Stroke IschemicNCT06845683
Effects of Dual-Task and Progressive Wall Squat Training in Stroke Survivors
A study testing Group A and Group B in people with Stroke Ischemic, run by Riphah International University at 1 site in Pakistan.
Trial summary
To determine the Effects of Dual-Task and Progressive Wall Squat Training on Cognition, Balance and Functional mobility in Stroke Survivors. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Stroke Ischemic
- What is being tested?
- Group A and Group B
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 30 Oct 2024to 15 Mar 2025
- 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 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: Stroke patients aged 45 to 65 years.
- Individuals with a single ischemic stroke.
- Within the first 2 months post-stroke. (Subacute stage)
- Medically stable without acute conditions interfering with exercise.
- Mini-Mental State Examination (MMSE) score≥24
- Ability to walk 10m without assistance
Who cannot join
- Unstable Medical Conditions (cardiovascular, respiratory, or other medical conditions)
- Recent Stroke or Medical Event
- Other Neurological Conditions such as Presence of other neurological conditions (e.g., Parkinson's disease).
- Uncontrolled Hypertension: Systolic BP >160 mm Hg or diastolic BP >100 mm Hg
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Dual-Task and Progressive Wall Squat Training on Cognition, Balance and Functional Mobility in Stroke Survivors
To determine the Effects of Dual-Task and Progressive Wall Squat Training on Cognition, Balance and Functional mobility in Stroke Survivors.
Read the detailed description
A stroke is a neurological disorder in which clots or ruptured vessels obstruct blood vessels, causing abnormal blood flow in the brain. This may lead to the unexpected death of brain cells and aggravate illnesses like depression and dementia.It is a disease with significant health and social consequences because of its high frequency and rate. Stroke is thought to affect 9.2% of the population in Europe, with a rate of 191.9 per 100,000 people annually. According to estimates, between 25 and 74% of those who survive this illness need assistance or become totally reliant on their everyday activities.The primary long-term effects of a stroke are dysphagia, paralysis, motor impairments, cognitive decline, and speech difficulties.
Dual-task training entails doing a motor task and a cognitive task at the same time. This method's justification is that a lot of daily tasks necessitate multitasking, and dual-task training can improve both cognitive and motor abilities by promoting brain plasticity and the interaction of the two systems. In the dual task training, cognitive task (like naming animals or counting backwards) is combined with a lower limb strengthening exercise called wall squats. Both tasks gradually increase in difficulty and intensity based on how well each person performs. By testing the muscle strength, endurance, and coordination of stroke survivors as well as their attention, memory, and executive function, this training seeks to improve their cognitive abilities, balance, and functional mobility.
- Conditions
- Stroke Ischemic
- Being tested
- Group A, Group B
- Keywords
- Balance, cognition, dual-task, functional mobility, stroke survivors, wall squat
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group AOther
Also called Dual task training (Wall squats + cognitive training along with routine rehabilitation
Progressive wall squat exercises will commence with a knee flexion angle of 135°, instructed to hold this position for 20 seconds, exercise progresses, the knee joint angle will be decreased by 10° until reaching the 95° stage or until participants can no longer maintain the knee joint angle within 5° of the target value due to volitional fatigue. Cognitive tasks during the intervention, including the recall of words and counting forward (1, 4, 7, 10...) and backward (...10, 7, 4, 1) by adding 3 to the digits. Sustained stretching (with a hold time of 10 seconds per stretch, totaling 10 repetitions per session) and active range of motion exercises (10 repetitions per session) targeting both the upper and lower extremities in routine rehabilitation.
Group BOther
Also called single-task intervention (Wall squats) along with routine rehabilitation
Progressive wall squat exercises will commence with a knee flexion angle of 135°, instructed to hold this position for 20 seconds, exercise progresses, the knee joint angle will be decreased by 10° until reaching the 95° stage or until participants can no longer maintain the knee joint angle within 5° of the target value due to volitional fatigue. Sustained stretching (with a hold time of 10 seconds per stretch, totaling 10 repetitions per session) and active range of motion exercises (10 repetitions per session) targeting both the upper and lower extremities in routine rehabilitation.
