Cognitive ImpairmentNCT06927492
Cognitive Sensorimotor Training With Whole Body Vibration for Cognitive Impairment
A study testing Cognitive Sensorimotor training along with whole body vibration and Cognitive Sensorimotor training in people with Cognitive Impairment, run by Riphah International University at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- Cognitive Impairment
- What is being tested?
- Cognitive Sensorimotor training along with whole body vibration and Cognitive Sensorimotor training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 30 Apr 2025to 30 Oct 2025
- 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 60 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Pakistan Society for the Rehabilitation of the Disabled (PSRD)
Lahore, 54660
About this study
Official title: 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.
Read the 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.
- Conditions
- Cognitive Impairment
- Being tested
- Cognitive Sensorimotor training along with whole body vibration, Cognitive Sensorimotor training
- Keywords
- Sensory motor training, WBV, Functional mobility, Short performance battery
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Sensorimotor training along with whole body vibrationOther
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.
Cognitive Sensorimotor trainingOther
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,
| Study group | Role | What they receive |
|---|---|---|
| A: Cognitive Sensorimotor training along with whole body vibration | Experimental | 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, Receives: Other: Cognitive Sensorimotor training along with whole body vibration |
| B: Cognitive Sensorimotor training | Experimental | 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, Receives: Other: Cognitive Sensorimotor training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montreal Cognitive Assessment (MoCA):
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).
Measured: 12 weeks
Mini Balance Evaluation Systems Test (Mini-BESTest):
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
Measured: 12 weeks
Short physical performance battery (SPPB)
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)
Measured: 12 weeks
The Stroop Color and Word Test (SCWT)
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2025
- Study start30 Apr 2025
- Primary completion30 Oct 2025
- Study completion30 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aruba Saeed, PhD, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06927492
- Sponsor's protocol ID
- REC/0260 Tooba Saher
- Status last verified
- Dec 2025
- First submitted
- 7 Apr 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cognitive Sensorimotor Training With Whole Body Vibration on Cognition and Balance in Older Adults With Cognitive Impairment
- ClinicalTrials.gov ID
- NCT06927492
- Acronym / sponsor ID
- REC/0260 Tooba Saher
- Conditions
- Cognitive Impairment
- Keywords
- Sensory motor training, WBV, Functional mobility, Short performance battery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 30 Apr 2025 (actual)
- Primary completion
- 30 Oct 2025 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 15 Apr 2025 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A: Cognitive Sensorimotor training along with whole body vibration | Experimental | Other: Cognitive Sensorimotor training along with whole body vibrationThis 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, |
| B: Cognitive Sensorimotor training | Experimental | Other: Cognitive Sensorimotor trainingThis 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, |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants fulfilling given criteria will be included in this study
Key exclusion criteria (6 listed)
- Participants having given criteria will be excluded from this study
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 |
|---|---|---|
| Cognitive Sensorimotor training along with whole body vibrationThis 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. | Other | A: Cognitive Sensorimotor training along with whole body vibration |
| Cognitive Sensorimotor trainingThis 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, | Other | B: Cognitive Sensorimotor training |
Primary outcome
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).
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
Short physical performance battery (SPPB)
Time frame: 12 weeks
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)
The Stroop Color and Word Test (SCWT)
Time frame: 12 weeks
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.
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 16 Dec 2025.
- 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.
Aruba Saeed, PhD 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 Cognitive Sensorimotor training along with whole body vibration and Cognitive Sensorimotor training in people with Cognitive Impairment, 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 5 inclusion and 6 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 16 Dec 2025. 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?
Montreal Cognitive Assessment (MoCA): (time frame: 12 weeks). 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 16 Dec 2025.