NCT03752788

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started May 2017

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 23, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 26, 2018

Completed
Last Updated

November 26, 2018

Status Verified

November 1, 2018

Enrollment Period

6 months

First QC Date

November 19, 2018

Last Update Submit

November 21, 2018

Conditions

Keywords

StrokeGait velocityStride lengthStep lengthBalance trainingDual taskInstitutional priority sets

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Mini-mental state examination (MMSE) or Folstein test

    Before the study intervention

  • Timed Up & Go (TUG) test

    Before the study intervention

Study Arms (2)

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.

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.

Behavioral: Dual-task Training Variable Priority

Interventions

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 Fixed 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.

Dual-task Training Variable Priority

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rehabilitation Research Chair

Riyadh, 11433, Saudi Arabia

Location

MeSH Terms

Conditions

StrokeInfarction, Middle Cerebral Artery

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesCerebral InfarctionBrain InfarctionBrain IschemiaCerebral Arterial DiseasesIntracranial Arterial DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • AMIR IQBAL, MPT

    Rehabilitation Research Chair

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 19, 2018

First Posted

November 26, 2018

Study Start

May 15, 2017

Primary Completion

November 1, 2017

Study Completion

April 23, 2018

Last Updated

November 26, 2018

Record last verified: 2018-11

Locations