| Study group | Role | What they receive |
|---|---|---|
| combining progressive wall squats with cognitive training | Experimental | Group A will receive dual-task intervention (combining progressive wall squats with cognitive training) along with routine rehabilitation. The group will undergo 45 minute treatment session three times per week over an eight weeks period, focusing on gradually intensifying the progressive wall squat exercises with careful supervision to ensure safety and proper form along with cognitive tasks. Receives: Other: Group A |
| progressive wall squats | Active comparator | Group B will receive single-task intervention (involving progressive wall squats) along with routine rehabilitation. A routine rehabilitation comprising slow sustained stretching (with a hold time of 10 seconds per stretch, totaling 10 repetitions per session) and active range of motion exercises (10 repetitions per session) targeting both the upper and lower extremities. The group will undergo 45 minute treatment session three times per week over an eight weeks period. Receives: Other: Group B |
What is being measured
The primary outcome is the main question the study is designed to answer.
MOCA (Montreal Cognitive Assessment)
A well-liked screening method for identifying the presence of cognitive impairment is the MoCA. It takes about ten minutes to finish. It assesses language, abstract reasoning, executive function, orientation, delayed recall, attention, and visuospatial skills. The MoCA is more sensitive and specific than the MMSE because it covers a wider range of domains.
Measured: 8 weeks
Tinneti POMA (Balance, gait)
The Tinetti Scale is a tool for assessing gait and balance. The test is used clinically to evaluate changes in gait time and balance, as well as to ascertain a subject's current level of mobility. The two sub-scales that make up the total POMA (POMA-T) are the gait evaluation scale (also known as the POMA-G) and the balance evaluation scale (also known as the POMA-B). The maximum score is 28 points; specifically, the POMA-B has a maximum score of 16 and the POMA-G has a maximum score of 12.
Measured: 8 weeks
Rivermead mobility index
RMI is a measure that evaluates a patient's degree of mobility .There are 14 questions on it, along with a section on observations. This index evaluates an individual's ability to do tasks like getting out of bed, sitting, maintaining balance, standing up, standing unassisted, moving around, walking indoors and outside, climbing and descending stairs, picking up objects off the floor, taking a shower, and running. Every activity receives one point, if at all possible. If the score is less than 14, it suggests that the person has mobility problems; if the score is 15, it means they don't have any problems at all
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 posted25 Feb 2025
- Study start30 Oct 2024
- Primary completion15 Mar 2025
- Study completion15 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Stroke IschemicStudies 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
- Assignment
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
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 Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06845683
- Sponsor's protocol ID
- REC/24/0211 Barira Shahid
- Status last verified
- Apr 2025
- First submitted
- 20 Feb 2025
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Morice E, Moncharmont J, Jenny C, Bruyneel AV. Dancing to improve balance control, cognitive-motor functions and quality of life after stroke: a study protocol for a randomised controlled trial. BMJ Open. 2020 Sep 30;10(9):e037039. doi: 10.1136/bmjopen-2020-037039.
PubMed 32998921Buvarp D, Rafsten L, Sunnerhagen KS. Predicting Longitudinal Progression in Functional Mobility After Stroke: A Prospective Cohort Study. Stroke. 2020 Jul;51(7):2179-2187. doi: 10.1161/STROKEAHA.120.029913. Epub 2020 Jun 17.
PubMed 32568652Lee Y, Kim K. The influence of Gait Training Combined with Portable Functional Electrical Stimulation on motor function, balance and gait ability in stroke patients. J Back Musculoskelet Rehabil. 2022;35(6):1171-1178. doi: 10.3233/BMR-210154.
PubMed 35754258Hurd MD, Goel I, Sakai Y, Teramura Y. Current status of ischemic stroke treatment: From thrombolysis to potential regenerative medicine. Regen Ther. 2021 Oct 12;18:408-417. doi: 10.1016/j.reth.2021.09.009. eCollection 2021 Dec.
PubMed 34722837Spano B, Lombardi MG, De Tollis M, Szczepanska MA, Ricci C, Manzo A, Giuli S, Polidori L, Griffini IA, Adriano F, Caltagirone C, Annicchiarico R. Correction: Spano et al. Effect of Dual-Task Motor-Cognitive Training in Preventing Falls in Vulnerable Elderly Cerebrovascular Patients: A Pilot Study. Brain Sci. 2022, 12, 168. Brain Sci. 2024 Apr 11;14(4):370. doi: 10.3390/brainsci14040370.
PubMed 38672060Kuriakose D, Xiao Z. Pathophysiology and Treatment of Stroke: Present Status and Future Perspectives. Int J Mol Sci. 2020 Oct 15;21(20):7609. doi: 10.3390/ijms21207609.
