|---|
| Otago exercise programAlso: Action Observation Training combined with Otago exercise programThe Otago Exercise Program is composed of strength training and balance training. Strength training consisted of flexion and extension exercises of the knee, ankle, and toe joints, as well as hip opening exercises to strengthen the sides of the pelvis. Balance training consisted of walking backwards, walking in a figure of eight, heel-toe walking, standing on one leg, walking on the heels, walking on the toes, heel-toe walking backwards, standing up from a sitting position, and walking up stairs. Otago exercise program will be performed with action observation train will be instructed to watch a video on a 22-inch screen positioned 1 meter away from them, while comfortably seated in a chair with armrests. They are not allowed to follow along or engage in any movement while watching the video. | Other | A. Otago Exercise Program, B. Action Observation Training combined with Otago exercise program |
Primary outcome
Berg Balance Scale (for balance)
Time frame: 8 weeks
The BBS is constructed to assess balance ability of older people and identify their risk for falling. The BBS is a 14-task scale that requires subjects to maintain their balance in positions and tasks of increasing difficulty. Specific components of the BBS parallel some gait requirements such as unsupported leg stance and standing with 1 foot in front of the other. Other components address tasks such as rising to stand or standing unsupported. It has an ordinal scale of 0 to 4 points (best performance, 56). The BBS is well documented and has strong psychometric properties for people with stroke. For subjects with stroke, the interrater and intrarater reliability were found to be .97 and .98, respectively. A score of 44 or less has been found to indicate a higher risk of falls.
Dynamic Gait Index (for gait)
Time frame: 8 weeks
The DGI is 8 items test that includes walking, walking while changing speed, walking while turning the head horizontally and vertically, walking with pivot turn, walking over and around obstacles, and stair climbing. The scoring of the DGI is based on a 4-point scale ranging from 0 to 3, with 0 indicating severe impairment and 3 indicating normal ability. The best performance total score is 24. A low composite DGI score thus indicates greater impairment in functional mobility. The DGI has been found to be reliable and valid for older people (.96) (ICC.98). Scores of or below 19 points on the DGI indicate a risk of falling in older people and a score of less than 12 points discriminated between fallers and non-fallers.
Functional Independence Measure (for functional activities)
Time frame: 8 weeks
The FIM instrument is a minimum data set that measures 18 functional activities, 13 of which involve motor activities and 5 of which involve cognitive activities. The tool has a 7-level scale for scoring each of the items. For example, a score of 1 means that a patient is dependent and is able to provide less than 25% of the effort for a given activity, and a score of 7 means that a patient is completely independent and can perform an activity without assistive devices in a safe and timely manner.
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 15 Apr 2025.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Cardiac CT Angiography in Acute Stroke Imaging (SCOPE-CT)
Acute Ischemic Stroke and Transient Ischemic Attacks
Recruiting
OPTION-EMEA Clinical Trial
Atrial Fibrillation (AF), Stroke Prevention in Patients With Atrial Fibrillation
Not yet recruitingPhase 3
Metformin in Acute Ischemic Stroke
Acute Ischemic Stroke
Recruiting
Music Therapy in Post-Stroke Patients: A Clinical Trial
CVA (Cerebrovascular Accident), Ictus
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
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.
Aruba Saeed, Phd principal investigator
Riphah International University
Questions about this trial
What is this clinical trial studying?
A study testing Otago exercise program in people with Stroke, run by Riphah International University.
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 7 inclusion and 5 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: opening soon, as of the sponsor's last update on 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Aruba Saeed, Phd (03344399403, arubasaeedpt@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 (for balance) (time frame: 8 weeks). 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?
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 15 Apr 2025.