- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07764250
Comparative Evaluation of Immediate vs Progressive Standing Dual Task Training in Elderly With Mild and Moderate Cognitive Impairment
Immediate Versus Progressive-Standing Dual-Task Training: A Comparative Evaluation in Elderly With Mild and Moderate Cognitive Impairment
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Capital
-
Islamabad, Capital, Pakistan
- Recruiting
- Pakistan Institute of Medical Sciences
-
Contact:
- Dr. Mansoor Iqbal, MBBS, FCPS Neurology
- Phone Number: +923335547069
- Email: drmansooriqbalch@gmail.com
-
Principal Investigator:
- Erica Arthur, DPT
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age ≥55 years
- Mild or moderate cognitive impairment
- MoCA 10-25
- MMSE 10-23
- Able to participate
- Provides informed consent
Exclusion Criteria:
- Severe cognitive impairment
- Severe sensory or musculoskeletal impairments
- Unstable medical conditions
- Participation in another intervention study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Immediate Standing Dual-Task Training (Mild Cognitive Impairment)
|
Motor-cognitive dual-task training is a rehabilitation intervention delivered by a physiotherapist over 8 weeks, with three sessions per week, each lasting 45 minutes. Every session consists of a 5-minute warm-up, 30-35 minutes of dual-task training, and a 5-minute cool-down. It simultaneously combines motor and cognitive tasks. Motor components include marching in place, finger tapping, hand transfer activities, side stepping, weight shifting, heel raises, heel-toe stepping, and balance challenges. Cognitive components include naming animals or fruits, counting forward, and months, serial subtraction by threes, backward digit span, alternate naming, and word recall. Participants allocated to the Immediate Standing intervention perform all dual-task activities in standing from the first treatment session.
Other Names:
|
|
Experimental: Progressive Standing Dual-Task Training (Mild Cognitive Impairment)
|
Motor-cognitive dual-task training is a rehabilitation intervention delivered by a physiotherapist over 8 weeks, with three sessions per week, each lasting 45 minutes. Every session consists of a 5-minute warm-up, 30-35 minutes of dual-task training, and a 5-minute cool-down. It simultaneously combines motor and cognitive tasks. Motor components include marching in place, finger tapping, hand transfer activities, side stepping, weight shifting, heel raises, heel-toe stepping, and balance challenges. Cognitive components include naming animals or fruits, counting forward, and months, serial subtraction by threes, backward digit span, alternate naming, and word recall. Participants allocated to the Progressive Standing intervention initially perform dual-task activities sitting and progressively transition to standing during the intervention period. |
|
Experimental: Immediate Standing Dual-Task Training (Moderate Cognitive Impairment)
|
Motor-cognitive dual-task training is a rehabilitation intervention delivered by a physiotherapist over 8 weeks, with three sessions per week, each lasting 45 minutes. Every session consists of a 5-minute warm-up, 30-35 minutes of dual-task training, and a 5-minute cool-down. It simultaneously combines motor and cognitive tasks. Motor components include marching in place, finger tapping, hand transfer activities, side stepping, weight shifting, heel raises, heel-toe stepping, and balance challenges. Cognitive components include naming animals or fruits, counting forward, and months, serial subtraction by threes, backward digit span, alternate naming, and word recall. Participants allocated to the Immediate Standing intervention perform all dual-task activities in standing from the first treatment session.
Other Names:
|
|
Experimental: Progressive Standing Dual-Task Training (Moderate Cognitive Impairment)
|
Motor-cognitive dual-task training is a rehabilitation intervention delivered by a physiotherapist over 8 weeks, with three sessions per week, each lasting 45 minutes. Every session consists of a 5-minute warm-up, 30-35 minutes of dual-task training, and a 5-minute cool-down. It simultaneously combines motor and cognitive tasks. Motor components include marching in place, finger tapping, hand transfer activities, side stepping, weight shifting, heel raises, heel-toe stepping, and balance challenges. Cognitive components include naming animals or fruits, counting forward, and months, serial subtraction by threes, backward digit span, alternate naming, and word recall. Participants allocated to the Progressive Standing intervention initially perform dual-task activities sitting and progressively transition to standing during the intervention period. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mini-Mental State Examination
Time Frame: Baseline and Week 8
|
The Mini-Mental State Examination (MMSE) is a 30-point measure of global cognitive function.
Scores range from 0 to 30, with higher scores indicating better cognitive function
|
Baseline and Week 8
|
|
Berg Balance Scale
Time Frame: Baseline and Week 8
|
The Berg Balance Scale (BBS) is a 14-item clinical measure of static and dynamic balance.
Total scores range from 0 to 56, with higher scores indicating better balance performance.
|
Baseline and Week 8
|
|
Timed Up and Go
Time Frame: Baseline and Week 8
|
The Timed Up and Go Test measures functional mobility.
The outcome is the time (seconds) required to stand from a chair, walk 3 meters, turn, return, and sit.
Lower completion times indicate better mobility.
|
Baseline and Week 8
|
|
Trail Making Test
Time Frame: Baseline and Week 8
|
The Trail Making Test Part assesses executive function and cognitive flexibility.
The outcome is the time (seconds) required to complete the test.
Lower completion times indicate better executive function.
|
Baseline and Week 8
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of Life in Alzhiemer's Disease Scale
Time Frame: Baseline and Week 8
|
The Quality of Life in Alzheimer's Disease (QoL-AD) questionnaire consists of 13 items, with total scores ranging from 13 to 52.
Higher scores indicate better quality of life.
|
Baseline and Week 8
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 099-26
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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