PubMed 33076218
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dual-Task and Progressive Wall Squat Training on Cognition, Balance and Functional Mobility in Stroke Survivors
- ClinicalTrials.gov ID
- NCT06845683
- Acronym / sponsor ID
- REC/24/0211 Barira Shahid
- Conditions
- Stroke Ischemic
- Keywords
- Balance, cognition, dual-task, functional mobility, stroke survivors, wall squat
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 30 Oct 2024 (actual)
- Primary completion
- 15 Mar 2025 (actual)
- Study completion
- 15 Mar 2025 (actual)
- 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 determine the Effects of Dual-Task and Progressive Wall Squat Training on Cognition, Balance and Functional mobility in Stroke Survivors.
Detailed description
A stroke is a neurological disorder in which clots or ruptured vessels obstruct blood vessels, causing abnormal blood flow in the brain. This may lead to the unexpected death of brain cells and aggravate illnesses like depression and dementia.It is a disease with significant health and social consequences because of its high frequency and rate. Stroke is thought to affect 9.2% of the population in Europe, with a rate of 191.9 per 100,000 people annually. According to estimates, between 25 and 74% of those who survive this illness need assistance or become totally reliant on their everyday activities.The primary long-term effects of a stroke are dysphagia, paralysis, motor impairments, cognitive decline, and speech difficulties.
Dual-task training entails doing a motor task and a cognitive task at the same time. This method's justification is that a lot of daily tasks necessitate multitasking, and dual-task training can improve both cognitive and motor abilities by promoting brain plasticity and the interaction of the two systems. In the dual task training, cognitive task (like naming animals or counting backwards) is combined with a lower limb strengthening exercise called wall squats. Both tasks gradually increase in difficulty and intensity based on how well each person performs. By testing the muscle strength, endurance, and coordination of stroke survivors as well as their attention, memory, and executive function, this training seeks to improve their cognitive abilities, balance, and functional mobility.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Assignment
| Arm | Type | Receives |
|---|---|---|
| combining progressive wall squats with cognitive training | Experimental | Other: Group AGroup A will receive dual-task intervention (combining progressive wall squats with cognitive training) along with routine rehabilitation. The group will undergo 45 minute treatment session three times per week over an eight weeks period, focusing on gradually intensifying the progressive wall squat exercises with careful supervision to ensure safety and proper form along with cognitive tasks. |
| progressive wall squats | Active comparator | Other: Group BGroup B will receive single-task intervention (involving progressive wall squats) along with routine rehabilitation. A routine rehabilitation comprising slow sustained stretching (with a hold time of 10 seconds per stretch, totaling 10 repetitions per session) and active range of motion exercises (10 repetitions per session) targeting both the upper and lower extremities. The group will undergo 45 minute treatment session three times per week over an eight weeks period. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age: Stroke patients aged 45 to 65 years.
- Individuals with a single ischemic stroke.
- Within the first 2 months post-stroke. (Subacute stage)
- Medically stable without acute conditions interfering with exercise.
- Mini-Mental State Examination (MMSE) score≥24
Key exclusion criteria (4 listed)
- Unstable Medical Conditions (cardiovascular, respiratory, or other medical conditions)
- Recent Stroke or Medical Event
- Other Neurological Conditions such as Presence of other neurological conditions (e.g., Parkinson's disease).
- Uncontrolled Hypertension: Systolic BP >160 mm Hg or diastolic BP >100 mm Hg
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 |
|---|---|---|
| Group AAlso: Dual task training (Wall squats + cognitive training along with routine rehabilitationProgressive wall squat exercises will commence with a knee flexion angle of 135°, instructed to hold this position for 20 seconds, exercise progresses, the knee joint angle will be decreased by 10° until reaching the 95° stage or until participants can no longer maintain the knee joint angle within 5° of the target value due to volitional fatigue. Cognitive tasks during the intervention, including the recall of words and counting forward (1, 4, 7, 10...) and backward (...10, 7, 4, 1) by adding 3 to the digits. Sustained stretching (with a hold time of 10 seconds per stretch, totaling 10 repetitions per session) and active range of motion exercises (10 repetitions per session) targeting both the upper and lower extremities in routine rehabilitation. | Other | combining progressive wall squats with cognitive training |
| Group BAlso: single-task intervention (Wall squats) along with routine rehabilitationProgressive wall squat exercises will commence with a knee flexion angle of 135°, instructed to hold this position for 20 seconds, exercise progresses, the knee joint angle will be decreased by 10° until reaching the 95° stage or until participants can no longer maintain the knee joint angle within 5° of the target value due to volitional fatigue. Sustained stretching (with a hold time of 10 seconds per stretch, totaling 10 repetitions per session) and active range of motion exercises (10 repetitions per session) targeting both the upper and lower extremities in routine rehabilitation. | Other | progressive wall squats |
Primary outcome
MOCA (Montreal Cognitive Assessment)
Time frame: 8 weeks
A well-liked screening method for identifying the presence of cognitive impairment is the MoCA. It takes about ten minutes to finish. It assesses language, abstract reasoning, executive function, orientation, delayed recall, attention, and visuospatial skills. The MoCA is more sensitive and specific than the MMSE because it covers a wider range of domains.
