StrokeNCT03752788
Dual-Task Training With Different Priority Instructional Sets on the Gait Parameters in Patients With Chronic Stroke
A study testing Dual-task Training Fixed Priority and Dual-task Training Variable Priority in people with Stroke and Middle Cerebral Artery Stroke, run by King Saud University at 1 site in Saudi Arabia.
Trial summary
Balance is controlled through a complex process involving sensory, visual, vestibular and cerebral functioning which get affected by various neurological disorders such as in stroke. Different types of exercises are designed to target to cope up with the imbalance developed due to these neurological disorders. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Stroke, Middle Cerebral Artery Stroke, Chronic Stroke
- What is being tested?
- Dual-task Training Fixed Priority and Dual-task Training Variable Priority
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 15 May 2017to 23 Apr 2018
- 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
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dual-Task Training With Variable Priority Instructional Sets Improve the Gait Parameters in Patients With Chronic Stroke
Balance is controlled through a complex process involving sensory, visual, vestibular and cerebral functioning which get affected by various neurological disorders such as in stroke. Different types of exercises are designed to target to cope up with the imbalance developed due to these neurological disorders. This study aimed to compare the efficacy of dual-task training using two different priority instructional sets in improving gait parameters such as self-selected velocity, fast speed, step length, and stride length in chronic stroke patients.
Read the detailed description
Balance is controlled through a complex process involving sensory, visual, vestibular and cerebral functioning which get affected by various neurological disorders such as in stroke. Different types of exercises are designed to target to cope up with the imbalance developed due to these neurological disorders. This study aimed to compare the efficacy of dual-task training using two different priority instructional sets in improving gait parameters such as self-selected velocity, fast speed, step length, and stride length in middle cerebral artery chronic stroke patients. A total of thirty middle cerebral artery chronic stroke patients were recruited on the basis of inclusion and exclusion criteria and equally allocated into two groups. Group 1 received dual-task training with fixed priority instructional sets for four weeks and group 2 received dual-task training with variable priority instructional sets for four weeks. The outcome was assessed using a 10-meter walk test and the comparison of footprints on the walkway paper before and after training.
- Conditions
- Stroke, Middle Cerebral Artery Stroke, Chronic Stroke
- Being tested
- Dual-task Training Fixed Priority, Dual-task Training Variable Priority
- Keywords
- Stroke, Gait velocity, Stride length, Step length, Balance training, Dual task, Institutional priority sets
- Medical subject headings
- Stroke, Infarction, Middle Cerebral Artery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual-task Training Fixed PriorityBehavioural
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.
Dual-task Training Variable PriorityBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Dual-task Training Fixed Priority | Experimental | 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. Receives: Behavioral: Dual-task Training Fixed Priority |
| Dual-task Training Variable Priority | Active comparator | 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. Receives: Behavioral: Dual-task Training Variable Priority |
What is being measured
The primary outcome is the main question the study is designed to answer.
10-meter walk test
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.
Measured: Change from Baseline 10-meter Walk Test scores at 4-Weeks
Secondary outcomes (2)
Mini-mental state examination (MMSE) or Folstein test
It is used to to determine any impaired cognition that would affect the ability of the participant with stroke to follow instructions.
Measured: Before the study intervention
Timed Up & Go (TUG) test
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.
Measured: Before the study intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2018
- Study start15 May 2017
- Primary completion1 Nov 2017
- Study completion23 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Saud University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AMIR IQBAL, King Saud University
- Investigators
- AMIR IQBAL, MPT, Principal investigator, Rehabilitation Research Chair
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03752788
- Sponsor's protocol ID
- RRC-2017-005
- Status last verified
- Nov 2018
- First submitted
- 19 Nov 2018
- Last updated
- 26 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual-Task Training With Variable Priority Instructional Sets Improve the Gait Parameters in Patients With Chronic Stroke
- ClinicalTrials.gov ID
- NCT03752788
- Acronym / sponsor ID
- RRC-2017-005
- Conditions
- Stroke, Middle Cerebral Artery Stroke, Chronic Stroke
- Keywords
- Stroke, Gait velocity, Stride length, Step length, Balance training, Dual task, Institutional priority sets
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- King Saud UniversityUniversity, hospital or other
- Study start
- 15 May 2017 (actual)
- Primary completion
- 1 Nov 2017 (actual)
- Study completion
- 23 Apr 2018 (actual)
- First posted
- 26 Nov 2018 (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.
