StrokeNCT07578948
Comparative Effects of Task Oriented Progressive Resistance Training and Modified Otago Exercise Among Stroke Patients.
A study testing Modified otago exercise and Task oriented progressive resistance training in people with Stroke, run by Riphah International University at 1 site in Pakistan.
Trial summary
Comparative Effects of Task Oriented Progressive Resistance Training and Modified Otago Exercise on Balance and Lower Limb Motor Function Among Stroke Patients. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Stroke
- What is being tested?
- Modified otago exercise and Task oriented progressive resistance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 sitePakistan
- Study dates
- 5 Apr 2025to 6 Jul 2026
- 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 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 45 to 65 years. (9)
- Both genders male and female.
- Clinically diagnosed with ischemic stroke.
- Chronic stroke patients 6 to 10 months.
- Presence of hemiparesis with mild to moderate motor deficits FMA-LE score 34.
- Cognitive impairment MMSE score more than 26.
- Ability to walk at least 10 meters with or without an assistive device
Who cannot join
- Dementia or major neurocognitive disorder. (6)
- Complete paralysis or unable to participate in active exercise. (11)
- Patients with severe joint pain or arthritis are excluded due to reduce risk of injury and avoid confounding factors.
- Recent fractures, or other musculoskeletal issues limiting exercise participation.
- Suffering from physical diseases that prevent full participation in training.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Effects of Task Oriented Progressive Resistance Training and Modified Otago Exercise on Balance and Lower Limb Motor Function Among Stroke Patients.
Comparative Effects of Task Oriented Progressive Resistance Training and Modified Otago Exercise on Balance and Lower Limb Motor Function Among Stroke Patients.
Read the detailed description
Stroke is a clinical syndrome marked by the sudden onset of localized neurological indications that persist longer than 24 hours or result in death. This definition includes stroke both due to infarction and due to hemorrhage. Stroke is the second or third most common cause of death, one of the main causes of adult disability worldwide, and a global health problem. The remaining 80% are due to ischemic stroke which itself has a number of different subtypes, including large artery disease, cardio embolism, and small vessel disease. This study aims to evaluate the effects of Task Related Progressive Resistance Training and Modified Otago Exercises on balance and lower limb motor function in stroke patients.
A randomized controlled trial will be conducted over eleven months. Fifty-two stroke patients aged 45 to 65 years will be selected using non-probability convenient sampling technique. Participants will be randomly allocated into two groups using a lottery method. Group A will receive Task-Oriented Progressive Resistance Training which includes functional strengthening activities targeting lower limb muscles, while Group B will undergo Modified Otago Exercise Program which involves balance and strength exercises used to prevent fall in stroke. Interventions will be carried out over eight weeks, with assessments conducted pre- and post-intervention using the Berg Balance Scale (for balance), Fugl-Meyer Assessment (for lower limb motor function) and Mini Mental State Examination (for cognitive function). Data will be analysed using SPSS version 26, applying parametric or non-parametric tests based on data normality.
- Conditions
- Stroke
- Being tested
- Modified otago exercise, Task oriented progressive resistance training
- Keywords
- Balance, Motor function, Modified otago exercises, Task oriented progressive resistance training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified otago exerciseOther
Also called MOE
Warm up Head, neck, back extension, trunk, and ankle movement
- Muscle strengthening:
- Front knee (3)
- Back knee
- Side hip
- Calf raises
- Toe rises
- Balance training:
- Knee bends
- Backward walking
- Walk and turn
- Sideways walk
- Heel toe stand
- Heel toe walk
- One leg stand
- Heel walk
- Toe walk
- Heel toe backward walk
- Sit to stand
- Stair walk
Task oriented progressive resistance trainingOther
Standing and reaching in different directions for objects beyond arm's length
- Sit to stand from various chair heights to strengthen lower limb extensors (3)
- Stepping forward and backward on blocks of various heights
- Stepping sideways on blocks of various heights
- Forward stepping on blocks of various heights
- Heel raise and lower in standing to strengthen plantar flexors (3)
| Study group | Role | What they receive |
|---|---|---|
| Modified otago exercises | Experimental | Not described Receives: Other: Modified otago exercise |
| Task oriented progressive resistance training | Active comparator | Participants receive interventions 3 session per week for 4 weeks Receives: Other: Task oriented progressive resistance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment (FMA)
Fugl-Meyer Assessment of Lower Extremity (FMA-LE) total score interpretation ranges from 0 to 34, with higher scores indicating better motor function. Generally, a score of 34 represents normal function, while scores below 29 indicate varying degrees of disability. (15) All FMA-LE forms and subscales showed a high internal consistency (Cronbach's alpha>0.91).