Tinneti POMA (Balance, gait)
Time frame: 8 weeks
The Tinetti Scale is a tool for assessing gait and balance. The test is used clinically to evaluate changes in gait time and balance, as well as to ascertain a subject's current level of mobility. The two sub-scales that make up the total POMA (POMA-T) are the gait evaluation scale (also known as the POMA-G) and the balance evaluation scale (also known as the POMA-B). The maximum score is 28 points; specifically, the POMA-B has a maximum score of 16 and the POMA-G has a maximum score of 12.
Rivermead mobility index
Time frame: 8 weeks
RMI is a measure that evaluates a patient's degree of mobility .There are 14 questions on it, along with a section on observations. This index evaluates an individual's ability to do tasks like getting out of bed, sitting, maintaining balance, standing up, standing unassisted, moving around, walking indoors and outside, climbing and descending stairs, picking up objects off the floor, taking a shower, and running. Every activity receives one point, if at all possible. If the score is less than 14, it suggests that the person has mobility problems; if the score is 15, it means they don't have any problems at all
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 9 Apr 2025.
- Background: PubMed 32998921Morice E, Moncharmont J, Jenny C, Bruyneel AV. Dancing to improve balance control, cognitive-motor functions and quality of life after stroke: a study protocol for a randomised controlled trial. BMJ Open. 2020 Sep 30;10(9):e037039. doi: 10.1136/bmjopen-2020-037039.
- Background: PubMed 32568652Buvarp D, Rafsten L, Sunnerhagen KS. Predicting Longitudinal Progression in Functional Mobility After Stroke: A Prospective Cohort Study. Stroke. 2020 Jul;51(7):2179-2187. doi: 10.1161/STROKEAHA.120.029913. Epub 2020 Jun 17.
- Background: PubMed 35754258Lee Y, Kim K. The influence of Gait Training Combined with Portable Functional Electrical Stimulation on motor function, balance and gait ability in stroke patients. J Back Musculoskelet Rehabil. 2022;35(6):1171-1178. doi: 10.3233/BMR-210154.
- Background: PubMed 34722837Hurd MD, Goel I, Sakai Y, Teramura Y. Current status of ischemic stroke treatment: From thrombolysis to potential regenerative medicine. Regen Ther. 2021 Oct 12;18:408-417. doi: 10.1016/j.reth.2021.09.009. eCollection 2021 Dec.
- Background: PubMed 38672060Spano B, Lombardi MG, De Tollis M, Szczepanska MA, Ricci C, Manzo A, Giuli S, Polidori L, Griffini IA, Adriano F, Caltagirone C, Annicchiarico R. Correction: Spano et al. Effect of Dual-Task Motor-Cognitive Training in Preventing Falls in Vulnerable Elderly Cerebrovascular Patients: A Pilot Study. Brain Sci. 2022, 12, 168. Brain Sci. 2024 Apr 11;14(4):370. doi: 10.3390/brainsci14040370.
- Background: PubMed 33076218Kuriakose D, Xiao Z. Pathophysiology and Treatment of Stroke: Present Status and Future Perspectives. Int J Mol Sci. 2020 Oct 15;21(20):7609. doi: 10.3390/ijms21207609.
- 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.
Aruba Saeed, PhD principal investigator
Riphah International University Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group A and Group B in people with Stroke Ischemic, 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 6 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: finished, as of the sponsor's last update on 9 Apr 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?
MOCA (Montreal Cognitive Assessment) (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?
On the ClinicalTrials.gov record for NCT06845683, which also lists 6 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 9 Apr 2025.