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

Primary Purpose

Stroke, Middle Cerebral Artery Stroke, Chronic Stroke

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Dual-task Training Fixed Priority
Dual-task Training Variable Priority
Sponsored by
King Saud University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Stroke, Gait velocity, Stride length, Step length, Balance training, Dual task, Institutional priority sets

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rehabilitation Research Chair

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dual-task Training Fixed Priority

Dual-task Training Variable Priority

Arm Description

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 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
November 19, 2018
Last Updated
November 21, 2018
Sponsor
King Saud University
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1. Study Identification

Unique Protocol Identification Number
NCT03752788
Brief Title
Dual-Task Training With Different Priority Instructional Sets on the Gait Parameters in Patients With Chronic Stroke
Official Title
Dual-Task Training With Variable Priority Instructional Sets Improve the Gait Parameters in Patients With Chronic Stroke
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
May 15, 2017 (Actual)
Primary Completion Date
November 1, 2017 (Actual)
Study Completion Date
April 23, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Saud University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Middle Cerebral Artery Stroke, Chronic Stroke
Keywords
Stroke, Gait velocity, Stride length, Step length, Balance training, Dual task, Institutional priority sets

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dual-task Training Fixed Priority
Arm Type
Experimental
Arm Description
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.
Arm Title
Dual-task Training Variable Priority
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Dual-task Training Fixed Priority
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Dual-task Training Variable Priority
Intervention Description
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 Measure Information:
Title
10-meter walk test
Description
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.
Time Frame
Change from Baseline 10-meter Walk Test scores at 4-Weeks
Secondary Outcome Measure Information:
Title
Mini-mental state examination (MMSE) or Folstein test
Description
It is used to to determine any impaired cognition that would affect the ability of the participant with stroke to follow instructions.
Time Frame
Before the study intervention
Title
Timed Up & Go (TUG) test
Description
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.
Time Frame
Before the study intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AMIR IQBAL, MPT
Organizational Affiliation
Rehabilitation Research Chair
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rehabilitation Research Chair
City
Riyadh
ZIP/Postal Code
11433
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Undecided

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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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