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Motor and Cognitive Dual-task Gait Training Effect Functional Outcome in Intellectual Disability

Primary Purpose

Intellectual Disability

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Motor dual-task gait training
Cognitive dual-task gait training
Sponsored by
Riphah International University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intellectual Disability focused on measuring Motor and cognitive dual task gait training

Eligibility Criteria

12 Years - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • District headquarter hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Motor dual-task gait training

Cognitive dual-task gait training

Arm Description

Motor dual task gait training was the protocol which performed by the patients after the measurement of the balance and gait ability

Cognitive dual task gait training was the protocol which performed by the patients after the measurement of the balance and gait ability

Outcomes

Primary Outcome Measures

Rancho Los Amigos Cognitive functional scales
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
Berg Balance Scale
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.
Walking while talking test
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
Stair climb test
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

Secondary Outcome Measures

Full Information

First Posted
February 20, 2022
Last Updated
April 15, 2022
Sponsor
Riphah International University
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1. Study Identification

Unique Protocol Identification Number
NCT05334498
Brief Title
Motor and Cognitive Dual-task Gait Training Effect Functional Outcome in Intellectual Disability
Official Title
Comparative Effects of Motor and Cognitive Dual-task Gait Training on Balance and Mobility in Persons With Intellectual Disabilities
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
November 30, 2021 (Actual)
Study Completion Date
January 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Riphah International University

4. Oversight

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

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intellectual Disability
Keywords
Motor and cognitive dual task gait training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Motor dual-task gait training
Arm Type
Experimental
Arm Description
Motor dual task gait training was the protocol which performed by the patients after the measurement of the balance and gait ability
Arm Title
Cognitive dual-task gait training
Arm Type
Experimental
Arm Description
Cognitive dual task gait training was the protocol which performed by the patients after the measurement of the balance and gait ability
Intervention Type
Other
Intervention Name(s)
Motor dual-task gait training
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Cognitive dual-task gait training
Intervention Description
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
Primary Outcome Measure Information:
Title
Rancho Los Amigos Cognitive functional scales
Description
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
Time Frame
4th week
Title
Berg Balance Scale
Description
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.
Time Frame
4th week
Title
Walking while talking test
Description
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
Time Frame
4th week
Title
Stair climb test
Description
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
Time Frame
4th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sara Aabroo, MSPT
Organizational Affiliation
Riphah International University
Official's Role
Principal Investigator
Facility Information:
Facility Name
District headquarter hospital
City
Mirpur
State/Province
Azad Jammu Kashmir
ZIP/Postal Code
10250
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

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Motor and Cognitive Dual-task Gait Training Effect Functional Outcome in Intellectual Disability

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