StrokeNCT06807879
EFFECTS of OTAGO EXERCISES in ADDITION to ROUTINE PHYSICAL THERAPY on BALANCE and FUNCTIONAL ACTIVITIES in PATIENTS with STROKE.
A study testing Modified Otago Exercise with Routine care Physical therapy and Routine Care Physical Therapy in people with Stroke and Balance, run by University of Lahore at 1 site in Pakistan.
Trial summary
Stroke is an extremely severe medical condition which is ranked as the second biggest cause of death worldwide as it claims an estimated 5.5 million lives per year. A stroke can result in enduring brain injury, prolonged disability, or fatality (Tsao et al., 2023) . Read more about this study
- Who is it for?
- Ages 60 to 70 years
- Conditions the study is for
- Stroke, Balance, Ischemic Stroke
- What is being tested?
- Modified Otago Exercise with Routine care Physical therapy and Routine Care Physical Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 sitePakistan
- Study dates
- 25 Jan 2024to 19 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 60 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants aged between 60 to 70 years old (Verheyden et al., 2013).
- Both genders (Khumpaneid et al., 2022).
- Patients who have been diagnosed with ischemic stroke by a medical professional(Khumpaneid et al., 2022).
- Eligible for movement without using any walking aid equipment (Khumpaneid et al.,2022).
- Exercise less than 150 mins per week (Khumpaneid et al., 2022).
- Timed Up and Go score is more than 10 (Khumpaneid et al., 2022).
- Mini-Mental State Examination (MMSE) score ≥ 24 (Page et al., 2007).
- Urinary and bowel continence (Jin et al., 2023) .
Who cannot join
- Patients who have severe cognitive impairment or communication difficulties (Jin et al., 2023).
- Participants who have neurological conditions (e.g., Parkinson's disease), vision problems or contagious diseases (Khumpaneid et al., 2022).
- Patients who have undergone surgery in the past 3 months (Jin et al., 2023
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
University Of Lahore Teaching Hospital
Lahore, Punjab Province, 54590
About this study
Stroke is an extremely severe medical condition which is ranked as the second biggest cause of death worldwide as it claims an estimated 5.5 million lives per year. A stroke can result in enduring brain injury, prolonged disability, or fatality (Tsao et al., 2023) . There are two major types of stroke: Hemorrhagic stroke and Ischemic stroke. The most prevalent type is Ischemic, accounting for approximately 87% of strokes worldwide. It arises from a blockage in a blood vessel supplying the brain (Collaborators, 2022) . Also, the affected brain areas can result in functional limitations, cognitive changes, and emotional difficulties (Fihla, 2024) .
Moreover, given the potential cost-effectiveness of OEP compared to more intensive rehabilitation methods, its implementation could offer a pragmatic solution to improving the quality of life for individuals grappling with the enduring consequences of ischemic stroke.
Therefore, exploring the effectiveness of OEP in this specific population holds promise for advancing stroke rehabilitation strategies and potentially improving the lives of individuals living with the long-term effects of ischemic stroke.
Read the detailed description
Study Design: Randomized Clinical Trial.
Screening:
Patients were screened to meet inclusion criteria. The consent form taken from patients then patients were randomly allocated into two groups ( 29 in each group).
Randomization:
Using the lottery approach, patients who met the inclusion criteria were split into experimental and control groups at random by the online tool for randomization.
Blinding:
To ensure precision and mitigating the bias the assessor of outcome was kept blind also. An independent assessor specialized in this technique and having more than 5 years experience screened patients, and they were subsequently randomly assigned to either the experimental group. The computer-generated allocation sequence was established prior to the study's commencement.
Assessment:
Data was collected at baseline, fourth week and then at the end of the eighth week. Baseline assessments will be conducted before the intervention. Post-intervention assessments will be conducted immediately after the intervention. Statistical analysis will include descriptive statistics, t-tests, and analysis of variance to compare the outcomes between the two groups.
Intervention:
The intervention group A received routine physical therapy in addition to the Otago Exercise Program, while the control group B received routine physical therapy alone.
