- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05334498
Motor and Cognitive Dual-task Gait Training Effect Functional Outcome in Intellectual Disability
April 15, 2022 updated by: Riphah International University
Comparative Effects of Motor and Cognitive Dual-task Gait Training on Balance and Mobility in Persons With Intellectual Disabilities
To find out the comparative effects of motor and cognitive dual gait training on improving the balance control and mobility skills among intellectual disable patients.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Previous studies had done a lot of work in improving balance and mobility skills by combining both motor and cognitive dual gait training (CDT and MDT) techniques among Down syndrome, Parkinsonism and so on but not a single study was conducted in order to determine the comparative effects of CDT and MDT especially in intellectual disability individuals to improve balance so the study was conducted in order to find the comparative effect for the better understanding of the treatment effects.
Study Type
Interventional
Enrollment (Actual)
54
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Azad Jammu Kashmir
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Mirpur, Azad Jammu Kashmir, Pakistan, 10250
- District headquarter hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 20 years (ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Both genders having IQ range between 50-69
- Walk without assistive devices
- Having a Grade I-IV on the RLACFS
Exclusion Criteria:
- Genetic disorders (Down syndrome).
- Age-related diseases like Parkinsonism and Alzheimer disease.
- Cerebrovascular accident, dementia, Cerebral palsy
- Severe visual impairment.
- Medications (sedatives or narcotics)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Motor dual-task gait training
Motor dual task gait training was the protocol which performed by the patients after the measurement of the balance and gait ability
|
Patients were instructed to walk either on treadmill or on the land.
During walk; patients were instructed to perform five tasks.
The patients performed tossing and catching the ball, rehanging loops on hoops, buttoning and unbuttoning the shirts, holding the cup in water without the spilling and receiving with returning the water.
Each activity were performed for three minute and 15 minutes were provided for performing all the tasks
|
|
EXPERIMENTAL: Cognitive dual-task gait training
Cognitive dual task gait training was the protocol which performed by the patients after the measurement of the balance and gait ability
|
Patients were instructed to walk either on treadmill or on the land.
During walk; patients were instructed to perform five tasks.
The patients performed sharp coloring, subtraction, counting, verbal analogical reasoning and backward spelling.
Each activity were performed for three minute and 15 minutes were provided for performing all the tasks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rancho Los Amigos Cognitive functional scales
Time Frame: 4th week
|
Ranchos Los Amigos Scale is the reliable tool for assessing the cognitive function of the patient as the scale score form grade 1 to 8 with ten level descriptive scale where grade 1 have zero response while grade 8 shows the activate participation of the patient with cut off value for 5.
It is the most reliable and valid assessment tool
|
4th week
|
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Berg Balance Scale
Time Frame: 4th week
|
Berg Balance Scale is the most reliable tool used for the assessment of balance performance among patients having balance problems and disease causing balance issues.
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4th week
|
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Walking while talking test
Time Frame: 4th week
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Walking while talking is the time measuring tool for assessing the risk of fall and gait performance in the intellectual disable patients as in this test the patient asked to narrate repeated words during walking for 20 feet having ICC= 0.89-0.99
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4th week
|
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Stair climb test
Time Frame: 4th week
|
Stair climbing test is the valid tool for assessing the velocity and level of mobility within the time as the patient asked to climb up and down the stairs and therapist record the number of the steps which are taken within the time period having MIC of -0.6 with 95% confidence interval
|
4th week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sara Aabroo, MSPT, Riphah International University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
August 1, 2021
Primary Completion (ACTUAL)
November 30, 2021
Study Completion (ACTUAL)
January 1, 2022
Study Registration Dates
First Submitted
February 20, 2022
First Submitted That Met QC Criteria
April 15, 2022
First Posted (ACTUAL)
April 19, 2022
Study Record Updates
Last Update Posted (ACTUAL)
April 19, 2022
Last Update Submitted That Met QC Criteria
April 15, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Riphah Maria Asghar /21923
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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