- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06845683
Effects of Dual-Task and Progressive Wall Squat Training in Stroke Survivors
Effects of Dual-Task and Progressive Wall Squat Training on Cognition, Balance and Functional Mobility in Stroke Survivors
Study Overview
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab
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Lahore, Punjab, Pakistan, 54840
- Society Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: combining progressive wall squats with cognitive training
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.
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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.
Other Names:
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Active Comparator: progressive wall squats
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.
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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MOCA (Montreal Cognitive Assessment)
Time Frame: 8 weeks
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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.
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8 weeks
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Tinneti POMA (Balance, gait)
Time Frame: 8 weeks
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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.
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8 weeks
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Rivermead mobility index
Time Frame: 8 weeks
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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
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8 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Aruba Saeed, PhD, Riphah International University Pakistan
Publications and helpful links
General Publications
- Kuriakose 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.
- 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.
- Buvarp 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.
- Lee 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.
- Hurd 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.
- Spano 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/24/0211 Barira Shahid
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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