GROUP A: ( Modified Otago Exercise with Routine care Physical therapy) GROUP B: ( ROUTINE CARE PHYSICAL THERAPY )
Outcome Measures:
Primary outcome:
Balance was assessed using the Berg Balance Scale (BBS)
Secondary outcomes:
Functional activities the physical performance was assessed using the 30-s Chair Stand Test (30 s-CST).
Ethical Considerations: This study has received ethical approval from the Institutional Review Board (IRB). Informed consent was obtained from all participants.
Data Analysis: Statistical software was used to analyze the data, with appropriate tests employed based on data normality to compare outcomes between groups.
- Conditions
- Stroke, Balance, Ischemic Stroke, Function, OEP
- Being tested
- Modified Otago Exercise with Routine care Physical therapy, Routine Care Physical Therapy
- Keywords
- Otago Exercise, Functional Activities, Balance, Ischemic Stroke, Physical therapy
- Medical subject headings
- Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Otago Exercise with Routine care Physical therapyBehavioural
To improve the efficacy of the balance improvement intervention, we modified the OEP by incorporating the additional walking, recommended by the OEP guidelines, into a single exercise session and conducting it as a group exercise program in accordance with a previous meta-analysis (Chiu et al., 2021) . As shown in Figure 1, the modified-OEP group intervention consisted of 15 min of walking followed by a 30 min Otago Exercise Program consisting of balance and strength training, followed by another 15 min of walking. The 15 min walking was accomplished through continuous walking at an individual pace in the ~15m training room. Participants were asked to walk 15 m, make a U-turn towards the left side, walk 15 m, then make a U-turn towards the right side at the next turning point, in order to achieve an equivalent effect on the promoted benefit of symmetry when turning left and right.
This was repeated until the session was complete.
Routine Care Physical TherapyBehavioural
The routine care physical therapy session typically involves a variety of exercises aimed at general strengthening, stretching, and basic gait training. 1 hour of standard physiotherapy exercises focusing on general strengthening, stretching, and basic gait training. The session included a combination of exercises aimed at general strengthening, such as core stability exercises, muscle-strengthening exercises with weights or resistance bands and functional movements like squats and lunges. Stretching exercises targeting key muscle groups like hamstrings will be incorporated to improve flexibility and range of motion. Gait training will focus on activities like side lunges, step-ups, and balance exercises to enhance walking ability and postural control. Additionally, the plan emphasized progressive challenges incorporating a mix of static and dynamic balance exercises using tools like foam pads or balance boards.
| Study group | Role | What they receive |
|---|---|---|
| Modified Otago Exercise with Routine care Physical therapy | Experimental | The modified-OEP group intervention consisted of 15 min of walking followed by a 30 min Otago Exercise Program consisting of balance and strength training, followed by another 15 min of walking. The 15 min walking was accomplished through continuous walking at an individual pace in the ~15 m training room. Participants were asked to walk 15 m, make a U-turn towards the left side, walk 15 m, then make a U-turn towards the right side at the next turning point, in order to achieve an equivalent effect on the promoted benefit of symmetry when turning left and right. This was repeated until the session was complete. Receives: Behavioral: Modified Otago Exercise with Routine care Physical therapy |
| Routine Care Physical Therapy | Experimental | The routine care physical therapy session typically involves a variety of exercises aimed at general strengthening, stretching, and basic gait training. 1 hour of standard physiotherapy exercises focusing on general strengthening, stretching, and basic gait training. Receives: Behavioral: Routine Care Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance
Balance was assessed using the Berg Balance Scale (BBS). To determine the effects of Otago exercises in addition to routine physical therapy on balance and functional activities in patients with stroke.
Measured: Baseline, mid-intervention (4 weeks), and post-intervention (8 weeks).
Secondary outcomes (1)
Functional activities
Functional activities was assessed using the 30-s Chair Stand Test (30 s-CST).
