- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06927492
Cognitive Sensorimotor Training With Whole Body Vibration for Cognitive Impairment
December 8, 2025 updated by: Riphah International University
Effects of Cognitive Sensorimotor Training With Whole Body Vibration on Cognition and Balance in Older Adults With Cognitive Impairment
Aging is associated with cognitive decline, ranging from normal to mild cognitive impairment or dementia.
This leads to physical and cognitive impairment, which are risk factors for loss of autonomy therefore physical and cognitive training are important for cognitively impaired older adults.
Cognitive somatosensory exercise (CSE) is a special comprehensive rehabilitation program for retraining sensory-induced motor control, and whole-body vibration (WBV), which enhances neuromuscular function, cognition, and balance.
This study aims to investigate the effects of combined cognitive sensory-motor training with whole-body vibration on cognition and balance in older adults with mild to moderate cognitive impairment.
Study Overview
Status
Completed
Conditions
Detailed Description
A double-blinded randomized control trial will be conducted for ten months.
The sample size was calculated through G-power and 50 participants will be recruited through the non-probability convenience sampling technique.
Those who meet the inclusion criteria will be randomized into two groups (25 in the experimental group and 25 in the control group) through the online randomizer tool.
The experimental group will receive cognitive sensorimotor training along with whole-body vibration.
The control group will receive the cognitive sensorimotor training and Motor-cognitive dual-task training (mCdtt) simultaneously.
Participants of each group will receive 60 minutes of training 3 times per week for 12 weeks.
Outcome measures include the Montreal Cognitive Assessment (MoCA), the Stroop test will be used for the measurement of cognition and cognitive flexibility, the Mini bESTest for static and dynamic balance, and the Short physical performance battery for functional mobility.
Assessment will be done at baseline, after the 6th week, 12th week, and at 16th week.
Data analysis will be performed by using SPSS 26 software.
Mixed ANOVA and repeated-measures ANOVA will be used for within-group analysis whereas between-group analysis will be performed by using one-way ANOVA.
Study Type
Interventional
Enrollment (Actual)
50
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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Lahore, Pakistan, 54660
- Pakistan Society for the Rehabilitation of the Disabled (PSRD)
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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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
Participants fulfilling given criteria will be included in this study
- Both male and female participants will be included
- The age limit for the participants will be 60 to 75
- Participants with mild to moderate cognitive impairment having a Montreal Cognitive Assessment (MoCA) score of 13-25 (out of 30)
- Participants with mild to moderate balance impairment having Mini BESTest cut-off score 13-28
Exclusion Criteria:
Participants having given criteria will be excluded from this study
- Participants having major depressive and anxiety disorder
- Participants having significant visual and auditory impairment
- Participants having a prior history of neurological disease or brain injury, and psychiatric disorders
- Participants having cerebrovascular infarction
- Participants having a neurological condition (epilepsy, loss of consciousness leading to a fall (e.g. vertigo syndrome)
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 Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: A: Cognitive Sensorimotor training along with whole body vibration
This group will receive sensorimotor training with cognitive dual-task training in addition to whole body vibration.
The participants will perform 36 sessions (3 times per week on alternate days over 12 weeks).
The duration of one session for each group will be 60 minutes,
|
This group will receive sensorimotor training with cognitive dual-task training in addition to whole body vibration.
The participants will perform 36 sessions (3 times per week on alternate days over 12 weeks).
The duration of one session for each group will be 60 minutes, The whole-body vibration will be administered using a vibration machine.
This includes asking the patient to stand barefoot on the vibrator platform evenly distributing their body weight on both feet with knees bent at 20 degrees as flexing of knees is a common postural adaptation used to minimize transmission of vibration to the head.
The patients will receive the whole body vibration at 30Hz consisting of three sessions per week with at least one day between sessions for 12 weeks.
The time for each session will be 15 minutes (five bouts of 2 min) .
There will be a rest of 1 minute between each bout of vibration therapy.
|
|
Experimental: B: Cognitive Sensorimotor training
This group will receive sensorimotor training with cognitive dual task training simultaneously.
The participants will perform 36 sessions (3 times per week on alternate days over 12 weeks).
The duration of one session for each group will be 60 minutes,
|
This group will receive sensorimotor training with cognitive dual task training simultaneously.
The participants will perform 36 sessions (3 times per week on alternate days over 12 weeks).
The duration of one session for each group will be 60 minutes,
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Montreal Cognitive Assessment (MoCA):
Time Frame: 12 weeks
|
The Montreal Cognitive Assessment (MoCA) is a one-page, 30-point cognitive screening measurement scale with 12 subtasks in the MoCA test including memory, visuospatial orientation, executive functioning, phonemic fluency, two-item abstract thinking task, attention, concentration, working memory, language, and orientation to time and place.
A score of 26 is a cutoff score to differentiate between normal and abnormal.
18-25 points: Mild cognitive impairment.
10-17 points: Moderate cognitive impairment.
Fewer than 10 points: Severe cognitive impairment.
Inter-rater Reliability (0.96) Cronbach's alpha (0.79).
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12 weeks
|
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Mini Balance Evaluation Systems Test (Mini-BESTest):
Time Frame: 12 weeks
|
The Mini-BESTest is a 14-item test that is a shortened version of the BESTest.
It assesses important aspects of dynamic balance, including postural response to perturbation and gait stability.
The Mini-BESTest has components of multiple individual balance assessments including items from the Berg Balance Scale, the Dynamic Gait Index, single-limb stance test, functional reach, Timed Up and Go, and modified Clinical Test of Sensory Interaction on Balance as well as a dual-task item and postural response items
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12 weeks
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Short physical performance battery (SPPB)
Time Frame: 12 weeks
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The Short Physical Performance Battery (SPPB) allows the evaluation of limitations in the functioning of the lower limbs concerning the lower limb strength by five chair lifts, the balance by the tandem/semi-tandem position, and the walking speed by the 4 m walk.
Each component is scored from 0 to 4 and summed to yield scores between 0 (poor) and 12 (best) performance (31).
The scores are added together to obtain an overall performance score, with a maximum of 12.
A high score is defined as a score above 10, a medium score between 9 and 7, and a low score below 6. (32).
Test-retest reliability of the SPPB was high: 0.87 (CI95%: 0.77-0.96)
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12 weeks
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The Stroop Color and Word Test (SCWT)
Time Frame: 12 weeks
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The Stroop test is a widely used executive function test to evaluate selective attention, speed of information processing, response inhibition and cognitive flexibility.
In general, the Stroop effect occurs when individuals are presented with incongruent colour-word stimuli (e.g., the task requires to read the word "red" printed in blue ink or to name the colour of the ink instead of reading the word).
Successful performance requires to inhibit an automatic behaviour (i.e., reading) in favour of a less practiced one (i.e., naming the colour of the ink).
For all Stroop subtests, the completion times were the shortest for the individuals in the 18-29 age group with the highest education level and longest for the individuals in the 70-83 age group with the lowest education level.
The test demonstrated acceptable internal consistency and high test-retest reliability.
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12 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Aruba Saeed, PhD, 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)
April 30, 2025
Primary Completion (Actual)
October 30, 2025
Study Completion (Actual)
October 30, 2025
Study Registration Dates
First Submitted
April 7, 2025
First Submitted That Met QC Criteria
April 7, 2025
First Posted (Actual)
April 15, 2025
Study Record Updates
Last Update Posted (Actual)
December 16, 2025
Last Update Submitted That Met QC Criteria
December 8, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/0260 Tooba Saher
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
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