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Dual-Task Training With Different Priority Instructional Sets on the Gait Parameters in Patients With Chronic Stroke

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ClinicalTrials.gov Identifier: NCT03752788
Recruitment Status : Completed
First Posted : November 26, 2018
Last Update Posted : November 26, 2018
Sponsor:
Information provided by (Responsible Party):
AMIR IQBAL, King Saud University

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Stroke Middle Cerebral Artery Stroke Chronic Stroke Behavioral: Dual-task Training Fixed Priority Behavioral: Dual-task Training Variable Priority Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dual-Task Training With Variable Priority Instructional Sets Improve the Gait Parameters in Patients With Chronic Stroke
Actual Study Start Date : May 15, 2017
Actual Primary Completion Date : November 1, 2017
Actual Study Completion Date : April 23, 2018

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.

Behavioral: Dual-task Training Fixed Priority

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.

Behavioral: Dual-task Training Variable Priority

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.





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Mini-mental state examination (MMSE) or Folstein test [ Time Frame: Before the study intervention ]
    It is used to to determine any impaired cognition that would affect the ability of the participant with stroke to follow instructions.

  2. Timed Up & Go (TUG) test [ Time Frame: Before the study intervention ]
    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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Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03752788


Locations
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Saudi Arabia
Rehabilitation Research Chair
Riyadh, Saudi Arabia, 11433
Sponsors and Collaborators
King Saud University
Investigators
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Principal Investigator: AMIR IQBAL, MPT Rehabilitation Research Chair

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Responsible Party: AMIR IQBAL, Principal Investigator, King Saud University
ClinicalTrials.gov Identifier: NCT03752788     History of Changes
Other Study ID Numbers: RRC-2017-005
First Posted: November 26, 2018    Key Record Dates
Last Update Posted: November 26, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by AMIR IQBAL, King Saud University:
Stroke
Gait velocity
Stride length
Step length
Balance training
Dual task
Institutional priority sets

Additional relevant MeSH terms:
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Stroke
Infarction, Middle Cerebral Artery
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Cerebral Infarction
Brain Infarction
Brain Ischemia
Cerebral Arterial Diseases
Intracranial Arterial Diseases