Measured: baseline to 4rth week
Berg Balance Scale (BBS)
The BBS is postural balance scale containing 14 items including standing and sitting unsupported, reaching forward, and placing the alternating foot on a stool. Administering the BBS takes approximately 15 min. Each of the 14 items are scored on a 5-level ordinal scale from 0 (-unable to perform or requiring help‖) to 4 (-normal performance‖), thus providing a potential maximum score of 56 points. (13) test-retest (ICC = 0.96; 95% CI, 0.93-0.98) and inter-rater (ICC = 0.93; 95% CI, 0.87-0.97) reliability was excellent
Measured: Baseline to 4rth week
Mini Mentel Scale (MMS)
The Mini-Mental State Examination (MMSE) is a brief test used to screen for cognitive impairment, particularly in older adults. It assesses different aspects of cognitive function, including orientation, attention, memory, and language. The MMSE is scored on a scale of 0-30, with a score of 24 or higher generally considered normal. (17) The Mini-Mental State Examination (MMSE) generally demonstrates good internal consistency reliability, as indicated by Cronbach's alpha values ranging from 0.78 to 0.81.
Measured: baseline to 4rth week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2026
- Study start5 Apr 2025
- Primary completion3 Jun 2026 (estimated)
- Study completion6 Jul 2026 (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 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sabiha Arshad, Ms, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07578948
- Sponsor's protocol ID
- REC/RCR&AHS/25/0214
- Status last verified
- May 2026
- First submitted
- 5 May 2026
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cekmece C, Sade I, Ozcan E, Balci S. Investigation of the effect of task-oriented occupational therapy on daily living activity performance in chronic stroke patients. Pak J Med Sci. 2024 Jul;40(6):1214-1218. doi: 10.12669/pjms.40.6.7954.
PubMed 38952526Appelros P, Stegmayr B, Terent A. Sex differences in stroke epidemiology: a systematic review. Stroke. 2009 Apr;40(4):1082-90. doi: 10.1161/STROKEAHA.108.540781. Epub 2009 Feb 10.
PubMed 19211488Murphy SJ, Werring DJ. Stroke: causes and clinical features. Medicine (Abingdon). 2020 Sep;48(9):561-566. doi: 10.1016/j.mpmed.2020.06.002. Epub 2020 Aug 6.
PubMed 32837228
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Task Oriented Progressive Resistance Training and Modified Otago Exercise on Balance and Lower Limb Motor Function Among Stroke Patients.
- ClinicalTrials.gov ID
- NCT07578948
- Acronym / sponsor ID
- REC/RCR&AHS/25/0214
- Conditions
- Stroke
- Keywords
- Balance, Motor function, Modified otago exercises, Task oriented progressive resistance training
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 5 Apr 2025 (actual)
- Primary completion
- 3 Jun 2026 (estimated)
- Study completion
- 6 Jul 2026 (estimated)
- First posted
- 11 May 2026 (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.
Comparative Effects of Task Oriented Progressive Resistance Training and Modified Otago Exercise on Balance and Lower Limb Motor Function Among Stroke Patients.
Detailed description
Stroke is a clinical syndrome marked by the sudden onset of localized neurological indications that persist longer than 24 hours or result in death. This definition includes stroke both due to infarction and due to hemorrhage. Stroke is the second or third most common cause of death, one of the main causes of adult disability worldwide, and a global health problem. The remaining 80% are due to ischemic stroke which itself has a number of different subtypes, including large artery disease, cardio embolism, and small vessel disease. This study aims to evaluate the effects of Task Related Progressive Resistance Training and Modified Otago Exercises on balance and lower limb motor function in stroke patients.
A randomized controlled trial will be conducted over eleven months. Fifty-two stroke patients aged 45 to 65 years will be selected using non-probability convenient sampling technique. Participants will be randomly allocated into two groups using a lottery method. Group A will receive Task-Oriented Progressive Resistance Training which includes functional strengthening activities targeting lower limb muscles, while Group B will undergo Modified Otago Exercise Program which involves balance and strength exercises used to prevent fall in stroke. Interventions will be carried out over eight weeks, with assessments conducted pre- and post-intervention using the Berg Balance Scale (for balance), Fugl-Meyer Assessment (for lower limb motor function) and Mini Mental State Examination (for cognitive function). Data will be analysed using SPSS version 26, applying parametric or non-parametric tests based on data normality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified otago exercises | Experimental | Other: Modified otago exercise |
| Task oriented progressive resistance training | Active comparator | Other: Task oriented progressive resistance trainingParticipants receive interventions 3 session per week for 4 weeks |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adults aged 45 to 65 years. (9)
- Both genders male and female.