Balance is controlled through a complex process involving sensory, visual, vestibular and cerebral functioning which get affected by various neurological disorders such as in stroke. Different types of exercises are designed to target to cope up with the imbalance developed due to these neurological disorders. This study aimed to compare the efficacy of dual-task training using two different priority instructional sets in improving gait parameters such as self-selected velocity, fast speed, step length, and stride length in chronic stroke patients.
Detailed description
Balance is controlled through a complex process involving sensory, visual, vestibular and cerebral functioning which get affected by various neurological disorders such as in stroke. Different types of exercises are designed to target to cope up with the imbalance developed due to these neurological disorders. This study aimed to compare the efficacy of dual-task training using two different priority instructional sets in improving gait parameters such as self-selected velocity, fast speed, step length, and stride length in middle cerebral artery chronic stroke patients. A total of thirty middle cerebral artery chronic stroke patients were recruited on the basis of inclusion and exclusion criteria and equally allocated into two groups. Group 1 received dual-task training with fixed priority instructional sets for four weeks and group 2 received dual-task training with variable priority instructional sets for four weeks. The outcome was assessed using a 10-meter walk test and the comparison of footprints on the walkway paper before and after training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dual-task Training Fixed Priority | Experimental | Behavioral: Dual-task Training Fixed PriorityDual-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 Variable Priority | Active comparator | Behavioral: Dual-task Training Variable PriorityDual-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. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Dual-task Training Fixed PriorityDual-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. | Behavioural | Dual-task Training Fixed Priority |
| Dual-task Training Variable PriorityDual-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. | Behavioural | Dual-task Training Variable Priority |
Primary outcome
10-meter walk test
Time frame: Change from Baseline 10-meter Walk Test scores at 4-Weeks
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.
2 secondary outcomes
Mini-mental state examination (MMSE) or Folstein test
Time frame: Before the study intervention
Timed Up & Go (TUG) test
Time frame: Before the study intervention
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 26 Nov 2018.
- Individual participant dataSharing planned: Undecided. Undecided
Related trials for Stroke
RecruitingPhase 1/2
Safety and Efficacy of CG-BM1 in Ischemic Stroke
Ischemic Stroke or High-risk TIA (ABCD² ≥ 4)
Not yet recruitingPhase 3
Recombinant Human Prourokinase for Acute Ischemic Stroke in the Extended Window Selected by CT-Based Artificial Intelligence
Acute Ischemic Stroke
Recruiting
Effects of Mirror Therapy and Motor Imagery on Upper Limb Motor Functions in Middle Cerebral Artery Stroke
Stroke
Recruiting
Rapid Local Ischemic Postconditioning on Stroke After Thrombectomy
Acute Ischemic Stroke
Not yet recruitingObservational study
The GEIR Registry: Rationale and Design of the First Nationwide Multicentre Retinal Stroke Registry in Spain
Retinal Artery Occlusion
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.
AMIR IQBAL, MPT principal investigator
Rehabilitation Research Chair
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual-task Training Fixed Priority and Dual-task Training Variable Priority in people with Stroke and Middle Cerebral Artery Stroke, run by King Saud University at 1 site in Saudi Arabia.
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 5 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: finished, as of the sponsor's last update on 26 Nov 2018. 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 Saudi Arabia. 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?
10-meter walk test (time frame: Change from Baseline 10-meter Walk Test scores at 4-Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Nov 2018.