Intellectual DisabilityNCT05334498
Motor and Cognitive Dual-task Gait Training Effect Functional Outcome in Intellectual Disability
A study testing Motor dual-task gait training and Cognitive dual-task gait training in people with Intellectual Disability, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 20 years
- Conditions the study is for
- Intellectual Disability
- What is being tested?
- Motor dual-task gait training and Cognitive dual-task gait training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Aug 2021to 1 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Both genders having IQ range between 50-69
- Walk without assistive devices
- Having a Grade I-IV on the RLACFS
Who cannot join
- Genetic disorders (Down syndrome).
- Age-related diseases like Parkinsonism and Alzheimer disease.
- Cerebrovascular accident, dementia, Cerebral palsy
- Severe visual impairment.
- Medications (sedatives or narcotics)
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
District headquarter hospital
Mirpur, Azad Jammu Kashmir, 10250
About this study
Official title: 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.
Read the 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.
- Conditions
- Intellectual Disability
- Being tested
- Motor dual-task gait training, Cognitive dual-task gait training
- Keywords
- Motor and cognitive dual task gait training
- Medical subject headings
- Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motor dual-task gait trainingOther
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
Cognitive dual-task gait trainingOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Cognitive dual-task gait training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
Measured: 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
Measured: 4th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start1 Aug 2021
- Primary completion30 Nov 2021
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intellectual DisabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sara Aabroo, MSPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05334498
- Sponsor's protocol ID
- Riphah Maria Asghar /21923
- Status last verified
- Apr 2022
- First submitted
- 20 Feb 2022
- Last updated
- 19 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effects of Motor and Cognitive Dual-task Gait Training on Balance and Mobility in Persons With Intellectual Disabilities
- ClinicalTrials.gov ID
- NCT05334498
- Acronym / sponsor ID
- Riphah Maria Asghar /21923
- Conditions
- Intellectual Disability
- Keywords
- Motor and cognitive dual task gait training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 19 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motor dual-task gait training | Experimental | Other: Motor dual-task gait trainingMotor 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 | Experimental | Other: Cognitive dual-task gait trainingCognitive dual task gait training was the protocol which performed by the patients after the measurement of the balance and gait ability |
Who may qualify
- Ages
- 12 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Both genders having IQ range between 50-69
- Walk without assistive devices
- Having a Grade I-IV on the RLACFS
Key exclusion criteria (5 listed)
- Genetic disorders (Down syndrome).
- Age-related diseases like Parkinsonism and Alzheimer disease.
- Cerebrovascular accident, dementia, Cerebral palsy
- Severe visual impairment.
- Medications (sedatives or narcotics)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motor dual-task gait trainingPatients 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 | Other | Motor dual-task gait training |
| Cognitive dual-task gait trainingPatients 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 | Other | Cognitive dual-task gait training |
Primary outcome
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
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.
Walking while talking test
Time frame: 4th week
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Aabroo, MSPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motor dual-task gait training and Cognitive dual-task gait training in people with Intellectual Disability, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rancho Los Amigos Cognitive functional scales (time frame: 4th week). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2022; AzTrials last refreshed its copy on 26 Oct 2026.