- Clinically diagnosed with ischemic stroke.
- Chronic stroke patients 6 to 10 months.
- Presence of hemiparesis with mild to moderate motor deficits FMA-LE score 34.
Key exclusion criteria (5 listed)
- Dementia or major neurocognitive disorder. (6)
- Complete paralysis or unable to participate in active exercise. (11)
- Patients with severe joint pain or arthritis are excluded due to reduce risk of injury and avoid confounding factors.
- Recent fractures, or other musculoskeletal issues limiting exercise participation.
- Suffering from physical diseases that prevent full participation in training.
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 exerciseAlso: MOEWarm up Head, neck, back extension, trunk, and ankle movement * Muscle strengthening: * Front knee (3) * Back knee * Side hip * Calf raises * Toe rises * Balance training: * Knee bends * Backward walking * Walk and turn * Sideways walk * Heel toe stand * Heel toe walk * One leg stand * Heel walk * Toe walk * Heel toe backward walk * Sit to stand * Stair walk | Other | Modified otago exercises |
| Task oriented progressive resistance trainingStanding and reaching in different directions for objects beyond arm's length * Sit to stand from various chair heights to strengthen lower limb extensors (3) * Stepping forward and backward on blocks of various heights * Stepping sideways on blocks of various heights * Forward stepping on blocks of various heights * Heel raise and lower in standing to strengthen plantar flexors (3) | Other | Task oriented progressive resistance training |
Primary outcome
Fugl-Meyer Assessment (FMA)
Time frame: baseline to 4rth week
Fugl-Meyer Assessment of Lower Extremity (FMA-LE) total score interpretation ranges from 0 to 34, with higher scores indicating better motor function. Generally, a score of 34 represents normal function, while scores below 29 indicate varying degrees of disability. (15) All FMA-LE forms and subscales showed a high internal consistency (Cronbach's alpha>0.91).
Berg Balance Scale (BBS)
Time frame: Baseline to 4rth week
The BBS is postural balance scale containing 14 items including standing and sitting unsupported, reaching forward, and placing the alternating foot on a stool. Administering the BBS takes approximately 15 min. Each of the 14 items are scored on a 5-level ordinal scale from 0 (-unable to perform or requiring help‖) to 4 (-normal performance‖), thus providing a potential maximum score of 56 points. (13) test-retest (ICC = 0.96; 95% CI, 0.93-0.98) and inter-rater (ICC = 0.93; 95% CI, 0.87-0.97) reliability was excellent
Mini Mentel Scale (MMS)
Time frame: baseline to 4rth week
The Mini-Mental State Examination (MMSE) is a brief test used to screen for cognitive impairment, particularly in older adults. It assesses different aspects of cognitive function, including orientation, attention, memory, and language. The MMSE is scored on a scale of 0-30, with a score of 24 or higher generally considered normal. (17) The Mini-Mental State Examination (MMSE) generally demonstrates good internal consistency reliability, as indicated by Cronbach's alpha values ranging from 0.78 to 0.81.
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 11 May 2026.
- Background: PubMed 38952526Cekmece C, Sade I, Ozcan E, Balci S. Investigation of the effect of task-oriented occupational therapy on daily living activity performance in chronic stroke patients. Pak J Med Sci. 2024 Jul;40(6):1214-1218. doi: 10.12669/pjms.40.6.7954.
- Background: PubMed 19211488Appelros P, Stegmayr B, Terent A. Sex differences in stroke epidemiology: a systematic review. Stroke. 2009 Apr;40(4):1082-90. doi: 10.1161/STROKEAHA.108.540781. Epub 2009 Feb 10.
- Background: PubMed 32837228Murphy SJ, Werring DJ. Stroke: causes and clinical features. Medicine (Abingdon). 2020 Sep;48(9):561-566. doi: 10.1016/j.mpmed.2020.06.002. Epub 2020 Aug 6.
- 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. This study is not recruiting at the moment.
Sabiha Arshad, Ms 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 Modified otago exercise and Task oriented progressive resistance training in people with Stroke, 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 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: under way, not looking for participants, as of the sponsor's last update on 11 May 2026. 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?
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?
Fugl-Meyer Assessment (FMA) (time frame: baseline to 4rth week). 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 NCT07578948, 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 11 May 2026.