- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03752788
Dual-Task Training With Different Priority Instructional Sets on the Gait Parameters in Patients With Chronic Stroke
Dual-Task Training With Variable Priority Instructional Sets Improve the Gait Parameters in Patients With Chronic Stroke
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Riyadh, Saudi Arabia, 11433
- Rehabilitation Research Chair
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- A diagnosed case of middle cerebral artery chronic stroke made by a neurologist and verified using CT/MRI
- Exhibited the age between 45 and 65 years
- Ability to walk 10 meters without assistance
- Their stroke onset within 12 months prior to the study and
- Scored greater than 24 on Mini-Mental State Examination (MMSE).
Exclusion Criteria:
- Participants had neurological conditions other than stroke
- Uncontrolled hearing or visual and vestibular impairment
- Took more than 15 seconds on Timed Up & Go (TUG) test
- Had lower extremity amputation
- A case of diagnosed speech-language impairment (not able to respond verbally to auditory stimuli) by a speech-language pathologist and noticed their concurrent participation in another clinical trial
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dual-task Training Fixed Priority
Dual-task Training with fixed priority instructional set for four weeks. Balance training sessions of 45 minutes per day, 3 times a week for four weeks, so as to complete 9-12 hours of training warm-up improve the balance performance. This included 12 repetitions in each session for 30 minutes after a 10-minutes warm up. Attention was focused on both postural and cognitive tasks throughout this session. In postural tasks, subjects were instructed to perform the following: walk narrow base of support with a cognitive task of counting backward by three walk narrow base of support with cognitive task of count forward by three, walk narrow base of support, step, sideways, backward avoiding the obstacles (holding a basket) with cognitive task to remember words. |
Dual-task training fixed priority instructional set for four weeks. Balance training sessions of 45 minutes per day, 3 times a week for four weeks, so as to complete 9-12 hours of training warm-up improve the balance performance. This included 12 repetitions in each session for 30 minutes after a 10-minutes warm up. Attention was focused on both postural and cognitive tasks throughout this session. In postural tasks, subjects were instructed to perform the following: walk narrow base of support with a cognitive task of counting backward by three walk narrow base of support with cognitive task of count forward by three, walk narrow base of support, step, sideways, backward avoiding the obstacles (holding a basket) with cognitive task to remember words. |
Active Comparator: Dual-task Training Variable Priority
Dual-task Training with variable priority instructional set for four weeks. Balance training sessions of 45 minutes per day, 3 times a week for four weeks, so as to complete 9-12 hours of training warm-up improve the balance performance. This included 12 repetitions in each session for 30 minutes after a 10-minutes warm up. During the first half of the training session, attention was focused on postural tasks, while during the remaining half of the session, attention was focused on cognitive tasks. |
Dual-task training variable priority instructional set for four weeks. Balance training sessions of 45 minutes per day, 3 times a week for four weeks, so as to complete 9-12 hours of training warm-up improve the balance performance. This included 12 repetitions in each session for 30 minutes after a 10-minutes warm up. During the first half of the training session, attention was focused on postural tasks, while during the remaining half of the session, attention was focused on cognitive tasks. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
10-meter walk test
Time Frame: Change from Baseline 10-meter Walk Test scores at 4-Weeks
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It is used to evaluate gate parameters such as gait velocity (self-selected velocity and fast velocity, step length and stride length ) in patients with chronic stroke.
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Change from Baseline 10-meter Walk Test scores at 4-Weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mini-mental state examination (MMSE) or Folstein test
Time Frame: Before the study intervention
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It is used to to determine any impaired cognition that would affect the ability of the participant with stroke to follow instructions.
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Before the study intervention
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Timed Up & Go (TUG) test
Time Frame: Before the study intervention
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It is used to identify the patient's mobility with respect to healthy elderly subjects, such as the gait parameters and walking endurance in subjects with chronic stroke.The TUG score correlates with gait speed, balance, functional level, ability to go out, and this score can change over time.
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Before the study intervention
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: AMIR IQBAL, MPT, Rehabilitation Research Chair
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
Keywords
Additional Relevant MeSH Terms
- Ischemia
- Pathologic Processes
- Necrosis
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Brain Ischemia
- Infarction
- Brain Infarction
- Cerebral Arterial Diseases
- Intracranial Arterial Diseases
- Cerebral Infarction
- Stroke
- Infarction, Middle Cerebral Artery
Other Study ID Numbers
- RRC-2017-005
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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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