Measured: Baseline, mid-intervention (4 weeks), and post-intervention (8 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2025
- Study start25 Jan 2024
- Primary completion13 Nov 2024
- Study completion19 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of LahoreThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- GROUP A :Modified Otago Exercise with Routine care Physical therapy GROUP B :Routine Care Physical Therapy
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Affaf Abid, University of Lahore
- Investigators
- Mehwish Saghir, MS Neuro, Principal investigator, University of LahoreSana Ikram, MS MSK, Study director, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06807879
- Sponsor's protocol ID
- REC-UOL-/380/08/24
- Status last verified
- Jan 2025
- First submitted
- 29 Jan 2025
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Khumpaneid N, Phoka T, Khongprasert S. Effects of Modified-Otago Exercise Program on Four Components of Actual Balance and Perceived Balance in Healthy Older Adults. Geriatrics (Basel). 2022 Aug 30;7(5):88. doi: 10.3390/geriatrics7050088.
PubMed 36136797Hatem SM, Saussez G, Della Faille M, Prist V, Zhang X, Dispa D, Bleyenheuft Y. Rehabilitation of Motor Function after Stroke: A Multiple Systematic Review Focused on Techniques to Stimulate Upper Extremity Recovery. Front Hum Neurosci. 2016 Sep 13;10:442. doi: 10.3389/fnhum.2016.00442. eCollection 2016.
PubMed 27679565Farooq A, Venketasubramanian N, Wasay M. Stroke Care in Pakistan. Cerebrovasc Dis Extra. 2021;11(3):118-121. doi: 10.1159/000519554. Epub 2021 Oct 25.
PubMed 34695824Everard G, Luc A, Doumas I, Ajana K, Stoquart G, Edwards MG, Lejeune T. Self-Rehabilitation for Post-Stroke Motor Function and Activity-A Systematic Review and Meta-Analysis. Neurorehabil Neural Repair. 2021 Dec;35(12):1043-1058. doi: 10.1177/15459683211048773. Epub 2021 Oct 25.
PubMed 34696645Davis JC, Khan KM, Hsu CL, Chan P, Cook WL, Dian L, Liu-Ambrose T. Action Seniors! Cost-Effectiveness Analysis of a Secondary Falls Prevention Strategy Among Community-Dwelling Older Fallers. J Am Geriatr Soc. 2020 Sep;68(9):1988-1997. doi: 10.1111/jgs.16476. Epub 2020 May 29.
PubMed 32472567Davis JC, Hsu CL, Barha C, Jehu DA, Chan P, Ghag C, Jacova P, Adjetey C, Dian L, Parmar N, Madden K, Liu-Ambrose T. Comparing the cost-effectiveness of the Otago Exercise Programme among older women and men: A secondary analysis of a randomized controlled trial. PLoS One. 2022 Apr 20;17(4):e0267247. doi: 10.1371/journal.pone.0267247. eCollection 2022.
PubMed 35442974Angeles CM, Laura AM, Consuelo CM, Manuel RR, Eva AC, Covadonga GA; Otago Project Working Group. The effect that the Otago Exercise Programme had on fear of falling in community dwellers aged 65-80 and associated factors. Arch Gerontol Geriatr. 2022 Mar-Apr;99:104620. doi: 10.1016/j.archger.2022.104620. Epub 2022 Jan 4.
PubMed 34999543Ambrosini E, Peri E, Nava C, Longoni L, Monticone M, Pedrocchi A, Ferriero G, Ferrante S. A multimodal training with visual biofeedback in subacute stroke survivors: a randomized controlled trial. Eur J Phys Rehabil Med. 2020 Feb;56(1):24-33. doi: 10.23736/S1973-9087.19.05847-7. Epub 2019 Sep 26.
PubMed 31556542Alsubiheen AM, Choi W, Yu W, Lee H. The Effect of Task-Oriented Activities Training on Upper-Limb Function, Daily Activities, and Quality of Life in Chronic Stroke Patients: A Randomized Controlled Trial. Int J Environ Res Public Health. 2022 Oct 29;19(21):14125. doi: 10.3390/ijerph192114125.
PubMed 36361001Albornos-Munoz L, Moreno-Casbas MT, Sanchez-Pablo C, Bays-Moneo A, Fernandez-Dominguez JC, Rich-Ruiz M, Gea-Sanchez M; Otago Project Working Group. Efficacy of the Otago Exercise Programme to reduce falls in community-dwelling adults aged 65-80 years old when delivered as group or individual training. J Adv Nurs. 2018 Jul;74(7):1700-1711. doi: 10.1111/jan.13583. Epub 2018 Jun 3.
