NCT05334498

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2021

Shorter than P25 for not_applicable

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

August 1, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 19, 2022

Completed
Last Updated

April 19, 2022

Status Verified

April 1, 2022

Enrollment Period

4 months

First QC Date

February 20, 2022

Last Update Submit

April 15, 2022

Conditions

Keywords

Motor and cognitive dual task gait training

Outcome Measures

Primary Outcomes (4)

  • 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

    4th week

  • 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.

    4th week

  • 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

    4th week

  • 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

    4th week

Study Arms (2)

Motor dual-task gait training

EXPERIMENTAL

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

Other: Motor dual-task gait training

Cognitive dual-task gait training

EXPERIMENTAL

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

Other: Cognitive dual-task gait training

Interventions

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

Motor dual-task gait training

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

Cognitive dual-task gait training

Eligibility Criteria

Age12 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Both genders having IQ range between 50-69
  • Walk without assistive devices
  • Having a Grade I-IV on the RLACFS

You may not qualify if:

  • Genetic disorders (Down syndrome).
  • Age-related diseases like Parkinsonism and Alzheimer disease.
  • Cerebrovascular accident, dementia, Cerebral palsy
  • Severe visual impairment.
  • Medications (sedatives or narcotics)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

District headquarter hospital

Mirpur, Azad Jammu Kashmir, 10250, Pakistan

Location

MeSH Terms

Conditions

Intellectual Disability

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Study Officials

  • Sara Aabroo, MSPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2022

First Posted

April 19, 2022

Study Start

August 1, 2021

Primary Completion

November 30, 2021

Study Completion

January 1, 2022

Last Updated

April 19, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations