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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03752788
Other study ID # RRC-2017-005
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 15, 2017
Est. completion date April 23, 2018

Study information

Verified date November 2018
Source King Saud University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date April 23, 2018
Est. primary completion date November 1, 2017
Accepts healthy volunteers No
Gender All
Age group 45 Years to 65 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Saudi Arabia Rehabilitation Research Chair Riyadh

Sponsors (1)

Lead Sponsor Collaborator
King Saud University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Change from Baseline 10-meter Walk Test scores at 4-Weeks
Secondary 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. Before the study intervention
Secondary 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. Before the study intervention
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