PubMed 29633328Ahmed, S., Manzoor, F., Naseem, H., & Ansari, A. Q. (2024). Effects of action observation therapy with Otago exercises on balance and quality of life in older adults. The Rehabilitation Journal, 15-21.
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECTS of OTAGO EXERCISES in ADDITION to ROUTINE PHYSICAL THERAPY on BALANCE and FUNCTIONAL ACTIVITIES in PATIENTS with STROKE.
- ClinicalTrials.gov ID
- NCT06807879
- Acronym / sponsor ID
- REC-UOL-/380/08/24
- Conditions
- Stroke, Balance, Ischemic Stroke, Function, OEP
- Keywords
- Otago Exercise, Functional Activities, Balance, Ischemic Stroke, Physical therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 25 Jan 2024 (actual)
- Primary completion
- 13 Nov 2024 (actual)
- Study completion
- 19 Dec 2024 (actual)
- First posted
- 4 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.
Stroke is an extremely severe medical condition which is ranked as the second biggest cause of death worldwide as it claims an estimated 5.5 million lives per year. A stroke can result in enduring brain injury, prolonged disability, or fatality (Tsao et al., 2023) . There are two major types of stroke: Hemorrhagic stroke and Ischemic stroke. The most prevalent type is Ischemic, accounting for approximately 87% of strokes worldwide. It arises from a blockage in a blood vessel supplying the brain (Collaborators, 2022) . Also, the affected brain areas can result in functional limitations, cognitive changes, and emotional difficulties (Fihla, 2024) .
Moreover, given the potential cost-effectiveness of OEP compared to more intensive rehabilitation methods, its implementation could offer a pragmatic solution to improving the quality of life for individuals grappling with the enduring consequences of ischemic stroke.
Therefore, exploring the effectiveness of OEP in this specific population holds promise for advancing stroke rehabilitation strategies and potentially improving the lives of individuals living with the long-term effects of ischemic stroke.
Detailed description
Study Design: Randomized Clinical Trial.
Screening:
Patients were screened to meet inclusion criteria. The consent form taken from patients then patients were randomly allocated into two groups ( 29 in each group).
Randomization:
Using the lottery approach, patients who met the inclusion criteria were split into experimental and control groups at random by the online tool for randomization.
Blinding:
To ensure precision and mitigating the bias the assessor of outcome was kept blind also. An independent assessor specialized in this technique and having more than 5 years experience screened patients, and they were subsequently randomly assigned to either the experimental group. The computer-generated allocation sequence was established prior to the study's commencement.
Assessment:
Data was collected at baseline, fourth week and then at the end of the eighth week. Baseline assessments will be conducted before the intervention. Post-intervention assessments will be conducted immediately after the intervention. Statistical analysis will include descriptive statistics, t-tests, and analysis of variance to compare the outcomes between the two groups.
Intervention:
The intervention group A received routine physical therapy in addition to the Otago Exercise Program, while the control group B received routine physical therapy alone.
GROUP A: ( Modified Otago Exercise with Routine care Physical therapy) GROUP B: ( ROUTINE CARE PHYSICAL THERAPY )
Outcome Measures:
Primary outcome:
Balance was assessed using the Berg Balance Scale (BBS)
Secondary outcomes:
Functional activities the physical performance was assessed using the 30-s Chair Stand Test (30 s-CST).
Ethical Considerations: This study has received ethical approval from the Institutional Review Board (IRB). Informed consent was obtained from all participants.
Data Analysis: Statistical software was used to analyze the data, with appropriate tests employed based on data normality to compare outcomes between groups.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- GROUP A :Modified Otago Exercise with Routine care Physical therapy GROUP B :Routine Care Physical Therapy
| Arm | Type | Receives |
|---|---|---|
| Modified Otago Exercise with Routine care Physical therapy | Experimental | Behavioral: Modified Otago Exercise with Routine care Physical therapyThe modified-OEP group intervention consisted of 15 min of walking followed by a 30 min Otago Exercise Program consisting of balance and strength training, followed by another 15 min of walking. The 15 min walking was accomplished through continuous walking at an individual pace in the ~15 m training room. Participants were asked to walk 15 m, make a U-turn towards the left side, walk 15 m, then make a U-turn towards the right side at the next turning point, in order to achieve an equivalent effect on the promoted benefit of symmetry when turning left and right. This was repeated until the session was complete. |
| Routine Care Physical Therapy | Experimental | Behavioral: Routine Care Physical TherapyThe routine care physical therapy session typically involves a variety of exercises aimed at general strengthening, stretching, and basic gait training. 1 hour of standard physiotherapy exercises focusing on general strengthening, stretching, and basic gait training. |
Who may qualify
- Ages
- 60 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participants aged between 60 to 70 years old (Verheyden et al., 2013).
- Both genders (Khumpaneid et al., 2022).
- Patients who have been diagnosed with ischemic stroke by a medical professional(Khumpaneid et al., 2022).
- Eligible for movement without using any walking aid equipment (Khumpaneid et al.,2022).
- Exercise less than 150 mins per week (Khumpaneid et al., 2022).
Key exclusion criteria (3 listed)
- Patients who have severe cognitive impairment or communication difficulties (Jin et al., 2023).
- Participants who have neurological conditions (e.g., Parkinson's disease), vision problems or contagious diseases (Khumpaneid et al., 2022).
- Patients who have undergone surgery in the past 3 months (Jin et al., 2023
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 |
|---|---|---|
| Modified Otago Exercise with Routine care Physical therapyTo improve the efficacy of the balance improvement intervention, we modified the OEP by incorporating the additional walking, recommended by the OEP guidelines, into a single exercise session and conducting it as a group exercise program in accordance with a previous meta-analysis (Chiu et al., 2021) . As shown in Figure 1, the modified-OEP group intervention consisted of 15 min of walking followed by a 30 min Otago Exercise Program consisting of balance and strength training, followed by another 15 min of walking. The 15 min walking was accomplished through continuous walking at an individual pace in the ~15m training room. Participants were asked to walk 15 m, make a U-turn towards the left side, walk 15 m, then make a U-turn towards the right side at the next turning point, in order to achieve an equivalent effect on the promoted benefit of symmetry when turning left and right. This was repeated until the session was complete. | Behavioural | Modified Otago Exercise with Routine care Physical therapy |
| Routine Care Physical TherapyThe routine care physical therapy session typically involves a variety of exercises aimed at general strengthening, stretching, and basic gait training. 1 hour of standard physiotherapy exercises focusing on general strengthening, stretching, and basic gait training. The session included a combination of exercises aimed at general strengthening, such as core stability exercises, muscle-strengthening exercises with weights or resistance bands and functional movements like squats and lunges. Stretching exercises targeting key muscle groups like hamstrings will be incorporated to improve flexibility and range of motion. Gait training will focus on activities like side lunges, step-ups, and balance exercises to enhance walking ability and postural control. Additionally, the plan emphasized progressive challenges incorporating a mix of static and dynamic balance exercises using tools like foam pads or balance boards. | Behavioural | Routine Care Physical Therapy |
Primary outcome
Balance
Time frame: Baseline, mid-intervention (4 weeks), and post-intervention (8 weeks).
Balance was assessed using the Berg Balance Scale (BBS). To determine the effects of Otago exercises in addition to routine physical therapy on balance and functional activities in patients with stroke.
1 secondary outcome
Functional activities
Time frame: Baseline, mid-intervention (4 weeks), and post-intervention (8 weeks).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- Background: PubMed 36136797Khumpaneid N, Phoka T, Khongprasert S. Effects of Modified-Otago Exercise Program on Four Components of Actual Balance and Perceived Balance in Healthy Older Adults. Geriatrics (Basel). 2022 Aug 30;7(5):88. doi: 10.3390/geriatrics7050088.
- Background: PubMed 27679565Hatem SM, Saussez G, Della Faille M, Prist V, Zhang X, Dispa D, Bleyenheuft Y. Rehabilitation of Motor Function after Stroke: A Multiple Systematic Review Focused on Techniques to Stimulate Upper Extremity Recovery. Front Hum Neurosci. 2016 Sep 13;10:442. doi: 10.3389/fnhum.2016.00442. eCollection 2016.
- Background: PubMed 34695824Farooq A, Venketasubramanian N, Wasay M. Stroke Care in Pakistan. Cerebrovasc Dis Extra. 2021;11(3):118-121. doi: 10.1159/000519554. Epub 2021 Oct 25.
- Background: PubMed 34696645Everard G, Luc A, Doumas I, Ajana K, Stoquart G, Edwards MG, Lejeune T. Self-Rehabilitation for Post-Stroke Motor Function and Activity-A Systematic Review and Meta-Analysis. Neurorehabil Neural Repair. 2021 Dec;35(12):1043-1058. doi: 10.1177/15459683211048773. Epub 2021 Oct 25.
- Background: PubMed 32472567Davis JC, Khan KM, Hsu CL, Chan P, Cook WL, Dian L, Liu-Ambrose T. Action Seniors! Cost-Effectiveness Analysis of a Secondary Falls Prevention Strategy Among Community-Dwelling Older Fallers. J Am Geriatr Soc. 2020 Sep;68(9):1988-1997. doi: 10.1111/jgs.16476. Epub 2020 May 29.
- Background: PubMed 35442974Davis JC, Hsu CL, Barha C, Jehu DA, Chan P, Ghag C, Jacova P, Adjetey C, Dian L, Parmar N, Madden K, Liu-Ambrose T. Comparing the cost-effectiveness of the Otago Exercise Programme among older women and men: A secondary analysis of a randomized controlled trial. PLoS One. 2022 Apr 20;17(4):e0267247. doi: 10.1371/journal.pone.0267247. eCollection 2022.
- Background: PubMed 34999543Angeles CM, Laura AM, Consuelo CM, Manuel RR, Eva AC, Covadonga GA; Otago Project Working Group. The effect that the Otago Exercise Programme had on fear of falling in community dwellers aged 65-80 and associated factors. Arch Gerontol Geriatr. 2022 Mar-Apr;99:104620. doi: 10.1016/j.archger.2022.104620. Epub 2022 Jan 4.
- Background: PubMed 31556542Ambrosini E, Peri E, Nava C, Longoni L, Monticone M, Pedrocchi A, Ferriero G, Ferrante S. A multimodal training with visual biofeedback in subacute stroke survivors: a randomized controlled trial. Eur J Phys Rehabil Med. 2020 Feb;56(1):24-33. doi: 10.23736/S1973-9087.19.05847-7. Epub 2019 Sep 26.
- Background: PubMed 36361001Alsubiheen AM, Choi W, Yu W, Lee H. The Effect of Task-Oriented Activities Training on Upper-Limb Function, Daily Activities, and Quality of Life in Chronic Stroke Patients: A Randomized Controlled Trial. Int J Environ Res Public Health. 2022 Oct 29;19(21):14125. doi: 10.3390/ijerph192114125.
- Background: PubMed 29633328Albornos-Munoz L, Moreno-Casbas MT, Sanchez-Pablo C, Bays-Moneo A, Fernandez-Dominguez JC, Rich-Ruiz M, Gea-Sanchez M; Otago Project Working Group. Efficacy of the Otago Exercise Programme to reduce falls in community-dwelling adults aged 65-80 years old when delivered as group or individual training. J Adv Nurs. 2018 Jul;74(7):1700-1711. doi: 10.1111/jan.13583. Epub 2018 Jun 3.
- BackgroundAhmed, S., Manzoor, F., Naseem, H., & Ansari, A. Q. (2024). Effects of action observation therapy with Otago exercises on balance and quality of life in older adults. The Rehabilitation Journal, 15-21.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
Mehwish Saghir, MS Neuro principal investigator
University of Lahore
Sana Ikram, MS MSK study director
University of Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Modified Otago Exercise with Routine care Physical therapy and Routine Care Physical Therapy in people with Stroke and Balance, run by University of Lahore 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 8 inclusion and 3 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: finished, as of the sponsor's last update on 4 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Balance (time frame: Baseline, mid-intervention (4 weeks), and post-intervention (8 weeks).). 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 NCT06807879, which also lists 11 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 4 Feb 2025.